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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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The Posey Bed 8070 is a hospital bed, canopy, and mattress system 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 8070 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 8070 is a restraint, and must be prescribed by a licensed physician that includes Rx use in the home environment.

The proposed device, the Posey Bed 8070 with modified labeling to include home use, is the same unchanged device previously cleared by the FDA under K103817 via the 510(k) notification process, and is substantially equivalent for design and materials. This 510(k) establishes that the Posey Bed 8070 is also substantially equivalent to the Soma Safe Enclosure, as used with an AC-powered hospital bed, for the home use adjustable environment, (K963701).

The Posey Bed 8070 is an enclosed bed canopy system which includes and attaches to a fully automatic. AC-powered adjustable hospital bed (either the Joerns Healthcare, Inc., Stevens Point, Wisconsin, Easy Care® 2003DC, Model B684DC or the Invacare Corporation, Elyria, Ohio, Model SC900DLX-POS Low Electric Bed), which has a six-inch enclosed mattress compartment to help reduce the risk of patient entrapment. The device also features a 70 cubic-foot rectangular green nylon canopy with four zippered access panels for easy access to patients and four ports for intravenous lines, call bells and drainage bag openings. The bed has a control that allows the frame to be raised to 30 inches for patient care or lowered to 19 inches for ease of wheelchair transfers. A perimeter guard is available as a temporary guard for use when patient care is being given.

The Posey Bed 8070 does not have side rails, headboards or footboards. Contained within the canopy is a specialized compartment for the mattress to prevent the mattress from moving within the canopy and the patient from crawling under the mattress. These features provide a system that minimizes the potential for patient entrapment.

Other safety features include a perimeter guard (reference: Soft Rails) that provides an additional measure to protect the patient from falling when the canopy is opened and a health care provider is attending to the patient.

Optional accessories include filler cushions, torso cushions, bed support surface, incontinence pads, and travel covers.

The Posey Bed 8070 is a hospital bed, canopy, and mattress system 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 8070 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 8070 is a restraint, and must be prescribed by a licensed physician that includes Rx use in the home environment.

The Posey Bed 8070 is the same product as that previously cleared under K103817, however, it is now being proposed for expanded use in the home environment. A comparison of device features in K103817 demonstrated that the Posey Bed 8070 is substantially equivalent to the currently marketed Soma Safe Enclosure, as used with an AC-powered adjustable hospital bed. Both devices utilize equivalent fabrics, mesh and zippers and are framed, enclosed canopies.

This document is a 510(k) Pre-Market Notification for the Posey Bed 8070, seeking clearance for expanded use in a home environment. It is primarily a submission to the FDA for regulatory clearance and focuses on establishing substantial equivalence to previously cleared devices.

Therefore, the document does not contain the kind of detailed information about acceptance criteria and a study design with specific performance metrics (like sensitivity, specificity, or reader improvement with AI) that would be relevant for an AI/ML medical device.

Here's a breakdown based on the information provided, and why most of the requested fields cannot be filled:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided text. The document is for a physical medical device (an enclosed bed system), not an AI/ML algorithm that predicts or diagnoses. Performance is assessed through demonstrating safety and substantial equivalence to existing devices.

2. Sample Size Used for the Test Set and Data Provenance

This information is not available in the provided text in the context of an AI/ML test set. The performance testing mentioned includes "biocompatibility (ISO 10993), human factors, and performance testing."

• Sample Size for Test Set: Not specified for any quantitative testing that would typically be associated with an AI/ML device.
• Data Provenance: Not applicable in the context of AI/ML data provenance. The human factors testing involved "caregivers," but the number or details are not provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not available. Ground truth for an AI/ML device typically involves expert annotations or diagnoses. For this physical device, "human factors testing" involved caregivers, but they are not described as experts establishing a ground truth for an AI model.

4. Adjudication Method

This information is not available. Adjudication methods (like 2+1, 3+1) are relevant for reconciling discrepancies in expert opinions when establishing ground truth for AI/ML models. This concept does not apply to the testing described for the Posey Bed 8070.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not available. An MRMC study is specific to evaluating diagnostic performance, often comparing human readers with and without AI assistance. This type of study is not mentioned as part of the clearance for the Posey Bed 8070.

6. Standalone (Algorithm Only) Performance Study

This information is not available. This refers to the performance of an AI algorithm without human intervention. The Posey Bed 8070 is a physical device, not an algorithm.

7. Type of Ground Truth Used

The concept of "ground truth" as it applies to AI/ML models (e.g., expert consensus, pathology, outcomes data) is not applicable here. For the Posey Bed 8070, the "truth" is established through demonstrating safety, functionality, and substantial equivalence to legally marketed predicate devices, as well as adherence to standards like ISO 10993 for biocompatibility and human factors validation.

8. Sample Size for the Training Set

This information is not available, as this device does not involve an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not available, as this device does not involve an AI/ML model that requires a training set and associated ground truth.

Summary of what the document does indicate about performance and acceptance:

The document states that the Posey Bed 8070, for home care use, is found to be "substantially equivalent" to:

• The previously cleared Posey Bed 8070 (under K103817).
• The Soma Safe Enclosure (K963701).

Performance testing mentioned includes:

• Biocompatibility (ISO 10993): This establishes that the materials used in the device are not harmful to biological systems. Meeting this standard acts as an acceptance criterion for material safety.
• Human Factors Testing: Conducted by caregivers, this was used to "validate the design of a training regimen and Instructions for Use to include safe and effective device interactions in a home environment." This implies that the device's usability and safety for its intended users (caregivers and patients in a home setting) were assessed and found acceptable through this testing.
• Performance Testing: A general category mentioned alongside biocompatibility and human factors, which likely refers to testing to ensure the bed's physical components function as intended (e.g., bed frame raising/lowering, canopy zippers, mattress compartment preventing entrapment).

The key "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to existing, legally marketed devices for the proposed expanded use. The studies performed (biocompatibility, human factors, general performance) support this claim by showing the device is as safe and effective as the predicates.

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