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The UIS Non-Contact Thermograph System is an ophthalmic imaging device that stores, archives, and manipulates digital images of ocular surface temperature measurements taken by a physician in adult patients.

The ocular surface temperature is measured by the thermal sensor of the thermograph system. The subject places his/her chin and forehead to the measuring bracket. Keep both eyes on the camera of the thermograph system. Listen to the voice instruction to close and open his/her eyes for recording the temperature variation of his/her ocular surface.

The provided text is a 510(k) summary for the United Integrated Non-Contact Thermograph System Model IT-85. This document primarily focuses on establishing substantial equivalence to a predicate device (LipView Ocular Surface Interferometer K091935) and provides general information about the device and its intended use. It does not contain information about acceptance criteria, device performance studies, or details regarding test sets, ground truth establishment, or sample sizes for performance evaluation.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory filing for market clearance, not a performance study report.

If you have a document that details the performance study for this device, please provide it, and I would be happy to analyze it for the information you've requested.

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The Multi-Channel Laser Therapy System (Model no.: LA-1200) is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and the joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.

The Multi-Channel Laser Therapy System LA-1200 is a noninvasive, portable therapeutic medical laser designed to deliver light energy to the target tissue. It is intended to emit energy in the infrared spectrum for the purpose of temporary relief of minor muscle and the joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles. LA-1200 is the low level laser of two wave bands. One is 660nm (red light, visibility) and the other is 808nm (infrared light, invisibility). LA-1200 contains twelve (12) channels of laser. For each channel of the Multi-Channel Laser Therapy System, LA-1200 makes use of cup + laser diode assembly hand-held to deliver the light energy to the designated treatment areas. The cup_ + laser diode assembly are put on the skin for treatment.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Multi-Channel Laser Therapy System, Model LA-1200:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states that "bench testing was also performed." However, it does not specify the sample size used for this testing. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective, beyond simply being "bench testing."

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 a ground truth for the test set. The validation appears to be based on direct physical measurements of temperature during bench testing.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned, as the validation was based on direct physical measurements rather than expert review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size:

No MRMC comparative effectiveness study was mentioned. The study described is bench testing of the device's physical performance, not a study comparing human readers with and without AI assistance.

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

The device is a physical therapeutic laser system, not an algorithm. Therefore, the concept of a "standalone" or "algorithm-only" performance study is not applicable in this context. The described bench testing assesses the standalone performance of the physical device.

7. The Type of Ground Truth Used:

The ground truth used was direct physical measurement (temperature readings) during bench testing.

8. The Sample Size for the Training Set:

This device is not an AI/ML algorithm that requires a training set. Therefore, this information is not applicable.

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

As there is no training set for an AI/ML algorithm, this information is not applicable.

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The Multi-Channel Laser Therapy System (Model no.: LA-400) is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and the joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.

The Multi-Channel Laser Therapy System LA-400 is a noninvasive, conamic casel Therapy System LA-400 is a not deliver light energy to the target tissue. It is intended to emit energy in the infrared spectrum for the purpose of temporary relief of minored spectrum for the purpos temporary relief of minor muscle and the joint pain associated with arthritis, for the temporary increase in local circulation where arthritis, for the temporary increase in le l Lacer The (Model no.: LA-400) is interapy System infrared spectrum to provide to emit energy in the infrared spectrum to provide topical heating for the of elevating tissue temporature for the purpose of elevating tissue temperature for the temporary relief of temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied minor muscle and the joint pain and stiffness, for the temporary relia temporary relief of miner in in in in the LA-400 is the low level laser of two wave bands. One is 660nm (red light, visibility) and the other is 808nm (infrared light, invisibility). LA-400 contains four (4) channels of laser. For each channel of the Multi-Channel Laser Therapy System , LA-400 makes use of cup + laser diode assembly hand-held to deliver the light energy to the designated treatment areas. The cup + laser diode assembly are put on the skin for treatment. Note A : Basic operation and treatment of LA-400 is utilizing the laser module mounted in the cup (we call laser module cup) which will be hand-held and put on skin easily.

The provided 510(k) summary for the Multi-Channel Laser Therapy System, Model no.: LA-400, focuses on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, and conformance to safety and EMC standards. It does not contain information about a clinical study involving human participants, performance metrics like sensitivity or specificity, or any form of a multi-reader multi-case (MRMC) study.

Therefore, many of the requested sections regarding acceptance criteria and a study proving those criteria cannot be directly answered from the provided text. The "performance summary" in this document refers to compliance with engineering and safety standards, not a clinical performance study in the way typically associated with diagnostic or AI-powered devices.

Here's a breakdown of what can be extracted and what cannot:

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

The acceptance criteria and reported "performance" for this device, as described in the 510(k) summary, are related to its adherence to electrical safety and electromagnetic compatibility (EMC) standards, not clinical efficacy or diagnostic accuracy.

2. Sample size used for the test set and the data provenance

Not applicable. No clinical test set data is described in this 510(k) summary. The performance summary refers to bench testing for conformance to standards, not a clinical study with human subjects.

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

Not applicable. There is no mention of a test set requiring expert ground truth in this submission.

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

Not applicable. There is no mention of a test set requiring adjudication in this submission.

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. A multi-reader multi-case (MRMC) comparative effectiveness study was not done, as this is a laser therapy system for pain relief, not a diagnostic imaging device typically associated with such studies. The device does not involve AI or human "readers."

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

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

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

Not applicable. No clinical ground truth data is discussed for this device in the provided text. The "ground truth" for this submission revolves around compliance with established engineering and safety standards for medical devices and demonstration of similar intended use and technology to a legally marketed predicate device.

8. 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.

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

Not applicable. There is no mention of a training set or ground truth for one.

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