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Each device is indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.

The devices under submission are a family of laser that emits a beam of coherent light in either continuous wave or pulse mode at the wavelengths previously described. Each device is a table device, easy to transport, usable also without electrical net, thanks to a battery pack. It is composed of a touch screen for managing all the device functions, an emitter, an handpiece for the delivery of light, software and an on/off button to activate and deactivate the infrared emission.

The provided text describes a 510(k) premarket notification for a medical device (K-LASER, a family of infrared lamps) and does not contain information about acceptance criteria or a study proving that the device meets such criteria.

Instead, the document focuses on:

• Substantial Equivalence: The primary assertion is that the K-LASER devices are substantially equivalent to previously cleared predicate devices (K091497 and K061656) due to sharing the same intended use, similar design, and functional features, without raising new issues of safety or effectiveness.
• Performance Standards: The document states that the device conforms to applicable requirements of 21 CFR section 1010, 21 CFR sections 1040.10, and 1040.11 (Performance Standards for Light-Emitting Products). These are general regulatory standards, not specific performance criteria for a study.
• Safety and Effectiveness Rationale: The submission asserts safety and effectiveness based on the similarity to predicate devices, adherence to quality management systems (21 CFR Part 820), design/change control, and verification/validation to applicable standards/guidance documents.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about a study proving the device meets these criteria, because such information is not present in the provided text. The document is a regulatory submission for premarket clearance based on substantial equivalence, not a detailed report of a clinical or performance study demonstrating specific acceptance criteria.

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The device is indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.

K-1200 is an infrared therapy table device, easy to transport, usable also without electrical net, thanks to a battery pack. It is composed of a touch screen for managing all the device functions, an emitter, an handpiece for the delivery of light, software and an on/off button to activate and deactivate the infrared emission.

This submission is for a 510(k) premarket notification for the K-1200 device, an infrared therapy device. The provided text is a summary of the safety and effectiveness, predicate devices, performance standards, description, intended use, and substantial equivalence rationale. It does not contain information about acceptance criteria, device performance, or a study that proves the device meets specific acceptance criteria in the manner a clinical trial or performance study would.

The document asserts substantial equivalence to predicate devices (K-LASER, K050070, and LCT-1000, K070400) based on shared basic characteristics and intended use. The safety and effectiveness are also stated generally to be due to similarity to existing technologies, mature quality management systems, and certifications (CERMET, 93/42 EEC Directive).

Therefore, I cannot fulfill your request for the specific details outlined (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, training set size, and ground truth establishment for training set) because this type of information is not present in the provided 510(k) summary. These details would typically be found in performance data sections of a more comprehensive submission, which are absent here.

The document does state that the device "conforms to the applicable requirements of 21 CFR section 1010 (Performance Standards for Electronic Products: General) and 21 CFR sections 1040.10 and 1040.11 (Performance Standards for Light-Emitting Products)." However, these are general regulatory compliance statements rather than specific acceptance criteria for a device's clinical performance.

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The device is indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.

Klaser is an infrared therapy device, composed of emitter, software, probe for the delivery of light and an on/off button to activate and deactivate the infrared emission.

The provided documentation for the K-Laser Heat Lamp (K050070) does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices.

Here's an breakdown based on the provided text, addressing your points:

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

Summary of Device Performance: The primary claim of performance is that the K-Laser functions identically to established predicate devices (ALT Laser, Model VTR 75; Vectra Genisys Laser System; Solaris D890) for the specified indications for use, and it adheres to relevant electrical and light-emitting product performance standards and quality system regulations. There is no specific performance data presented in terms of efficacy metrics (e.g., how much pain reduction, how much blood circulation increase). The "performance" is implicitly deemed acceptable because it directly mirrors that of already cleared devices.

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

• None provided. The document does not describe a clinical study with a test set of patients or data. The submission relies on substantial equivalence to predicate devices, not de novo clinical testing for performance.

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. No test set or ground truth establishment by experts is described in this 510(k) summary.

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

• Not applicable. No test set or adjudication method 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. This document is for an infrared therapy device, not an AI-assisted diagnostic tool.

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

• Not applicable. This is not an algorithm-based device. Its "performance" is its ability to emit infrared radiation for therapeutic purposes, which is demonstrated by its technical specifications and compliance with standards, and its similarity to predicate devices already cleared for similar applications.

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

• Not explicitly defined as "ground truth" in the context of a new study. The "ground truth" for the K-Laser's safety and effectiveness relies on the prior clearance of its predicate devices and its adherence to established performance standards for electronic and light-emitting products. The manufacturer also highlights their robust Quality Management System.

8. The sample size for the training set

• Not applicable. This device is not developed using machine learning or AI models with training sets.

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

• Not applicable. This device is not developed using machine learning or AI models with training sets.

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