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The Posey Bed 8040/8060 is an A-Frame canopy system. When attached to a compatible commercially available hospital bed (not included) the 8040/8060 is designed to help provide a safe, controlled environment for patients at extreme risk of injury from a fall or unassisted bed exit. The Posey Bed 8040/8060 is a less restrictive alternative to physical restraints such as belts, vests, or jackets for patients at least 46 inches tall, weighing between 46 and 300 pounds. The Posey Bed 8040/8060 is a restraint, and must be prescribed by a licensed physician that includes Rx use in the home environment.

The Posey Bed 8040 and Posey Bed 8060 (Posey Bed 8040/8060) is an enclosed bed canopy system with an adjustable enclosed mattress compartment. The Posey Bed 8040 features a 73 cubic-foot, A-Frame, green nylon canopy with one zippered access panel and one drainage port opening. The Posey Bed 8060 features a 73 cubic-foot, A-Frame green nylon canopy with four zippered access panels for easy patient access, and ten ports for intravenous lines, call bells and drainage bags. When attached to a compatible commercially available hospital bed (not included), the 8040/8060 is designed to help provide a safe, controlled environment for patients at extreme risk of injury from a fall or unassisted bed exit.

The provided text is a 510(k) summary for a medical device called the "Posey Bed 8040 and Posey Bed 8060," an enclosed bed canopy system. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a performance study with detailed acceptance criteria and results against those criteria. As such, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size) is not present in the provided text.

Here's an analysis of what can be extracted:

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

• Acceptance Criteria:

  • Substantial equivalence to the Posey Bed 8070 (K103817) and Soma Safe Enclosure (K963701) in terms of safety and intended use.
  • Suitability for intended use based on biocompatibility, human factors, and performance testing.
  • Compatibility with hospital beds meeting specific dimensions (Length ≤ 96" and does not retract < 76"; Width ≤ 36"; Bed platform height for 8040: 13-22 inches, for 8060: 16-25 inches).
  • Operational limits (e.g., head of bed angle ≤ 70°) must be observed.
  • Minimization of patient entrapment (e.g., side rails down, mattress compartment preventing movement).
  • Intended for patients 46-300 pounds and at least 46 inches tall.
  • Fabric, mesh, and zippers are the same as predicate devices.

• Reported Device Performance:

  • The document states: "Results of biocompatibility (ISO 10993), human factors, and performance testing have established that the Posey Bed 8040/8060 is suitable for the intended use indicated and is substantially equivalent to the Posey Bed 8070 and the Soma Safe Enclosure."
  • The FDA concurred with the substantial equivalence conclusion.

Table:

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

• The document mentions "performance testing" and "human factors testing" were conducted, but does not specify any sample sizes, data provenance, or whether the studies were retrospective or prospective.

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)

• The document states: "Human factors testing conducted by caregivers was used to validate the design of a training regimen and Instructions for Use for safe and effective device interactions."
• No specific number or qualifications of "caregivers" (experts) are provided.

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

• No adjudication method is described for any testing mentioned.

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

• No MRMC or comparative effectiveness study is mentioned. The device is a physical bed canopy, not an AI or diagnostic tool.

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

• Not applicable. The device is a physical bed canopy.

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

• For "performance testing" related to safety, compatibility, and entrapment, the "ground truth" would likely be based on engineering standards, biomechanical principles, and direct observation of the device's physical interactions and function.
• For "human factors testing," "ground truth" would be established through observation and feedback from caregivers regarding usability and effectiveness of training/instructions.
• The document does not detail the specific methodology for establishing this "ground truth."

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that uses a "training set."

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

• Not applicable. This is not an AI/machine learning device that uses a "training set."

Summary of what is present and what is missing:

The provided 510(k) summary primarily focuses on demonstrating substantial equivalence through comparison of features, materials, and a blanket statement about internal testing (biocompatibility, human factors, performance). It does not provide the granular detail of a clinical or performance study that would elaborate on specific quantitative acceptance criteria or detailed results to meet those criteria. Many of the questions are not applicable due to the nature of the device (a physical restraint system, not a diagnostic or AI tool).

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