(339 days)
Sterile stockinette is used primarily as an surgical extremity drape to establish a sterile field. Bias cut sterile stockinette is used as a dressing retainer where swelling is expected.
Sterile stockinette includes single and double ply rolls, bias cut rolls and impervious stockinette in various widths and lengths.
The provided text describes a 510(k) summary for the "Tex-Care Sterile Stockinette." However, the device is a medical textile (surgical drape), not an AI/ML powered device. As such, concepts like "acceptance criteria and reported device performance" in the context of diagnostic accuracy (e.g., sensitivity, specificity), "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication methods," "MRMC studies," "standalone performance," and "training set details" are not applicable to this type of device and the information provided.
The "studies" conducted for this product are physical and biological material property tests to ensure safety and effectiveness as a surgical drape, rather than diagnostic performance studies.
Therefore, I cannot populate the table or provide information for most of the requested points in the context of an AI/ML device.
Here's an interpretation of the relevant information provided, rephrased to fit the non-AI nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Criterion | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Imperviousness | Withstand synthetic blood penetration without compromise | All 32 samples passed ASTM ES 21 Synthetic Blood Penetration Test. |
| Withstand viral penetration without compromise | All 32 samples passed ASTM ES 22 Viral Penetration Test. | |
| Biocompatibility | No significant local irritation in dermal tissues (USP Intracutaneous Test) | No apparent irritation observed in association with test article extracts. |
| No clinical signs of toxicity (USP Systemic Injection Test) | None of the test animals showed any clinical signs consistent with toxicity. | |
| No allergic potential/sensitization (Guinea Pig Maximization Test) | 0% sensitization incidence. | |
| Material Strength | Adequate breaking force (ASTM D 5034-90) | Shown to be adequate. |
| Adequate bursting strength (ASTM D 3787-89) | Shown to be adequate. | |
| Flammability | Meet requirements for Normal Flammability (CS-191-53 Part 1610) | Met Classification 1 - Normal Flammability requirements for both cotton and impervious stockinettes. |
2. Sample size used for the test set and the data provenance:
- For Synthetic Blood Penetration: 32 samples
- For Viral Penetration: 32 samples
- For Biocompatibility tests (Intracutaneous, Systemic Injection, Sensitization): Animal models (rabbits and guinea pigs), specific sample sizes not given but typically small and determined by assay standards.
- For Material Strength & Flammability: Not explicitly stated, typically a representative sample set is tested according to the ASTM/CS standards.
- Data Provenance: Not specified, but standard laboratory testing results for the device material. These are prospective tests performed on the manufactured product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable. The "ground truth" for these tests is the objective measurement against a standard and observation of physical/biological responses, not expert consensus on an image or clinical case. The tests would be conducted by trained laboratory technicians/scientists.
4. Adjudication method for the test set:
- Not applicable. Results are typically pass/fail based on objective criteria defined by the test standard (e.g., "no penetration," "no irritation," "strength above threshold").
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- Not applicable, as this is not a diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an AI/ML algorithm.
7. The type of ground truth used:
- Objective Test Standards and Biological/Physical Responses: The "ground truth" is defined by the established ASTM and USP test methods themselves, which provide objective criteria for passing or failing, or quantifiable measurements (e.g., no observed irritation/toxicity, material strength values).
8. The sample size for the training set:
- Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
- 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.