(96 days)
Exact Medical Manufacturing Surgical Drape - Spunlace w/PE Sides are sterile or non-sterile single use devices 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 Exact Medical Manufacturing Surgical Drape - Spunlace w/PE Sides are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization
Exact Medical Manufacturing Surgical Drape -Spunlace w/PE Sides are sterile or non-sterile single use devices 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.
Exact Medical Manufacturing Surgical Drapes-Spunlace w/PE Sides are comprised of Spunlace, Polyethylene, 3M Medical Adhesive Tape.
The document provided describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the "Exact Medical Manufacturing Surgical Drape-Spunlace w/PE Sides, Model 13-004".
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance/Result |
|---|---|---|
| Water Resistance: Impact Penetration Test (AATCC 42:2007) | 50 cm hydrostatic resistance (Ref: AAMI PB70:2003/(R)2009, Level 3) | Pass |
| Biocompatibility: In Vitro Cytotoxicity (ISO 10993-5:1999) | Evidence of cell lysis or toxicity 3.5 sec. average flame spread | Pass (Class 1) |
| Tearing Strength of Fabrics by Trapezoid Procedure (ASTM D5587-08) | Acceptance criteria not established in recognized standard. Exceeds predicate performance. | Pass |
| Breaking Strength and Elongation of Textile Fabrics (Grab Test) (ASTM D5034-09) | Acceptance criteria not established in recognized standard. Exceeds predicate performance. | Pass |
| Sterilization of health care products - Ethylene oxide (ISO 11135-1:2007) | SAL of > $10^{-6}$ | Pass |
| Ethylene Oxide Sterilization Residuals (ISO 10993-7:2008) | Average daily dose of EO/ECH shall not exceed 4mg/9mg | Pass |
| Lint and other particles generation in the dry state (ISO 9073-10:2003) | Acceptance criteria not established in the recognized standard. | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not explicitly state the sample size for each test. However, for each test, a single "Finished Good Lot Number" (0980APA2) of the device (Model No. 13-004 Sterile) was used as the "Test Article". This suggests that samples from this specific lot were subjected to all listed tests.
- Data Provenance: The tests were conducted across several accredited laboratories:
- Nelson Labs, Utah, USA
- LexaMed, Ohio, USA
- LexaMed/NAMSA, Ohio, USA
- SCDC, Shanghai, CN
- GOALS Sterilization Co., Jiaxing, CN
The data appears to be prospective as it involves pre-market testing of the device against established standards.
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 type of information is not applicable to this document. The tests performed are objective, physical, and chemical performance tests for a medical device (surgical drape), not diagnostic tests requiring expert interpretation of results or ground truth derived from expert consensus. The "ground truth" is established by the specified industry standards and their defined acceptance criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the type of testing described. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, where multiple experts might disagree on an outcome. For these performance tests, the results either objectively meet or do not meet the predefined numerical or qualitative criteria of the standard.
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 is not applicable. The device is a surgical drape, not an AI-powered diagnostic tool, and therefore, MRMC comparative effectiveness studies involving human readers and AI assistance are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical surgical drape, not an algorithm, so the concept of standalone algorithm performance does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests of the surgical drape is based on recognized industry standards and their predefined acceptance criteria. This includes standards like AATCC, ASTM, ISO, and 16CFR, which specify objective measurements and thresholds for properties such as water resistance, biocompatibility, flammability, and tensile strength.
8. The sample size for the training set
This is not applicable. The device is a physical product, not a machine learning model, so there is no concept of a "training set" in its evaluation.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this device.
§ 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.