(57 days)
Reduce patient movement in recover, in bed, or other uses as determined by the health care professiona user.
The devices are fabricated using nylon or nylon and polyethol foam of various lengths and widths as described in advertising. The closure is Velcro® or Velcro®-like hook and loop.
This document is a 510(k) summary for "Various General Purpose Straps" manufactured by AliMed®, inc. It focuses on establishing substantial equivalence to pre-amendment devices rather than proving a device meets specific acceptance criteria through a study. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics is not applicable or cannot be extracted from the provided text.
Here is an analysis based on the available information:
1. Table of acceptance criteria and the reported device performance
Not applicable. The document does not describe specific acceptance criteria or quantitative performance metrics for the device. The goal is to demonstrate substantial equivalence to pre-amendment devices, not to meet a defined performance standard through testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No formal test set or study is described to evaluate performance against acceptance criteria. The document relies on historical use and the lack of adverse events.
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. No ground truth establishment by experts for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method 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 document is for general purpose straps, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for general purpose straps, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No ground truth determination for performance evaluation against acceptance criteria is described. The "ground truth" in this context is the historical, safe use of similar general purpose straps.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of available information related to safety/effectiveness from the document:
- Intended Use: Reduce patient movement in recovery, in bed, or other uses as determined by the healthcare professional user.
- Materials: Nylon or nylon and polyethol foam with Velcro® or Velcro®-like hook and loop closures.
- Substantial Equivalence Claim: To "Various Preamendments General Purpose Straps." The applicant states they were "unable to locate pre-Amendment catalogs, or similar materials," but it is "generally known that they were in use prior to May of 1976 and that they have continued to be supplied by other firms since that time."
- Biocompatibility: "Based on the materials used in construction of these straps, and the topological application with the normal use arrangement having some other material between the patient's skin and the strap, there is little likelyhood of a biocompatibility concern arising."
- User Experience (Safety): "The firm has received no information related to a death, serious injury or allegent reaction to the materials during the time these devices have been manufactured." This statement covers devices manufactured from 1989 and 1990 (Econo-straps) and 1994 (Universal 1 piece).
In conclusion, this 510(k) summary for general purpose straps relies on demonstrating substantial equivalence to devices that were legally marketed prior to the Medical Device Amendments of 1976, and on the absence of reported adverse events during the device's manufacturing history. It does not present a study with acceptance criteria and measured performance in the way that would be expected for a novel medical device requiring such proof of performance.
§ 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.