(96 days)
The Applied Alexis Wound Retractor is indicated for use to:
- Access the abdominal cavity during surgery through an atraumatically retracted incision.
- Deliver maximum exposure of the abdominal cavity with minimum incision size.
- Protect against wound contamination during laparoscopic and open surgery.
The smaller two sizes of Alexis are also intended to be used to: - Scal off the incision opening to permit insufflating the peritoneum.
- Convert the incision wound to an additional trocar port site.
The Applied Wound Retractor consists of a flexible polymer membrane formed into the shape of a cylinder. Attached to each open end of the cylinder are two semi-rigid polymer rings. The rings are molded in a plastic material. The Wound Retractor package also includes an incision template. The device will be manufactured in four sizes, small, medium-large and large. The small and medium products will have an iris valve feature that allows the wound protector to be adjusted from fully open to fully closed. This capability allows Alexis to seal the incision area or to seal around a trocar.
The provided 510(k) summary for the Alexis™ Wound Retractor describes a medical device and its substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria from an AI/algorithm performance perspective.
This document is for a physical medical device (a surgical wound retractor), not a software or AI-powered device. Therefore, the questions related to AI/algorithm performance, such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this submission.
Instead, the submission focuses on the biological safety, material properties, and functional performance of the physical device, and its sterilization process, demonstrating substantial equivalence to a predicate device.
Here's an analysis of the provided text based on the questions, acknowledging that the focus is on a physical medical device:
Analysis of the Provided Information
1. A table of acceptance criteria and the reported device performance
The document doesn't present a formal table of acceptance criteria with numerical performance metrics as would be expected for an AI/algorithm. However, it does state that the device underwent specific tests and "passed" or "complied" with relevant standards:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Was found non-toxic and non-irritant when tested in accordance with ISO 10993, Part I: Biological Evaluation of Medical Devices. |
| Material Tensile Strength | Materials tested in accordance with applicable standards and was determined to pass tensile strength (ASTM D 412). |
| Material Elongation | Materials tested in accordance with applicable standards and was determined to pass elongation (ASTM D 412). |
| Material Tear Strength | Materials tested in accordance with applicable standards and was determined to pass Tear Strength (ASTM D 624). |
| Functional Performance | Functional performance testing has been completed and has passed the required testing. |
| Sterility Assurance Level | Sterilization using 100% EO provides a sterility assurance level of 10⁻⁶. |
| Sterilant Residue Levels | Will be in compliance with ANSI/AAMI/ISO 10993-7:1995 for limited exposure devices (≤ 20 mg ethylene oxide, ≤ 12 mg ethylene chlorohydrin). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the device is a physical surgical retractor, not a software or AI-powered diagnostic/analytic tool that processes data from a test set. The "testing" referred to is for material and functional properties, not data analysis.
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)
This is not applicable for the same reasons as above. "Ground truth" in the context of this device would refer to the successful operation of the device in a clinical setting, which is inferred from its design and material testing, not from expert review of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of data, which is not part of the submission for a physical device like this.
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
This is not applicable. An MRMC study is used for evaluating diagnostic performance (often of imaging devices or AI algorithms). This device is a surgical tool, not a diagnostic one, and does not involve "human readers" or AI assistance in decision-making.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This question refers to the performance of an algorithm without human intervention, which is irrelevant for a physical surgical retractor.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As it's a physical device, the "ground truth" for its performance is assessed through physical and chemical testing standards, not clinical pathology or outcomes data in the sense of a diagnostic device. The "ground truth" that the device effectively retracts and protects wounds is supported by its design and material properties, and its substantial equivalence to a predicate device that is already cleared for such functions.
8. The sample size for the training set
This is not applicable as there is no AI algorithm being trained.
9. How the ground truth for the training set was established
This is not applicable as there is no AI algorithm being trained.
In summary: The provided text details the regulatory submission for a physical medical device (a wound retractor). The "acceptance criteria" and "studies" mentioned relate to the device's material properties, biocompatibility, sterilization, and functional design, ensuring it meets safety and effectiveness standards, primarily through conformance to established ISO and ASTM standards and demonstrated substantial equivalence to a legally marketed predicate device. The questions posed are primarily relevant to AI/software as a medical device submissions.
§ 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.