FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The provided documents (K970363) are a 510(k) clearance letter for the HydroTec™ Low Air Loss Therapy Bed. This kind of document typically doesn't contain a detailed report of a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study report would.

The FDA 510(k) process is primarily about demonstrating substantial equivalence to a legally marketed predicate device, not necessarily proving efficacy through new, rigorous clinical trials with detailed acceptance criteria for a new class of device. Therefore, much of the requested information (like specific acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in these specific documents.

However, based on the provided text, I can infer some information relevant to the device's intended use and the nature of product clearance:

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

No specific acceptance criteria or tabulated performance data are present in these documents. The 510(k) clearance indicates that the device is "substantially equivalent" to predicate devices, meaning it has the same intended use and similar technological characteristics, or if there are differences, they do not raise new questions of safety and effectiveness.
Intended Use (from the document): "The Apex Metal HydroTec™ is indicated for the prevention and treatment of pressure ulcers (bed sores)."

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

Not explicitly mentioned in these documents. For a 510(k) submission, the "test set" would typically refer to data submitted to demonstrate substantial equivalence, which could include engineering testing, biocompatibility data, or potentially clinical data if differences from the predicate raised new questions. However, the details of such studies (sample sizes, provenance) are not provided in this clearance letter.

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 mentioned. The concept of "ground truth" established by experts, particularly regarding interpretations like in imaging, is not relevant to this type of device (a therapy bed) and the documentation provided.

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

Not applicable/not mentioned. Adjudication methods are typically used in studies involving subjective assessments (e.g., image interpretation), which is not the primary focus for a therapy bed's substantial equivalence demonstration.

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 type of study (MRMC for AI assistance) is not relevant to a low air loss therapy bed.

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

Not applicable. This concept pertains to AI/software as a medical device, not a physical therapy bed.

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

Not applicable in the sense of expert review for diagnostic purposes. For a therapy bed, "ground truth" would relate to performance characteristics (e.g., pressure redistribution, air loss rates, safety features) verified through engineering tests, and potentially clinical outcomes if clinical data were required to demonstrate substantial equivalence, but such details are not in the clearance letter itself.

8. The sample size for the training set

Not applicable. This concept is relevant for machine learning algorithms, not a physical therapy bed.

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

Not applicable. As above, this relates to machine learning.

Summary

Regulation Number and Section

§ 890.5170 Powered flotation therapy bed.

(a)
Identification. A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.