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The mJoule RF System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The mJOULE RF System consists of console and radio frequency delivery accessories. The control console houses the power supply, cooling system and RF delivery system. The treatment parameters are entered via a touchscreen on the console. The user activates RF emission by means of a footswitch.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of diagnostic accuracy or clinical outcomes. Instead, it details the FDA 510(k) clearance for the mJOULE RF System, focusing on its substantial equivalence to a predicate device (Potenza K192545) based on technical specifications and safety testing.

However, I can extract the information about the performance testing that was conducted to demonstrate safety and effectiveness for the purpose of regulatory clearance.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative "acceptance criteria" in the format of a clinical performance study with sensitivity, specificity, or similar metrics. Instead, it describes a series of engineering and safety performance tests designed to show the device operates within specifications and is safe. The "reported device performance" is that the device successfully passed these tests.

2. Sample Size for the Test Set and Data Provenance:

• Sample Size for Test Set: Not explicitly stated as a number of patients or cases. For bench testing, it refers to the number of tests performed on the device. For thermal testing, "ex vivo porcine tissue" was used, but the quantity of samples is not given.
• Data Provenance: The bench and thermal testing were conducted by Sciton, Inc. and are therefore considered internal company data. The thermal testing used "ex vivo porcine tissue." This is likely retrospective, as it's part of the development and verification process before submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The "ground truth" for the performance tests is derived from engineering specifications and established scientific standards (e.g., ISO, IEC). For thermal testing, the evaluation of coagulative zones would typically be done by qualified personnel, but their number and specific qualifications are not mentioned.

4. Adjudication Method for the Test Set:

Not applicable or not described for the types of tests mentioned. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies with human evaluators to resolve discrepancies in diagnostic interpretations. These tests are primarily technical performance and safety assessments against predefined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. The device (mJOULE RF System) is an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic tool for human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable in the context of this device. This device is a physical instrument for medical procedures, not a standalone algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the tests described is based on:

• Engineering Specifications: For parameters like frequency, power, energy, impedance, needle depth, motor speed, and safety mechanisms.
• International Standards: For biocompatibility (ISO 10993), sterilization (SAL of 10^-6), and electrical safety/EMC (IEC 60601 series).
• FDA Guidance: For software verification and validation, and for thermal testing procedures (Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, March 9, 2020).
• Ex Vivo Observation: For thermal testing, confirming the creation of coagulative zones.

8. The Sample Size for the Training Set:

Not applicable. This device is a hardware system, not a machine learning algorithm that requires a training set in the conventional sense.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for a machine learning algorithm.

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The Joule 2940 nm ProFractional System with its accessories is intended for use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dernatology and plastic Surgery: Skin resurfacing Treatment of wrinkles; Epidermal nevi: Telangiectasia: Spider veins: Actinic chelitis: Keloids: Verrucae: Skin tags: Keratoses: Scar revision (including acne scars).

The JOULE ProFractional System consists of a console and laser deliver accessories. It uses focusing optics to deliver optical energy to the treatment site. The control console houses the power supply, cooling system, articulated arm delivery system and/or fiber optic arm delivery system with a handpiece. The user activates laser emission by means of a footswitch.

This document is a 510(k) premarket notification for the Sciton, Inc. JOULE ProFractional System. It demonstrates substantial equivalence to legally marketed predicate devices, rather than establishing new acceptance criteria or presenting a new clinical study for device performance.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a new device is not explicitly present in the provided text.

The document primarily focuses on demonstrating that the JOULE ProFractional System is substantially equivalent to existing devices based on technological characteristics and intended use.

Here's a breakdown of what can be extracted and what is not available based on your request:

1. A table of acceptance criteria and the reported device performance

This document does not present specific acceptance criteria for this new device's performance in a clinical study, nor does it report new device performance data against such criteria. Instead, it compares the technical specifications and intended uses of the JOULE ProFractional System to those of predicate devices to demonstrate substantial equivalence. The table on page 4 provides a comparison of specifications:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a 510(k) submission based on substantial equivalence, not a clinical study with a test set. There is no mention of a specific test set, data provenance, or data type (retrospective/prospective) for a clinical performance evaluation of the JOULE ProFractional System.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment for a test set is discussed in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method for a test set is discussed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. An MRMC study is beyond the scope of this type of 510(k) submission. There is no mention of AI assistance or human reader improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a laser surgical instrument, not an algorithm. Therefore, standalone performance in the context of an algorithm is not relevant.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. No clinical ground truth is established for this submission. The "ground truth" for this 510(k) is the established performance and safety of the predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device and therefore does not have a training set in that context.

9. How the ground truth for the training set was established

Not applicable, for the same reason as point 8.

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The JOULE 810/940/980 Multi-Platform System (and delivery accessories used to deliver optical energy) are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue.

The device is specifically indicated for use as follows:

810nm and 980nm
Dermatology/Aesthetics:

• Photocoagulation of vascular & dermatological lesions of the face and extremities
• Photocoagulation of telangiectasia, veinulectasia of the legs and face
• Treatment of reticular veins and branch varicosities
• Pyrogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas
• Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venous lakes Couperosis, Cherry angioma, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi.
• Dermatological surgery: Condyloma acuminate, warts, small non malignant skin tumors, small semi-malignant tumors as basalomas, Bowe, Kaposi sarcom. Warty leucoplasty and ulcers debridment.
• Seborrheic keratosis
• Mixoid cyst
• Papillary varix
• Acne treatment
• Hair removal of unwanted hair from skin type I-V

Plastic Surgery:

• Cut, coagulation & vaporization
• Resurfacing
• Blepharoplasty

Vascular Surgery:

• Endoluminal or endovenous laser surgery for saphenous incompetent veins

810nm
Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions.

The JOULE Multi-Platform System is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. It is also indicated for hair removal, permanent hair reduction, and the treatment of benign pigmented lesions and leg veins. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

940nm
The JOULE Multi-Platform System (and their delivery accessories used to deliver optical energy) are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, and for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

980nm
The JOULE Multi-Platform System (and their delivery accessories used to deliver optical energy) is indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue endovenous occlusion of the greater saphenous vein. The JOULE 980 System is further indicated for laser assisted lipolysis.

The device is specifically indicated for use as follows:

Dermatology, Plastic Surgery and Podiatry:
Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, skin, fat or muscle tissue and dermabrasion. Examples include:

• Matrixectomy
• Excision of neuromas
• Excision of periungual and subungual warts
• Excision of plantar warts
• Excision of keloids
• Excision of cutaneous lesions
• Dermabrasion
• Vaporization and hemostasis of capillary hemangioma
• Debridement of wounds
• Photocoagulation of teleangectasia of the legs and face
• Photocoagulation of vascular lesions of the face and extremities
• Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
• Treatment of reticular veins and branch varicosities

Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux:
Indicated for use with their delivery accessories in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

The JOULE 810/940/980 Multi-Platform System consist of a console and laser deliver accessories. It uses focusing optics to deliver thermal energy to the treatment site. The control console houses the power supply, cooling system, articulated arm delivery system and/or fiber optic arm delivery system with a handpiece. The user activates laser emission by means of a footswitch.

The provided document is a 510(k) Summary for the JOULE 810/940/980 Multi-Platform System. This type of document establishes substantial equivalence to legally marketed predicate devices, rather than presenting a study with acceptance criteria for device performance in the way a clinical study or performance study for a novel device would.

Therefore, the Acceptance Criteria in this context are primarily based on demonstrating that the JOULE system's technological characteristics and intended uses are substantially equivalent to those of existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is a Substantial Equivalence (SE) determination based on a comparison to legally marketed predicate devices. This is not a traditional clinical trial or performance study in the sense of collecting new patient data. Instead, it's an analytical comparison.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not applicable in the context of a 510(k) submission focused on substantial equivalence through comparison of technical specifications and intended uses. No an independent "test set" of patient data was used for this submission. The comparison is made against the established characteristics of already approved predicate devices.
• Data Provenance: The data provenance is from the technical specifications and intended use statements of previously cleared 510(k) devices (K112031, K102036, K100558, K100143, K053628). This is retrospective in nature, as it relies on existing regulatory clearances and documented device designs. The country of origin of the data is implicitly the USA (FDA regulatory filings).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• Number of Experts: Not applicable. Ground truth for a clinical "test set" is not established in this type of submission. The "ground truth" here is the established safety and effectiveness of the predicate devices as determined by the FDA in their original clearances. FDA reviewers (experts in medical devices) assess the substantial equivalence.
• Qualifications of Experts: The experts would be the FDA reviewers from the Center for Devices and Radiological Health (CDRH)'s Office of Device Evaluation, specifically the Division of Surgical Devices, who are responsible for assessing 510(k) submissions. Their qualifications include expertise in medical device regulations, engineering, and medical science.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. No clinical test set requiring adjudication was used. The adjudication process is the formal FDA review process to determine substantial equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed in imaging diagnostics to compare human reader performance with and without AI assistance. The JOULE system is a surgical laser, not an imaging diagnostic device that would involve human readers interpreting images.
• Effect Size of Human Readers with vs. without AI: Not applicable for this device type and submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

• Not applicable. The JOULE system is a physical laser device operated by a human, not an algorithm or AI system that would operate in a standalone manner without human intervention.

7. The Type of Ground Truth Used:

• The "ground truth" in this context is the established safety and effectiveness of the legally marketed predicate devices, as acknowledged by their prior FDA clearances. The applicant is demonstrating that their new device is fundamentally similar in terms of technology and intended use, thus inheriting the "ground truth" of the predicates.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This submission does not involve machine learning or AI models that would require a training set. The device's design and performance are compared directly to predicate devices.

9. How the Ground Truth for the Training Set was Established:

• Not applicable as there is no training set for this type of medical device submission.

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The JOULE ClearSense Laser System is indicated for ablation, vaporization, incision, excision and coagulation of soft tissue, including:

• Matrixectomy
• Periungual and subengual warts
• Planter warts
• Radical nail excision
• Neuromas

It is also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

The JOULE ClearSense Laser System is a transportable medical device used for the treatment of temporary increase in clear nail in patients with onychomycosis. It uses Nd:YAG laser with a wavelength of 1064 nm.

ClearSense uses the laser energy to heat the target to a temperature that is sufficient to destroy it, but not to the point that the heat damages skin and surrounding tissue.

The ClearSense system consists of a control console, a foot switch, articulated. arm and a handpiece with a stainless steel guide tip (spacer) attached at its end.

Control Console houses the power supply, control electronics, cooling system and optics to direct the laser beam to the input of the articulated arm.

The provided text is a 510(k) summary for the JOULE ClearSense Laser System. It focuses on demonstrating substantial equivalence to predicate devices for its intended uses, particularly for the temporary increase of clear nail in patients with onychomycosis, and other soft tissue procedures.

However, the document does not contain specific acceptance criteria or details of a study designed to prove the device meets such criteria in terms of performance metrics (like sensitivity, specificity, accuracy, or quantitative clinical outcomes). The document primarily outlines the device's technical specifications and compares them to predicate devices to establish substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study proving it meets those criteria, as this information is not present in the provided text.

Based on the nature of the document (a 510(k) summary for a laser system), the "study" described is a declaration of substantial equivalence, not a clinical trial proving specific performance metrics against pre-defined acceptance criteria.

Here's an analysis of the requested information based on what is available:

1. A table of acceptance criteria and the reported device performance

• Not available. The document does not specify quantitative acceptance criteria for performance (e.g., successful treatment rates, clearance percentages, or specific diagnostic accuracy metrics). It focuses on substantial equivalence of technological characteristics and indications of use to predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable/Not available. No "test set" in the context of a performance study for AI/imaging devices is mentioned. The document is for a laser system.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not available. This data is irrelevant for a laser device 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not available.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable/Not available. This type of study is relevant for AI-powered diagnostic devices, not a therapeutic laser system like the JOULE ClearSense.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable/Not available.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not available.

8. The sample size for the training set

• Not applicable/Not available.

9. How the ground truth for the training set was established

• Not applicable/Not available.

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The 755 nm Alexandrite system is designed for use in: The ClearScan ALX 755nm Alexandrite laser system with its accessories is indicated for stable long-term, or permanent hair reduction for all skin types (Fitzpatrick I - VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions and wrinkles.
Q-Switched 755 nm Alexandrite Indications for Use: The JOULE Q-Switched 755 nm Alex Multi-Platform Systems with accessories are indicated for the following uses: Pigmented Lesions Tattoos
The 1064 nm Nd:YAG Indications for Use: Coagulation and hemostasis of benign vascular lesions such as, but not limited to, telangiectasias and rosacea. Removal of unwanted hair (for stable, long term or permanent hair reduction) through selective targeting of melanin in hair follicles and for the treatment of Pseudofolliculitis Barbae (PFB). Treatment of facial wrinkles. The JOULE 1064 nm Nd:YAG with fiber delivery is indicated for laser assisted lipolysis.
Q-Switched 1064/532 nm Nd: YAG Indications for Use: The JOULE Q-Switched 1064/532 nm Nd:YAG Multi-Platform Systems with accessories are indicated for the following uses; Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis. Specific Indications: 1064 nm wavelength Tattoo Removal (dark ink: blue and black) Nevus of Ota Removal or lightening of hair with or without adjuvant preparation Skin Resurfacing for Acne Scars and Wrinkles Benign Cutaneous Lesions, such as, but not limited to: striae and scars Reduction of Red Pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. 532 nm wavelength Tattoo Removal (light ink: yellow, red, light blue, green) Vascular Lesions including but not limited to: port wine stains/birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi Epidermal Pigmented Lesions including but not limited to: Cafe-au-lait birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus Other Pigmented Cutaneous Lesions including verrucae, skin tags, keratoses and plaques Skin Resurfacing for Acne Scars and Wrinkles Benign Cutaneous Lesions, such as, but not limited to: striae and scars Reduction of Red Pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The 1319 nm Nd:YAG Indications for Use: Treatment of fine lines and wrinkles. Treatment of atrophic acne scars. Treatment of mild to moderate inflammatory acne vulgaris. The JOULE 1319 nm Nd:YAG with fiber delivery is indicated for laser assisted lipolysis. The JOULE 1319 nm Nd:YAG with fiber delivery is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities, and for treatment of incompetence and reflux of superficial veins in the lower extremity.
1470 nm Indications for Use: The JOULE 1470 nm Multi-Platform Systems and delivery accessories are intended for delivery of laser light to soft tissue for use in incision, excision, vaporization, ablation, hemostasis or coaqulation of soft tissue. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities. The JOULE 1470 nm Multi-Platform Systems with ProFractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.
1550 nm Indications for Use: The JOULE 1550 nm Multi-Platform Systems with ProFractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.
2940 nm Indications for Use: The JOULE 2940 nm Multi-Platform Systems with delivery accessories are designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Aesthetic Surgery: Skin resurfacing and treatment of wrinkles. Dermatology & Plastic Surgery: Indications include epidermal nevi, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, and decubitis ulcers. It is also used for laser assisted site preparation for hair transplantation. The JOULE 2940 nm Multi-Platform Systems with ProFractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing, and ablation and coagulation of soft tissue.
BBL (300-1400nm) Indications for Use: The Joule Multi-Platform Systems and Accessories are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dematology. It is intended for use for: Mild to moderate inflammatory and pustular inflammatory acne vulgaris. (420nm BP filter, 515nm LP filter, 560 LP filter) The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles) (515nm LP filter, 560nm LP filter) The treatment of cutaneous lesions including warts, scars and striae; (515nm LP filter, 560nm LP filter) The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; (560nm LP filter, 590nm LP filter) The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction (590nm LP filter, 640nm LP filter, 695 LP filter) Topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain. (800 nm LP filter) The integral thermo-electric cooler is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to: Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling); Reduce discomfort during and/or associated with light or laser treatment: Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation; Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

The JOULE Multi-Platform System is a modular, multi-wavelength laser/light system. The system uses scanning and focusing optics to deliver a pattern of thermal energy to the treatment site. The system consists of control console which houses the power supply, cooling system, fiber optic delivery system and/or articulated arm delivery system with handpiece and/or scanner.

This document, a 510(k) Summary for the JOULE Multi-Platform System, is a pre-market notification to the FDA. It asserts substantial equivalence to legally marketed predicate devices, rather than providing a detailed study that proves the new device meets specific acceptance criteria based on performance data.

Therefore, many of the requested details about a study for proving acceptance criteria cannot be extracted from this document, as it describes the device and its intended uses and argues for equivalence, not a performance study against acceptance criteria for a novel algorithm or AI.

However, I can extract information related to the device's intended uses and the basis of its substantial equivalence.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Assertion, Not a Performance Study):

This document does not present specific quantitative acceptance criteria or detailed performance results in the way a clinical trial or algorithm validation study would. Instead, it asserts "substantial equivalence" to existing legally marketed predicate devices. The "performance" is implicitly deemed acceptable if it is comparable to the predicate devices and meets its described indications for use.

Details Regarding the "Study" (Basis for Substantial Equivalence):

The document describes a comparison study to predicate devices for the purpose of demonstrating substantial equivalence, rather than a standalone clinical performance study of the JOULE Multi-Platform System itself against specific acceptance criteria. This is typical for a 510(k) submission.

1. Sample size used for the test set and data provenance:

   • Test Set Sample Size: Not applicable in the context of a performance study with a 'test set.' The submission relies on comparative analysis against the characteristics and indications of existing predicate devices. No specific patient or image test set is mentioned for the JOULE system's performance validation itself.
   • Data Provenance: Not applicable in the context of a performance study. The data provenance refers to the regulatory clearances (K-numbers) of previously approved predicate devices, which are legally marketed in the USA. The data itself would have come from the original studies for those predicate devices, but these are not detailed here.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The document is a 510(k) summary demonstrating substantial equivalence based on technical characteristics and intended use, not a clinical study requiring expert-established ground truth for a novel device's performance.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. There is no mention of a test set or adjudication for performance evaluation in this 510(k) summary.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done or described in this document. The comparison is not about human readers with or without AI assistance. It's a technical and indications-based comparison of a new laser system to prior laser systems.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a laser/light system, not an algorithm or AI. No standalone algorithm performance study is relevant or described.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable. No ground truth in the context of a performance study is described. The "truth" here is essentially the FDA's prior determination that the predicate devices are safe and effective for their stated indications.

7. The sample size for the training set:

   • Not applicable. This is not an AI/algorithm device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. This is not an AI/algorithm device that requires a training set.

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755 nm Indications for Use:
The 755 nm Profile Multi-Platform System with its accessories is indicated for stable long-term, or permanent hair reduction for all skin types (Fitzpatrick I - VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions and wrinkles.
1320 nm Indications for Use:
The 1320nm Profile Multi-Platform System with its accessories is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Profile 1320nm laser is further indicated for laser assisted lipolysis.
2940 nm Indications for Use:
The 2940 nm Profile Multi-Platform System with Profractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.

The Profile Multi-Platform System is a modular, multi-wavelength laser/light system. The system uses scanning and focusing optics to deliver a pattern of thermal energy to the treatment site. The system consists of control console which houses the power supply, cooling system, fiber optic delivery system and/or articulated arm delivery system with handpiece and/or scanner.

The provided text is a 510(k) Summary for the Sciton, Inc. Profile Multi-Platform System (K081352). This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, many of the requested fields cannot be directly extracted from the provided text.

Here is an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or report specific performance metrics from a study to demonstrate device performance against such criteria. The submission relies on demonstrating substantial equivalence to predicate devices.

2. Sample size used for the test set and the data provenance

Not applicable. The document does not describe a clinical performance study with a test set. It is a 510(k) submission based on substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The document does not describe a clinical performance study involving experts to establish ground truth.

4. Adjudication method for the test set

Not applicable. The document does not describe a clinical performance study with a test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a laser/light system, not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a laser/light system, not an algorithm or AI product.

7. The type of ground truth used

Not applicable. The document does not describe a study involving ground truth. The submission's argument for safety and effectiveness is based on the technological characteristics and indications for use being substantially equivalent to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. The document does not describe a training set for an algorithm or AI model.

9. How the ground truth for the training set was established

Not applicable. The document does not describe a training set for an algorithm or AI model.

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1064 nm Indications for Use: Coagulation and hemostasis of benign vascular lesions such as, but not limited to-telangiectasia and rosacea. Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles. Incision/excision and cutting, vaporization, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. It is further indicated for laser assisted lipolysis.

1320 nm Indications for Use: It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne, atrophic acne scars and mild to moderate inflammatory acne vulgaris. Profile Multi-Platform System with fiber delivery is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities, and for treatment of incompetence and reflux of superficial veins in the lower extremity.

2940 nm Indications for Use; Skin resurfacing and treatment of wrinkles.

Pulsed Light (300-1400 nm) Indications for Use: The Profile Multi-Platform Systems and Accessories are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology. It is intended for use for: The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); (515nm LP filter, 560nm LP filter) The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; (560nm LP filter, 590nm LP filter) The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction: (590nm LP filter, 640nm LP filter, 695nm LP filter) Treatment of facial wrinkles, treatment of fine lines and wrinkles; and (590nm LP filter, 640nm LP filter, 695nm LP filter, 800nm LP filter) Topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain. (800nm LP filter)

The Profile Multi-Platform System is a modular, multi-wavelength laser/light system. The system uses scanning and focusing optics to deliver a pattern of thermal energy to the treatment site. The system consists of control console which houses the power supply, cooling system, fiber optic delivery system and/or articulated arm delivery system with handpiece and/or scanner.

This submission (K070388) is for the Sciton Profile Multi-Platform System, a modular, multi-wavelength laser/light system. It is a 510(k) submission, meaning the device is seeking clearance based on substantial equivalence to existing legally marketed predicate devices, rather than requiring new clinical studies to prove safety and effectiveness from scratch.

Therefore, the document does not contain explicit acceptance criteria and a study demonstrating the device meets those criteria in the way one might expect for a novel device or a device claiming superior performance. Instead, the "acceptance criteria" are implied by the substantial equivalence determination process, where the device must demonstrate comparable performance and safety characteristics to established predicates.

Here's an analysis of the provided information in the context of a substantial equivalence submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a substantial equivalence submission, there are no explicit "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy that a diagnostic AI device would typically have. The "performance" is demonstrated by asserting that the device shares the same intended use, similar design features, and functional features as the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

This is a physical medical device submission (laser/light system), not an AI/software device that requires a test set of data for performance evaluation. Therefore, there is no "test set" in the context of an algorithm's performance on a dataset. The device's performance is established through equivalence to predicate devices, which implies that the predicate devices have already demonstrated safety and effectiveness through their own clinical use and/or studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As described in point 2, there is no "test set" or ground truth establishment in the context of evaluating an algorithm's performance.

4. Adjudication Method for the Test Set

Not applicable. There is no test set in the context of evaluating an algorithm's performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. The Sciton Profile Multi-Platform System is a laser/light system, not an AI software intended to assist human readers (e.g., radiologists interpreting images). Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. This is a physical laser/light system, not an AI algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable. There is no "ground truth" in the context of evaluating an AI algorithm's performance. The basis for safety and effectiveness is substantial equivalence to legally marketed predicate devices, which would have had their own evidence for safety and effectiveness, potentially including clinical outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is a physical medical device.

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1064 nm Indications for Use:
The Profile Multi-Platform Systems and Accessories are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.
Dermatology:
Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser/light treatments.
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles.
The intended use of the contact cooling system in the Profile handpiece is to provide cooling of the skin prior to, during and after laser treatment, for the epidermal protection and reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
Surgical Applications:
Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.
1320 nm Indications for Use;
The Profile Multi-Platform Systems and Accessories are intended for use in general surgery and dematology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne, atrophic acne scars and mild to moderate inflammatory acne vulgaris.
Profile Multi-Platform System with fiber delivery is indicated for the treatment of reflux of saphenous veins associated with varicose veins and varicosities.
Profile 2000 nm Indications for Use:
The Profile Multi-Platform Systems and Accessories are indicated for incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an endoscope, in contact and non-contact with tissue, with or without a hand piece, in the following indications:
Dermatology and Plastic Surgery
Dermatologic and Plastic Surgery of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars, tattoo removal, vascular lesions (including port wine stains, hemangioma, telangiectasias [facial, leg] and rosacea), corns, papillomas, basal cell carcinomas, lesions of skin and subcutaneous tissue, plantar warts, periungual and subungual warts, debridement of decubitus ulcer, skin tag vaporization,
Gastroenterological/Gastrointestinal Surgery
Open and endoscopic gastroenterologic surgery of soft tissue(for incision, excision, resection, ablation, vaporization, coagulation and hernostasis) including; cholecystectorny, lysis of adhesions, appendectorny, biopsy, pylorostenotorny, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, uicers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding furnors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Oster-Weber-Rendu disease.
General Surgery
General surgery of soft tissues, including; skin incision, tissue dissection, excision of external turnors and lesions, complete or partial resection of internal organs, turnors and lesions, and tissue ablations; removal of benign and malignant lesions; mastectorny, hepatectorny, pancreatectorny, splenectorny, thyroidectorny, parathyroidectorny, herniorthaphy, tonsillectorny, lymphadenectorny, partial nephrectomy, pilonidal cystectomy, resection of lipoma, pelvic adhesiolysis, debridement of decubitus ulcer, hemorrhoids, pilonidal cyst removal and repair, debridement of statis ulcer, biopsy, appendectorny, pylorostenotomy, removal of polyps of the sigmoid colon, lysis of adhesions, cholecystectomy.
Genitourinary Surgery/Urology
Genitourinary surgery of soft tissue, including: treatment of bladder, urethral and ureteral tumors, superficial urinary bladder tumors, invasive bladder carcinomas; urethral and penile hemangioma; urethral strictures; lesions of the external genitalia; condylomas; bladder neck obstructions.
Endoscopic transurethral incision of prostate, ablation of benign prostatic hypertrophy, transurethral incision of prostate, laser resection of the prostate, laser enuculeation of the prostate, laser ablation of the prostate, bladder neck incision of the prostate, laser ablation, enucleation and resection of prostate, hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy.
Gynecological Surgery
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue, including condyloma acuminate, intra-uterine treatment of submucous fibroids, benign endometrial polyps and uterine septurn by incision, excision, ablation and or vessel coagulation, soft tissue excision procedures such as excisional conization of the cervix.
Lithotripsy and Percutaneous Urinary Lithotripsy
Lithotripsy and percutaneous urinary lithotripsy, including: fragmentation of urinary calculi, fragmentation of calculi in the ureter and ureteropelvic junction, fragmentation of kidney calculi, fragmentation of urethral calculi and treatment of distal impacted fragments of steinstrasse when guide wires cannot be passed.
Lumbar Discectorny
Lumbar discectorny in soft, cartilaginous and bony tissue, including: vaporization of the L.4-5 and L.5-S1 lumbar discs of the vertebral spine; open, percutaneous and endoscopic spine procedures; foraminotomy.
Orthopedic Surgery and Arthroscopy
Orthopedic surgery in soft and catiliaginous tissue in small and large joints, including. knee meniscectorny, knee synovectorny, chondrornalacia and tears, loose body debridement, lateral retinacular release, plica removal, ligament and tendon release, contouring and sculpting of articular surfaces, debridement of inflamed synovial tissue, loose body debridement, capsulectorny in the knee, chondroplasty in the knee, chondromalacia ablation, ablation of soft and cartilaginous tissue in minimal invasive spinal surgery including percutaneous laser disc decompression/ discectorny, foraminoplasty, ablation and coaqulation of soft vascular and non-vascular tissue in minimally invasive spinal surgery.
Otorhinolaryrigological (ENT) Surgery
Otorhinolaryrigological (ENT) surgery in soft, mucosal, cartilaginous and bony tissue. including: endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinoplasty, turbinectorny), dacı yocystorhinostomy (DCR), ethmoidectorny, polypectorny, maxillary antrotomy, frontal sinusotomy, sphenoidotomy, hereditary hemorrhagic telangectasia, septoplasty, lesions or turnors of the oral, nasal, glossal, pharyngeal, tonsillectomy, adenoidectorny, adenoidectorny.
Thoracic and Pulmonary Surgery
Open and endoscopic thoracic and pulmonary surgery (incision, resection, ablation. vaporization, coagulation and hernostasis) of soft tissue, including laryngeal lesions, airway obstructions including carcinoma, polyps and granulomas, palliation of obstructing carcinomas of the tracheobroncial tree.
2940 nm Indications for Use:
The Profile Multi-Platform Systems and Accessories are designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Surgical specialties and applications include general surgery, plastic surgery, aesthetic surgery, dermatology, urology, gynecology, genitourinary, ENT, pulmonary surgery, thoracic surgery, podiatry, oral & maxillofacial surgery, opthamology (including oculoplasty), small and large joint arthroscopy, microdiscectomies, and endoscopic procedures.
Aesthetic Surgery
Skin resurfacing and treatment of wrinkles.
Dental Application of Er: YAG
It is indicated for a variety of hard tissue (tooth and bone) applications, and for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry.
Hard Tissue Indications of Er. YAG Laser Energy: Caries removal, cavity preparation, enamel etching, enameloplasty, excavation of pits and fissures for placement of sealant.
Bone Indications of ETYAG Laser Energy. Contact and non-contact cutting, shaving, contouring, and resection of oral osseous tissue, apicoectorny, osseous crown lengthening, culting bone to prepare a window access to the apex of the root, osseoplasty, osteotomy.
Soft Tissue and Periodontal Indications of Er.YAG Laser Energy. Excisional and incisional biopsies, exposure of unerrupted teeth, incision and drainage of abscesses, gingival incision and excision, gingivoplasties, gingivectomies, gingivectorny in case gingwal mondow of the gingival or excision of hyperplasias, gingival troughing for or nyperplasias of the girls of the start recovery, frenectomies and frenotomies, fibromatosis, benign and malignant lesion removal, operculectorny, oral papillectornies, reduction of gingival hypertrophy, soft tissue crown lengthening, papilletin surgery (flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasia, epulides, papilomas, fibrormatoses, benign growths), vestibuloplasty, sucular debridement
Endodontal Applications of Er.YAG Laser Energy: Tooth preparation to obtain access to root canal, pulpotomy, pulpotomy as an adjunct to root canal therapy, pulp extirpation, root canal debridement and cleaning, root canal preparation including enlargement.
Dermatology & Plastic Surgery
Indications include, epidermal nevi, telangietasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers. It is also used for laser assisted site preparation for hair transplantation.
Gastroenterology
Gastroenterologic surgery of soft tissue, including: cholecystectorny, lysis of adhesions, appendectorny, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, nonbleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding turnors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Osler-Weber-Rendu disease.
General Surgery
The Er: YAG is intended for the surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of external turnors and lesions, complete or partial resection of internal organs, tumors, tissue ablation and/or vessel coagulation.
Genitounnary/Urology
Genitounnary surgery of soft tissue, including: treatment of bladder, urethral and ureteral tumors; superficial urinary bladder turnors; invasive bladder carcinomas; urethral and penile hemangioma; urethral strictures; lesions of the external genitalia; condylomas; bladder neck obstructions.
Endoscopic transurethral incision of prostate, bladder neck incision of the prostate, laser ablation, enucleation and resection of prostate, hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy.
Gynocology
Indications include cervical intracpithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.
Ophthalmology
Optimalitions include soft tissue surrounding the eye and orbit and anterior capsulotomy.
Oral/Maxillofacial
Indications include oral/dental procedures for incision, excision, ablation, vaporization mulations more of soft tissue during gingivoplasties, gingivectornies, frenectomies, benign and malignant lesion removal, biopsies, leukoplakia and fibrotorny,
Otorhinolaryrigological (ENT) Surgery
Otominolaryngological (ENT) surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate including. Chaosinus ourgery, turbinectomy), dacryocystorhinostomy (DCR), ethmoidectorny, polypectorny, maxillary antrotomy, frontal sinusotomy, sphenoidotomy, hereditary hemorrhagic telangectasia, septoplasty.
Podiatry
Indications include warts, plantar verruae, large mosaic verrucae and matrixectorny.
Pulmonary Surgery
Open and endoscopic pulmonary surgery.
Thoracic Surgery
Intended for the surgical incision/excision, vaporization and coagulation of soft tissue during any thoracic surgery.
Pulsed Light (300-1400 nm) Indications for Use:
The Profile Multi-Platform Systems and Accessories are indicated for use in surgical. aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.
It is intended for use for.

• · The treatment of tattoos;
• (560nm LP filter, 590nm LP filter)
• · The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); (515nm LP fifter, 560nm LP fifter)
• · The treatment of cutaneous lesions including warts, scars and striae; (515nm LP filter, 560nm LP filter)
• · The treatment of benign cutaneous vascular lesions, including port wine stains, The treathern of beliginical and leg telangiectasias, rosacea, erytherna of rosacea, angiomas and spider angiomas, poikilodema of Civatte, leg veins and venous malformations; (580nm LP filter, 590nm LP filter)
• · Treatment of psociasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, (350nm BP filter)
• · The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction; and
• (590nm LP filter, 640nm LP filter, 695 LP filter)
• · Mild to moderate inflammatory and pustular inflammatory acne vulgaris, (420nm BP filter, 515nm LP filter, 560 LP filter)
  The integral thermo-electric cooler is indicated for use in cooling the epidemis at the r the integral them of during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
• · Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
• · Reduce discomfort during and/or associated with light or laser treatment:
• · Ninimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation;
• · Allow the use of higher light or laser fluences for light or laser treatments (such Allow the use of mgner light of the treatment of vascular or pigmented lesions); and
• as for hair removal and the a suarront of laser treatments (such as for hair removals and the treatment of vascular or pigmented lesions).

The Profile Multi-Platform System is a modular, multi-wavelength laser/light system. The system uses scanning and focusing optics to deliver a pattern of thermal energy to the treatment site. The system consists of control console which houses the power supply, cooling system, fiber optic delivery system and/or articulated arm delivery system with handpiece and/or scanner.

This is not a medical device that uses AI/ML. The device appears to be a laser/light system intended for various surgical and aesthetic applications. The provided text primarily focuses on establishing substantial equivalence to predicate devices and detailing the wide range of indications for use across different wavelengths and surgical specialties.

Here's an analysis of the provided text based on your request, highlighting why many points cannot be addressed due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission is for a multi-platform laser/light system, not an AI/ML diagnostic or predictive device with performance metrics like sensitivity, specificity, etc., that would typically have acceptance criteria. The document establishes substantial equivalence based on indications for use, design features, and functional features being comparable to predicate devices.

2. Sample Size for the Test Set and Data Provenance

Not applicable. This is not an AI/ML device that underwent a performance study with a test set. Substantial equivalence is claimed based on device characteristics comparable to existing predicate devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. There's no AI/ML model being evaluated against a ground truth.

4. Adjudication Method for the Test Set

Not applicable. There's no AI/ML model being evaluated against a ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This is a laser/light device, not an AI/ML system where human reader improvement with AI assistance would be relevant.

6. If a Standalone (Algorithm Only) Performance Study Was Done

Not applicable. This is a hardware device, not a standalone algorithm.

7. The Type of Ground Truth Used

Not applicable. There is no AI/ML algorithm being evaluated against ground truth.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device, not an AI/ML system requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is a hardware device, not an AI/ML system.

Summary of Device and Regulatory Basis:

The "Profile Multi-Platform System" is a modular, multi-wavelength laser/light system. It is intended for a broad range of surgical and aesthetic applications across various medical specialties (dermatology, plastic surgery, general surgery, gastroenterology, gynecology, ENT, neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery, urology).

The submission, K060033, establishes substantial equivalence to existing legally marketed predicate devices (K023881, K041879, K032459, etc.). The basis for this claim is that the Profile Multi-Platform System shares:

• The same indications for use.
• Similar design features (wavelength, laser/light medium, delivery systems, power supply, cooling and control system).
• Similar functional features (power output, repetition rate, energy, spot size, fluence).

The FDA's letter explicitly states that they have reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This approval means the device can be marketed subject to general controls and, if applicable, special controls.

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The Profile 2000 Laser System, and Delivery Devices and Accessories, is indicated for incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an endoscope, in contact and non-contact with tissue, with or without a hand piece, in the following indications: Dermatology and Plastic Surgery, Gastroenterological/Gastrointestinal Surgery, General Surgery, Genitourinary Surgery/Urology, Gynecological Surgery, Lithotripsy and Percutaneous Urinary Lithotripsy, Lumbar Discectomy, Orthopedic Surgery, Otorhinolaryrigological (ENT) Surgery, Pulmonary Surgery.

The Profile 3000 Laser System, and Delivery Devices and Accessories, is indicated for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Aesthetic Surgery, Dermatology & Plastic Surgery, Gastroenterology, General Surgery, Genitourinary/Urology, Gynecology, Ophthalmology, Oral/Maxillofacial, Otorhinolaryrigological (ENT) Surgery, Podiatry, Pulmonary Surgery, Thoracic Surgery.

The Profile 2000 and Profile 3000 emits laser energy with wavelength of 2.01 µm and 2.94 µm respectively. The laser consists of a system console, internal computer, control panel and display, and a fiber optic delivery system and footswitch.

1. Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical "acceptance criteria" or specific "reported device performance" in the way one might find for a diagnostic algorithm. Instead, the acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices.

2. Sample Size and Data Provenance for Test Set:

Not applicable. This device is a laser system, not a diagnostic algorithm that would typically use a test set of data for performance evaluation in the context of the requested questions. The equivalence is based on design features, intended use, and functional features.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. Ground truth for a test set of data is not relevant for this type of device submission.

4. Adjudication Method:

Not applicable. Adjudication methods are typically used in studies involving expert review of diagnostic outputs, which is not relevant here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This type of study assesses how AI might improve human reader performance, which is not relevant for a laser surgical instrument.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a physical laser system, not a standalone algorithm.

7. Type of Ground Truth Used:

Not applicable. The ground truth concept, as it pertains to AI/algorithm development, is not applicable to the substantial equivalence determination for this laser system. The "truth" in this context is the safety and effectiveness profile of the predicate devices.

8. Sample Size for Training Set:

Not applicable. This device does not involve a training set for an AI algorithm.

9. How Ground Truth for Training Set Was Established:

Not applicable. This device does not involve a training set for an AI algorithm.

Summary of the Study for Device Acceptance:

The acceptance of the Profile 2000 and Profile 3000 Laser Systems, and Delivery Devices and Accessories, is based on a substantial equivalence determination to legally marketed predicate devices. This is a common pathway for medical device clearance (510(k)) in the U.S.

The study, or rather, the justification for acceptance, presented in the 510(k) summary (sections {0}-{4} of the provided text) highlights the following:

• Rationale for Substantial Equivalence: The key argument is that the Profile 2000 and Profile 3000 Laser Systems share:

  • Intended Use: They are both laser surgical instruments.
  • Indications for Use: The current devices are indicated for a broad range of surgical applications, which are outlined in detail for both Profile 2000 and Profile 3000 systems. These indications are explicitly stated to be "based upon the indications for use for predicate systems."
  • Similar Design Features: This includes wavelength (2.01 µm for Profile 2000 and 2.94 µm for Profile 3000), power supply, cooling system, and control system.
  • Functional Features: This includes power output, repetition rate, and pulse duration.

• Predicate Devices: A comprehensive list of legally marketed predicate devices (both for Profile 2000 and Profile 3000 equivalents) is provided. These predicate devices serve as the benchmark against which the new device is compared.

• Safety and Effectiveness Information: The document states that because the new devices are "technologically substantially equivalent to the listed predicate devices," their "risks and benefits... are comparable to the predicate devices." This implies that the safety and effectiveness of the predicate devices, established through their marketing history, implicitly serve as the "acceptance criteria" which the new device meets by virtue of its equivalence.

In essence, the "study" proving the device met acceptance criteria was a regulatory comparison demonstrating that the new laser systems are sufficiently similar in design, function, and intended use to already cleared devices, and therefore share a comparable safety and effectiveness profile. There are no explicit performance metrics in this document because the regulatory pathway is based on equivalence rather than de novo performance benchmarks against a "ground truth" data set in the way an AI algorithm might be evaluated.

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The Sciton, Inc. Profile 1320 Laser is intended for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation, with hemostasis of soft tissue. It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne and atrophic acne scars.

Profile 1320 Laser System is an Nd:YAG laser producing emission at a wavelength of 1320 nm. It consists of a laser console, internal computer, control panel and displav. an optical delivery system comprised of an articulated arm and a handpiece or scanner with cooling capability, and a footswitch.

The provided text is related to a 510(k) premarket notification for a medical device called the "Profile 1320 Laser System." This document establishes the substantial equivalence of the device to existing predicate devices based on design, functional features, and intended use.

Based on the provided text, there is no information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. The document focuses on regulatory compliance through substantial equivalence to predicate devices, rather than detailed performance metrics or clinical study results as you would expect for AI/ML device evaluations.

Therefore, I cannot fulfill your request for the specific details outlined (points 1-9) because the necessary information is not present in the provided 510(k) summary. This type of regulatory submission typically does not include the detailed performance study information you are asking for if the device is deemed substantially equivalent to a predicate device.

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