(68 days)
The Ankle Restraint System is intended to be used in situations requiring patient control while the patient is lying on a cot or stretcher. The Ankle Restraint System is intended to secure the patient's ankles by keeping them in a fixed position.
The Ankle Restraint System is designed for situations requiring patient control. The Ankle Restraint System is a restraint system that secures the patient's ankles in a fixed position. It consists of two individual ankle restraints that are permanently attached at a specific distance apart from each other to a long security strap. The security strap is constructed using a nylon woven webbing that is 2 inches wide and 17 inches long. Straps attached to both ends of the security strap secure the ankle restraint system to a cot or stretcher. The individual ankle restraints are also constructed using a nylon woven webbing. A nylon hook and loop closure is secured to the webbing and is used to securely close the ankle restraint.
This document is a 510(k) premarket notification for an Ankle Restraint System by Morrison Medical Products. It does not contain the kind of detailed study information (acceptance criteria, sample sizes, expert qualifications, etc.) that would typically be found in a study demonstrating device performance for a modern AI/ML medical device.
The document states that the subject device is identical to the predicate device in terms of intended use, design, materials, manufacturing process, physical and mechanical specifications, and issues of safety and effectiveness. The only difference mentioned is a revision to product labeling to comply with agency requirements.
Therefore, the "study" that proves the device meets the acceptance criteria is essentially a claim of substantial equivalence to a predicate device, which implies that the predicate device already met such criteria. This document does not describe a new performance study for the Ankle Restraint System itself.
Given this, I cannot answer the requested points with specific details about acceptance criteria, sample sizes, experts, or AI performance, as they are not present in the provided text.
Here is a breakdown of what can be inferred or directly stated from the document regarding the closest analogous concepts:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The implicit acceptance criteria are that the device is "safe and effective for its intended use" and "substantially equivalent to the predicate device."
- Reported Device Performance:
- Safety: "Morrison Medical Products is not aware of any reports or complaints of skin irritation associated with the materials used in these devices. A biocompatibility review of these materials indicated little potential to evoke an adverse reaction."
- Effectiveness: "The Ankle Restraint System is designed for situations requiring patient control... intended to secure the patient's ankles by keeping them in a fixed position." The claim of substantial equivalence implies it performs this function comparably to the predicate.
For points 2 through 9, the information is not applicable or not provided in the context of a new performance study.
- 2. Sample size used for the test set and the data provenance: Not applicable. No new test set for performance was described. The claim is based on equivalence to a predicate device.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No formal ground truth establishment for a new test set was described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication process was 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 device is a physical restraint system, not an AI/ML diagnostic or assistive tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical restraint system, not an AI/ML algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a new performance study. The "ground truth" here is the prior acceptance of the predicate device.
- 8. The sample size for the training set: Not applicable. No training set for an AI/ML algorithm was described.
- 9. How the ground truth for the training set was established: Not applicable. No training set for an AI/ML algorithm was described.
§ 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.