(24 days)
The Convertors®SMS Polyolefin Gowns are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
The standard, fabric- and poly-reinforced gowns are comprised of a single layer of SMS Polyolefin fabric. The fabric-reinforced gowns have an additional layer of SMS Polyolefin fabric in the sleeve and body areas; the poly-reinforced gowns have an additional layer of polyolefin film in the sleeve and body areas.
The provided text describes the 510(k) summary for the Convertors®SMS Polyolefin Gowns, detailing its intended use, substantial equivalence, and summary of testing. However, it does not include detailed acceptance criteria or the specific study results proving the device meets those criteria in the format requested (e.g., specific performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods).
The information provided focuses on the regulatory submission and biocompatibility testing, not a performance study in the context of AI/medical imaging device evaluation.
Therefore, I cannot populate the table or answer most of the questions as the necessary information is not present in the provided text.
Based on the provided text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Met requirements of ISO 10993 Part-1 | Found acceptable for intended use |
| Cytotoxicity | Not specified | Met requirements of ISO 10993 Part-1 |
| Sensitization | Not specified | Met requirements of ISO 10993 Part-1 |
| Irritation/Intracutaneous Reactivity | Not specified | Met requirements of ISO 10993 Part-1 |
| Protection from microorganisms, body fluids, particulate material | Not specified (implied by intended use) | "the performance attributes are the same" as predicate device (specific attributes not detailed) |
Explanation: The document states that "All materials used... were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 'Biological Evaluation of Medical Devices'." It concludes that these materials "have met the requirements of the guidance and were found to be acceptable for the intended use." Specific quantitative acceptance criteria or detailed results for these tests (e.g., specific scores or thresholds) are not provided in this summary. The comparison to the predicate device mentions "the performance attributes are the same," but these attributes are not elaborated upon.
Missing Information/Not Applicable Based on Provided Text:
- 2. Sample sized used for the test set and the data provenance: Not applicable. This refers to biocompatibility testing, not a dataset for an algorithm. The sample size for material testing is not specified.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Biological testing relies on laboratory standards, not expert radiologists/medical practitioners for ground truth.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is a surgical gown, not an AI diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For biocompatibility, the ground truth would be established by the adherence to ISO 10993-1 standards and the results of laboratory tests.
- 8. The sample size for the training set: Not applicable. The device is a physical product, not an AI model.
- 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.