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The Allegiance Kwik Kold™ Peri Cold Pack is an over-thecounter, single-use, non-sterile device. It is a cold therapy pack intended to be used post delivery to absorb postpartum lochea while providing cold therapy relieving edema and inflammation associated with an episiotomy incision.

The Allegiance Kwik Kold™ Peri Cold Pack is comprised of a multi layer pouch which is secured to a perineal pad and then wrapped in a one ply polyester material The cold source pouch consist of ammonium nitrate and water. The water "bubble" is housed in a separate plastic pouch surrounded by ammonium nitrate. The perineal pad is made of a non-woven wrapped cellulose wood pulp fiber. Activation of the cold source occurs by folding and shaking the unit, thus resulting in a cooled solution from an endothermic reaction lasting approximately 30 to 35 minutes with a coldest temperature of approximately 33° F.

This document appears to be a 510(k) summary for a medical device, the Allegiance Kwik Kold™ Peri Cold Pack, rather than a study report describing the acceptance criteria and performance of an AI/ML powered medical device. Therefore, the information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) is not available in the provided text.

The provided text focuses on demonstrating substantial equivalence to predicate devices and describes basic physical and biological safety testing for the cold pack itself.

However, I can extract the information that is present:

1. A table of acceptance criteria and the reported device performance

Notes on the Acceptance Criteria:

• The document implies that the acceptance criteria for "coldest temperatures achieved are comparable" and "performance attributes are equal" to predicate devices. The specific acceptable range or threshold for these characteristics (e.g., darkest comfortable temperature, duration of cold) is not explicitly defined in a quantitative manner but is stated as "comparable" or "equal" to predicate devices.
• For biological tests (skin sensitization, irritation, cytotoxicity), the acceptance criteria are "passed" as per ISO 10993 Part 1.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided text, as this is a safety and effectiveness summary for a physical medical device, not an AI/ML 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)

This information is not available in the provided text. Ground truth as typically understood in AI/ML contexts is not relevant for this device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available in the provided text.

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

This information is not available in the provided text, as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not available in the provided text, as this is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this physical device, the "ground truth" for the performance characteristics like temperature and duration was established through physical testing and measurements (e.g., using thermometers, stopwatches) in a laboratory setting. For biological compatibility, the "ground truth" was established by standardized biological testing (e.g., guinea pig maximization, in vitro cytotoxicity assays) as per ISO 10993 Part 1.

8. The sample size for the training set

This information is not available in the provided text. This device does not use a "training set" in the AI/ML sense.

9. How the ground truth for the training set was established

This information is not applicable as there is no "training set" for this physical device.

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