(16 days)
The DeRoyal Industries Inc. Infant Transport Mattress is to be used to assist in maintaining infant body temperature.
The DeRoyal Industries, Inc. Infant Transport Mattress is a device intended for medical purposes to provide warm therapy that helps maintain infant body temperature. Device Design/Materials UsedPhysical Properties: The DeRoyal Infant Transport Mattress is designed similar to those marketed by other manufacturers. The pouch is comprised of a low-density polyethylene (LDPE) film bag which contains the activation ingredient, sodium acetate (food grade).
The provided text describes a 510(k) summary for the DeRoyal Industries, Inc. Infant Transport Mattress, a medical device for providing warm therapy to infants. However, it does not include detailed information about acceptance criteria, specific studies, sample sizes, expert involvement, or ground truth establishment for a device performance study.
The document is a premarket notification (510(k)) indicating that the device is "substantially equivalent" to legally marketed predicate devices. The primary focus of a 510(k) submission is to demonstrate this substantial equivalence through a comparison of technological characteristics and intended use.
Here's a breakdown of what can be inferred from the provided text and why the requested information is largely absent:
1. A table of acceptance criteria and the reported device performance:
The document implicitly uses the performance of the predicate device as an acceptance criterion for the DeRoyal device's key characteristic: temperature achieved at activation.
| Characteristic | Acceptance Criteria (based on predicate) | Reported Device Performance (DeRoyal) |
|---|---|---|
| Approximate Temperature Achieved at Activation | 104° F | 105° F |
Explanation: The comparison table explicitly states that the predicate device achieves "104° F" for approximate temperature at activation. The DeRoyal device reports achieving "105° F". This indicates that the DeRoyal device meets or exceeds the temperature performance of the predicate. Other characteristics are primarily comparisons of materials and dimensions, not performance metrics with explicit acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not provided. The document does not mention any specific test sets, sample sizes, or data provenance from a performance study. The "test" here refers to a comparison against a predicate, not a clinical trial or extensive standalone performance study with a dedicated test set as you might see for a more complex device.
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/Not provided. No "ground truth" in the sense of expert consensus on clinical findings is discussed. The assessment is primarily based on comparing the physical and functional characteristics of the DeRoyal mattress to a known, legally marketed predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/None mentioned. There's no indication of an adjudication process for a test set. The review process is by the FDA, determining substantial equivalence.
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 an infant transport mattress, not an AI-powered diagnostic tool. MRMC studies are used for assessing diagnostic performance, typically for imaging devices with human reader involvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical product for warmth, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Implicitly, the performance of the legally marketed predicate device. For a 510(k) submission like this, "ground truth" for demonstrating safety and effectiveness often comes from the established performance and safety record of the predicate device. The DeRoyal device aims to show it is at least as safe and effective as the predicate, not necessarily to establish new clinical efficacy against a "true" medical condition outcome.
8. The sample size for the training set:
Not applicable/Not provided. There is no "training set" as this is not an AI/machine learning device. The design and materials are based on existing technology and knowledge.
9. How the ground truth for the training set was established:
Not applicable/Not provided. No training set exists for this type of device and submission.
In summary:
The provided document details a 510(k) submission for a simple medical device. The "study" referenced is the comparison of the DeRoyal Infant Transport Mattress to a legally marketed predicate device (Prism Technologies). The "acceptance criteria" are implicitly that the DeRoyal device must be substantially equivalent to the predicate in terms of materials, design, intended use, and performance characteristics (like achieving a similar therapeutic temperature). Since this is a comparison for substantial equivalence, formal clinical trials with extensive test sets, expert ground truth establishment, or AI-specific studies are not typically part of such a submission. The FDA's letter confirms that based on the provided information, the device was deemed substantially equivalent.
§ 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.