(84 days)
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:
| Acceptance Criteria Category | Specific Criteria (Explicitly Stated or Inferred) | Reported Device Performance |
|---|---|---|
| Safety | Absence of patient injury complaints | "During this time, Kenad received no patient injury... complaints about Vest Restraints." (Referencing ~5000 patient contacts over 5 years). |
| Effectiveness (Implied by no product failure) | Absence of product failure complaints | "During this time, Kenad received no ... product failure complaints about Vast Restraints." (Referencing ~5000 patient contacts over 5 years). |
| Clinical Efficacy (Implied by Intended Use) | Device limits patient movement sufficiently | No explicit quantitative measure. Implied by the absence of reported issues given the intended use "where patient movement must be limited to the extent necessary for treatmant, examination, protection of the patient or others, or posture control." |
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.
§ 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.