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The Contour Light CL-100 device is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

The Contour Light CL-100 device is indicated to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle spasm, and pain and stiffness associated with arthritis, for promoting relaxation of the muscle tissue, and to temporarily increase local blood circulation.

The Contour Light CL-100 is a low level laser (red light LED) system that applies 635nm light for the purpose of reducing the circumference of the hips, waist and thighs for aesthetic benefit, and 630nm light for the purpose of temporarily elevating skin temperature.

The Contour Research, LLC Contour Light CL-100 device applies a light emitting diode (LED) technology, and is used to perform red light LED-based circumferential reduction of the hips, thighs and waist in adults, or red light and IR LEDs for temporary elevation of skin temperature, within a treatment time of 30 minutes. The device is comprised of a panel of LEDs that is adjustable to conform generally to the outer dimensions of the individual being treated, a software controlled console that is used to select and maintain the application of the LED light, a power adaptor, and cables that connect to the energy source. The device is powered by connecting it to an 85-264 VAC, at 3 amps, 47-63 Hz. power source.

The provided document is a 510(k) summary for a medical device called "Contour Light CL-100". It focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving the device meets specific performance acceptance criteria through a clinical study.

Therefore, the information required to answer your request (acceptance criteria, details of a study proving the device meets acceptance criteria, sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is largely absent from this document.

This 510(k) summary explicitly states:

• "9. Clinical Performance Data: None submitted." (Page 7)

This means no clinical study was conducted or submitted as part of this 510(k) application to demonstrate the device's performance against pre-defined acceptance criteria. The basis for clearance is substantial equivalence to predicate devices, supported by non-clinical performance data (electrical safety, EMC, software, shelf life, internal design validation).

However, I can extract the following relevant, albeit limited, information:

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

• Acceptance Criteria: Not explicitly defined in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity, or quantifiable reduction in circumference). The "acceptance criteria" for this 510(k) revolved around demonstrating substantial equivalence in intended use and technological characteristics to legally marketed predicate devices, and passing non-clinical safety tests.
• Reported Device Performance:
  • The device passed Electrical safety testing per IEC 60601-1.
  • The device passed Electromagnetic Disturbance testing per IEC 60601-1-2.
  • Software verification and validation per IEC 62304/FDA Guidance were Completed.
  • Shelf Life Testing Supports useful device life of 5 years.
  • Internal Design Validation Testing results were also mentioned (no specific metrics provided).

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

• Sample Size: Not applicable. No clinical test set data was submitted.
• 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. No clinical test set and thus no expert ground truth establishment method was described.

4. Adjudication method (e.g. 2+1, 3+1, none) 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:

• No MRMC study was done, as no clinical data was submitted. The device is a "Low Level Laser System For Aesthetic Use" and "Infrared Lamp," not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. This is a physical device, not an algorithm.

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

• Not applicable. No clinical ground truth was established, as no clinical study was performed or submitted.

8. The sample size for the training set:

• Not applicable. There is no indication of machine learning or deep learning models being trained with a training set for this device.

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

• Not applicable.

Summary of what the document does describe as the basis for clearance:

The device (Contour Light CL-100) was cleared based on its substantial equivalence to predicate devices (Strawberry and Cream Low Level Laser system, Zerona Z6 OTC, BioPhotas LifeLight). This equivalence was argued through:

• Identical/Similar Indications for Use: The Contour Light CL-100's indications for reducing circumference of hips, waist, and thighs, and topical heating for pain relief and circulation, are presented as essentially identical to those of the predicate devices.
• Similar Technological Characteristics: All devices are low-level light/laser systems for aesthetic use and/or pain relief. Minor differences in wavelength and intensity were deemed not to raise new safety or effectiveness concerns.
• Non-Clinical Performance Data: As listed in point 1, the device successfully completed various safety and performance tests (electrical safety, EMC, software validation, shelf life, internal design validation).

This 510(k) submission chose a pathway that did not require a clinical study demonstrating performance against specific quantitative acceptance criteria on human subjects, relying instead on the established safety and effectiveness of the predicate devices and the non-clinical testing of the subject device.

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