(133 days)
Arrow Surgical Drapes are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
Arrow Surgical Drapes are sterile, disposable patient coverings for use in surgical procedures. They are composed of one or more of the following materials: Barrier, Absorbent, and Repellant materials. They may incorporate one or more fenestration openings for surgical site access and can also include medical grade patient fixation adhesive.
The provided document is a 510(k) summary for a surgical drape, which is a medical device. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device through performance testing, rather than clinical studies involving humans or AI algorithms. Therefore, many of the requested categories are not applicable to the information contained within this 510(k) summary.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists performance tests. While it specifies the types of tests performed, it does not provide explicit numerical acceptance criteria for these tests nor does it report the specific numerical results obtained for the Arrow Surgical Drape. It broadly states that the results "demonstrate that Arrow's Surgical Drapes are safe, effective and perform favorably when compared to the predicate drapes."
| Performance Test | Acceptance Criteria | Reported Device Performance |
|-----------------------------------------------------------|------------------------------------------------------------|
| Resistance to Liquid Penetration (Synthetic Blood) | "perform favorably when compared to the predicate drapes" |
| Resistance to Liquid Penetration (Hydrostatic Pressure) | "perform favorably when compared to the predicate drapes" |
| Spray Impact | "perform favorably when compared to the predicate drapes" |
| Linting - Gelbo Flex Test | "perform favorably when compared to the predicate drapes" |
| Tear Resistance | "perform favorably when compared to the predicate drapes" |
| Puncture Penetration | "perform favorably when compared to the predicate drapes" |
| Tensile Grab | "perform favorably when compared to the predicate drapes" |
| Flammability | "perform favorably when compared to the predicate drapes" |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the sample size for the "bench tests."
- Data Provenance: The tests are "bench tests" performed to demonstrate substantial equivalence against predicate devices. The country of origin of the data is not specified, but it would typically be conducted by or for the submitter (ARROW International, Inc. based in Reading, PA, USA). The study is non-clinical performance data, not a human study, so terms like "retrospective" or "prospective" are not applicable in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- N/A. This is a physical product (surgical drape) and the evaluation is based on non-clinical performance testing (bench tests) against recognized standards (AAMI, ASTM, ISO, AATCC, CFR). There is no "ground truth" established by human experts in the context of diagnostic accuracy, as is typical for AI device evaluations.
4. Adjudication Method for the Test Set:
- N/A. As mentioned above, there are no human readers or expert consensus required for these physical and material property tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is not an AI device or a diagnostic imaging device. It's a surgical drape, and its effectiveness is determined through physical performance tests, not through human reader interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- N/A. This is not an algorithm or AI device.
7. Type of Ground Truth Used:
- The "ground truth" in this context refers to the defined standards and methodologies for evaluating physical and material properties (e.g., AAMI PB70, ASTM F 1670, ISO 9073-10). The performance of the device is measured against these established standards and then compared to the performance of predicate devices.
- The document explicitly states: "The results of the bench tests demonstrate that Arrow's Surgical Drapes are safe, effective and perform favorably when compared to the predicate drapes." This comparison to predicate devices acts as a form of "ground truth" for substantial equivalence.
8. Sample Size for the Training Set:
- N/A. This device does not involve machine learning or AI, so there is no training set.
9. How the Ground Truth for the Training Set Was Established:
- N/A. As there is no training set, this question is not applicable.
§ 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.