(66 days)
The Applied Wound Retractor is indicated for use to retract and protect an incision in the abdominal wall during both laparoscopic and open surgery. It is intended to allow the surgeon to access the abdominal cavity during surgery through an atraumatically retracted wound, providing maximum exposure with minimum incision size. In addition to incision retraction, it is intended to protect against wound contamination during both laparoscopic and open surgery.
The Applied Wound Retractors come in-four sizes, small, medium-large and large and in two shapes, round and elliptical. The shape of a wound retractor is defined by its wound retracting ring. The Wound Retractor consists of a wound retractor ring and a wound protecting sheath. The wound retractor ring is molded from a plastic material. The wound protecting sheath is comprised of a cylindrical elastic sheath with a ring at one end. The Wound Retractor package also includes an incision template. The Wound Retractor is a disposable, single-use device and is packaged inside Tyvek/Mylar The would which is standard packaging material for medical products. The packaged product will then be packaged in an outer product carton in 1 to 10 pieces per carton.
This document is a 510(k) summary for a medical device called a "Wound Retractor." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria or a study proving the device meets those criteria, as typically found in more detailed performance reports.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance
- Sample sizes, data provenance, number of experts, qualifications of experts, adjudication method,
- Multi-reader multi-case (MRMC) comparative effectiveness study results,
- Standalone algorithm performance, or
- Details about the ground truth for training or test sets.
The information provided is purely for regulatory clearance based on substantial equivalence, not a detailed technical performance study.
Here's what I can extract from the provided text based on your prompt, even though it doesn't contain the specific performance study details you're looking for:
The document does NOT contain information regarding:
- Acceptance criteria or reported device performance
- Sample sizes for test sets or their data provenance
- Number of experts or their qualifications for establishing ground truth
- Adjudication methods
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes
- Standalone algorithm (AI) performance (as this is a physical medical device, not an AI/software device)
- Sample size for training sets
- How ground truth for training sets was established
Therefore, a table of acceptance criteria and reported device performance cannot be generated from this document. This 510(k) summary is focused on establishing substantial equivalence to a predicate device for regulatory clearance, rather than presenting detailed performance study results against specific criteria.
§ 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.