(152 days)
The InCare HOT/ICE Lite Machine is intended to provide cold therapy to body surfaces by pumping and circulating chilled water through a plastic blanket that has been secured to the patient's anatomy.
The InCare HOT/ICE Lite Machine incorporates state of the art technology with solid state electronics. The device is designed to deliver cold therapy to a localized area. This is accomplished by circulating cold water through a plastic blanket or bag that has been secured to the patient's anatomy. The device is intended to be used in an institution or home environment.
Here's an analysis of the provided text regarding the acceptance criteria and study for the InCare HOT/ICE Lite Machine:
The provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria through extensive clinical studies. As such, many of the typical elements you'd expect for AI/ML device studies (like expert consensus, ground truth for training data, MRMC studies) are not present.
Here's the breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) summary for a physical medical device, "acceptance criteria" here are implicitly linked to the technical characteristics of the predicate devices. The performance testing section describes a functional evaluation rather than defining specific statistical metrics for clinical performance.
| Feature/Metric (Implicit Acceptance Criteria - based on predicate devices) | Reported Device Performance (InCare HOT/ICE Lite) |
|---|---|
| Intended to provide cold therapy to body surfaces | Yes |
| Solution Flow Rates (GPH) | 4 GPH (nominal) |
| Operating Pressure (PSI) | 3.5 PSI (nominal) |
| Liquid media | Water / Alcohol |
| Liquid Capacity | 500 ml (350 ml Water + 150 ml Alcohol) |
| Therapy temperature range | 50° to 72° F (10° to 22° C) |
| Weight | approx 7.1 lbs |
| Power Supply | 120VAC, 136 watts, 50/60Hz |
| Ability to reduce patient skin temperature | Demonstrated (results indicated reduction) |
Note on Acceptance Criteria: The document doesn't explicitly state quantitative acceptance criteria for "ability to reduce patient skin temperature" (e.g., "reduce skin temperature by X degrees within Y minutes"). Instead, it states that "The results indicated that the InCare HOT/ICE Lite Machine in its ability to reduce patient skin temperature." This suggests a qualitative or demonstrative acceptance rather than a statistically defined threshold. The primary acceptance criteria for a 510(k) are typically that the device is substantially equivalent in terms of safety and effectiveness to legally marketed predicate devices, which is assessed by comparing technological characteristics and, if necessary, performance data.
Study Information for InCare HOT/ICE Lite Machine
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document states "the InCare HOT/ICE Lite Machine with a HOT/ICE blanket was evaluated for its ability to cool the test subjects skin." It does not mention how many "test subjects" were involved.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). Given the context of a 510(k) for a physical device, it's likely a controlled, prospective in-lab or limited clinical test.
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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/Not specified. This device is not an AI/ML diagnostic tool where expert ground truth is typically established for image interpretation. The "ground truth" here would be the actual skin temperature measurements.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/None. Adjudication methods are typically used for disagreements in expert interpretation of complex data (e.g., medical images, pathology slides) to establish a consensus ground truth. Here, the "truth" is direct physical measurement (skin temperature).
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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
- No. This is not an AI/ML device that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not an AI/ML algorithm. The "performance" assessment was for the device's functional capability to cool skin. Therefore, the equivalent would be a standalone device performance test, which was done ("The InCare HOT/ICE Lite Machine with a HOT/ICE blanket was evaluated for its ability to cool...").
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance test appears to be direct measurement (skin temperature) recorded by a temperature probe on the skin surface.
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The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that requires a training set.
§ 890.5720 Water circulating hot or cold pack.
(a)
Identification. A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.