(175 days)
Hot disposable pack intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot therapy for body surfaces.
The Porta-Warm™ Mattress consists of a heat source housed in a plastic pouch. The heat source pouch consists of a supercooled solution of sodium thiosulfate, dextrose and water. The sodium thiosulfate, dextrose and water "bubble" is housed in a separate plastic pouch inside the outer pouch. Activation of the heat source occurs by folding the unit to open the inner bubble which releases the liquid, thus creating a physical exothermic reaction.
The provided document (K98657) is a 510(k) submission for the Allegiance Porta-Warm™ Mattress, a hot therapy pack. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a detailed study format. Therefore, several aspects of your request, such as a formal table of acceptance criteria with reported performance values, specific sample sizes for test sets, expert-established ground truths, and MRMC studies, are not explicitly provided in this type of regulatory document.
However, I can extract the information that is available within the document regarding testing and how equivalence was established.
Here's a breakdown of the available information based on your request:
Acceptance Criteria and Device Performance
Due to the nature of a 510(k) submission for a predicate device, explicit acceptance criteria with numerical performance targets are not detailed. Instead, the document establishes substantial equivalence based on material composition, performance attributes, and intended use.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criteria Category (Inferred) | Specific Criteria (Inferred from Predicate Equivalence) | Reported Device Performance / Justification |
|---|---|---|
| Chemical Composition | Must be the same as the predicate devices (Preamendment Porta-Warm™ Mattress and Allegiance Infant Heel™ Warmer). | "the chemical composition is the same" (for both internal heat source and general materials). Active chemical ingredient (Sodium Thiosulfate) meets Food Chemicals Codex, 3rd Ed. (1981), p. 304 specifications (21 CFR 184.1807) and all food grade requirements. |
| Performance Attributes | Must be the same as the predicate devices (Preamendment Porta-Warm™ Mattress and Allegiance Infant Heel™ Warmer for active chemical ingredients; Preamendment Porta-Warm™ Mattress and Prism Technologies, Inc. Transwarmerl™ for overall performance). | "performance attributes of active chemical ingredients are the same." "performance attributes are the same." Physical tests completed include: "temperature performance" and "tensile strength tests." (No specific numerical results for these tests are provided in the summary, implied acceptable.) |
| Method of Activation | Must be the same as the predicate devices (Preamendment Porta-Warm™ Mattress and Allegiance Infant Heel™ Warmer). | "method of activation is the same" (folding to open inner bubble, releasing liquid, creating exothermic reaction). |
| Intended Use | Must be the same as the predicate devices (Preamendment Porta-Warm™ Mattress and Prism Technologies, Inc. Transwarmerl™). | "intended use is the same" (single-use, non-sterile heat therapy pack for medical purposes providing hot therapy for body surfaces). |
| Biocompatibility | Materials must be biologically safe for skin contact, as per ISO Standard 10993 Part 1. Active chemical mixture must be safe for intended usage. | Materials were "identified, evaluated and tested as required in ISO Standard 10993 Part 1." Tests included: "skin sensitization, intracutaneous reactivity and cytotoxicity testing." Active chemical mixture subjected to "primary skin irritation testing." This mixture was "found to be toxicologically acceptable for its intended usage." |
| Compliance | Must comply with established standards where applicable, and be deemed acceptable for its intended use. | "This product is in compliance with established standards, where applicable, and was deemed acceptable for its intended use." (Implied compliance with 21 CFR 820 for GMP, etc., as per FDA letter). Active chemical ingredient meets Food Chemicals Codex specifications. |
Additional Information on Testing and Ground Truth:
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document states that various tests (skin sensitization, intracutaneous reactivity, cytotoxicity, temperature performance, tensile strength, primary skin irritation) were performed, but it does not provide the number of samples or units tested for each.
- Data Provenance: The tests were conducted by the manufacturer, Allegiance Healthcare Corporation. The specific country of origin of the raw data/testing is not explicitly stated beyond the manufacturer's address in Moberly, Missouri, USA and McGaw Park, Illinois, USA. The testing appears to be "prospective" in the sense that it was conducted specifically for this submission to demonstrate safety and equivalence.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. For biocompatibility and physical performance tests, the "ground truth" is typically defined by accepted laboratory standards (e.g., ISO, Food Chemicals Codex) and interpreted by qualified laboratory personnel, not by a panel of medical experts establishing a diagnostic ground truth. The document does not detail the specific experts or their qualifications involved in these lab tests, beyond implicitly assuming adequately qualified personnel.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret medical images or data. The tests described are laboratory and material science-based, not reliant on human reader interpretation in that context. Results are presumed to be objective measurements against predefined standards.
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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:
- No MRMC study was conducted or described. This device is a simple, non-AI medical product.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm or AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission relies on established scientific and regulatory standards:
- Chemical Composition: Conformance to Food Chemicals Codex specifications (e.g., Sodium Thiosulfate on page 1).
- Biocompatibility: Conformance to ISO Standard 10993 Part 1 (skin sensitization, intracutaneous reactivity, cytotoxicity, primary skin irritation).
- Physical Performance: Conformance to internal specifications for "temperature performance and tensile strength tests" (no numerical details provided).
- Substantial Equivalence: Direct comparison to already legally marketed predicate devices for chemical composition, performance attributes, method of activation, and intended use.
- The "ground truth" for this submission relies on established scientific and regulatory standards:
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The sample size for the training set:
- Not applicable. This device is a physical product, not an AI, so there is no "training set" in the context of machine learning. The "training" could conceptually be considered the development and refinement of the manufacturing process and material selection.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/algorithm. For the development of the product, the "ground truth" for design and manufacturing would have been established through internal engineering specifications, material science principles, and regulatory requirements (e.g., Good Manufacturing Practices).
§ 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.