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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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The Centurion® Protective Restraint is a device, including a wristlet, anklet, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.

This device is intended for use on neonatal/newborn patients by or on the order of a physician in a hospital or clinic setting.

The device is contraindicated for use on patients with dislocations, fractures, open wounds on the affected limb, or if I.V. site can be compromised.

The Centurion® Protective Restraint is a device comprised of hook and loop material, 100% nylon fabric with polyester foam core, and nylon tricot backing.

The provided text describes a 510(k) premarket notification for the Centurion® Protective Restraint. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety or effectiveness through extensive clinical trials. Therefore, the study described is a comparative bench performance test.

Here’s an analysis of the provided information, framed by your questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The text only mentions "Comparative bench performance testing was performed."
• Data Provenance: The study was a "bench performance testing," implying it was conducted in a laboratory setting, likely by the manufacturer (Tri-State Hospital Supply Corporation). There is no information regarding country of origin or whether it was retrospective or prospective, as these terms are typically applied to clinical studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not provided as this was a bench performance test, not a clinical study involving human judgment on clinical outcomes. Ground truth for a bench test would be based on engineering specifications and direct measurements against those specifications.

4. Adjudication Method for the Test Set

• This is not applicable/not provided as no human expert adjudication of clinical performance was involved in this bench test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

• No, an MRMC comparative effectiveness study was not done. The submission describes a 510(k) for a Class I device, which relies on demonstrating substantial equivalence through bench testing, not clinical studies like MRMC.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

• This question is not applicable as the device is a physical protective restraint, not an AI algorithm or software.

7. The Type of Ground Truth Used

• The ground truth for this bench testing would have been based on pre-defined engineering specifications, material properties, and functional requirements for protective restraints, derived from regulatory standards, internal product design specifications, and the characteristics of the predicate device. It's not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• Not applicable. This section describes a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. As above, this device does not utilize AI/ML and therefore does not have a "training set" or ground truth established for one.

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The Geriatric Products Restraints are for use by a responsible licensed healthcare professional to limit patient movement to the extent necessary for treatment, examination, protection of patient and others, or postural control.

Protective Restraint Models #302,440,750, 850, and 905

This prompt is about a 510(k) premarket notification for "Protective Restraint Models #302, 440, 750, 850, and 905" by Geriatric Products Incorporated.

The provided document is an FDA clearance letter and an Indications for Use statement. This type of document does not include information about acceptance criteria, study details, or performance data for a medical device. It primarily confirms that the FDA has reviewed the submission and found the device substantially equivalent to a legally marketed predicate device.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study details.
• Standalone performance details.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This information would typically be found in the 510(k) submission itself (e.g., in sections describing performance testing, clinical studies, or bench testing), which is not part of the provided text.

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The DePuy OrthoTech Heavy Duty Vest Restraint is intended to limit body movement and provide support for patients in chairs, wheelchairs and beds who (a) may be susceptible to lifethreatening falls, (b) may be suicidal, or (c) are aggressive.

The body of the vest restraint is constructed from three main pattern pieces, two front panels and a back panel which are cut from polyester mesh fabric. The vest comes equipped with four pairs of long straps which are used for securing the patient to the chair, wheelchair or bed. The subject vest restraint is supplied in five sizes from X-small to X-large to fit chests from 28" to 56". It may be hand washed in warm water and air dried.

The provided document K971742 is a 510(k) premarket notification for a medical device (DePuy OrthoTech Heavy Duty Vest Restraint). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical studies with acceptance criteria in the same way a Premarket Approval (PMA) application would.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, device performance studies, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance.

The "Basis of Substantial Equivalence" section explicitly states that the device is considered substantially equivalent based on similarities in design, construction, materials, and intended uses to previously cleared devices. This means the device's "performance" is implicitly considered acceptable because it is similar to other devices already on the market.

Here's a breakdown of why each point of your request cannot be fulfilled by this document:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document doesn't define specific performance criteria for the device beyond its intended use, nor does it report any testing against such criteria.
2. Sample sized used for the test set and the data provenance: Not applicable. No test set or study data is presented.
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 or expert review process is described.
4. Adjudication method for the test set: Not applicable.
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 device is a physical restraint, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical restraint, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable. No machine learning or algorithm training is involved.
9. How the ground truth for the training set was established: Not applicable.

In summary, the K971742 document is a regulatory submission for a physical medical device based on substantial equivalence, and it does not involve the type of performance data and study methodologies typically associated with digital health technologies or AI/ML devices that would require the information outlined in your request.

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The Safety International Corp. Restraint Belt is designed to effectively secure the patient on a ambulance cot, backboard, stretcher or wheelchairs. They are also used for application as wrist or ankle restraints in conjunction with the patient restraints already on the equipment on which the patient is being carried.

The Safety International Corp.'s Patient Restraints are easy to use devices which are used to secure patients to a ambulance cot, backboard, stretcher or wheelchairs. The belts utilize 2 inch wide, 2 piece nylon web with quick release automatic push button buckle. Auto chrome plated metal push button buckle provides positive closure and resists rust and corrosion. Buckle end is sewn and the adjusted end provides adjustment on the size of the restraints for the patient by pulling the open end of the restraint and adjusting to the desired size. The belts are available in black, orange, burgundy, blue, red and yellow. The material used for the web is either nylon or polypropylene and has been in use with no adverse effects.

The provided text is for a 510(k) summary for a patient restraint device (belts) and does not contain any information about acceptance criteria or a study proving device performance in the context of medical AI/software.

The document discusses:

• Device Name: Patient Restraints
• Intended Use: To secure patients on ambulance cots, backboards, stretchers, or wheelchairs.
• Device Description: Nylon or polypropylene belts with quick-release buckles.
• Substantial Equivalence Claim: Compares the device to previously approved protective restraints, asserting similarity in indications, design, and features.
• Biocompatibility: States that the materials (nylon or polypropylene) have been in use with no adverse effects, similar to predicate devices.
• Comparison Table: Highlights similarities with a predicate device (Morrison Medical Products) in indication, mode of operation, material, and sterility.

Crucially, under the "Substantial Equivalence Comparison" section, it explicitly states:

"The determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical."

Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies because the document explicitly states that such data was not used for this submission. The device approval (at the time of this 510(k) summary) was based on substantial equivalence to predicate devices, not on direct performance testing against acceptance criteria.

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Kenad Waist Holders are indicated for medical purposes where patient movement must be limited to the extent necessary for treatment, examination or protection of the patient or others.

The Kenad Waist Holders subject to this Premarket Notification are devices that comprise the following modules, cited in this document

Blue, polyurethane foam Belt-

Side Strap-Flexible, polypropylane

Quick Release Buckle-Plastic buckle

Anchor Strap-Flexible, polypropylane

Walst Holders are placed comfortably around the waist as a belt. The Side Straps are then affixed by Quick Disconnect to an Anchor Strap affixed to an immovable object either on a bed, for bed application, or on a chair, for chair application.

This document describes a 510(k) premarket notification for a medical device called the "Kenad Waist Holder," a protective restraint. The information provided is primarily for regulatory clearance and does not contain traditional acceptance criteria and study data as you would find for an AI/ML medical device or a performance study with detailed metrics.

Here's a breakdown based on the provided text, addressing your points where possible, and noting where information is absent due to the nature of this particular submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are inferred from the safety and efficacy conclusion, essentially stating that the absence of reported issues demonstrates the device meets a standard of safety and effectiveness.

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

• Sample Size: "More than 10,000 Kenad Waist Holders were sold over the last 5 years." This implies a "test set" of over 10,000 patient uses.
• Data Provenance: The data is based on "complaints about the Waist Holders" received by Kenad, spanning 5 years. It is retrospective complaint data. The country of origin is not explicitly stated, but Kenad SG Medical Inc. is based in Memphis, TN, USA, suggesting the data is likely from the US market.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The "ground truth" for this device's performance evaluation is the absence of reported patient injuries or product failures, not an expert consensus on a diagnostic outcome.

4. Adjudication Method for the Test Set

This is not applicable. There was no adjudication of specific cases or outcomes by experts; rather, it was a count of reported complaints.

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

This is not applicable. This submission is for a physical medical device (protective restraint), not an AI/ML algorithm requiring a comparison of human reader performance with and without AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This is not applicable. This is a physical device, not an algorithm.

7. Type of Ground Truth Used

The ground truth used is absence of reported adverse events/complaints (patient injuries and product failures) based on market surveillance.

8. Sample Size for the Training Set

This is not applicable. This device is not an AI/ML algorithm that requires a training set. The "performance data" is derived from post-market surveillance.

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

This is not applicable as there is no training set for this type of device.

Summary of the Document's Approach to Demonstrating Safety and Effectiveness:

The 510(k) submission for the Kenad Waist Holder relies on a comparison to a legally marketed predicate device (Danek Medical, Inc. Waist Holder, K823815) and market surveillance data. The primary evidence for safety and efficacy is:

• Substantial Equivalence: The device's design, function, application, and intended use are similar to a previously cleared device.
• Absence of Adverse Events: Over 5 years and more than 10,000 estimated uses, Kenad received no patient injury or product failure complaints. This lack of reported issues is presented as evidence that the Waist Holders are safe and effective.

This approach is common for lower-risk medical devices seeking 510(k) clearance, where extensive clinical trials or complex performance studies are not typically required if substantial equivalence can be demonstrated and existing market data supports safety.

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Kenad Protective Mitts are indicated for medical purposes where hand and finger movement must be limited to prevent grasping tubes or picking or scratching dressings and wounds.

The Kenad Protective Mitts subject to this Premarket Notification are devices that comprise the following modules, cited in this document: Mitt- Two sided flexible material. The inside, which faces the hand, is polyurethane, and the outside is polyester foam. Mesh Port Covering- Nylon mesh. Wrist Strap and Buckle- Flexible polypropylene and polished nickle plated buckle. Stay-Inflexible aluminum strip.

This submission describes a medical device, the Kenad Protective Mitt, and compares it to a legally marketed device. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way described in the prompt. The document primarily focuses on establishing substantial equivalence to a predicate device and relies on a historical safety record rather than a formal performance study with defined acceptance criteria.

The information requested in the prompt is not available in the provided text.
Here's a breakdown of why this information is missing:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states a lack of complaints, which is a retrospective safety observation, not a prospective performance metric with acceptance criteria.
2. Sample size used for the test set and the data provenance: Not applicable. There was no formal "test set" or prospective study. The "sample" is the historical usage of "more than 5000 pairs over 5 years," which is observational rather than a controlled test. Data provenance is implied to be real-world usage in various medical settings.
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 establishment process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No 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: Not applicable. This device is a physical restraint, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not a software/algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of device performance. The closest thing to "ground truth" here is the absence of reported patient injury or product failure complaints as an indicator of safety and effectiveness.
8. The sample size for the training set: Not applicable. This device does not involve a training set as it's not an AI or learning-based system.
9. How the ground truth for the training set was established: Not applicable.

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Kenad Vest Restraints are indicated for medical purposes where patient movement must be limited to the extent necessary for treatmant, examination, protection of the patient or others, or posture control.

The Kenad Vest Restraints subject to this Premarket Notification are devices that comprise the following modules, cited in this document: Vest- blue, flame retardant polyester cotton twill fabric. Shoulder Ring- nickle plated, polished metal buckle. Side Strap- flexible, polypropylene material. Quick Release Buckle- plastic buckle. Anchor Strap- flexible, polypropylene material.

The provided 510(k) summary for the Kenad Vest Restraints addresses safety and effectiveness through a post-market experience evaluation rather than a formal study with pre-defined acceptance criteria. Therefore, the information requested in your prompt detailing acceptance criteria and study particulars cannot be fully extracted in the format you've requested.

However, I can describe what is provided in the document regarding the device's performance assessment:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: "More than 5000 Kenad Vest Restraints were sold over the last 6 years. Assuming 100% usage, there have been more than 5000 patient contacts with Vest Restraints over the last 5 years." So, >5000 patient contacts.
• Data Provenance: This is retrospective post-market surveillance data. The country of origin is not specified, but the submission is to the FDA in the US, implying the data is relevant to the US market or intended for it.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not Applicable. This document does not describe a study involving "experts" to establish ground truth in the traditional sense of a clinical trial or performance study. The data is based on reported complaints (or lack thereof) from actual users/patients in a real-world setting.

4. Adjudication Method for the Test Set:

• Not Applicable. There was no formal adjudication process for this type of post-market complaint data. The absence of complaints is the primary metric.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. An MRMC study was not conducted as this is not a diagnostic imaging device or a device where human interpretation is a primary variable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not Applicable. This is a physical medical device (vest restraint), not an algorithm or AI system.

7. The Type of Ground Truth Used:

• The "ground truth" here is the absence of reported adverse events or product failures in a real-world usage scenario over an extended period. It implicitly suggests that the device performed as intended (i.e., restrained patients without causing injury or failing) given the lack of complaints.

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" in the context of this type of post-market safety and effectiveness assessment for a physical medical device.

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

• Not Applicable. As per point 8.

Summary of Approach:

The provided 510(k) summary relies on real-world post-market experience data to demonstrate that the Kenad Vest Restraints are safe and effective. The argument for substantial equivalence is based on the absence of patient injury or product failure complaints over an extended period (>5 years) and a large number of patient contacts (>5000 uses), combined with a comparison to a legally marketed predicate device (K823815). The "acceptance criteria" are implicitly met by the documented lack of adverse events or product failures.

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