(64 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:
- Seal off the incision opening to permit insufflating the peritoneum.
- Convert the incision wound to an additional trocar port site.
- Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical through an atraumatically-retracted incision.
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 device will be manufactured in five sizes, extra-small, small, medium, medium-large and large. The extra-small, small and medium products will have two additional indications. These models 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 procedure may then be returned to fully laparoscopic and an additional trocar may be placed through the incision site. The Wound Retractor package also includes an incision template. The Applied Wound Retractor is a disposable, single-use device and is packaged inside a Tyvek/Mylar peel pouch.
This 510(k) summary for the Alexis™ Wound Retractors does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria in the format you've outlined for performance studies of AI/diagnostic devices.
Instead, this document describes a traditional medical device (wound retractor), and its clearance process is based on substantial equivalence to a predicate device, rather than a performance study with defined sensitivity/specificity metrics.
Here's a breakdown of what is provided and why it doesn't fit your requested format:
What's in the document that relates to device evaluation (though not in your requested format):
- Biological Evaluation: "The Alexis Wound Retractor has been found non-toxic and non-irritant when tested in accordance with ISO 10993, Part I: Biological Evaluation of Medical Devices." This is a pass/fail criterion for biocompatibility, not a performance metric like sensitivity or AUC.
- Material Testing: "The materials used in the manufacturing of the Alexis Wound Retractor have been tested in accordance with applicable standards and was determined to pass tensile strength, elongation, (ASTM D 412) and Tear Strength (ASTM D 624)." These are material property tests, again with pass/fail criteria.
- Functional Performance Testing: "Functional performance testing has been completed and has passed the required testing." This is a very general statement, indicating the device performs its intended functions (retraction, protection). The specific acceptance criteria and results are not detailed here.
- Sterilization Validation: "Applied's 100% EO sterilization cycle provides a sterility assurance level of 10⁻⁶." This is a specific performance metric for sterility.
Why this document doesn't provide the requested information for an AI/diagnostic device performance study:
- Nature of the Device: The Alexis™ Wound Retractor is a physical surgical tool, not an AI algorithm or a diagnostic test that generates quantitative results (like a score or a classification) requiring metrics such as sensitivity, specificity, or AUC.
- Regulatory Pathway: This device was cleared through the 510(k) pathway based on substantial equivalence to a predicate device (Heartport Soft Tissue Retractor). This means the FDA determined it is as safe and effective as a legally marketed device, circumventing the need for extensive clinical trials or complex performance studies generally associated with novel diagnostics or AI. The argument is that it "introduces no new safety or effectiveness issues."
- Lack of AI/Diagnostic Metrics: The document doesn't discuss "ground truth," "expert consensus," "sample sizes for test/training sets," "MRMC studies," or "standalone performance" because these concepts are not applicable to the physical wound retractor's clearance.
Attempting to map the available information to your requested structure, acknowledging its limitations:
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-toxic and non-irritant (as per ISO 10993, Part I) | "The Alexis Wound Retractor has been found non-toxic and non-irritant when tested in accordance with ISO 10993, Part I: Biological Evaluation of Medical Devices." |
| Material Strength | Pass tensile strength, elongation (ASTM D 412), and Tear Strength (ASTM D 624) | "The materials used in the manufacturing of the Alexis Wound Retractor have been tested in accordance with applicable standards and was determined to pass tensile strength, elongation, (ASTM D 412) and Tear Strength (ASTM D 624)." |
| Functional Performance | Device performs intended functions (e.g., retraction, protection, sealing, trocar conversion) | "Functional performance testing has been completed and has passed the required testing." (Specific criteria and detailed results are not provided in this summary.) |
| Sterility | Sterility Assurance Level (SAL) of 10⁻⁶ | "Applied's 100% EO sterilization cycle 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 which is 20 mg ethylene oxide and 12 mg ethylene chlorohydrin." (Implied compliance is the performance here). |
2. Sample size used for the test set and the data provenance:
- This is not applicable as it's not a diagnostic/AI study. Testing for biological evaluation, material properties, and functional performance would have involved a sufficient number of device samples or components according to the respective standards, but a "test set" in the context of image data or patient outcomes is not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" to be established by experts in this context. Rather, compliance with engineering and biological standards is assessed.
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. This is not an AI/diagnostic device. The clearance is based on substantial equivalence to a predicate device, implying similar effectiveness without a comparative clinical study in this submission.
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. The "ground truth" for this device's safety and effectiveness is compliance with recognized standards (ISO, ASTM) and demonstrated equivalence to a predicate device's established safety and effectiveness.
8. The sample size for the training set:
- Not applicable.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document describes the regulatory clearance of a conventional medical device via the 510(k) pathway, focusing on substantial equivalence and compliance with established engineering and biocompatibility standards, rather than performance metrics typically associated with AI or diagnostic evaluations.
§ 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.