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Laser-D68 System provides visible red and infrared therapy to provide topical heating for the temporary:

• Increase in local blood circulation
• Relief of minor muscles and joint aches, pains and stiffness .
• Relaxation of muscles .
• . Relief of muscle spasms
• . Relief of minor pain and stiffness associated with arthritis

The Laser-D68 is a non-invasive, low energy infrared therapeutic medical laser that is intended to perform laser therapy in healthcare centers, physical therapy laboratories, and family doctor practices. The Laser D68 is supplied with three different probes that are used to generate, laser radiation when connected to the D68 driver unit. Probe #1 is a 660nm, Indium Gallium Aluminum Phoshpide (InGaAIP) laser diode (visible red light) with an adjustable treatment power output from 1 milliwatts (mW) to 50 milliwatts (mW) (in 1mW increments). Probe #2 is an 830nm, Gallium Aluminum Arsenide (GaAIAs) Iaser diode (infrared light) with an adjustable treatment power output from 20 milliwatts to 400 milliwatts (in 5mW increments). Probe #3 is a 904nm, Gallium Arsenide (GaAs) laser diode (infrared light) with adjustable treatment power output of either SmW to 90mW (in 5mW increments) (45W laser power source) or 5 mW to 150mW (in 5 mW increment) (75W modulated laser power source). Each of the laser probes are fully interchangeable with the D68 driver.

The provided 510(k) summary for the Laser-D68 device (K061656) does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria related to its intended therapeutic effects.

The document focuses on demonstrating substantial equivalence to predicate devices (Eltech s.r.l K-Laser (K050070) and Advanced Medical Technologies Maestro MDTTL Laser System (K053473)) in terms of intended use, technological characteristics, and safety testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Increase in local blood circulation
• Relief of minor muscles and joint aches, pains and stiffness
• Relaxation of muscles
• Relief of muscle spasms
• Relief of minor pain and stiffness associated with arthritis | Not explicitly stated. The document asserts the device's intended use is to provide these effects but does not present specific performance metrics, targets, or results from a clinical study to prove these claims against defined acceptance criteria. |
  | Electrical Safety | The Laser-D68 included electrical safety testing and meets the applicable requirements of CFR 1040. The device has been certified to the requirements of the Medical Devices Directive 93/42/EEC, and is CE Marked. |
  | Laser Safety | The Laser-D68 included laser safety testing and meets the applicable requirements of CFR 1040. The device has been certified to the requirements of the Medical Devices Directive 93/42/EEC, and is CE Marked. |
  | Electromagnetic Compatibility (EMC) | The Laser-D68 included electromagnetic compatibility testing and meets the applicable requirements of CFR 1040. The device has been certified to the requirements of the Medical Devices Directive 93/42/EEC, and is CE Marked. |

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

The document does not describe any clinical test set or data related to the therapeutic efficacy of the device. The "testing" mentioned ([1] section VII) refers to electrical safety, laser safety, and electromagnetic compatibility testing, which are engineering and compliance tests, not clinical performance studies involving a test set of human subjects or cases. Therefore, there's no information on sample size, data provenance, or study design for therapeutic effectiveness.

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 for therapeutic efficacy is described, there's no mention of experts establishing ground truth for such a set.

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

Not applicable. No clinical test set for therapeutic efficacy 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 Laser-D68 is a therapeutic medical laser, not an AI-assisted diagnostic device that would involve human readers or MRMC studies.

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

Not applicable. The Laser-D68 is a therapeutic medical laser, not a diagnostic algorithm. The "standalone" performance here might refer to the device's physical output (e.g., power, wavelength), which is described in section I, but not in the context of a "standalone study" akin to AI performance.

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

For the mentioned safety and compatibility tests, the "ground truth" would be compliance with established regulatory standards (e.g., CFR 1040, Medical Devices Directive 93/42/EEC). For therapeutic efficacy, no ground truth or clinical data is provided. The submission relies on "substantial equivalence" to predicate devices, implying that the known efficacy of the predicates is sufficient.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning system that requires a "training set."

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

Not applicable. This device is not an AI/machine learning system that requires a "training set."

Summary Explanation:

This 510(k) submission for the Laser-D68 relies on demonstrating "substantial equivalence" to already legally marketed predicate devices, rather than presenting a de novo clinical study proving the therapeutic efficacy of the Laser-D68 itself against specific acceptance criteria.

The testing mentioned (electrical safety, laser safety, and EMC) confirms that the device functions safely and as designed according to regulatory standards (CFR 1040, MDD 93/42/EEC), but these are not studies evaluating its direct therapeutic performance (e.g., how much it increases blood circulation or reduces pain). The assumption is that because it is technologically similar and has the same intended use as the predicate devices, it will achieve the same therapeutic outcomes. No performance metrics or clinical study results for the stated therapeutic indications are provided in this document.

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