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The Apex Metal HydroTec™ is indicated for the prevention and treatment of pressure ulcers ( bed sores).

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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.

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The Apex Metal AirTec2 Low Air Loss Therapy Bed is indicated for pressure relief for patients with pressure sores, burns, amputations, shin flap or graft surgery, that may be in Neurology, Dermatology, Rehabilitation or Orthopedics. For pain management and pressure relief consider the AirTec2 for patients with arthritis, AIDS or cancer.

AirTec2™ Low Air Loss Therapy Bed

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the HydroTec™ Low Air Loss Therapy Bed and AirTec2™ Low Air Loss Therapy Bed, indicating they are substantially equivalent to devices marketed prior to May 28, 1976. This type of document typically does not contain details of specific performance studies or acceptance criteria beyond regulatory compliance.

The information provided only includes:

• Trade Name: HydroTec™ Low Air Loss Therapy Bed and AirTec2™ Low Air Loss Therapy Bed
• Regulatory Class: II
• Product Code: IOQ
• Indications for Use: Pressure relief for patients with pressure sores, burns, amputations, shin flap or graft surgery (in Neurology, Dermatology, Rehabilitation or Orthopedics), and pain management and pressure relief for patients with arthritis, AIDS or cancer.

Ask a specific question about this device

Ask a specific question about this device