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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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