(191 days)
The Centurion® Protective Restraint is a device, including a wristlet, anklet, 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.
This device is intended for use on neonatal/newborn patients by or on the order of a physician in a hospital or clinic setting.
The device is contraindicated for use on patients with dislocations, fractures, open wounds on the affected limb, or if I.V. site can be compromised.
The Centurion® Protective Restraint is a device comprised of hook and loop material, 100% nylon fabric with polyester foam core, and nylon tricot backing.
The provided text describes a 510(k) premarket notification for the Centurion® Protective Restraint. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety or effectiveness through extensive clinical trials. Therefore, the study described is a comparative bench performance test.
Here’s an analysis of the provided information, framed by your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Integrity | Not explicitly detailed, but implied: ability to withstand forces of restraint, maintain structural integrity. | The device satisfies all performance, physical, and functional requirements. |
| Performance | Not explicitly detailed, but implied: ability to effectively limit patient movement as intended. | The device satisfies all performance, physical, and functional requirements. |
| Functional Requirements | Not explicitly detailed, but implied: proper operation of hook and loop material, appropriate design for neonatal/newborn use, secure fastening. | The device satisfies all performance, physical, and functional requirements. |
| Safety | Not explicitly detailed, but implied: no new safety concerns compared to the predicate device. | No new issues of safety or efficacy were found. The device is as safe as the predicate device. |
| Effectiveness | Not explicitly detailed, but implied: performing its intended use to limit patient movement, comparable to the predicate device. | No new issues of safety or efficacy were found. The device is as effective as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text only mentions "Comparative bench performance testing was performed."
- Data Provenance: The study was a "bench performance testing," implying it was conducted in a laboratory setting, likely by the manufacturer (Tri-State Hospital Supply Corporation). There is no information regarding country of origin or whether it was retrospective or prospective, as these terms are typically applied to clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided as this was a bench performance test, not a clinical study involving human judgment on clinical outcomes. Ground truth for a bench test would be based on engineering specifications and direct measurements against those specifications.
4. Adjudication Method for the Test Set
- This is not applicable/not provided as no human expert adjudication of clinical performance was involved in this bench test.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
- No, an MRMC comparative effectiveness study was not done. The submission describes a 510(k) for a Class I device, which relies on demonstrating substantial equivalence through bench testing, not clinical studies like MRMC.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- This question is not applicable as the device is a physical protective restraint, not an AI algorithm or software.
7. The Type of Ground Truth Used
- The ground truth for this bench testing would have been based on pre-defined engineering specifications, material properties, and functional requirements for protective restraints, derived from regulatory standards, internal product design specifications, and the characteristics of the predicate device. It's not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- Not applicable. This section describes a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, this device does not utilize AI/ML and therefore does not have a "training set" or ground truth established for one.
§ 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.