(84 days)
These products are intended to hinder egress or aid in positioning of a patient in a wheelchair, hospital bed, genatric chair, or gurney
The devices included in this 510(k) submission support the waist or torso area. The product is closed around the patient by encircling the hips, legs or chest. The product is secured to the bed, geriatric chair, wheelchair, or gurney via straps. These straps are securely connected to the bed, geriatric chair, or wheelchair by one or more of the following: knots, double D rings, hook and loop, standard buckles, or quick release buckles or hardware (screws).
This document is a 510(k) premarket notification for protective restraints (belts) by the J.T. Posey Company, dated November 27, 1996. It is a summary of safety and effectiveness designed to demonstrate substantial equivalence to legally marketed predicate devices.
Crucially, this document does not contain acceptance criteria or a study proving device performance in the sense of a clinical trial or performance evaluation with specific metrics.
Instead, it argues for substantial equivalence based on the fact that the devices are already legally marketed by the company and are identical to their current products. The "study" here is essentially a comparison to existing, legally marketed products rather than a performance study against predefined criteria.
Therefore, most of the requested information cannot be extracted from this specific document because the nature of the submission (510(k) for protective restraints already in commercial distribution) does not require such a typical performance study.
However, I can extract what is present and explain why other information is absent:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criterion implicitly is "substantial equivalence" to the predicate devices.
- Reported Device Performance: Not reported in quantitative metrics. The document states: "The devices used for comparative purposes are identical to the belts as described in this submission and produced or sold by the J.T. Posey Co." This implies that the performance is "identical" to their legally marketed products.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. There is no traditional "test set" in the context of a clinical performance study. The comparison is to the company's own existing products.
- Data Provenance: Not applicable. No new data from a clinical trial or study is referenced.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There is no "ground truth" establishment in the context of a performance study for these devices as described in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or 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
- No. This document predates widespread AI in medical devices and is for physical restraints, not image-based diagnostics. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth established for performance metrics. The "ground truth" for the submission is the regulatory status and design of existing comparable devices.
8. The sample size for the training set
- Not applicable. No training set for an algorithm is used.
9. How the ground truth for the training set was established
- Not applicable. No training set is used.
Summary of the "Study" mentioned in the document:
The "study" or justification for safety and effectiveness is:
- Predicate Device Comparison: The company is referencing its current products (belts, limb holders) as legally marketed devices for comparison. They state these devices are "identical" to those described in the submission.
- Regulatory Context: The submission is in response to a March 4, 1996 Federal Register rule revoking exemptions for protective restraints from 510(k) premarket notification procedures.
- FDA Guidance: The June 13, 1996 Meeting Minutes, HIMA Body Holder Task Force and FDA CDRH established the rationale that manufacturers could reference their current legally marketed products as predicate devices.
- History of Marketing: The devices (limb holders specifically mentioned) have been manufactured and in commercial distribution for up to 20 years.
In essence, this 510(k) submission is a declaration that the devices meet the regulatory acceptance criteria of being substantially equivalent to devices already legally on the market, rather than a presentation of a study proving specific performance metrics.
§ 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.