(118 days)
Exact Medical Manufacturing Surgical Drape SMS 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 Surgical Drape SMS 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 Drapes Surgical Drape SMS 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 SMS w/PE Sides are comprised of a single layer of SMS (spunbond/meltblown/spunbond polypropylene), PE Layer, 3M Medical Adhesive Tape.
The provided text is for a 510(k) Summary for a medical device called "EMM Surgical Drape SMS w/PE Sides." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against specific acceptance criteria for a novel AI or diagnostic device.
Therefore, many of the requested items related to AI/diagnostic device studies (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect size of AI assistance, standalone performance, and how ground truth was established) are not applicable to this type of submission.
However, I can extract the acceptance criteria and the summary of testing performed to demonstrate that the device met these criteria, in comparison to a predicate device.
Acceptance Criteria and Reported Device Performance
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from Predicate Device/Industry Standards) | Reported Device Performance (EMM Surgical Drape SMS w/PE Sides) |
|---|---|
| Indications for Use: Protective patient covering to isolate a site of surgical incision from microbial and other contamination. | Substantially Equivalent (Same indications for use) |
| Classification: KKX, Surgical Drapes, 21CFR878.4370, Class II | Substantially Equivalent (Same classification) |
| Materials & Construction: SMS, absorbent reinforcement, 3M medical grade adhesive | Substantially Equivalent (SMS, Polyethylene, Absorbent Reinforcement, 3M medical grade adhesive) |
| Barrier properties (AAMI PB70:2003 /(R)2009): Hydrostatic head = 30.5 cm (Predicate) | Hydrostatic Head =/> 50 cm (meets AAMI PB70 Level 3) |
| Sterility: Non-sterile (Predicate) | Sterile (via EO Gas) ISO 11135-1:2007 (also available non-sterile) |
| Biocompatibility (ISO 10993-5:1999, ISO 10993-10:2002): Cytotoxicity, Irritation, Sensitization PASS | Substantially Equivalent (Cytotoxicity, Irritation, Sensitization tests PASS) |
| Tear Strength (ASTM D5587-08): Md=1.83 lbs, Cd= 3.24 lbs (Predicate) | Substantially Equivalent (Md and Cd within general industry tolerance +/- 20%) |
| Tensile Strength (ASTM D5034-09): Md=13.8 lbs, Cd=18.8 lbs (Predicate) | Substantially Equivalent (Md and Cd within general industry tolerance +/- 20%) |
| Flammability (16CFR1610:2010): Class 1 (Predicate) | Substantially Equivalent (Class 1 - PASS) |
| Lint and other Particles (ISO 9073-10:2003): No test specified for predicate | Test performed (Not Applicable for direct comparison against predicate criteria as predicate had no test) |
| Sterile Packaging: Not Applicable (Predicate) | Chevron peel pouch (coated paper, PET12/PE40 film construction), individual CSR internal wrap |
Note: The reported device performance often states "Substantially Equivalent" indicating that the EMM Surgical Drape met or exceeded the performance characteristics of the predicate device, or adhered to recognized standards. For Barrier Properties, the EMM device reports a higher hydrostatic head, meeting a higher level (Level 3) compared to the stated predicate value, which implies it exceeds the predicate's performance.
Study Details (as applicable for this type of submission)
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable in this context. This submission is for a physical medical device (surgical drape) and relies on laboratory-based performance testing rather than clinical data or a diagnostic test set with patient data. The "test set" here refers to samples of the surgical drape material. The document does not specify sample sizes for each physical test, beyond stating that "All results of the testing met acceptance criteria." Data provenance (country of origin, retrospective/prospective) is not mentioned or relevant for these types of material property tests.
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)
- Not Applicable. Ground truth, in the sense of expert review for diagnostic accuracy, is not relevant here. The "ground truth" for material properties is established by defined physical and chemical testing standards (e.g., ISO, ASTM, AATCC) and the results obtained from those standardized tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically for subjective expert review of medical images or clinical cases. The testing for the surgical drape involves objective physical property measurements.
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
- Not Applicable. This is a physical medical device, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an AI or diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is established by objective measurements against recognized industry standards and regulatory requirements for material properties and biocompatibility. This includes compliance with standards such as ISO 10993 (Biocompatibility), AAMI PB:70 (Barrier properties), ASTM D5587 (Tear Strength), ASTM D5034 (Tensile Strength), 16CFR1610 (Flammability), and ISO 9073-10 (Linting). The predicate device's established performance also serves as a benchmark for "substantial equivalence."
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of physical medical device testing for substantial equivalence.
9. How the ground truth for the training set was established
- Not Applicable. No training set is used.
§ 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.