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All four devices are indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the MR4 Multi Radiance Therapy System and its accessories. This type of document establishes substantial equivalence to a predicate device and permits marketing. It outlines the regulatory classification and general controls.

However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.
Specifically, the requested information about device performance, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details is completely absent from the provided text.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the given input, as the necessary information is not present.

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The TerraQuant MQ2000 v.5 with the TQ-1TENS is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated, as well as for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.

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While the provided document is a 510(k) clearance letter for a medical device (TerraQuant MQ2000 v.5 with TQ-1TENS), it does not contain the information requested about acceptance criteria and a study proving the device meets those criteria.

This letter is an FDA determination of "substantial equivalence" to a legally marketed predicate device, allowing the manufacturer to market the device. It focuses on regulatory compliance and does not describe the specific performance studies, acceptance criteria, or ground truth establishment that might have been part of the manufacturer's submission to support their claims.

Therefore, I cannot populate the table or answer the subsequent questions based solely on the provided text. The document acts as an approval, not a detailed technical report of the device's performance validation.

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The Terraquant MQ2000 v.5 and HandyRx MQ2007 Lasers are non-invasive infrared lamps intended to provide topical heating. The Terraquant MQ2000 v.5 and HandyRx Laser MQ2007 Lasers are indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

The Escada Terraquant MQ2000 Laser Therapy Device has been modified resulting in the Terraquant MQ2000 v.5 and HandyRx MQ2007 Lasers. The Terraquant MQ2000 was modified to increase the power level range for the laser from .4 to 1.4 mW to .4 to 7.5 mW and to provide the device in a hand held configuration. The proposed Terraquant MQ2000 v.5 (increased power but same configuration as Terraquant MQ2000) and the HandyRx MQ2007 (increased power level in a hand held configuration) are essentially identical in intended use and fundamental technology to the parent Terraquant MQ2000 Laser Therapy Device described in K043055. As with the original Terraquant MQ2000 system, the Terraquant MQ2000 v.5 and HandyRx MQ2007 System utilize heating lamps consisting of a laser diode, infrared diodes, and a visible red light emitting diodes (LED). It combines the clinically accepted therapeutic treatment of numerous predicate light therapy systems currently in commercial distribution into one complete, compact system.

The parent Terraquant MQ2000 system and the Terraquant MQ2000 v. 5 consist of a desktop control unit, and a hand-held emitter from which the laser and other radiances are released, and a 110 V power adaptor. The proposed HandyRx MQ2007 consists of only the handheld emitter from which the laser and other radiances are released. Both the parent and proposed device laser and light therapies release radiation with wavelengths that fall within the range as defined in 21 CFR 890.5500 for an infrared lamp.

Under its 510(k) summary, Escada International, Inc. describes the acceptance criteria and the study that proves the Terraquant MQ2000 v.5 and HandyRx MQ2007 Lasers meet the acceptance criteria:

1. Table of acceptance criteria and the reported device performance:

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

   • Sample Size: Not specified beyond "human subjects."
   • Data Provenance: The study was conducted on "human subjects," implying prospective, clinical testing. The country of origin is not mentioned.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. The ground truth was based on direct temperature measurement, not expert consensus or interpretation.

4. Adjudication method for the test set: Not applicable. The study involved direct measurement of skin temperature.

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 device is a heating lamp, not an AI-powered diagnostic tool requiring human reader studies.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The "device performance" described is essentially standalone, demonstrating the device's ability to achieve and maintain target temperatures without human intervention beyond initial setup.

7. The type of ground truth used:

   • Ground Truth: Direct measurement of skin surface temperature in human subjects. The target temperature range of 40-45°C (104-113°F) was specified by the FDA.

8. The sample size for the training set: Not applicable. This device's performance was evaluated through direct physical measurements rather than a machine learning model requiring a training set.

9. How the ground truth for the training set was established: Not applicable, as there was no training set for an algorithm.

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The TerraQuant MQ2000 is a non-invasive infrared lamp intended to provide topical heating. The Terraquant MQ2000 is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

The TerraQuant MQ2000 is a non-invasive pain therapy system, which utilizes heating lamps consisting of laser, infrared, and visible red light emitting diodes (LED). It combines the clinically accepted therapeutic treatment of numerous predicate light therapy systems currently in commercial distribution into one complete, compact system.

The TerraQuant MQ2000 system consists of a desktop control unit, a hand-held emitter from which the laser and other radiances are released, and a 110 V power adaptor. The laser and light therapy releases radiation with wavelengths that fall within the range as defined in 21 CFR 890.5500 for an infrared lamp.

The provided text is a 510(k) Summary for the TerraQuant MQ2000 Laser Therapy Device, seeking substantial equivalence to a predicate device. It describes the device's intended use and technological characteristics but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot populate the requested table or answer the specific questions about studies, sample sizes, and ground truth based on the provided text.

The document indicates that the basis of approval was a "Predicate Device (PD)", implying substantial equivalence was established by comparing its technological characteristics and intended use to an already legally marketed device, not through new clinical trials or performance studies with specific acceptance criteria that would generate the kind of data requested.

Summary based on the provided text:

• Acceptance Criteria and Reported Device Performance: Not provided in the document. The clearance is based on substantial equivalence to a predicate device, not on specific performance metrics or acceptance criteria from a study.
• Sample size for the test set and data provenance: Not applicable. No test set or performance study data is described.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. No ground truth was established for a test set described in this document.
• Adjudication method for the test set: Not applicable. No test set is described.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This document does not describe any MRMC study.
• If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a laser therapy system, not an algorithm.
• The type of ground truth used: Not applicable. No ground truth data is mentioned for this 510(k) submission.
• The sample size for the training set: Not applicable. No training set is mentioned as this is a physical device, not an AI/ML algorithm.
• How the ground truth for the training set was established: Not applicable.

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