(77 days)
The Alexis Orthopaedic Wound Retractor is indicated for use to access the musculoskeletal system through an atraumatically retracted wound
Wound retractors convert straight incisions into round openings that facilitate access to internal body cavities and spaces. APPLIED's wound retractors consist of a cylindrical flexible film sheath that has a semi-rigid polymer ring on each end. Retractors of this design are useful in open orthopaedic procedures that require unimpeded access while simultaneously protecting the wound.
Here's a breakdown of the acceptance criteria and study information for the Alexis Orthopaedic Wound Retractor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Ability to retract a wound | Substantially equivalent or superior to predicate device |
| Resistance to tearing | Substantially equivalent or superior to predicate device |
| Durability (cycling test) | Substantially equivalent or superior to predicate device |
| Maximum allowable incision size | Substantially equivalent or superior to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "These tests were performed on predicate and subject device."
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not provided in the document. The tests appear to be performance-based against objective criteria rather than subjective expert assessment.
4. Adjudication Method for the Test Set
This information is not provided as the tests described are non-clinical, functional and performance-based rather than involving human assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical, functional, and performance testing of the device against a predicate device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable as the device is a physical wound retractor, not an algorithm. Therefore, "standalone" performance in the context of AI is not relevant.
7. The Type of Ground Truth Used
The ground truth was established through functional and performance testing of the device against predefined, objective laboratory established criteria related to its mechanical properties and intended function (wound retraction, tearing resistance, durability, incision size). The predicate device (Applied Medical Alexis Wound Retractor) served as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
This is not applicable as the device is a physical product and does not involve a "training set" in the context of machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8.
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.