(92 days)
TempStat" is a daily activity assist device that is intended to assist a patient to visualize the image and condition of the soles of their feet in connection with a daily self-examination for signs of inflammation on the sole of the foot. TempStat" will assist the patient in determining when they should contact their healthcare provider for further diagnosis and treatment regarding any skin changes seen by a mirror and/or highlighted by the liquid crystal foot pads. TempStat™ is intended to be used as an adjunct to, and not in replacement of, periodic foot care and examinations conducted by a health care professional and used under the direction of a health care professional and does not diagnose any specific disease state.
The Visual Footcare Technologies TempStat® device is a daily activity assist designed to make the examination of the plantar surface of the foot simple and easy to accomplish. It consists of a plastic pancl that has a 2X convex mirror in the center third scction, with two polycarbonate plastic pads on either side of the mirror. The plastic pads are contructed primarily of liquid crystallinc cholesteric esters that react to skin surface temperature and change to a specific color relative to that level of temperature. With this device, the patient can visually examine his foot and also see a graphical representation of the heat pattern on the plantar solc of his foot. The device is designed to sit on the floor in front of the patient, who is seated in a chair. The patient leans over and raises his foot to see the bottom of his foot in the mirror, and then places them on the polycarbonate pads. After 60 seconds, the patient can remove his feet and can visualize the pattern of skin tempcrature from the plantar surface of his foot.
The Visual Footcare Technologies, LLC TempStat™ device, as described in the 510(k) summary, includes performance testing centered on the accuracy of its liquid crystal pads and its ability to assist patients in visualizing their foot's plantar surface. Here's a breakdown based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Liquid Crystal Pad Temperature Accuracy: The liquid crystal pads must accurately reflect skin surface temperature changes. (Implicitly, the device should provide reliable temperature indications for detecting signs of inflammation). | The TempStat™ liquid crystal pads are accurate within 1ºF with respect to color changes, as assessed following Section 5.2 of the ASTM E 1061-01 Standard. |
| Patient Assistance in Visualization: The device should effectively assist subjects in visualizing the plantar surface of their feet. (Implicitly, users should find the device helpful for self-examination). | All study subjects in a patient preference study felt that the TempStat™ device enhanced their ability to visualize the plantar surface of their feet. |
Detailed Study Information
The provided 510(k) summary offers limited detail on the specific study methodologies for each criterion. Based on the available information:
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Sample size used for the test set and the data provenance:
- Temperature Accuracy Study: Not explicitly stated. The study references ASTM E 1061-01 Standard, which might specify sample sizes for such tests, but this detail is not present in the 510(k).
- Patient Preference Study: Not explicitly stated. The text says "All study subjects felt...", which implies a sample was used, but the number is not provided.
- Data Provenance: Not explicitly stated, but given it's for a US regulatory submission, it's highly likely to be US data, and given the nature of the device, likely prospective studies (i.e., experiments designed to test the device).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Temperature Accuracy Study: No experts were mentioned for establishing ground truth for the temperature accuracy. The ground truth would likely be established by a calibrated reference thermometer or laboratory equipment against which the device's color changes are compared, as per ASTM E 1061-01.
- Patient Preference Study: No experts were described as establishing ground truth. This type of study relies on direct feedback from the "study subjects" themselves regarding their perception of the device's utility in visualization, rather than an expert's assessment of their visualization ability.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not specified for either study.
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If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The studies focused on functional accuracy and user preference rather than reader performance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Temperature Accuracy Study: This would be considered a standalone performance test of the device's physical components (liquid crystal pads) to accurately reflect temperature. It assesses the intrinsic accuracy of the temperature display mechanism.
- Patient Preference Study: This involved human interaction ("study subjects" viewing their feet), so it was not standalone in the sense of "algorithm only."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Temperature Accuracy Study: The ground truth was likely established by reference to a calibrated temperature standard (e.g., a precise thermometer) as implied by the ASTM E 1061-01 standard.
- Patient Preference Study: The "ground truth" was the self-reported perception of the study subjects regarding the device's assistance in visualization.
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The sample size for the training set: Not applicable, as this device does not use machine learning algorithms that would require a training set. Its functionality is based on physical properties of liquid crystals and mirror optics.
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How the ground truth for the training set was established: Not applicable, as there is no training set for this device.
§ 890.5050 Daily activity assist device.
(a)
Identification. A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. If the device is not labeled or otherwise represented as sterile, the device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.