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The Quantum Light Therapy System is a non-heating lamp, infrared as described under the provisions of 21 CFR §890.5500 and is indicated for: Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin using the QS-2; QS-4; and/or the QS-L applicator heads.

The Quantum Light Therapy System is a hand-held, non-invasive, pain therapy system which utilizes non-heating lamps consisting of both laser and light emitting diodes(LED) in three optional applicator heads. It combines the clinically accepted therapentic treatment of numerous predicate light therapy callor itsacs: It commercial distribution and 510(k) approved into one complete, compact, and costeffective system. The system consists of a basic hand-held, battery operated control unit and three optional (one-LED; two-laser) and interchangeable applicator heads which can only be used with the Quantum Light Therapy System control unit. The three distinct applicator heads produce wavelengths that range between 609-645mm which falls within the spectrum as defined by 21 CFR §890.5500. The two laser applicator heads produce an output power of <Smw prom-convergent beam and I he two laser apprication neads produced wavelength of 635mm 11% and ontinued of themse are classified as Class IIIa lastis. Bour operate and included on tortly in 21CFR Part 1040. Stargeton tional, Inc. has filed as a registered laser manufacturer with the Food and Drug Administration. The distinct LED applicator head produces a non coherent diffuse light source. This applicator head operates at a measured wavelength of 628mm ±3%.

Here's an analysis of the provided text regarding the Quantum Light Therapy System, focusing on acceptance criteria and the study (or lack thereof) proving its performance.

It's important to note that this document is a 510(k) summary for a medical device. 510(k) clearances typically establish substantial equivalence to a predicate device, rather than requiring extensive clinical trials to prove efficacy against specific acceptance criteria. Therefore, the information provided focuses more on demonstrating equivalence and compliance with standards than on a detailed clinical study demonstrating specific performance metrics.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the typical sense of numerical thresholds for clinical performance (e.g., minimum sensitivity, specificity, accuracy, or reduction in a pain score). Instead, the "acceptance criteria" for a 510(k) device like this are primarily related to substantial equivalence to predicate devices, safety, and compliance with relevant technical standards.

The "reported device performance" is framed in terms of its intended use, similarity to predicate devices, and adherence to various electromagnetic and safety standards.

Here's a table summarizing what can be inferred as "acceptance criteria" from the document and the corresponding "performance" as stated:

Study Information:

Based on the provided document, the "study" conducted for this 510(k) submission is primarily focused on bench testing and comparison to predicate device specifications, rather than a clinical trial measuring patient outcomes against specific performance criteria.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the context of a clinical test set with patient data for performance evaluation. The "test set" here refers to the device itself and its components undergoing engineering and safety testing.
   • Data Provenance: The data provenance is from internal testing by Stargate International, Inc. and testing by an outside independent laboratory to confirm compliance with various standards. The document does not mention human subject data or a clinical study. It's retrospective in the sense that it's comparing against existing predicate devices and established standards. The country of origin of the data would likely be the USA, where the company is based and the testing was presumably conducted, though not explicitly stated for the independent lab.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This is not a study involving expert assessment of clinical images or patient conditions to establish a ground truth. Ground truth, in this context, would be the established specifications of the device (e.g., wavelength, power output) and the requirements of the compliance standards.

3. Adjudication method for the test set:

   • Not applicable. There's no clinical data or expert review that would require an adjudication method like 2+1 or 3+1. Adjudication was likely the process of confirming the device properties met the specified engineering and safety requirements.

4. 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, a MRMC comparative effectiveness study was not done. This device is a therapeutic light system, not an AI-powered diagnostic tool, so such a study would be irrelevant.

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

   • Not applicable. This is a physical medical device, not a standalone algorithm. Its performance is inherent to its physical properties and operation.

6. The type of ground truth used:

   • The "ground truth" for this 510(k) submission is based on:
     • Technical Specifications: Measured wavelengths and power outputs of the device compared against design specifications and regulatory requirements.
     • Predicate Device Characteristics: Comparison of the Quantum Light Therapy System's features, intended use, technological characteristics (e.g., non-heating lamp, specific wavelengths and power output range) to those of the legally marketed predicate devices.
     • Compliance Standards: Meeting the requirements of various FCC, UL, IEC, and CFR standards, as verified by testing.

7. The sample size for the training set:

   • Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

   • Not applicable, as there is no training set involved.

In summary: The document describes a 510(k) submission focusing on demonstrating substantial equivalence to predicate devices and compliance with safety and performance standards. It does not present a clinical study with patient data, acceptance criteria for clinical outcomes, or expert-based ground truth establishment in the typical sense of a diagnostic or AI device study. The "study" here is primarily engineering and regulatory compliance testing.

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