(67 days)
The device provides instant hot treatment used for first aid purposes to reduce local pain and discomfort.
INSTANT HOT PACK
This K963768 510(k) submission for the "INSTANT HOT PACK" from KIck Ice, Inc. is a very basic submission for a low-risk device that was on the market for a long time prior to this submission (32 years). As such, it does not contain the kind of detailed performance study data, acceptance criteria, and ground truth establishment information typically required for more complex or novel medical devices.
The submission is claiming substantial equivalence to an existing device (Jack Frost Laboratories Instant Hot Pack). The key argument for safety and effectiveness is the device's long history of use. Therefore, the information you're requesting regarding acceptance criteria, specific study details, sample sizes, and ground truth establishment is not applicable to this particular 510(k) submission.
Here's a breakdown based on the provided text, indicating why your requested information is not present:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This 510(k) does not define specific performance metrics or quantitative acceptance criteria (e.g., temperature range, duration of heat, material strength). Its equivalency claim is based on the long history of safe and effective use of this type of device, rather than a new performance study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No specific test set or clinical study is described. The "data provenance" mentioned is the 32 years of market history, implying real-world usage data rather than a controlled study.
3. 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. No ground truth establishment process for a test set is described. The "ground truth" for this device's safety and effectiveness relies on its established use over decades.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication process is mentioned.
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 simple medical product (instant hot pack), not an AI-driven diagnostic or treatment technology. No MRMC study was performed or needed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithmic or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the safety and effectiveness of this device, as presented in this 510(k), is historical market performance and widespread acceptance of hot therapy. The submission states: "This type of hot therapy application has been on the market for approximately 32 years and has proven to be a safe and effective for giving medical attention wherever heat therapy is way indicated." This is essentially an appeal to established clinical utility and a long history of positive outcomes with similar products.
8. The sample size for the training set
- Not Applicable. No training set for an algorithm is involved.
9. How the ground truth for the training set was established
- Not Applicable. No training set or ground truth establishment for an algorithm is involved.
Summary:
The provided 510(k) is a straightforward substantial equivalence submission for a simple, well-understood, and long-standing medical device. It relies heavily on the historical context and established safety and effectiveness of the device type rather than presenting new, detailed performance study data. The kind of rigorous clinical trial, AI performance metrics, or ground truth establishment you're asking about are typically reserved for novel devices, diagnostics, or AI/software-as-a-medical-device (SaMD) products, which this hot pack is not.
§ 890.5710 Hot or cold disposable pack.
(a)
Identification. A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.(b)
Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.