(154 days)
The Bio-Mat is indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis; the temporary relief of muscle spasms, minor sprains and strains, and minor muscular back pain; the relaxation of muscles; and the temporary increase of local circulation where applied.
The Bio-Mat is an electrically powered mattress pad that applies infrared heat to the user's body for the temporary relief of minor body aches and pains. A control panel allows the user to turn the product on/off, modify the temperature, and set the product's timer.
The provided document is a 510(k) summary for the RichWay International, Inc.'s Bio-Mat 2000, an infrared heat pad. The performance data section refers primarily to safety and functionality testing, not a clinical study proving therapeutic effectiveness against specific acceptance criteria for a medical condition.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not applicable or estimable from this document. The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and safety testing.
Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for therapeutic efficacy for specific clinical endpoints (e.g., pain reduction scores, range of motion improvements). Instead, it relies on the device functioning "as intended" and passing safety/durability tests.
| Acceptance Criteria (Therapeutic Efficacy) | Reported Device Performance |
|---|---|
| Not explicitly defined for therapeutic efficacy in this document. The primary criteria described are related to safety and functional performance. | "In all instances, the Bio-Mat functioned as intended, and passed the UL (Underwriters Laboratories) detailed/extensive tests (see Attachment 18A). These tests included the function, performance, safety, and durability of the Bio-Mat." |
Study Information
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Sample size used for the test set and the data provenance:
- Sample Size: "A total of 70 Bio-Mats were eventually sent to the Underwriters Laboratories which indicates how complete the testing was." This sample size refers to the number of devices tested for safety and functionality, not a patient test set for therapeutic efficacy.
- Data Provenance: The testing was conducted by Underwriters Laboratories (UL). The document doesn't specify the country of origin of the data beyond this. It's an engineering/safety test, not a clinical study on human subjects, so retrospective/prospective distinction for a patient test set is not applicable.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this was not a clinical study involving experts establishing ground truth for patient outcomes. The "ground truth" for the device's functional and safety performance relied on UL's testing protocols and standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this was not a clinical study involving human assessment or adjudication of patient outcomes.
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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 heat pad, not an AI-assisted diagnostic or therapeutic device that would involve human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-only medical device. The "performance" refers to the device's electrical, thermal, and mechanical safety/functionality.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance data in this submission is compliance with established safety and functional standards, specifically those of Underwriters Laboratories (UL). This is a technical/engineering ground truth, not a clinical one.
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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 or a clinical trial with a training phase.
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How the ground truth for the training set was established:
- Not applicable for the reasons stated above.
In summary: The provided 510(k) summary for the Bio-Mat 2000 focuses on demonstrating the device's safety, functionality, and substantial equivalence to legally marketed predicate devices through technical testing by Underwriters Laboratories. It does not present detailed clinical study data with specific acceptance criteria, patient test sets, or ground truth establishment relevant to therapeutic efficacy, which is often a feature of submissions for different types of medical devices or higher-risk classifications.
§ 890.5740 Powered heating pad.
(a)
Identification. A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.