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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

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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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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 (Rx Only).

The patented 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 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, cushions, cushions, bed support torso suface, incontinence pads, and travel covers.

The provided text is a 510(k) summary for the Posey Bed 8070, which is an enclosed bed system. It discusses the device's description, intended use, and substantial equivalence to a predicate device, but it does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the format requested.

The document states that "Results of biocompatibility (ISO 10993), human factors, and performance testing (including to IEC 60601-2-38} have established that the Posey Bed 8070 is suitable for the intended use indicated and is substantially equivalent to the Soma Safe Enclosure." However, it does not provide the details of these tests, such as:

• Specific acceptance criteria for each test (e.g., maximum force, minimum durability, specific safety thresholds).
• Reported device performance against those criteria.
• Sample sizes for any of these tests (other than "caregivers" for human factors).
• Data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details, or ground truth establishment for training set.

Therefore, I cannot populate the requested table and answer the study-related questions based solely on the provided text. The document confirms that testing was done, but the specifics of that testing, particularly concerning quantitative acceptance criteria and detailed study methodology, are not present.

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These products are intended to hinder egress or aid in positioning of a patient in a wheelchair, hospital bed, genatric chair, or gurney

The devices included in this 510(k) submission support the waist or torso area. The product is closed around the patient by encircling the hips, legs or chest. The product is secured to the bed, geriatric chair, wheelchair, or gurney via straps. These straps are securely connected to the bed, geriatric chair, or wheelchair by one or more of the following: knots, double D rings, hook and loop, standard buckles, or quick release buckles or hardware (screws).

This document is a 510(k) premarket notification for protective restraints (belts) by the J.T. Posey Company, dated November 27, 1996. It is a summary of safety and effectiveness designed to demonstrate substantial equivalence to legally marketed predicate devices.

Crucially, this document does not contain acceptance criteria or a study proving device performance in the sense of a clinical trial or performance evaluation with specific metrics.

Instead, it argues for substantial equivalence based on the fact that the devices are already legally marketed by the company and are identical to their current products. The "study" here is essentially a comparison to existing, legally marketed products rather than a performance study against predefined criteria.

Therefore, most of the requested information cannot be extracted from this specific document because the nature of the submission (510(k) for protective restraints already in commercial distribution) does not require such a typical performance study.

However, I can extract what is present and explain why other information is absent:

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

• Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criterion implicitly is "substantial equivalence" to the predicate devices.
• Reported Device Performance: Not reported in quantitative metrics. The document states: "The devices used for comparative purposes are identical to the belts as described in this submission and produced or sold by the J.T. Posey Co." This implies that the performance is "identical" to their legally marketed products.

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

• Sample Size: Not applicable. There is no traditional "test set" in the context of a clinical performance study. The comparison is to the company's own existing products.
• Data Provenance: Not applicable. No new data from a clinical trial or study is referenced.

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. There is no "ground truth" establishment in the context of a performance study for these devices as described in the document.

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

• Not applicable. No test set or adjudication process is described.

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. This document predates widespread AI in medical devices and is for physical restraints, not image-based diagnostics. No MRMC study was conducted.

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

• No. This is not an algorithm-based device.

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

• Not applicable. No ground truth established for performance metrics. The "ground truth" for the submission is the regulatory status and design of existing comparable devices.

8. The sample size for the training set

• Not applicable. No training set for an algorithm is used.

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

• Not applicable. No training set is used.

Summary of the "Study" mentioned in the document:

The "study" or justification for safety and effectiveness is:

• Predicate Device Comparison: The company is referencing its current products (belts, limb holders) as legally marketed devices for comparison. They state these devices are "identical" to those described in the submission.
• Regulatory Context: The submission is in response to a March 4, 1996 Federal Register rule revoking exemptions for protective restraints from 510(k) premarket notification procedures.
• FDA Guidance: The June 13, 1996 Meeting Minutes, HIMA Body Holder Task Force and FDA CDRH established the rationale that manufacturers could reference their current legally marketed products as predicate devices.
• History of Marketing: The devices (limb holders specifically mentioned) have been manufactured and in commercial distribution for up to 20 years.

In essence, this 510(k) submission is a declaration that the devices meet the regulatory acceptance criteria of being substantially equivalent to devices already legally on the market, rather than a presentation of a study proving specific performance metrics.

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The devices included in this 510(k) submission facilitate attachment of protective restraint devices to vehicles. These devices provide anchor points for tying quick release knots and/or adapts protective restraints with quick release buckles. The products are then secured to the bed, geriatric chair, or wheelchair via the accessory device. The accessory devices attach directly to the vehicle.

These products are facilitate attachment of devices that are intended to hinder egress or aid in positioning of a patient in a wheelchair, hospital bed, geriatric chair, or gumey.

The devices included in this 510(k) submission facilitate attachment of protective restraint devices to vehicles. These devices provide anchor points for tying quick release knots and/or adapts protective restraints with quick release buckles. The products are then secured to the bed, geriatric chair, or wheelchair via the accessory device. The accessory devices attach directly to the vehicle.

This document is a 510(k) premarket notification for "Protective Restraints" by the Posey Company, dated November 22, 1996. It states that the submission is in response to a new FDA final rule requiring 510(k)s for these devices, which were previously exempt. The core of the submission revolves around demonstrating substantial equivalence to devices already legally marketed by the Posey Company itself.

Therefore, the document does not contain information about acceptance criteria or a study that proves a device meets specific performance criteria in the way a diagnostic or treatment device might. Instead, it focuses on the regulatory framework of demonstrating equivalence to existing products.

Here's why the requested information cannot be fully provided from this document:

• Acceptance Criteria & Device Performance: This document is about regulatory classification and equivalence for restraint accessories (which facilitate attachment of restraints), not about performance metrics like sensitivity, specificity, accuracy, or other measurable clinical outcomes.
• Study Details: There is no clinical or technical performance study described in this document to evaluate the "effectiveness" of these restraint accessories in the sense of a medical device clinical trial. The "comparative purposes" mentioned refer to comparing the device itself to an already marketed version of the same device for regulatory purposes, not a performance study against a ground truth.

Based on the provided text, here's what can be extracted and why other points are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Not Applicable (The submission focuses on substantial equivalence to legally marketed devices, not specific performance criteria for these restraint accessories.)	Not Applicable (No performance metrics are reported as no performance study was conducted in the context of this submission.)

2. Sample size used for the test set and the data provenance:

   • Not Applicable. No "test set" in the context of a performance study is described. The comparison is against the company's own legally marketed devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. No ground truth for device performance is established in this document, as it's not a performance study.

4. Adjudication method for the test set:

   • Not Applicable. No performance study or test set requiring adjudication is described.

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 document is about physical restraint accessories, not an AI-enabled diagnostic or imaging device.

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

   • Not Applicable. This is not an algorithm-based device.

7. The type of ground truth used:

   • Not Applicable. No ground truth for device performance is established. The "ground truth" in this context is the regulatory status of "legally marketed" predicate devices.

8. The sample size for the training set:

   • Not Applicable. There is no "training set" as this is not a machine learning or AI device.

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

   • Not Applicable.

In summary: This document is a regulatory submission demonstrating substantial equivalence for previously exempt physical restraint accessories. It does not describe a performance study with acceptance criteria, sample sizes, ground truth definitions, or expert evaluation as the basis for its claim. The "effectiveness" mentioned in the summary title refers to a general regulatory requirement for all medical devices, but the demonstration of it in this specific submission is through comparison to already marketed predicate devices, not through a new performance study.

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These products are intended to limit movement in a hospital patient.

The devices included in this 510(k) submission limit movement. The product is closed around the patient by encircling the wrists, hands, or ankles. The product is secured around the patient via straps. These straps are secured behind the patient with either heavy duty corset buckles or heavy duty standard buckles.

I am sorry, but the provided text does not contain the necessary information to describe the acceptance criteria and the study proving the device meets them. The document is a 510(k) submission for "Straight Jackets" and primarily focuses on regulatory classification, common names, and a historical context of their marketing and exemption status.

Specifically, the text is a "SAFETY AND EFFECTIVENESS SUMMARY" but it does not include any performance data, clinical study results, or explicitly stated acceptance criteria for the device. It discusses the device's purpose (limiting patient movement) and its comparison to legally marketed devices (the manufacturer's own current products), but it does not detail any studies proving its safety or effectiveness in terms of measureable outcomes or performance metrics.

Therefore, I cannot provide any of the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, or expert details for test sets.
3. Adjudication methods.
4. MRMC study details or effect sizes.
5. Standalone performance studies.
6. Types of ground truth used.
7. Training set sample sizes or ground truth establishment methods.

The document is purely a regulatory statement about the device's status and comparison within the 510(k) framework, not a summary of performance studies.

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These products are intended to hinder egress of a patient and/or assist body alignment in a hospital bed, geriatric chair, wheelchair, or gurney,

The devices included in this 510(k) submission support the torso area. The product is closed around the patient by one or more of the following: criss crossing the fabric and straps, a zipper, hook and loop, or tie strings. The product is secured to the bed geriatric chair, wheelchair, or gurney via straps. These straps are securely connected to the bed, geriatric chair, or wheelchair by one or more of the following: knots, double D rings, hook and loop, standard buckles, or quick release buckles.

This document is a 510(k) summary for protective restraints (jackets and vests) manufactured by JT Posey Company. It describes the device, its intended use, and the regulatory context for its submission. However, it does not contain the specific information requested about acceptance criteria, device performance, study details, or ground truth establishment.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details based on the provided text.

The document states that the devices used for comparative purposes are "identical to the jackets and vests as described in this submission and produced or sold by the J.T. Posey Co." and that these products are "currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations and are legally marketed by JT Posey Co. as of the date of this submission." This indicates that the submission is primarily for regulatory compliance of existing products rather than providing new performance data from a specific study designed to meet new acceptance criteria.

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These products are intended to limit limb movement or finger movement in a hospital bed or crib.

The devices included in this 510(k) submission limit limb movement and/or finger movement. The product is closed around the patient by encircling the wrists, hands, or ankles. The product is secured to the hospital bed or crib via straps. These straps are securely connected to the hospital bed or crib by quick release knots or with the use of a safety pin.

This document describes an application for a 510(k) premarket notification for "Protective Restraints" (Pediatric limb holders) by J.T. Posey Co. It is a safety and effectiveness summary. The core of the submission emphasizes that the devices are identical to existing, legally marketed products by the same company, which were previously exempt from 510(k) procedures.

Given the nature of the document, which pertains to a premarket notification for a device that is identical to already marketed devices, it does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, as typically understood for new or significantly modified medical devices that rely on performance metrics.

Here's why and what information is present:

• No Acceptance Criteria or Performance Study: The document explicitly states: "The devices used for comparative purposes are identical to the pediatric limb holders as described in this submission and produced or sold by the J.T. Posey Co." This means the submission is based on substantial equivalence to existing devices, not on a new performance study demonstrating specific acceptance criteria. The purpose of this 510(k) is a response to a regulatory change ("Revocation of Exemptions from 510(k) Premarket Notification Procedures") rather than a technological advance requiring new clinical evidence.
• "Predicate device" rationale: The document highlights that FDA indicated manufacturers could reference their current products as legally marketed devices for comparison. This is the entire basis of the submission.
• Device history: The limb holders have been manufactured and in commercial distribution for up to 20 years.

Therefore, I cannot fill in the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this submission is not about demonstrating new performance but rather establishing legal equivalence to existing, long-marketed products under new regulatory requirements.

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The devices included in this 510(k) submission provide anterior postural support. The products are closed around the wheelchair by hook and loop straps. An optional strap can be secured behind the patient to prevent the tray from being pushed forward. If the patient cannot easily self release the product, it may be considered a restraint. These products are intended to provide postural support and a surface for activities.

The devices included in this 510(k) submission provide anterior postural support. The products are closed around the wheelchair by hook and loop straps. An optional strap can be secured behind the patient to prevent the tray from being pushed forward. If the patient cannot easily self release the product, it may be considered a restraint.

This document is a 510(k) premarket notification for "Posey® Laptop Trays." It does not contain information about an AI/ML powered medical device, an associated study, or acceptance criteria related to a device's performance characteristics.

The document discusses:

• The device: Posey® Laptop Trays, designed for anterior postural support and a surface for activities for wheelchair users.
• Regulatory context: The submission is in response to a new FDA rule requiring 510(k) notification for protective restraints, specifically revoking exemptions for devices like these.
• Predicate device: The "devices used for comparative purposes are identical to the laptop trays as described in this submission and produced or sold by the J.T. Posey Co." This indicates that the comparison is against their own legally marketed products that were previously exempt, not against a different type of device or technology.

Therefore, I cannot provide the requested information regarding acceptance criteria or a study proving a device meets them, as this submission is for a traditional medical device and not an AI/ML powered one.

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These products are intended to hinder egress of a patient and/or assist body alignment in a hospital bed, genatric chair, wheelchair, or gurney.

The devices included in this 510(k) submission support the torso and/or pelvic area. The product is closed around the patient by one or more of the following: a zipper, fabric alone, straps, or straps and buckles. The product is secured to the bed, geriatric chair, wheelchair, or gurney via straps. These straps are securely connected to the bed, geriatric chair, or wheelchair by one or more of the following: knots, or straps and buckles.

The provided text is a Safety and Effectiveness Summary for a 510(k) submission regarding protective restraints, specifically "Pelvic Holders" and "Protective Restraints." It outlines the device's purpose, classification, and regulatory context.

However, the document does not contain any information relevant to the acceptance criteria or a study proving the device meets those criteria, as requested in the prompt.

Here's why and what's missing:

• No Acceptance Criteria: The document describes the device's function and regulatory classification but does not list any quantitative or qualitative performance metrics (e.g., strength, durability, patient comfort scores, restraint effectiveness percentages) that would serve as acceptance criteria.
• No Study Details: There are no descriptions of any studies conducted to evaluate the device's performance against specific criteria. The text mentions "comparative purposes" and referencing "current products as legally marketed devices for comparison purposes," but this refers to regulatory comparison for the 510(k) process, not a performance study as typically understood in medical device validation.
• Missing Specifics for Performance Evaluation: All the sub-points requested in the prompt (sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, ground truth, training set size, training ground truth) are entirely absent because no such performance study is described.

Therefore, based on the provided text, I cannot complete the requested table or answer the questions. The document focuses solely on the regulatory process for a 510(k) submission for protective restraints.

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