(84 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No patient injury complaints | 0 complaints over 5 years (10,000+ uses) |
| No product failure complaints | 0 complaints over 5 years (10,000+ uses) |
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.
§ 880.6760 Protective restraint.
(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, 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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.