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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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Collagentex RX-1 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.

Collagentex RX-1 model is a stand alone device of a single quartz lamp, emitting polychromatic visible to near infrared light from 580nm to 1500nm, non-collimating, non pulsing in order to offer exposure to the user where directed at a distance of 8" and farther from the body, non topical light therapy in order to relieve minor pain temporarily. The unit can be mounted on a table top or rolled on a base with casters. Narrow band filter and acrylic shield are designed to eliminate any emission of ultraviolet or wavelength shorter than 480nm wavelengths. The lamp replacement life is 500hrs. The exposure dosage is controlled by a user set timer. Exposure area is set to receive 44.2miliWatt/sqcm or 2.6 Joule/minute of exposure at the minimum distance. The device runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to main power.

The provided text is a 510(k) summary for the Collagentex RX-1 device, which is an infrared lamp intended for temporary relief of minor chronic neck and shoulder pain. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing details of a study with specific acceptance criteria and performance metrics in the way one might expect for an AI/ML device.

Therefore, many of the requested elements for describing acceptance criteria and a study demonstrating device performance cannot be found in this document, as the submission is not based on a clinical efficacy study with quantitative performance measures against a ground truth.

Here's an attempt to answer the questions based only on the provided text, indicating where information is unavailable.

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

The concept of "acceptance criteria" and "reported device performance" in the context of this 510(k) is heavily focused on demonstrating substantial equivalence to a predicate device (Bioptron Pro Light Therapy System and Bioptron Compact III Light Therapy System, K032216). There are no specific quantitative clinical performance metrics (e.g., accuracy, sensitivity, specificity for a diagnostic device) with defined acceptance thresholds. Instead, the acceptance criteria are implicitly that the device's technical characteristics and intended use are similar to the predicate device, and that it meets relevant safety and electromagnetic compatibility standards.

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. The submission relies on technical characteristics comparison and compliance with standards rather than a clinical human subject test set for efficacy.

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 applicable/provided. No clinical test set requiring expert-established ground truth is described.

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

This information is not applicable/provided. No clinical test set 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

This information is not applicable/provided. The device is an infrared lamp, not an AI/ML diagnostic or assistive tool, and no MRMC study is mentioned.

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

This information is not applicable/provided. The device is an infrared lamp, not an algorithm.

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

This information is not applicable/provided in the context of a clinical performance study. The "ground truth" for this submission is the established safety and efficacy of the predicate device and compliance with recognized standards.

8. The sample size for the training set

This information is not applicable/provided. The device is an infrared lamp, not an AI/ML algorithm requiring a training set.

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

This information is not applicable/provided. The device is an infrared lamp, not an AI/ML algorithm requiring a training set.

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The intended use of the T-Series tanning beds and booth is solely for the tanning of the human skin.

The T-Series tanning beds and booth are devices that omit ultraviolet radiation in the UVA and UVB range to produce a cosmetic tan. The T-Series family of units is made up of five (5) lay-down beds and one (1) stand-up unit. All the lay-down beds in the T-Series are similar in design. They are made up of 3 sections, a canopy or top section (tans the front side of the user), a base or bed section (tans the back side of the user) and a side console (made up of cooling fans and controls). The beds are all 87" long and vary in width from 35 inches to 59 inches. The main difference in the bed design between the five (5) models is the amount of ultraviolet sunlamps they are equipped with. The T-32 is equipped with 32 ultraviolet sunlamps. The T-40 is equipped with 40 ultraviolet sunlamps. The T-44 is equipped with 44 ultraviolet sunlamps. The T-52 is equipped with 52 ultraviolet sunlamps. The T-72 is equipped with 64 ultraviolet sunlamps. The laydown beds are also designed to be equipped with optional face bulbs. The face bulbs are installed in the canopy section. Each unit can be outfitted with up to 3 face bulbs. The lay-down beds are constructed of the same materials. Their frames are made up of power coated steel, stainless steel and anodized aluminum. All the beds are equipped with an acrylic sheet in both the base and canopy sections. The acrylic sheet is designed specifically for the transmission of ultraviolet light in the UVA and UVB range. The acrylic sheets also server as a barrier to protect the user from lamp breakage and for sanitary purposes. The lay-down beds also share the exact same electrical components which mainly consist of a choke type ballast, starter and fluorescent sunlamp. The choke ballast acts like a valve and limits the amount of power/wattage to the lamp. The starter is needed in the initial start-up of the lamp; it generates an inductive kick which provides the high voltage needed to start the lamp. The fluorescent sunlamp is made specifically for tanning equipment. It is a low pressure mercury vapor gas-discharge lamp that emits most of its energy in the UVA and UVB range between 260nm-400nm. The ballast, starter and fluorescent sunlamp used in our lay-down beds are available in 100 Watt, 160 Watt or 200 Watt confiquration. The face bulbs are physically smaller than the fluorescent sunlamps and are made of a quartz glass. They also work with a ballast and starter system. The ballast, starter/ignitor and face bulb are 400 watts. The T-series booth (TT-50) is designed for a vertical application. It has the same metal construction as in the lay-down beds and also outfitted with the same electrical components. The booth is made up of 7 sections. One (1) floor platform which is made of stainless steel. Five (5) vertical columns, each equipped with ten (10) fluorescent sunlamps One (1) overhead section which consists of an 18 inch cooling fan and controls. Each sunlamp column is equipped with a powder coated steel grid to prevent the user from contacting the lamps. There handles attached to the overhead section in which the user can hold on to while tanning. The handles are made of steel and chromes plated. Face tanners are not available for the stand-up booth. Both our lay-down beds and stand-up unit are configured to work with a timer system to ensure than the users of the equipment do not overexpose themselves to the ultraviolet light. The T-Series tanning beds and booth require 220 volts AC.

This FDA 510(k) summary is for a medical device submission (tanning beds/booths), not an AI/ML powered device. Therefore, it does not contain the specific information requested about acceptance criteria and study designs that would typically be associated with performance evaluation of an AI/ML device.

The document primarily focuses on demonstrating substantial equivalence to a predicate device, which is a common pathway for medical device clearance. The "performance testing" described is related to electrical safety and photobiological safety standards for tanning equipment, not the performance of an algorithm.

Therefore, it is not possible to extract the requested information (acceptance criteria, device performance, sample sizes, ground truth details, MRMC studies, standalone performance) related to an AI/ML device from this document.

The "Conclusion" section clearly states that the device is substantially equivalent to its Class-I predicate models. This indicates that the evaluation was primarily against existing safety and efficacy standards for tanning beds, not an AI/ML performance evaluation.

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