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The CP&S Disposable Ice Pack Limb Kit Transporter provides an environment above freezing for a severed body part while being transported to the hospital emergency room or replantation surgery.

The CP&S Disposable Instant Ice Pack Limb Kit Transporter is an instant ice pack with an added pouch for the insertion of a severed body part for transport to the hospital emergency room or replantation surgery. The Instant Cold Pack Limb Kit Transporter is activated in the same manner as the Disposable Instant Cold Pack and provides cooling for the severed limb within the gauze lined zip lock top bag. A cool environment above freezing is maintained for approximately 30 minutes. The additional pouch does not affect the safety or efficacy of the disposable Instant Cold Pack.

This submission describes a medical device, the "Instant Cold Pack Limb Kit Transporter," which is essentially an instant cold pack with an added pouch for transporting severed body parts. The key claim is that it maintains a cool, above-freezing environment for approximately 30 minutes, which is crucial for limb preservation.

Here's an analysis of the acceptance criteria and the study as described in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify a sample size for a test set or data provenance. The "study" mentioned appears to be an internal verification (Attachment C) and a reference to general medical studies (Attachment D) rather than a formal pre-market clinical study on this specific device with a defined test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The provided text does not mention using experts to establish ground truth for a test set related to the device's performance. The "ground truth" for the medical necessity of above-freezing temperatures for severed limbs is based on general medical knowledge, as implied by "studies showing that the severed limb should be stored at above freezing temperatures" (Attachment D).

4. Adjudication Method for the Test Set

No test set for expert adjudication is mentioned, therefore, no adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted. This device is a physical product designed for basic physiological effect (cooling), not a diagnostic algorithm where human-in-the-loop performance would typically be evaluated.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This device is a physical product, not an algorithm. Therefore, no standalone algorithm performance study was conducted or is applicable. The "standalone" performance here refers to the physical cold pack's ability to maintain temperature, which is described in the Acceptance Criteria table.

7. Type of Ground Truth Used

The "ground truth" referred to in the context of this submission is:

• Performance of the predicate device: The instant cold pack component's efficacy is assumed to be similar to the predicate Disposable Instant Cold Pack (K890553).
• General Medical Knowledge/Literature: Expert consensus and outcome data from existing medical literature regarding the optimal storage temperature for severed limbs, as indicated by "studies showing that the severed limb should be stored at above freezing temperatures and that proper techniques for preservation of the amputated part are important for survival" (Attachment D).

8. Sample Size for the Training Set

No training set is mentioned as this is a physical medical device, not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm.

Summary of the "Study" that Proves Acceptance Criteria:

The "study" referenced in the 510(k) submission to demonstrate the device meets acceptance criteria is primarily based on:

1. Assertion of Equivalence: The manufacturer asserts that the "Instant Cold Pack Limb Kit Transporter" is activated in the same manner as their existing "Disposable Instant Cold Pack" (predicate device K890553) and provides cooling.
2. Internal Testing/Verification (Attachment C): The text states, "A cool environment above freezing is maintained for approximately 30 minutes. (Attachment C)". This indicates some form of internal testing or verification was conducted to determine the duration of cooling and temperature maintenance. Details of this testing (methodology, number of units tested, conditions, etc.) are not provided in the summary.
3. Assertion of Non-Interference: The manufacturer states, "The additional pouch does not affect the safety or efficacy of the disposable Instant Cold Pack." This is likely based on design analysis and potentially additional testing similar to the above.
4. Reference to Established Medical Practice (Attachment D): The submission leverages existing medical knowledge, stating, "studies showing that the severed limb should be stored at above freezing temperatures and that proper techniques for preservation of the amputated part are important for survival. (Attachment D)." This supports the rationale for the device's design (maintaining above-freezing temperatures) rather than directly proving the device's performance through a clinical trial.

In essence, this 510(k) submission relies heavily on the substantial equivalence to a predicate device and internal performance claims, rather than a large-scale clinical study with a defined test set, expert adjudication, or comparative effectiveness. The "study" mentioned for performance focuses on the physical properties of the cold pack.

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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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