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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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Kenad Limb Holders are indicated for medical purposes where a patient's arm and leg movement must be limited to the extent necessary for treatment, examination or protection of the patient or others.

The Kenad Limb Holders subject to this Premarket Notification are depicted in the figure at ATTACHMENT 6. As depicted in this figure. Kenad Limb Holders are assemblies of the following modules: Ankle/Wrist Cuff, Ankle/Wrist Strap, Connector Strap, Quick Release Buckle and Bed Strap.

The Ankle/Wrist Cuff is a rectangular, two sided material. On the side which contacts skin, the cuff is made from blue or white polyurethane foam. At one end of the rectangle, a patch of Velcro hooks are stitched to the foam with 12 pound nylon thread. Heat bonded to the foam back is a piece of blue or white Velcro pile.

Except for Black Limb Holder with Removable Cuff (Catalog # 50-1600), the Ankle/Wrist Strap is affixed to the Ankle/Wrist Cuff by sewing using 12 pound nylon thread. For Black Limb Holder, a Velcro hook strip is sewn to one end of the Ankle/Wrist Strap. The Velcro hook strip then affixes to the Velcro pile of the cuff. Affixed by sewing to one end of the Ankle/Wrist Strap is a polished metal buckle for locking the Ankle/Wrist strap in place around the ankle/wrist.

The Connector Strap is affixed by sewing with 12 pound nylon thread to the Ankle/Wrist Strap. Affixed by sewing to the other end of the Connector Strap is the female or male end of the Quick Release Buckle.

The Bed Strap comes as either a loop able or threadable end for anchoring to a fixed object. Affixed by sewing to one end of the Connector Strap is the complementary female or male end of the Quick Release Buckle.

The material used to make the straps is woven polypropylene. The polypropylene color is either black or white, and its width is either a nominal 1 or 1.5 inch. The variations are outlined in more detail in the Table also included at ATTACHMENT 6.

This 510(k) summary describes a medical device called the "Patient Protective Limb Holder (Universal)" and its variations. This product is a limb restraint system. The submission relies on a predicate device (Danek Medical, Inc.'s "Patient Protective Limb Holder", K823815). The information provided does not describe a clinical study in the traditional sense, but rather relies on a historical performance review.

Here's an analysis of the provided text with respect to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not explicitly state quantitative acceptance criteria or a formal study design with measured outcomes against those criteria. Instead, it leverages a retrospective review of complaint data as evidence of safety and effectiveness.

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

• Sample Size: "More than 150,000 pairs of Kenad Limb Holders were sold over the last 5 years. Assuming 100% usage, there have been more than 300,000 contacts between ankles and/or wrists over the last 5 years." This suggests the "test set" consists of all these instances of product use.
• Data Provenance: The data is retrospective, derived from the company's internal complaint records over a 5-year period. The country of origin of the data is not explicitly stated, but given the company's address (Memphis, TN), it is likely US-based.

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

• Not applicable. This submission does not involve expert-established ground truth as it is not a diagnostic device or a device requiring human interpretation of results. The "ground truth" here is the absence of recorded complaints over extensive real-world use.

4. Adjudication Method for the Test Set

• Not applicable. There was no formal adjudication process for a "test set" in the context of this submission. The performance relies solely on the company's complaint logging system.

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

• No. An MRMC study was not conducted as this is a medical restraint device, not a diagnostic imaging device typically requiring human reader performance analysis.

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

• Not applicable. This is a physical medical device, not an algorithm or AI. The "performance" assessment is based on real-world usage without reported failures or injuries.

7. The Type of Ground Truth Used

• Real-world performance/Complaint Data: The ground truth is established by the absence of patient injury or product failure complaints over a large volume of actual product usage in clinical settings. This serves as evidence that the device performs as intended for its stated indications without causing harm.

8. The Sample Size for the Training Set

• Not applicable. This submission does not involve a "training set" in the context of an algorithm or machine learning. The device's design and manufacturing are based on established engineering principles and prior experience, not data-driven machine learning.

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

• Not applicable. As there is no training set mentioned, there is no ground truth established for it.

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