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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 diVa Laser Device with its accessories is intended for coagulation, ablation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes).

The JOULE diVa Laser System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.

The JOULE diVa Laser Device 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.

The provided document is a 510(k) summary for the Sciton JOULE diVa Laser Device, which is a medical device and not an AI/ML-driven device. Therefore, the information requested about acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies, which are typically relevant for AI/ML device evaluations, is not applicable to this submission.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, intended use, and non-clinical performance (safety).

Here's a breakdown of the information provided in the document from the perspective of non-AI device validation, aligning with the sections of your request where applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table with specific acceptance criteria directly alongside performance metrics in the way one would for an AI model's accuracy, sensitivity, or specificity. Instead, it demonstrates performance by showing compliance with recognized consensus standards for safety and electrical characteristics.

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

Not applicable in the context of an AI/ML device validation. The performance evaluation here relies on standardized testing protocols (e.g., electrical safety tests, EMC tests, biocompatibility tests), not a "test set" of data in the AI sense.

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

Not applicable. Ground truth as typically defined for AI model validation (e.g., expert-labeled data) is not relevant for this type of device submission. Compliance with standards and successful completion of physical and software tests are the "ground truth" here, established by accredited testing bodies and internal quality controls.

4. Adjudication Method for the Test Set:

Not applicable. There is no "test set" or human-driven adjudication process described for the device's technical performance in the AI/ML context.

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

Not applicable. The JOULE diVa Laser Device is a hardware-based medical device for surgical procedures, not a diagnostic or AI-powered imaging interpretation tool that would typically undergo MRMC studies.

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

Not applicable. This is not an algorithm-only device. Its performance is evaluated through its physical and electrical characteristics and compliance with safety standards.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is established by:

• Compliance with recognized consensus standards: This includes electrical safety (IEC 60601-1, IEC 60601-2-22), electromagnetic compatibility (IEC 60601-1-2), and usability (IEC 60601-1-6).
• Biocompatibility testing: Performed according to international standards (ISO 10993-5, ISO 10993-10, ISO 10993-23) to assess cytotoxicity, irritation, and sensitization.
• Software verification and validation: Demonstrated against FDA guidance for medical device software.

8. The Sample Size for the Training Set:

Not applicable. This device does not use an AI/ML model that requires a training set.

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

Not applicable. As noted, there is no AI/ML training set for this device.

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The mJoule 1064 laser systems and accessories is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastic, 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, venous lake, leg 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. The lasers are indicated for pigmented 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 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 of melanin in hair follicles, and for the treatment for pseudo folliculitis barbae (PFB). The mJoule 1064 laser system and accessories is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The mJoule 1064 laser system and accessories is indicated for the treatment of facial wrinkles.
Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and T.
mentagrophytes, and/or yeasts Candida albicans, etc.).
Treatment of Aphthous Ulcers.
Excision and Vaporization of Herpes Simplex I and II.
Laser assisted uvulopalatoplasty (LAUP).
Laser assisted lipolysis.
Treatment of mild to moderate inflammatory acne vulgaris.

Surgical Applications:
Incision/excision and cutting, ablation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastic, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g., menorrhagia) and urology.

The mJOULE 1064nm Laser System consists of a console and laser delivery accessories. It uses focusing optics to deliver optical energy to the treatment site. The control console houses the power supply, cooling system, fiber arm delivery system with a handpiece. The user activates laser emission by means of a footswitch.

1. Acceptance Criteria and Device Performance:

The provided document does not explicitly present a table of acceptance criteria and reported device performance in the typical format of quantitative metrics (e.g., sensitivity, specificity, accuracy) against predefined thresholds. Instead, it demonstrates substantial equivalence to predicate devices based on shared technical characteristics and indications for use.

The "acceptance criteria" are implied by the substantial equivalence determination process itself. The device (mJOULE System) is deemed to meet the acceptance criteria because its specifications and performance are comparable to legally marketed predicate devices, and it has successfully passed various recognized safety and performance standards.

Here's a table summarizing the comparative technical specifications that serve as the basis for demonstrating equivalence:

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JOULE 1927nm Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).

The JOULE 1927nm Laser 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.

The Sciton, Inc. JOULE 1927nm Laser System is a laser surgical instrument intended for dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions. The device received 510(k) clearance (K182173) on March 6, 2019, based on demonstrating substantial equivalence to predicate devices, namely the Solta FraxelDUAL (K130193) and the Lutronic LASEMD Laser System (K171009).

This device did not undergo a study to prove it met specific acceptance criteria in terms of clinical performance metrics like sensitivity, specificity, or reader improvement. Instead, its acceptance was based on non-clinical performance data and a comparison of its technological characteristics and indications for use to legally marketed predicate devices.

Here's the breakdown of the information provided in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not presented as a table of acceptance criteria for clinical performance in the provided document. The device's acceptance was based on demonstrating substantial equivalence to predicate devices in terms of its technological characteristics, intended use, and safety. The provided table (on page 4) lists the specifications of the JOULE 1927nm Laser System and its predicate devices, indicating where they are substantially equivalent.

   Specification	Predicate Device (FraxelDUAL)	Predicate Device (LASEMD Laser System)	This Application (JOULE 1927nm)	Substantially Equivalent
   Indications for Use	Same as JOULE	Same as JOULE	Dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions.	Yes
   CDRH Laser Class	Class 4	Class 4	Class 4	Yes
   Laser Type	Thulium Laser	Thulium Laser	Thulium Laser	Yes
   Energy Source	1927 nm	1927 nm	1927 nm	Yes
   Spot Size	256 – 620 µm	100 - 200 µm	100 – 620 µm	Yes
   Maximum Tip Width	7 and 15 mm	10 mm	15 mm	Yes
   Wavelength	1927 nm	1927 nm	1927 nm	Yes
   Pulse Repetition Rate	0 – 3 kHz	43.5 - 307.7 Hz	0 – 3 kHz	Yes
   Pulse Duration	Up to 10 ms	Up to 20 ms	Up to 20 ms	Yes
   Energy	Up to 20 mJ	Up to 20 mJ	Up to 20 mJ	Yes
   Utilities	120-240 VAC, 50/60 Hz	100-240 VAC, 50/60 Hz	200-240 VAC/25A, 50/60 Hz	Yes
   Power	12 W (1927 nm)	5 W (1927 nm)	12 W (1927 nm)	Yes
   Aiming Beam	Red	Red	Red	Yes
   Delivery System	Fiber optic	Fiber and Handpiece	Articulated Arm or Fiber optic	Yes
   Emission Control	Footswitch	Footswitch	Footswitch	Yes
   Display Screen	Yes	Yes	Yes	Yes
   Cooling System	Air to Air	Air to Air	Water to Air	Yes

(Functionally Equivalent) |
| Control System | Microprocessor | Microprocessor | Microprocessor | Yes |
| Energy Monitor | Display Indicates Energy Delivered to Tissue | Display Indicates Energy Delivered to Tissue | Display Indicates Energy Delivered to Tissue | Yes |
| Safety | Safety Eyewear and Remote Interlock Connector | Safety Eyewear and Remote Interlock Connector | Safety Eyewear and Remote Interlock Connector | Yes |

2. Sample size used for the test set and the data provenance: Not applicable. The FDA clearance was based on non-clinical performance data and substantial equivalence arguments, not on a clinical test set with patient data for assessing diagnostic or treatment efficacy in the same way an AI device might be. The non-clinical tests relate to device safety and functionality.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there was no clinical test set for which ground truth needed to be established by experts for performance evaluation.

4. Adjudication method for the test set: Not applicable.

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 system for treatment, not an AI-assisted diagnostic device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device, a laser system, not an algorithm.

7. The type of ground truth used: For the non-clinical performance data, the "ground truth" would be established by validated test methods and engineering specifications. For example, for electrical safety, the ground truth is adherence to standards like IEC 60601-1. For biocompatibility, the ground truth is determined by testing against ISO 10993-1. These are objective measures against established standards.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of the "Study" and Acceptance Criteria:

The "study" in this context refers to the non-clinical performance testing and the comparative analysis against predicate devices to demonstrate substantial equivalence.

• Acceptance Criteria: The primary acceptance criterion was demonstrating substantial equivalence to the legally marketed predicate devices (Solta FraxelDUAL K130193 and Lutronic LASEMD Laser System K171009) in terms of:

  • Intended Use: The JOULE 1927nm Laser System shares the same Indications for Use as the predicates (dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions).
  • Technological Characteristics: The device shares similar design features (wavelength, laser medium and delivery systems, power supply, cooling and control system) and functional features (power output, repetition rate, energy, spot size, and fluence). Minor differences in cooling system (Water to Air vs. Air to Air) and physical dimensions were deemed not to raise new questions of safety or effectiveness.
  • Safety Standards: Adherence to recognized electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, and IEC 60825-1).
  • Software Verification and Validation: Successful performance of software V&V.
  • Biocompatibility: Patient-contacting components were tested for biocompatibility per ISO 10993-1.

• Device Performance:

  • Non-Clinical Performance Data: Electrical safety, electromagnetic compatibility, software verification and validation, and biocompatibility testing were all "successfully performed" according to the relevant standards.
  • Comparative Performance: The JOULE 1927nm Laser System's specifications (e.g., energy, pulse repetition rate, spot size, wavelength) fall within the range or are comparable to those of the predicate devices, supporting the claim of substantial equivalence for its intended use.

In conclusion, the FDA clearance for the JOULE 1927nm Laser System was based on non-clinical engineering and safety tests, and a direct comparison of its technical specifications and indications for use against already-cleared predicate devices, rather than a clinical study evaluating its direct performance against a ground truth from a patient-based test set or an AI algorithm's performance.

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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 2940 nm ProFractional System with its accessories is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, benign pigmented lesions, and vascular dyschromia.

The JOULE ProFractional System consists 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 text is a 510(k) Summary for the Sciton JOULE ProFractional System. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It does not contain acceptance criteria or details of a study proving the device meets specific performance criteria in the way a clinical trial report would.

Instead, the document focuses on demonstrating substantial equivalence by comparing the technological characteristics and indications for use of the JOULE ProFractional System to those of several predicate devices already on the market.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's what can be extracted based on your request and the limitations of the provided document:

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

This information is not available in the provided 510(k) summary. The document focuses on demonstrating "substantial equivalence" to predicate devices, not on meeting specific, quantitative acceptance criteria for performance as would be seen in a clinical study report. The table presents a comparison of technical specifications between the proposed device and predicate devices.

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

This information is not available in the provided 510(k) summary. The document does not describe a clinical test set or study data in this manner.

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)

This information is not available in the provided 510(k) summary. The document does not describe a process for establishing ground truth using experts.

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

This information is not available in the provided 510(k) summary.

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

This information is not available in the provided 510(k) summary. This device is a laser surgical instrument, and the document does not mention AI assistance or MRMC studies.

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

This information is not available in the provided 510(k) summary. This is a medical device, not an AI algorithm, and thus standalone performance for an algorithm is not applicable.

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

This information is not available in the provided 510(k) summary.

8. The sample size for the training set

This information is not available in the provided 510(k) summary as it is not an AI/algorithm-based device and does not refer to a "training set."

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

This information is not available in the provided 510(k) summary for the reasons mentioned above.

Summary of what the document DOES provide regarding comparison:

The document relies on demonstrating "substantial equivalence" to predicate devices (K101916, K081352, K100270, K110907, K142376) rather than defining and meeting specific, quantitative acceptance criteria via a new study.

The comparison table on page 4 (labeled "5") shows how the JOULE 2940 Fractional Handpiece (This Application) aligns with or is comparable to predicate devices across various technical specifications:

• Indications for Use: "Yes" - indicates substantial equivalence to all listed predicates.
• Ref. 510(k): K173285 for "This Application."
• Energy Source: 2940 nm Er:YAG for all, "Yes" for substantial equivalence.
• Spot Size: Range from 1.3x1.3mm to 20x20mm for the new device, comparable to predicates. "Yes" for substantial equivalence.
• Wavelength: 2940 nm for all, "Yes" for substantial equivalence.
• Maximum Repetition Rate: Up to 3 Hz for the new device, comparable to predicates. "Yes" for substantial equivalence.
• Pulse Duration: 0.5 to 1.5 msec for the new device, comparable to predicates. "Yes" for substantial equivalence.
• Energy: Up to 70 mJ/microbeam for the new device, comparable to predicates. "Yes" for substantial equivalence.
• Utilities: 230 VAC/25A, 50/60 Hz for the new device, comparable to predicates. "Yes" for substantial equivalence.
• Aiming Beam: Red/Green for new device and some predicates. "Yes" for substantial equivalence.
• Delivery System: Articulated Arm for the new device, comparable to predicates. "Yes" for substantial equivalence.
• Cooling System: Water to Air for all, "Yes" for substantial equivalence.
• Control System: Microprocessor for all, "Yes" for substantial equivalence.
• Energy Monitor: "Display Indicates Energy Delivered to Tissue" for all, "Yes" for substantial equivalence.
• Safety: Safety Eyewear and Remote Interlock Connector for the new device and some predicates. "Yes" for substantial equivalence.
• Console Dimensions: 14" x 21" x 41" high for the new device, comparable to some predicates. "Yes" for substantial equivalence.
• Weight: 200 lbs for the new device, comparable to some predicates. "==" (presumably "Yes") for substantial equivalence.

The study that proves device meets acceptance criteria, in this context of a 510(k), is the comparison to legally marketed predicate devices, demonstrating that its technological characteristics and intended use are sufficiently similar. The "proof" is the argument of substantial equivalence, not data from a new clinical study with specific acceptance criteria.

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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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