(47 days)
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.
§ 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.