(52 days)
DeRoyal Surgical Gowns are identified in 21 CFR, part 878.4040 as surgical attire to be worn by operating room personnel during surgical procedures to protect both operating room personnel and the patient from the transfer of microorganisms, body fluids and other particulate materials.
The DeRoyal Surgical Gowns are comprised of Polypropylene Spunbond Meltblown Spunbond (SMS) material commonly used in the industry for these devices have been tested according to relevant performance standards (ISO 10993, AATCC 127, AATCC42, ASTM1671, 16 CFR 1610, ASTM 1342, ASTM D1424, ASTM D5034, NFPA Standards) to determine their equivalency to the predicate devices.
The provided document is a 510(k) premarket notification for DeRoyal Surgical Gowns. It states that the device is substantially equivalent to legally marketed predicate devices based on a comparison of technological characteristics and performance standards. However, it does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial or algorithm performance study would.
This document is for a medical device (surgical gowns), which are evaluated based on material properties, performance standards, and comparison to legally marketed predicate devices, rather than a "study proving device meets acceptance criteria" in the context of an AI/ML device or a device requiring a clinical efficacy trial.
Therefore, many of the requested fields cannot be directly extracted from this document, as they pertain to a different type of device evaluation (e.g., diagnostic device, software as a medical device).
Here's an attempt to answer the questions based only on the provided text, while acknowledging its limitations for this type of query:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list specific "acceptance criteria" for performance values in a table format that are then compared to reported device performance. Instead, it states that the device materials "have been tested according to relevant performance standards (ISO 10993, AATCC 127, AATCC42, ASTM1671, 16 CFR 1610, ASTM 1342, ASTM D1424, ASTM D5034, NFPA Standards) to determine their equivalency to the predicate devices."
The "device performance" is implicitly that it meets the requirements of these standards and is equivalent to the predicate devices. The specific numeric results of these tests are not provided in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Compliant with ISO 10993 (Biocompatibility) | Yes, tested compliant |
| Compliant with AATCC 127 (Water Resistance: Hydrostatic Pressure) | Yes, tested compliant |
| Compliant with AATCC 42 (Water Resistance: Impact Penetration) | Yes, tested compliant |
| Compliant with ASTM 1671 (Resistance to Penetration by Blood-Borne Pathogens) | Yes, tested compliant |
| Compliant with 16 CFR 1610 (Flammability) | Yes, tested compliant |
| Compliant with ASTM 1342 (Permeability of Air to Porous Materials) | Yes, tested compliant |
| Compliant with ASTM D1424 (Tear Strength of Woven Fabrics) | Yes, tested compliant |
| Compliant with ASTM D5034 (Breaking Strength and Elongation of Textile Fabrics) | Yes, tested compliant |
| Compliant with NFPA Standards (various protective clothing) | Yes, tested compliant |
| Equivalency to predicate devices (material, color, sizes, sterility, disposable, package) | Yes, claimed and accepted |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. For material testing, sample sizes would depend on the specific ASTM, ISO, or AATCC standards, but these details are not disclosed in this 510(k) summary. The concept of "data provenance" (country, retrospective/prospective) is not applicable here as it relates to clinical data, not material performance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable to the evaluation of surgical gown material properties. "Ground truth" in this context would be established by standardized laboratory testing methods, not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for clinical trial data or expert review scenarios, not for material property testing according to established international standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device or an AI-assisted tool where human reader performance would be measured or improved.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance
Not applicable. Surgical gowns are physical medical devices, not algorithms.
7. Type of Ground Truth Used
The "ground truth" for the device's properties is established through standardized laboratory testing according to the listed international and national consensus standards (ISO, AATCC, ASTM, NFPA, 16 CFR).
8. Sample Size for the Training Set
Not applicable. Surgical gowns do not involve machine learning algorithms with a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.