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The Poly Rejuv Model 633 is intended to emit energy in the red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

The Poly Rejuv is a portable device that has a detachable treatment head, containing a total of 1,820 red LEDs in the treatment head. The treatment head is attached to a lifting stand that is attached to the main frame on a rolling stand. The user interface for applying treatment is a key lock to power ON/Off the device and a display screen attached to the main frame that runs the software (password protected-lockout code, runs treatment time/ treatment head) for the device. 12 pairs of protective eyewear are included with the device. The device is sold as Over the Counter (OTC) to commercial establishments only and not for home use. The Poly Rejuv is not intended to be used by laypersons. Poly Rejuv is intended to only be operated by a person who has been trained by the Sponsor according to their Customer Training Plan.

The Poly Rejuv device (Model 633) is intended for dermatological use to treat periorbital wrinkles by emitting red region energy. The clearance is based on substantial equivalence to predicate devices, supported by non-clinical testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for the Poly Rejuv Model 633 does not explicitly state "acceptance criteria" in terms of clinical performance metrics (e.g., specific percentage reduction in wrinkles, or a statistical significance level for improvement). Instead, substantial equivalence is established through comparison of technological characteristics with a predicate device and extensive non-clinical (bench) testing. The "acceptance criteria" can be inferred as demonstrating that the device is as safe and effective as legally marketed predicate devices, with no new issues regarding safety and effectiveness.

The table below summarizes the key comparative characteristics presented in the 510(k) summary that serve as the basis for demonstrating this "acceptance."

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

The submission does not describe a clinical study or a test set of data (e.g., patient data). The clearance is based on non-clinical (bench) testing and comparison of technical specifications to predicate devices. Therefore, there is no mention of sample size for a test set or data provenance from a human study.

The testing conducted was primarily hardware-related (electrical safety, EMC, lamp safety, device-specific safety, usability, and bench testing for power density, timer, functions, use life, and storage conditions) and software validation. These tests are conducted on the device itself, not on human subjects.

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, as no clinical test set or ground truth by medical experts was described for this 510(k) submission. The evaluation was based on engineering and performance standards conformance.

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

Not applicable, as no clinical test set requiring adjudication was 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

Not applicable. This device is an LED therapy system for wrinkle reduction, not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.

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

Not applicable. This is a physical medical device (LED therapy system), not an algorithm.

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

Not applicable, as no clinical ground truth from human studies was used for this 510(k) submission. The "ground truth" for the non-clinical testing was based on established engineering and safety standards (e.g., IEC standards) and the specified performance characteristics of the device and its predicates.

8. The sample size for the training set

Not applicable. As no artificial intelligence (AI) or machine learning (ML) algorithm is mentioned in the submission, there is no "training set" in that context. The device's software was subjected to validation testing, but this is distinct from training an AI model.

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

Not applicable, as no training set for an AI/ML algorithm was described.

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The BioPhotas Celluma3 is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full face wrinkles.

The Biophotas Celluma is a portable, therapeutic device whose purpose is to provide even, cool, narrow-band wavelengths of polychromatic light (blue, 465nm red, 640nm and Near infrared, 880nm) produced by super-luminous LEDs (light emitting diodes) to treat a variety of skin and musculoskeletal conditions. The Celluma' uses a combination of visible red light (640mm) in combination with near infrared light (880nm) and is intended to improve the appearance of full-face wrinkles. Near infra-red (880nm) is intended to provide topical heating tissue temperature: for the temporary relief of minor muscles and joint pain, arthritis and muscle spasm; relieving stiffness; promotion the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum (465nm) is intended to reduce mild to moderate inflammatory acne vulgaris. The Biophotas Celluma' is intended for use on areas of the body such as the full face, back, chest, knees or other areas where the therapeutic light may be beneficial. The system comprises of a semi-rigid, shape-taking frame upon which is mounted an array of LEDs, this allows the device to be contoured to the treatment area. The LEDs are embedded within a biocompatible Poron® foam covering that holds a transparent polycarbonate cover recessed within it. The biocompatibility nature of Poron® allows the device to be placed in contact with the skin. Nevertheless, the design of the device provides for maintaining a small distance between the surface of the skin and the surface of the device. The flexible LED panel is permanently connected by a three-foot long cable attached to a control panel that contains the circuitry and software that controls the device. The control panel contains several push buttons beneath a sealed cover. A power button that switches the device ON/OFF, a mode button that allows the user to select from 3 preprogrammed treatment modes; "Acne", "Wrinkles", and "Aches and Pains", a pulse button which allows the user to switch between pulse (default setting) or non-Pulse and a Start button that activates the desired treatment mode. The control panel receives its power from a separate cable that connects via an AC adaptor for 110-220 Volts to a standard U.S. electrical power outlet. The control panel contains an automatic shut-off safety feature.

The provided text is a 510(k) summary for the Biophotas Celluma3, a device intended for the treatment of full face wrinkles. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with reported performance metrics.

Therefore, the following information regarding acceptance criteria and a study proving the device meets these criteria cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and if so, the effect size of how much human readers improve with AI vs without AI assistance
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• The sample size for the training set
• How the ground truth for the training set was established

The document primarily relies on non-clinical performance testing and a comparison of technological characteristics to assert substantial equivalence. It explicitly states: "Biophotas Celluma' is technologically identical to the previously cleared Biophotas Cellumas device (K152280). In this application, only the indication for use has been revised to expand the treatment of periorbital wrinkles to include full face wrinkles, a logical extension given the fact that the subject device in both submission has a large panel covering the entire face. In addition, the mechanism of action of low level light therapy for the treatment of "wrinkles" is well known to be the same irrespective of area that is being treated."

The provided text details non-clinical performance testing to demonstrate safety and effectiveness for the Biophotas Celluma system, but this is distinct from a clinical study to prove efficacy in meeting acceptance criteria for wrinkle reduction.

Non-Clinical Performance Testing Summary:

The Biophotas Celluma3 underwent several non-clinical performance tests in line with recognized standards to demonstrate safety and effectiveness and substantial equivalence to predicate devices. These tests addressed general requirements, biocompatibility, electrical safety, and software.

• Electrical safety and safety standards: The device passed testing per:
  • IEC 60601-1:2012 (Electrical safety)
  • IEC 60601-1-2:2007 (EMC testing)
• Software verification and validation testing:
  • The software was classified as Class A according to IEC 62304:2006 (Medical device Software - software life cycle process).
  • The FDA level of concern matrix classified the device software as "Minor."
• Biocompatibility: Based on transient and limited contact with intact skin, Biophotas Inc believes the device is safe and compliant with ISO 10993 and the FDA - Blue Book Memorandum #G95-1, supported by ISO 10993-1:2009 annex B.
• Usability Study: Per IEC 62366.

The document argues that "Where there are slight differences in technological parameters, these fall within the range of the predicate devices and those devices cleared under the OHS device code, or have been negated by non-clinical performance testing." This indicates that the non-clinical tests were used to negate potential differences from predicate devices, rather than to establish new performance criteria for wrinkle reduction through a standalone clinical study.

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The LightStim Professional System #3A panel is intended for the treatment of full-face wrinkles.

The LightStim Professional System #3B panel is intended for the treatment of mild to moderate acne.

The LightStim Professional System #4 panel is intended for the treatment of mild to moderate acne.

The LightStim Professional 2-Panel Light System is a portable device that has two (2) separate interchangeable 2-panel treatment heads, each containing 1.130 LEDs. Each treatment heads is attached to a fully retractable and articulating arm with a 42" reach. Either one of these arms can be attached to the rolling stand for use. There is an on/off switch, and an AC to DC power supply.

The LightStim 2-Panel Light System is intended to be operated only by a person who has been personally trained by Company personnel. Each device includes a detailed Instruction Manual and includes one-on-one training and instruction by Company training staff. That training includes a thorough review of the Instruction Manual for the device and actual one-on-one training on the operation of the device with the end user.

This document describes the LightStim Professional 2-Panel Light System, a device for treating facial wrinkles and acne. However, it does not contain the specific information required to complete your request about acceptance criteria and a study proving the device meets those criteria. The provided text is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance study results against specific acceptance criteria.

Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

The document primarily focuses on regulatory approval by demonstrating substantial equivalence to previously cleared devices. It states that "the LightStim Professional 2-Panel Light System raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate devices."

The 'Performance Testing' section only mentions conformance to general electrical and electromagnetic compatibility standards (IEC/EN 60601-1 and IEC/EN 60601-1-2) which are related to device safety and essential performance, not clinical effectiveness or specific acceptance criteria for treating wrinkles or acne. No clinical study data or performance metrics against specific efficacy endpoints are provided in this document.

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