(133 days)
ProPel SG3TM Surgical Gown is intended to protect both surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 3 surgical gowns in accordance with ANSI/AAMI PB70.
The reusable Propel Surgical Gown is provided non-sterile and must be sterilized before use. Stertlization parameters are as follows:
Prevacuum Steam Sterilization: 132°C/270°F (temperature)/ 4 minutes (exposure time)/15 minute (dry time)
The ProPel SG3TM Surgical Gown is a reusable, woven surgical gown that provides an ANSI /AAMI PB70:2022 Level 3 Liquid Barrier Performance Barrier using 100% polyester with silicone coating in the critical zone. The critical zone inner ply and back of the surgical gown is made of polyester with electrostatic dissipative yarn (graphene) and silicone coating. The gown has polyester mesh and vented cape on the back panels of the gown for ventilation. The ProPel SG3TM Surgical Gown may undergo up to 60 reprocessing cycles.
The ProPel SG3™ Surgical Gown is available in small, medium, large, extra large (XL), 2XL and 3XL. The device will be sold as a non-sterile surgical gown that is to be laundered, sterilized and processed by the healthcare facility prior to first use and after each subsequent use.
The provided text describes the non-clinical testing performed on the ProPel SG3™ Surgical Gown to demonstrate its equivalence to a predicate device. It is important to note that this is a 510(k) submission, which aims to show substantial equivalence, not necessarily a study proving clinical effectiveness in the same way a new drug or high-risk device might.
Here's the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Test Method/Applicable Standard(s) | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Tensile Strength | ASTM D5034/ASTM F2407-20 | ≥ 30 N (≥ 7 lbf) | PASS |
| Tear Strength | ASTM D5587/ASTM F2407-20 | ≥ 10 N (≥ 2.3 lbf) | PASS |
| Seam Strength | ASTM D1683/ASTM F2407-20 | ≥ 30 N (≥ 7 lbf) | PASS |
| Hydrostatic Resistance | AATCC Method 127/ANSI/AAMI PB70 | ≥ 50 cm per AAMI PB70 for Level 3 | PASS |
| Impact Penetration | ATCC Method 42/ANSI/AAMI PB70 | ≤ 1.0 g per AAMI PB70 for Level 3 | PASS |
| Lint Generation | ISO 9073-10 | --- (No explicit quantitative acceptance criteria listed; qualitative comparison) | Coefficient for linting is 3 for both predicate and subject device |
| Flammability | 16 CFR 1610 | Pass Class I Flammability | PASS (Class I) |
| Snap Strength | ASTM D4846-96 | Fasteners provide peel strength of ≤ 1.5 lbf (easy doff) and shear force ≥ 4.5 lbf (secure) | PASS |
| Evaporative Resistance | ASTM F1868-17 | Evaporative resistance of critical zone (average of 3 specimens) ≤ 350 Pa m²/W; evaporative resistance of the back mesh (2-ply average of 3 specimens) ≤ 5 Pa m²/W | PASS |
| Critical Zone Fabric Weight Testing | ASTM D3776/D3776M-20 | --- (No explicit acceptance criteria; result is a specific measurement) | Gown critical zone fabric construction weighs less than 7.83 OSY |
| Use Life Tracking | --- | QCM label is legible and RFID Chip can be read at the beginning and end of use life (after 60 reuses) | PASS |
| Cytotoxicity | ISO 10993-5 | Less than/equal to grade 2 (mild reactivity) | PASS |
| Sensitization | ISO 10993-10 | No evidence of causing delayed dermal contact sensitization | PASS |
| Irritation | ISO 10993-23 | No erythema, no edema | PASS |
| Pyrogenicity | USP /ISO 10993-11 | Temperature rise within acceptable limits | PASS |
| Acute Systemic Toxicity | ISO 10993-11 | No mortality or evidence of systemic toxicity | PASS |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to non-clinical testing of the physical and biological properties of the surgical gown material and design. For each test, "specimens" or "gowns" would be used as samples. However, the exact sample size (N) for each specific test (e.g., number of gowns for tensile strength, number of fabric pieces for hydrostatic resistance, number of biological samples for cytotoxicity) is not explicitly stated in this summary. For Evaporative Resistance, it mentions "average of 3 specimens".
The data provenance (country of origin, retrospective/prospective) is not provided in this document. Given that it's non-clinical testing of a manufactured product, it is likely that the testing was performed in a controlled laboratory environment, but the location is not specified.
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 is a non-clinical, laboratory-based study for a surgical gown. It does not involve medical imaging, diagnosis, or clinical decision-making by human experts where "ground truth" would be established by referring radiologists or other clinicians. The "ground truth" or "acceptance criteria" for these tests are based on established national and international standards (like ANSI/AAMI, ASTM, ISO, AATCC, 16 CFR, USP), which reflect a consensus of scientific and technical experts in materials science, biology, and medical device regulations. Therefore, this question is not applicable in the context of this device and study type.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since this is non-clinical laboratory testing against predefined, objective standards, an adjudication method like 2+1 or 3+1 (typically used for resolving discrepancies in expert interpretations) is not applicable. The 'adjudication' is inherent in the test method itself, where results are measured objectively and compared against numerical acceptance criteria in a pass/fail manner.
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
A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study is performed for diagnostic devices, particularly those involving human interpretation (e.g., radiologists reading images). This device is a surgical gown, which is a physical barrier protection device. Therefore, an MRMC study and effects related to human reader improvement with AI assistance are not applicable. The document explicitly states "SUMMARY OF CLINICAL TESTING Not Applicable", further confirming no clinical effectiveness study (which would include MRMC) was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of an AI algorithm without human involvement. Since the device is a surgical gown and not an AI-powered diagnostic or assistive tool, this question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance claims of the surgical gown is based on established national and international standards and test methods. These standards define measurable physical and biological properties (e.g., tensile strength, tear strength, barrier performance, biocompatibility) and their respective acceptance criteria.
8. The sample size for the training set
This question typically applies to machine learning or AI models. Since this is non-clinical testing of a physical medical device (surgical gown), there is no "training set" in the context of an AI algorithm. The gown samples tested were used to demonstrate compliance with the specified performance standards.
9. How the ground truth for the training set was established
As there is no "training set" for an AI algorithm in this context, this question is not applicable. The "ground truth" for evaluating the gown's performance was established by recognized industry standards and test methodologies.
§ 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.