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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.

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The device provides instant cold treatment used for first aid purposes to reduce minor local pain, swelling and discomfort.

The Kick Ice pack consists of a bag containing Ammonium Nitrate and a liquid bubble bag containing water. The Ammonium Nitrate in the water produces a chemical reaction- When pressure is applied to the inner bubble through the outer bag the inner bubble of water opens up mixing it with the Ammonium Nitrate thereby producing cold. The material for the bag will consist of either polyester, or laminated polyethylene.

The provided 510(k) summary for the "Kick Ice" Instant Cold Pack is a regulatory document seeking market clearance, not a scientific study describing performance against acceptance criteria in the manner of an AI/ML medical device submission.

Therefore, the requested information (acceptance criteria table, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, training set specifics) is not applicable to this type of device and submission.

Here's why and what can be inferred from the provided text:

• Device Type: The "Kick Ice" Instant Cold Pack is a chemical-based cold therapy device, not an AI/ML-driven medical device. Its function is purely mechanical and chemical (mixing chemicals to generate cold), not involving data analysis, image interpretation, or diagnostic algorithms.
• 510(k) Summary Purpose: A 510(k) summary's primary purpose is to demonstrate substantial equivalence to a legally marketed predicate device. This is typically achieved by comparing design, materials, intended use, and performance characteristics (where relevant, e.g., temperature range for a cold pack) to established products. It does not typically involve the extensive clinical trial or performance validation studies seen for AI/ML or high-risk diagnostic devices.
• Lack of Performance Data: The summary states: "The device provides instant cold treatment used for first aid purposes to reduce minor local pain, swelling and discomfort." This is a statement of intended function, not a quantifiable performance metric with an associated acceptance criterion. There are no numerical performance data (e.g., cooling rate, minimum temperature, duration of cold) provided in this summary.
• "Equivalency is being claimed": This phrase is key. It indicates the 510(k) submission relies on demonstrating similarity to existing devices (ACE Brand Instant Cold Pack, 3M, and Jack Frost) rather than presenting novel performance data from a new study against specific acceptance criteria. The assumption is that if it's equivalent to predicate devices, and those predicates are safe and effective, then the new device is also safe and effective.

In summary, none of the requested points regarding acceptance criteria, study details, expert consensus, MRMC studies, or AI/ML-specific validation methods are present or applicable to this particular 510(k) submission. The document is for a simple, physical medical device relying on chemical reaction, not a complex diagnostic or intervention system.

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