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The CURVE Laser System is indicated for non-invasive aesthetic treatment for the temporary reduction in circumference of the waist.

The CURVE Laser System consists of a main console and 4 treatment paddles. The console houses the main electronics, controls and embedded software. The liquid crystal display (LCD) identifies all key treatment parameters. The main console is also equipped with a micro controller that provides automatic calculation of energy output for a specific set of treatment parameters. The treatment paddles are constructed so that each paddle contains 8 laser emission diode sources at a power output of 40mW per laser diode. These treatment paddles are non-thermal and non-invasive, at a wavelength of 630-680.

The provided document is a 510(k) summary for the CURVE Laser System and details the device's indications for use, substantial equivalence, and performance data, including a clinical study.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

(Note: The document doesn't explicitly state the acceptance criteria as a separate "acceptance criteria" section but directly presents the primary efficacy endpoint of the clinical study as the measure for success.)

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

• Sample Size:
  • CURVE Laser System treatment group: 19 subjects
  • Control (sham) device group: 18 subjects
  • Total: 37 subjects
• Data Provenance: The document does not explicitly state the country of origin of the data. The study was a "randomized, double blind clinical study," indicating it was prospectively collected.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

The document does not mention the use of experts to establish ground truth for the test set in the context of image analysis or diagnostic interpretation. The primary outcome was a physical measurement (waistline circumference).

4. Adjudication Method for the Test Set:

Not applicable. The study involved direct physical measurements of waistline circumference, not interpretive assessments requiring adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study involved a comparison between a device and a sham, not a comparison of human readers with and without AI assistance.

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

A standalone study was not done. The CURVE Laser System is a physical device that delivers laser treatment, not an algorithm, and its performance is evaluated in direct application to subjects.

7. Type of Ground Truth Used:

The ground truth used was direct physical measurement of waistline circumference.

8. Sample Size for the Training Set:

The document does not mention a training set. This is a clinical study for a physical device, not an AI/algorithm where a separate training set is typically used to develop the model.

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

Not applicable, as there was no mention of a training set.

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The Lipofina Laser System is indicated for non-invasive aesthetic treatment for the temporary reduction in circumference of the waist.

The Lipofina Laser System (Figure 1) consists of a main console and 8 treatment paddles. The console houses the main electronics, controls and embedded software. The liquid crystal display (LCD) identifies all key treatment parameters. The main console is also equipped with a micro controller that provides automatic calculation of energy output for a specific set of treatment parameters. The treatment paddles are constructed so that each paddle contains 12 laser emission diode sources at a power output of 35mW per laser diode. These treatment paddles are non-thermal and noninvasive, at a wavelength of 658 (central).

The provided document is a 510(k) summary for the Lipofina Laser System, which is indicated for non-invasive aesthetic treatment for the temporary reduction in circumference of the waist. The document details a clinical study conducted to demonstrate the device's safety and effectiveness.

Here's an analysis of the acceptance criteria and the study, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Sample Size (Test Set):
  • Lipofina Laser System treated group: 20 subjects
  • Control (sham) device group: 21 subjects
• Data Provenance: The study was "at the request of CDRH," implying it was conducted as part of the FDA regulatory process. The geographical origin of the data (country) is not explicitly stated, but the sponsor, YOLO Medical Inc., is located in British Columbia, Canada, and the submission correspondent Rockin' Regulatory, Inc. is in California, USA, suggesting a North American context. The study was prospective as it was a "randomized, double blind clinical study."

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for the test set in the conventional sense of medical image interpretation (e.g., radiologists reviewing images). The ground truth here is directly measured waistline circumference loss and observed adverse events.

4. Adjudication Method for the Test Set

Not applicable in the context of this study. The "ground truth" was objective measurement (waistline circumference) and direct observation for adverse events.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically involves multiple human readers evaluating medical images or data, with and without AI assistance, to assess the impact of AI on diagnostic accuracy or efficiency. The Lipofina Laser System is a physical device used for aesthetic treatment, not an AI-powered diagnostic tool.

6. Standalone Performance Study

Yes, a standalone performance study was done in the sense that the device's effect was directly measured on subjects without human intervention in the treatment application that would alter the device's output. The clinical study was a randomized, double-blind trial demonstrating the device's efficacy on its own when applied as intended.

7. Type of Ground Truth Used

The ground truth used was objective measurement (waistline circumference loss) and clinical observation (for adverse events and skin color changes).

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning. The Lipofina Laser System is a low-level laser system, not an AI/ML-based device that would typically have a training set. The clinical study described served as the primary validation set to demonstrate the device's safety and efficacy.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no mention or indication of an AI/ML training set for this device.

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The YOLO CURVE is intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.

The YOLO CURVE has a hand-held treatment probe, is non-invasive, low level visible lamp that provides continuous heat therapy at fixed frequency. The System consists of a Drive Unit, Power Supply, controls and optional treatment probes that contain the visible radiating elements. The YOLO CURVE generator automatically calculates energy output in relation to set treatment parameters. The parameters (treatment time, output power delivered) can be adjusted by using key, treatment specifications and menus. The progress of the treatment is displayed on the LCD display in real time. The YOLO CURVE generator operates simultaneous and independent management of outputs for connecting probes with laser sources from the Red wavelength. The YOLO CURVE generator is supplied with 2 completely independent outputs for using two treatment probes. The LCD displays operating parameters from both channels. This allows two operators to carry out laser therapy independently: just like having two separate instruments.

The provided text describes a 510(k) summary for the YOLO CURVE, an infrared lamp device. However, it does not contain information related to acceptance criteria, specific performance data with numerical results, or detailed study methodologies that would typically be associated with proving a device meets acceptance criteria through a clinical trial or extensive performance testing.

Instead, the document primarily focuses on establishing "substantial equivalence" to predicate devices, which is a regulatory pathway for lower-risk medical devices.

Here's an analysis based on the information available in the text, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The text states "Performance data is attached which showed that elevated skin temperature as required for this type of device. (Please See Appendix III)", but Appendix III is not included in the provided excerpt. Therefore, no specific acceptance criteria or numerical performance metrics are available.

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

This information is not provided. The document makes a general statement about "Performance data" but does not specify any test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. The document does not describe any test set where ground truth would need to be established by experts.

4. Adjudication Method for the Test Set

This information is not provided. As there's no described test set requiring expert ground truth establishment, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided document. The focus is on substantial equivalence to existing devices rather than a comparative study with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the YOLO CURVE is described as a medical device (infrared lamp) for direct therapeutic application, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant to this device description.

7. The Type of Ground Truth Used

This information is not provided. No specific test data or ground truth establishment is detailed. The performance data mentioned (likely about elevated skin temperature) would imply physiological measurements as "ground truth," but the specifics are absent.

8. The Sample Size for the Training Set

This information is not provided. There is no mention of a "training set" as this device is not described as involving machine learning or AI algorithms that would require such data.

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

This information is not provided and is not applicable as there is no training set described for an AI/ML algorithm.

Summary of Device and Regulatory Context (Based on available text):

The YOLO CURVE is an infrared lamp cleared through the 510(k) pathway, which means it demonstrated "substantial equivalence" to legally marketed predicate devices (LAPEX BCS K081962 and LUCIA K102375). Its intended use is to emit visible and infrared energy for topical heating to provide temporary relief of minor muscle/joint pain, stiffness, arthritis pain, or muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscle.

The argument for substantial equivalence relies on the device having the "same intended use as and similar technological characteristics" as the predicate devices, specifically utilizing laser diodes to elevate tissue temperature. While "Performance data is attached which showed that elevated skin temperature as required for this type of device," the details of this data, including acceptance criteria and specific results, are in an unprovided "Appendix III."

In conclusion, the provided text from the 510(k) summary focuses on the regulatory clearance process through substantial equivalence and does not offer the detailed performance study information with acceptance criteria and numerical results that your request outline specifies.

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