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Medi-Tech International Corporations Easy-View Mitts are intended to be utilized as a patient safety device when patients are assessed at risk of disrupting life-saving treatments or could cause self-injury.

The Medi-Tech International Corp. Protective Restraint is a protective restraint device which is intended for medical purposes to control the movement of a patient's hand or finger movements thereby enabling examination or protection of the patient or others. Device Design Materials Used/Physical Properties: The Medi-Tech Protective Restraint is designed similar to those marketed by other manufacturers. Primarily comprised of cotton and polyester material and polyester fiber filling.

The Medi-Tech International Corp. Protective Restraint (Easy-View Mitts, Model #MTRM281) is a protective restraint device intended to control the movement of a patient's hand or finger movements to enable examination or protection of the patient or others, particularly when patients are at risk of disrupting life-saving treatments or causing self-injury.

Here's an analysis of the acceptance criteria and study:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:
  • Non-Clinical Data: One individual, Marilyn Geiger, Medi-Tech International Corporation's Product Manager, was used for the "Non-Clinical Data" tests (Safety, Effectiveness, Function).
  • Bench Testing: The document does not specify the number of units or samples tested for each of the bench tests (e.g., how many fabric swatches for tearing resistance, how many mitts for seam failure). The tests were performed by Intertek testing facility.
• Data Provenance: Retrospective, as these tests were conducted to demonstrate substantial equivalence to an already marketed device (J.T. Posey Company Protective Restraint K963413). The document doesn't specify country of origin for the data beyond the testing facility (Intertek) being utilized.

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

• Non-Clinical Data: One "expert" (Marilyn Geiger, Product Manager) conducted the tests and reported the results. Her specific qualifications beyond being the company's Product Manager are not detailed in the provided text. No independent expert consensus was explicitly stated.
• Bench Testing: The testing was performed by Intertek, a third-party testing facility. While not explicitly stated as "experts," Intertek is a recognized testing institution, implying their personnel are qualified to conduct the specified ASTM and AATCC tests. No ground truth was established by human consensus for these physical tests; they are objective measurements against established standards.

4. Adjudication method for the test set

• Non-Clinical Data: No explicit adjudication method (like 2+1 or 3+1) is mentioned. The testing appears to have been observed and reported by a single individual (Marilyn Geiger).
• Bench Testing: The concept of "adjudication" as typically applied to clinical or image-based studies doesn't apply directly here. The bench tests involve objective measurements and visual inspections against defined criteria and standards. The results would be objectively determined by the testing equipment and qualified technicians at Intertek.

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 comparative effectiveness study was done. This device is a physical protective restraint and not an AI-assisted diagnostic or therapeutic tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

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

• No standalone algorithm performance study was done, as this is a physical medical device, not a software algorithm or AI.

7. The type of ground truth used

• Non-Clinical Data (Safety, Effectiveness, Function): The ground truth was based on observational assessment and comparison to the predicate device by the Product Manager. The "ground truth" was essentially the subjective judgment that the device performed "as intended" and "similar" to the predicate.
• Bench Testing: The ground truth was based on objective physical measurements against established industry standards (e.g., ASTM, AATCC) and visual inspections for compliance with design specifications (e.g., labeling, workmanship, sharp edges). The predicate device served as a comparative benchmark for several functional and material properties (e.g., strap strength, material composition).

8. The sample size for the training set

• No specific training set in the context of machine learning or AI is mentioned, as this is a physical medical device. The "training" for such a device would typically involve design, engineering, and manufacturing processes, not data-driven algorithm training.

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

• Not applicable, as there is no training set in the context of AI/ML for this device. The design and development of the device would have been guided by engineering principles, material science, and regulatory requirements, and benchmarked against existing devices.

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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 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 and A30" x 30" Belt)

The provided document is a 510(k) premarket notification letter for a Protective Restraint device (Models #302, 440, 750, and A30" x 30" Belt) from Geriatric Products Incorporated. This type of document, particularly from 1997, does not typically contain information about objective acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment in the detailed manner that a modern regulatory submission for an AI/ML medical device would.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This means the device's clearance was based on demonstrating substantial equivalence to a predicate device, not on meeting specific, pre-defined quantitative acceptance criteria through a formal study as would be required for a novel or high-risk device today. The substantial equivalence pathway often relies more on comparisons of technological characteristics and intended use rather than rigorous performance metric studies against acceptance criteria.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth types, training set details) from this document, as it is not present. This document is a regulatory clearance letter, not a detailed study report or performance specification document.

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ProVest should only be used with proper medical authorization. The licensed medical practitioner will determine when a restraint is indicated, the type of device needed, and the duration and frequency of use of the device. ProVest is intended to be used as a gentle reminder to remain in the bed or wheelchair and for postural support.

ProVest - Protective Restraint

This document is a 510(k) clearance letter from the FDA for the "ProVest - Protective Restraint" device. It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, the provided text DOES NOT contain any information regarding:

• Acceptance criteria or reported device performance.
• Any study details (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details).

The document primarily focuses on:

• The FDA's decision of substantial equivalence.
• Regulatory classifications and requirements.
• Indications for Use for the ProVest device, which state: "ProVest should only be used with proper medical authorization. The licensed medical practitioner will determine when a restraint is indicated, the type of device needed, and the duration and frequency of use of the device. ProVest is intended to be used as a gentle reminder to remain in the bed or wheelchair and for postural support."

Therefore, I cannot provide the requested table and study details based on the input text. The document is a regulatory approval, not a performance study report.

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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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These devices are Universal Gait Belt, Wheelchair Belt, Foam Limb Restraint, Double Buckle Limb Restraint, Comfort Safety Belt, Comfort Slider Belt, Universal Roll Belt and belt style restraints used to restrain patients in a wheelchair or bed. The devices are labeled for prescription use and are not intended for lay use.

These devices are made of polyester, cotton, nylon and polyethelen configured into either a mesh or weave substrate. Each device utilizes straps for securing (tie) the patient in place.

This 510(k) summary (K96-3490) is for patient restraint devices, not a digital health device or AI-powered medical device. Therefore, the requested information about acceptance criteria, study details, ground truth, and AI performance metrics is not applicable to this submission.

The document describes physical patient restraint devices (Gait Belts, Wheelchair Belts, Limb Restraints, Safety Belts, Roll Belts). The summary states: "These devices have been commercially distributed for over for years and have not been associated with an MDR type complaint." This statement serves as the de facto "proof" that the device meets safety and effectiveness criteria for substantial equivalence, implying a history of safe use rather than a formal clinical study with performance metrics.

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The Economy Restraint, Jacket Restraint, Two Piece Vest Restraint, Safety Vest and Hand Control Mitt are incended for use to assist cooperative patients who require minimum support in wheelchair. The devices are labeled for prescription use and are not intended for lay use.

These devices are vest, jacket and mitt style restraints used to restrain patients in a wheelchair or bed. These devices are made of polyester, cotton, nylon and polyethelen configured into either a mesh or weave substrate. Each device utilizes straps for securing (tie) the patient in place.

This 510(k) summary (K96-3492) describes patient restraints (Economy Restraint, Jacket Restraint, Two Piece Vest Restraint, Safety Vest, and Hand Control Mitt) manufactured by Smith & Nephew DonJoy Inc.

Based on the provided text, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving performance against specific acceptance criteria through a study with detailed statistical analysis. Therefore, most of the requested information regarding acceptance criteria and study design is not present in this document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The implicit acceptance criterion appears to be "no association with an MDR type complaint" over four years of commercial distribution.
• Reported Device Performance:
  • "intended for use to assist cooperative patients who require minimum support in wheelchair."
  • "labeled for prescription use and are not intended for lay use."
  • "vest, jacket and mitt style restraints used to restrain patients in a wheelchair or bed."
  • "made of polyester, cotton, nylon and polyethelen configured into either a mesh or weave substrate."
  • "Each device utilizes straps for securing (tie) the patient in place."
  • "have been commercially distributed for over four years and have not been associated with an MDR type complaint."

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

• Sample Size: Not specified. The performance claim of "commercially distributed for over four years" implies a real-world usage base, but no specific number of devices or patient uses is provided.
• Data Provenance: The data is retrospective, based on a four-year period of commercial distribution. The country of origin is not explicitly stated for the "data," but the manufacturer is based in the USA.

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

• Not applicable. This submission relies on a lack of adverse events from commercial distribution rather than expert-adjudicated test data.

4. Adjudication method for the test set:

• Not applicable. There's no test set in the traditional sense with adjudicated ground truth. The "adjudication" is essentially the absence of adverse event reports (MDRs) during commercial use.

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 or diagnostic imaging device.

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

• Not applicable. This device is a physical restraint.

7. The type of ground truth used:

• The "ground truth" for the safety aspect is the absence of adverse event reports (MDRs) during commercial distribution. For effectiveness, the "ground truth" is the presumed successful use of the devices for their intended purpose in the market, supported by the lack of complaints.

8. The sample size for the training set:

• Not applicable. There is no "training set" for this type of device submission. The device design is based on established engineering principles for restraints and materials, not machine learning.

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

• Not applicable.

In summary:

This 510(k) summary leverages the established market history and safety record of the devices as evidence for substantial equivalence, rather than providing a detailed study against specific numerical acceptance criteria. The focus is on demonstrating that the devices are similar to existing legally marketed devices and have a safe history of use.

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