(74 days)
New to protect patient from injury or injury to others.
Full Body Restraint System
This looks like a 510(k) clearance letter for a "Full Body Restraint System" from the FDA, dated August 15, 1997. This document grants market clearance based on substantial equivalence to a predicate device, rather than a rigorous study proving specific performance metrics against acceptance criteria. Therefore, most of the requested information cannot be found in this document.
Here's a breakdown of what can be inferred or directly stated, and what is missing:
1. A table of acceptance criteria and the reported device performance
Missing. This document is a clearance letter, not a performance report. It states that the device is "substantially equivalent" to a predicate device, which implies that its performance is presumed to be similar and acceptable, but it does not specify quantitative acceptance criteria or reported performance figures.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing. The letter does not detail any specific test set data or its provenance. The clearance is based on a determination of substantial equivalence, which typically involves demonstrating that the device has the same intended use, technological characteristics, and safety and effectiveness as a predicate device, often through bench testing and comparisons rather than clinical trials with large test sets.
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)
Missing. As there's no mention of a test set with established ground truth, this information is not applicable to this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing. Not applicable.
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
Missing. This device is a "Full Body Restraint System," which is a physical medical device, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing. This is a physical restraint system, so the concept of "standalone performance" for an algorithm is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing. Not applicable to this type of device and clearance document.
8. The sample size for the training set
Missing. As this is a physical device, the concept of a "training set" in the context of machine learning or AI is not applicable.
9. How the ground truth for the training set was established
Missing. Not applicable.
Summary based on the provided document:
The provided document is a 510(k) clearance letter. It indicates that the "Full Body Restraint System" by Gillen Industries (K972046) has been deemed "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This substantial equivalence determination means the FDA believes the device is as safe and effective as a legally marketed device that does not require premarket approval.
The primary "acceptance criterion" for this type of clearance is substantial equivalence to a predicate device for the stated "Indications For Use: To protect patient from injury or injury to others." The document does not provide specific quantitative performance metrics or details about clinical studies, test sets, or ground truth establishment, as these are typically not required for 510(k) clearances if substantial equivalence can be demonstrated through other means (e.g., bench testing, comparison of technological characteristics).
§ 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.