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Collagentex RX-6 model is intended to emit light energy in the near infrared spectrum to provide non heating adjunctive use for temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

The Collagentex Rx-6 is a stand alone light device which emits polychromatic visible to near infrared light in the 580 to 1500 nanometer range. The light is non-collimating and non-pulsing. There are a total of 6 exposure areas, each set to receive 44.2miliWatt/sqcm or 2.6 Joule/minute at the minimum distance of 8 inches.

The device measures 96 inches long by 27.68 inches wide by 96 inches tall and is made up of 3 main sections. There are 2 vertical towers positioned 84 inches apart. The towers are made of metal and house the main electrical components for the device. A control console which includes a set timer, emergency stop button, oscillating on/off switch and a mechanical hour counter is mounted on left positioned tower.

In between the towers, positioned horizontally is a lamp module. The lamp module is made up of 6 individual lamp assemblies placed inline. The lamps are all 500w quartz type and each cover an exposure area of 23cm diameter. The height of the lamp module is adjustable via actuators positioned in the vertical columns. The actuators are controlled by a wired remote control. The device is to be mounted on the floor above a massage table provided by the device owner.

The document provided is a 510(k) summary for a medical device (Collagentex Rx-6). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical trial data or detailed performance metrics against specific acceptance criteria.

Therefore, the available information does not contain the following data for a typical clinical study evaluating device performance and acceptance criteria:

• A table of acceptance criteria and reported device performance.
• Sample size for a test set, its provenance, or retrospective/prospective nature.
• Number of experts for ground truth establishment or their qualifications.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
• Standalone (algorithm only) performance results.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

However, based on the provided text, here's what can be extracted regarding the device's validation for substantial equivalence:

The "Performance Data" section primarily addresses safety and electrical compatibility standards compliance, not clinical efficacy acceptance criteria.

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

The document doesn't provide a table of performance-based acceptance criteria related to efficacy (e.g., pain reduction percentage, visual analog scale score improvement) or specific reported performance against such criteria. Instead, it asserts substantial equivalence based on technical characteristics and compliance with safety standards.

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

No clinical test set or data provenance is mentioned for establishing efficacy or performance against clinical acceptance criteria. The performance data refers to compliance with voluntary recognized standards.

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 requiring expert-established ground truth is described for performance evaluation.

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

Not applicable, as no clinical test set requiring expert adjudication 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:

Not applicable. The device is an infrared lamp, not an AI-assisted diagnostic or therapeutic tool that would involve human "readers."

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

Not applicable. The device is a physical infrared lamp, not an algorithm.

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

Not applicable for clinical efficacy. The "ground truth" here is compliance with established safety and electrical standards.

8. The sample size for the training set:

Not applicable. The device is not an AI/ML algorithm that requires a training set.

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

Not applicable.

Summary of available "Performance Data" and "Conclusion" from the document regarding meeting safety and electrical standards (not clinical efficacy acceptance criteria):

The device (Collagentex Rx-6) was tested for and complied with the following recognized standards:

• IEC60601-1-2 3rd edition: Electromagnetic compatibility requirements.
• NRTL, CSA, ANSI: Electrical safety standards.
• ANSI/IESNA RP-27.1-05: Photobiological safety standards for the device.
• ANSI/IESNA RP-27.3-07: Photobiological safety standards for eye protection.

The conclusion states that the Collagentex RX-6 model is substantially equivalent to its predicate device (K162022, Collagentex RX-1) because it uses:

• The same technology (Quartz Lamp with filter)
• Outputs the same wavelength spectrum (580nm to 1500nm)
• Has the same irradiation intensity (44.2 miliWatt/sqcm or 2.6 Joule/minute)
• Has the same treatment time (20 minutes per site/per patient)
• Identical testing (referring to the listed safety and electrical standards compliance).
• Also notes the same skin surface temperature rise (1.8°C max).

The primary evidence presented is the technical equivalence to a predicate device which itself has been cleared for marketing, and compliance with relevant safety and electrical performance standards. There isn't a study proving the device meets clinical efficacy acceptance criteria provided in this 510(k) summary; rather, it hinges on substantial equivalence for the stated indications for use.

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