(15 days)
The Alexis Laparoscopic System 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. .
- Seal off the incision opening to permit insufflation of 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 procedures through an atraumatically retracted incision.
Wound retractors convert straight incisions into semi round openings that facilitate access to internal body cavities and operative sites. These retractors are particularly useful in open or laparoscopic procedures that require removal of large quantities of tissue. The predicate and subject wound retractors share a common construction. Each 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. One ring (the inner ring) is positioned inside a body cavity while the other (outer ring) remains outside the patient. Rotating the outer ring inward - similar to rolling up a shirt sleeve - shortens the retractor and anchors the device in the patient. It also retracts the wound and converts the incision into a round opening. The flexible membrane that connects the rings protects the incised tissue throughout the procedure. The subject device has a snap-on silicone cap that closes and seals the wound opening. This allows the body cavity to be insufflated and the procedure to be completed under laparoscopic conditions. The center of the cap is designed to accommodate a 12mm trocar which effectively converts the wound retractor into a trocar port site.
The provided 510(k) summary for the Alexis Laparoscopic System describes a non-clinical comparison study against a predicate device (Applied Alexis Wound Retractor, K041711). The study aimed to demonstrate substantial equivalence or superiority of the new device.
Here's an breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with specific numerical thresholds, nor does it provide detailed quantitative "reported device performance" values for each criterion. Instead, it lists the types of tests performed and makes a general conclusion about substantial equivalence or superiority.
However, based on the Discussion of Nonclinical Tests Submitted, we can infer the performance aspects that were evaluated:
| Acceptance Criterion (Inferred from Test Titles) | Reported Device Performance (General Conclusion) |
|---|---|
| Leak rate of the device when the retracted wound is closed | Substantially equivalent or superior to predicate |
| Leak rate of the device when the retracted wound is closed and when a trocar is in place | Substantially equivalent or superior to predicate |
| Force required to fasten and to detach the cap | Substantially equivalent or superior to predicate |
| Retention strength of inner (green) ring | Substantially equivalent or superior to predicate |
| Maximum retraction of wound | Substantially equivalent or superior to predicate |
| Sealing integrity during manipulation of trocars | Substantially equivalent or superior to predicate |
| Potential for trocars that are placed through the cap to inflict undue stress on wound | Substantially equivalent or superior to predicate |
| Flammability evaluation of cap material | Substantially equivalent or superior to predicate |
The conclusion states: "APPLIED's functional and performance testing has demonstrated that the subject device is substantially equivalent or superior to its predicate device and introduces no new safety and effectiveness issues when used as instructed." This implies that the device met or exceeded the performance of the predicate device for all evaluated criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test set or the data provenance. It only mentions that "Several of these tests were performed on both predicate and subject devices."
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 section is not applicable as the study described is a non-clinical functional and performance test of a wound retractor device, not a study involving diagnostic interpretation or human subject data requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reason as point 3. It's a non-clinical device performance test.
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 section is not applicable. The study is a non-clinical evaluation of a physical medical device (wound retractor), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The study is a non-clinical evaluation of a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This section is not applicable as the study is a non-clinical functional and performance test of a physical device. The "ground truth" would be the direct measurement of physical properties and performance characteristics against predefined engineering specifications or the performance of the predicate device.
8. The sample size for the training set
This section is not applicable. The study is a non-clinical evaluation of a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as 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.