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The Venus Versa System is a multi-application device intended to be used in aesthetic procedures. The SR515 and SR580 IPL applicators are indicated for the following:

Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules.

Treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas, poikiloderma of civatte, leg veins and venous malformations.

The HR650, HR690, HR650XL, and HR690XL IPL applicators are indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the longterm stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

The Venus Concept ACDUAL applicator is intended to be used for the treatment of acne vulgaris.

The Diamondpolar and Octipolar applicators are non-invasive devices intended for use in dermatologic and general surgery procedures for the non-invasive treatment of moderate to severe facial wrinkles and rtides in Fitzpatrick skin types I-IV.

The Viva applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.

The Venus Versa System is comprised of a console (controller/CPU) and ten detachable handpieces (applicators). The system can deliver three types of energies to the patient's skin using the associated applicators:

• Intense Pulsed Light (IPL); ●
• Radiofrequency (RF); .
• Magnetic Pulse (MP2). .

The following ten handpieces are included with the device system: SR515, SR580, HR650, HR690, HR650XL, HR690XL, ACDUAL, Diamondpolar, Octipolar, and Viva.

The provided document is a 510(k) summary for the Venus Versa System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific clinical acceptance criteria through a standalone study with a predefined ground truth and expert adjudication. Therefore, much of the requested information (like specific acceptance criteria based on clinical efficacy, sample sizes for training/test sets, expert qualifications, or MRMC comparative effectiveness studies) is not typically found or required in a 510(k) summary for this class of device and type of submission.

The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and bench testing (system verification testing) rather than clinical performance data against specific endpoints.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria described are largely related to technical specifications and safety, not clinical efficacy. The reported performance refers to the device meeting these technical specifications.

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

The document does not describe "test sets" in the context of clinical data for performance evaluation. The "testing" mentioned refers to engineering and safety verification on the device itself. Therefore, specific sample sizes for clinical test sets or data provenance (country, retrospective/prospective) are not applicable to the information provided for this 510(k) submission.

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

This information is not applicable as the document describes technical verification and safety testing, not clinical studies requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a clinical test set requiring adjudication.

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

No MRMC comparative effectiveness study is mentioned. The submission relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety (bench testing), not comparative clinical efficacy with human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

This information is not applicable as the Venus Versa System is a physical device (multi-application aesthetic system), not an AI algorithm. Its performance is inherent in its operation, not an "algorithm only" in the sense of AI.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation described would be engineering and manufacturing specifications/standards. For example, the "truth" for fluence measurement is the expected fluence value, and the "truth" for biocompatibility is conformance to ISO 10993-5. There is no clinical or pathological "ground truth" established from patient data mentioned in this submission for proving performance.

8. Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as the device is a physical system, not a machine learning model.

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

This information is not applicable for the reasons stated above.

Summary of Device Acceptance and Study:

The Venus Versa System gained acceptance (clearance) through the 510(k) pathway by demonstrating substantial equivalence to previously cleared predicate devices. The "study" proving this involves:

• Comparison of Technical Characteristics: Showing that the Venus Versa System's intended use, indications for use, technological characteristics (energy type, IPL spectrum, frequency, spot size, pulse duration, energy density), and principles of operation are similar to its predicate devices, with minor differences that do not raise new safety or effectiveness concerns.
• Bench Testing / System Verification: Conducting a series of engineering, safety, and performance evaluations on the device itself. This included:
  • Electromagnetic Compatibility (EMC) testing.
  • Electrical Safety testing.
  • Biocompatibility testing of patient-contacting materials.
  • Validation of cleaning, disinfection, and sterilization parameters.
  • Software validation.
  • Specific system verification for each applicator type (IPL, Bipolar RF & PMF, Fractional RF) to ensure measured outputs (e.g., fluence, RF voltage, output power, temperature) met predefined technical specifications and expected values.

In essence, the "acceptance criteria" were regulatory requirements for safety and performance equivalence to predicate devices, and the "study" was a combination of documentation outlining feature similarity and rigorous engineering verification testing. Clinical efficacy for specific indications, while implied by equivalence to predicates, was not proven through new clinical trials with patient cohorts described in this document.

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The Venus Versa System is a multi-application device intended to be used in aesthetic procedures.

The SR515 and SR580 IPL applicators are indicated for the following:

· Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules.

· Treatment of benign cutaneous vascular lesions including: port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas, poikiloderma of civatte, leg veins and venous malformations. The HR650 and HR690 IPL applicators are indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is 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 regimen.

The Venus Versa System is comprised of a console (controller/CPU) and applicators that deliver Intense Pulsed Light (IPL) optical energy to the treatment area. Four IPL handpieces (SR515, SR580, HR650, HR690) are included with the device system. The Versa device provides individual adjustment of light fluency and pulse duration, and has integrated skin cooling features. Using the IPL applicators, the light energy delivered to the patient's skin is used to treat various conditions via the mechanism of selective photothermolysis.

The provided text is related to a 510(k) premarket notification for the "Venus Versa System", an Intense Pulsed Light (IPL) device used in aesthetic procedures. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed clinical study report with acceptance criteria and performance metrics for a specific AI/ML medical device.

Therefore, I cannot fully address your request to "Describe the acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device, as this document does not contain that type of information. Specifically, it does not include:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Sample sizes for test sets used for AI/ML model validation.
• Information about data provenance (e.g., country of origin, retrospective/prospective) for AI/ML data.
• Number of experts and their qualifications for establishing ground truth for AI/ML test sets.
• Adjudication methods for AI/ML test sets.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies for AI+human vs. human-only.
• Standalone (algorithm only) performance metrics for AI/ML.
• Type of ground truth used for AI/ML (e.g., pathology, outcomes data).
• Sample size for training sets for an AI/ML model.
• How ground truth for a training set was established for an AI/ML model.

However, based on the provided text, I can infer some aspects related to general device performance and regulatory acceptance for a non-AI/ML device.

The document describes the regulatory review for the Venus Versa System, focusing on its substantial equivalence to predicate IPL devices. The "performance data" mentioned is primarily related to engineering and safety standards, rather than clinical efficacy studies with specific acceptance criteria for diagnostic or therapeutic accuracy in the way an AI/ML device would be evaluated.

Here's what can be extracted from the document regarding performance and "acceptance":

General Device Performance and Acceptance (as presented in this document for a non-AI/ML device):

The acceptance criteria are implicitly defined by compliance with recognized standards and the demonstration that the device's technological characteristics and performance are "substantially equivalent" to legally marketed predicate devices, and that it "performs as intended for the indicated uses."

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the document for this non-AI/ML device):

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

• Not Applicable / Not provided for clinical performance: This document does not describe a clinical study with a "test set" in the context of an AI/ML model for accuracy evaluation. The "testing" mentioned refers to engineering and safety compliance tests, and the "sample size" for such tests is typically governed by engineering standards (e.g., number of units tested for electrical safety or energy output consistency).
• Data Provenance: Not applicable.

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

• Not Applicable: This document does not describe the establishment of ground truth for a clinical test set as would be done for an AI/ML device.

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

• Not Applicable: This document does not describe this type of clinical adjudication process.

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 an IPL system, not an AI-powered diagnostic or assistive tool.

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

• Not Applicable: There is no AI algorithm being evaluated for standalone performance.

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

• Not Applicable: As there is no AI/ML model here, there is no need for this type of clinical "ground truth." The "ground truth" for the engineering tests would be the established specifications and regulatory standards.

8. The sample size for the training set:

• Not Applicable: This is not an AI/ML device, so there is no training set mentioned.

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

• Not Applicable: This is not an AI/ML device, so there is no training set ground truth to establish.

In summary, the provided document is a 510(k) clearance letter and summary for a non-AI/ML medical device (IPL system). It focuses on demonstrating substantial equivalence through technological comparison and compliance with engineering and safety standards, rather than clinical performance based on AI model evaluation and ground truth establishment.

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The 2940 Ablative Laser Handpiece is intended for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications: skin resurfacing, treatment of wrinkles, epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors, debulking cysts and superficial skin lesions.

The 2940 Fractional Ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.

The 1540 Fractional Non-ablative Laser Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.

The 1440 Fractional Non-ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures.

The 1540 and 2940 Fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.

The 1440 and 2940 Fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.

The IR Handpiece is intended for photocoagulation of soft tissue in dermatologic applications. In addition, it is intended to provide 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.

The 1064 Laser Handpiece is intended for the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction; treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, cafe-au-lait macules, and plaques; verrucae, skin tags, seborrheic keratosis; tattoos (significant reduction in the intensity of black and/or blue-black tattoos); 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; treatment of vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea, venus lake, facial and leg veins; reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; coagulation and hemostasis of soft tissue; treatment of wrinkles and pseudofolliculitis barbae (PFB).

The Max Series Intense Pulsed Light Handpieces are intended for the treatment of inflammatory acne (acne vulgaris) and for the treatment of benign pigmented epidermal and cutaneous lesions, including warts, scars and striae; removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction; treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.

The Skintel™ Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot starting fluence.

The Palomar Icon Aesthetic System consists of a console with an internal power supply, chiller, and electronics. The light and laser handpieces individually connect to the system via the console connection port.

This 510(k) submission (K110907) is for the Palomar Icon™ Aesthetic System, a light and laser system intended for various dermatological and surgical applications. The submission primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than providing detailed performance studies with acceptance criteria for a new AI/software device.

Therefore, most of the requested information cannot be extracted directly from this document. The document states:
"The review of the technical characteristics. indications for use, clinical data, verification and validation information provided in the 510(k) Premarket Notification demonstrates that the Palomar Icon Aesthetic System is substantially equivalent to its predicate i device." and "The Palomar Icon Aesthetic System is substantially equivalent to its predicate devices when used according to its intended use. This is based on the information provided in this 510(k) Premarket Notification which demonstrates that the Palomar Icon Aesthetic System shares the same technological characteristics, mechanism of action, intended use and physical properties when compared to its predicates."

This indicates that the focus was on demonstrating similar technological characteristics and intended use to existing devices, rather than presenting new performance data against specific acceptance criteria for a novel AI or software component.

However, I can extract information related to the Skintel™ Reader, which is a component of the system and has a specific function:

Skintel™ Reader Information:

• Intended Use: "The Skintel™ Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot starting fluence."

Based on the provided text, the following information cannot be determined:

• A table of acceptance criteria and reported device performance (for the overall system or the Skintel™ reader, as this is a substantial equivalence submission)
• Sample size used for the test set
• Data provenance
• Number of experts used to establish ground truth
• Qualifications of experts
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• Effect size of human readers improvement with AI vs without AI assistance
• If a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

Missing Information/Why it cannot be provided from the text:

The provided 510(k) summary is a high-level overview focused on demonstrating substantial equivalence to predicate devices, as is typical for many medical device clearances. It does not contain the detailed performance study results, acceptance criteria, or methodological specifics that would be required for an AI/software device. For instance, the "Performance Data" section simply states that the review "demonstrates that the Palomar Icon Aesthetic System is substantially equivalent," without providing specific metrics or criteria.

To answer the requested questions comprehensively for a device like the Skintel™ Reader (an "objective measurement tool"), one would typically need a much more detailed technical report or clinical study report, which is not part of this 510(k) summary. This report would describe validation studies showing the accuracy and precision of the melanin content measurement, comparison to a gold standard, and how these measurements correlate with "setting a test spot starting fluence."

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The Fotona OX Nd: YAG/KTP Laser System Family is indicated for incision, excision, ablation and vaporization of soft tissue for general dermatology.

Specific Indications:

1064 nm wavelength in Q-switched mode:

• Removal of dark ink (black, blue and brown) tattoos
• Treatment of nevus of Ota
• Treatment of common nevi
• Removal or lightening of unwanted hair
• Skin resurfacing procedures for the treatement of acne scars and wrinkles

1064 nm wavelength in non- Q-switched mode:

• Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin
• Photocoagilation and hemostasis of pigmented and vascular lesions, such as, but not limited to. port wine stains, hemaongiomae, warts, telangiectasiae, venus lake, leg veins and spider veins
• Coagulation and hemostasis of soft tissue
• Treatment of wrinkles
• Treatment of mild to moderate inflammatory acne vulgaris

532 nm wavelength in Q-switched mode (nominal delivered energy of 585 nm and 650 nm with the optional 585 nm and 650 mm dye converter handpieces):

• Removal of light ink (red, sky blue, green, tan, purple, and orange) tatoos
• Treatment of vascular lesions including, but not limited to:
  • port wine birthmarks
  • telangiectasias
  • spider angioma
  • cherry angioma
  • spider nevi
• Treatment of pigmented lesions including, but not limited to:
  • cafe-au-lait birthmarks
  • solar lentigines
  • senile lentigines
  • -Becker's nevi
  • freckles
  • common nevi
  • nevus spilus
• Treatment of seborrheic keratosis
• Treatment of post inflammatory hyperpigmentation
• Skin resurfacing procedures for the treatment of acne scars and wrinkles.

The Fotona QX laser system family is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd: YAG (532 nm) laser technology. There is one optical cavity containing the Nd: YAG crystal. The frequency doubled KTP Nd: YAG wavelength is achieved by directing the Nd: YAG laser beam through a frequency doubling non-linear crystal. The Nd: YAG laser is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by articulated arm to a focusing variable spot handpiece. Optionally, the KTP Nd: YAG beam can be guided to a 585nm dye converter handpiece, or to a 650nm dye laser converter handpiece. The dye handpieces convert the KTP 532 nm wavelength beam into a 585 mm or a 650 nm wavelength, correspondingly. Both lasers are used in non-contact mode. The user activates laser emission by means of a footswitch.

The Nd:YAG (1064 nm) laser can be operated in a Q-switched (nominal pulse duration 5-20 nsec) and in a non-Qswitched mode (nominal pulse duration 0.25 msec) of operation. The KTP: YAG (532 nm) laser with optional 585 nm and 650 nm wavelengths can be operated only in a Q-switched mode (nominal pulse duration 5-20 nsec).

In the O-switched mode, the Nd: Y AG (1064 nm) laser is capable of delivering up to 1.6 J of laser energy. Spot sizes available range from 2 to 8 mm.

In the non-Q-switched mode, the Nd: YAG (1064 nm) laser is capable of delivering up to 5 J of laser energy. Spot sizes range from 2 to 8 mm.

The frequency doubled Nd:YAG (532 nm) KTP laser delivers up to 0.6 J of laser energy in 5-20 nanosecond pulses. Spot sizes available range from 2 to 8 mm.

All three modes of operation are intended to be used for incision/excision, ablation, vaporization of soft tissue in general dermatology and for the indications for use as stated below.

The provided document is a 510(k) summary for the Fotona QX Nd:YAG/KTP Laser System Family. This type of submission to the FDA focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than conducting new clinical studies to prove safety and effectiveness from scratch. Therefore, the document does not describe acceptance criteria or a study that proves the device meets those criteria in the way a clinical trial might for a novel device.

Instead, the core of this submission is a comparison to predicate devices, asserting that the new device shares similar indications for use, technical specifications, operating performance features, and general design features with already cleared devices.

Based on the provided text, here's an analysis of the requested information:

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

The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of a clinical study demonstrating effectiveness. The acceptance criteria for a 510(k) submission are typically related to demonstrating substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device.

The document lists the indications for use for the Fotona QX Nd:YAG/KTP Laser System Family (pages 5-6). These are the intended uses for which the device is considered substantially equivalent to predicates. The "performance" is implicitly deemed acceptable because it is similar to the performance of the predicate devices for the same indications.

• Treatment of nevus of Ota
• Treatment of common nevi
• Removal or lightening of unwanted hair
• Skin resurfacing procedures for the treatment of acne scars and wrinkles | Deemed similar to predicate devices. |
  | 1064 nm non-Q-switched mode | - Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin
• Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemangiomae, warts, telangiectasiae, venus lake, leg veins and spider veins
• Coagulation and hemostasis of soft tissue
• Treatment of wrinkles
• Treatment of mild to moderate inflammatory acne vulgaris | Deemed similar to predicate devices. |
  | 532 nm Q-switched mode | - Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
• Treatment of vascular lesions including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi
• Treatment of pigmented lesions including, but not limited to: cafe-au-lait birthmarks, solar lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus
• Treatment of seborrheic keratosis
• Treatment of post inflammatory hyperpigmentation
• Skin resurfacing procedures for the treatment of acne scars and wrinkles. | Deemed similar to 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 provided in the document. As a 510(k) submission based on substantial equivalence, there is no mention of a "test set" in the context of a new clinical study. The submission relies on the established safety and effectiveness of the predicate devices.

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 provided in the document. No specific "test set" requiring ground truth establishment by experts is mentioned, as this is not a de novo clinical trial.

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

This information is not provided in the document. No "test set" or adjudication method is described.

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

An MRMC comparative effectiveness study is not mentioned in the document. This type of study is not relevant for a laser device submission focused on substantial equivalence to existing laser systems, nor does the device involve AI assistance.

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

This information is not applicable as the device is a laser system, not an algorithm, and the concept of "standalone performance" for an algorithm is not relevant here.

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

This information is not provided in the document. The submission is based on the previously established ground truth (safety and effectiveness) of the predicate devices for their respective indications.

8. The sample size for the training set

This information is not provided in the document. There is no mention of a "training set" as this is not an algorithm being developed or validated.

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

This information is not provided in the document. Not applicable for the reasons stated above.

In summary:

The provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence. It does not contain the details typically found in a clinical study report or a submission for a novel device that requires de novo clinical validation. The "acceptance criteria" and "performance" are implicitly linked to the existing cleared status and indications for use of the specified predicate devices.

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