(86 days)
The Johnson & Johnson Safety Vests are designed to protect patients that are at risk of self injury or interruption of medical care by restraining them . These products can be used in restraining patients to a bed or chair.
The Johnson & Johnson Limb Holders are designed to protect patients that are at risk of self injury or interruption of medical care by restraining them . These products can be used in restraining patients to a bed or chair.
The Johnson & Johnson Safety Vests are constructed of lightweight nylon mesh with webbed tie straps and shoulder loops. These vests may be attached to either a chair or a bed.
The Johnson & Johnson Canvas Limb Holder is constructed of a cotton canvas wrist protector with a soft cotton lining, and a polyester strap. The Economy Limb Holder is constructed of a nylon laminated foam with hook and loop closure and polyester straps.
Here's an analysis of the provided text regarding the "Johnson & Johnson Safety Vests" based on your request. It's important to note that the provided text is a "Summary of Safety & Effectiveness Data" for medical devices, and as such, it does not contain the kind of detailed information about AI algorithm development, acceptance criteria studies, or ground truth establishment that would be present for an AI/ML medical device.
The document describes a traditional medical device (physical restraint vest), not an AI-powered diagnostic or predictive tool. Therefore, many of your requested points regarding AI/ML studies are not applicable.
However, I will extract the available information and highlight what is missing based on your template.
Device Name: Johnson & Johnson Safety Vests
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device prevents self-injury or interruption of medical care. | "The safety and effectiveness of the Johnson & Johnson Safety Vest and the Safety Vest Poncho Style is substantiated by its similarity in design, characteristics, and indications for use, to the currently marketed Posey Waist & Chest Vest and the Posey Criss-Cross Vest, by J.T. Posey Company." (This implies performance is equivalent to existing predicate devices, rather than a specific numerical performance metric.) |
| Effectiveness: Device restrains patients to a bed or chair. | "The safety and effectiveness of the Johnson & Johnson Safety Vest and the Safety Vest Poncho Style is substantiated by its similarity in design, characteristics, and indications for use, to the currently marketed Posey Waist & Chest Vest and the Posey Criss-Cross Vest, by J.T. Posey Company." (Again, equivalence is the basis.) |
| Physical Description: Constructed of lightweight nylon mesh with webbed tie straps and shoulder loops. May be attached to a chair or bed. | "The Johnson & Johnson Safety Vests are constructed of lightweight nylon mesh with webbed tie straps and shoulder loops. These vests may be attached to either a chair or a bed." (This is a design specification, not a performance metric.) |
Study that proves the device meets the acceptance criteria:
The document states: "The safety and effectiveness of the Johnson & Johnson Safety Vest and the Safety Vest Poncho Style is substantiated by its similarity in design, characteristics, and indications for use, to the currently marketed Posey Waist & Chest Vest and the Posey Criss-Cross Vest, by J.T. Posey Company."
This indicates that no primary clinical trial or performance study was conducted for this specific device to establish its safety and effectiveness against explicit performance criteria. Instead, the device's acceptance is based on demonstrating substantial equivalence to existing, legally marketed predicate devices. This is a common regulatory pathway for Class I and II medical devices in the US (510(k) pathway), where new devices do not necessarily require de novo studies if they can prove to be "as safe and effective" as a predicate.
The following information is NOT APPLICABLE or NOT PRESENT in the provided document, as it pertains to AI/ML device studies, not traditional medical device regulatory submissions based on substantial equivalence:
2. Sample size used for the test set and the data provenance: Not applicable (no test set in the AI/ML sense).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable (no ground truth in the AI/ML sense for this type of device).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: 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: Not applicable (no AI component, no human readers involved in diagnostic interpretation).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable (no ground truth in the AI/ML sense). The "truth" of its safety and effectiveness is inferred from the established safety and effectiveness of the predicate devices.
8. The sample size for the training set: Not applicable (no training set for an AI algorithm).
9. How the ground truth for the training set was established: Not applicable.
§ 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.