(157 days)
A surgeon's vest contructed of OREX nonwoven fabric for use as additional protection for surgeons during a surgical procedure.
A surgeon's vest contructed of OREX nonwoven fabric for use as additional protection for surgeons during a surgical procedure. The material is flame resistant, and is resistant to fluid penetration. The material also has low lint characteristics, meets suitable strength requirements for its intended use, and is resistant to tearing. The material is dissolvable after use in an OREX processor or may be disposed of using the hospital or healthcare facilities standard disposal method.
This document is a 510(k) summary for a medical device called "OREX Surgeon's Vest." It focuses on demonstrating substantial equivalence to a predicate device ("Surgeon's Vest Isolyser/White Knight") rather than presenting a study with specific acceptance criteria and detailed performance metrics as you would find for a diagnostic or AI-powered device.
Therefore, many of your requested points are not applicable to the information provided in this 510(k) summary. I will address the points that are relevant and explain why others cannot be answered from this document.
Detailed Breakdown based on the provided text:
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A table of acceptance criteria and the reported device performance
- Not applicable in the format requested for specific quantitative metrics. This 510(k) summary describes that "All testing conducted on the fabric used in this product was tested according to guidance documents published for biocompatibility." It also states, "The results from these tests were found to be acceptable when compared to that of the predicate device. In some instances test results were found to exceed those of the predicate device."
- It generally implies acceptance criteria are met if the new device's performance is comparable to or better than the predicate device for parameters like flame resistance, fluid penetration resistance, low lint characteristics, suitable strength, and tearing resistance. However, no specific numerical thresholds or performance values are provided.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document does not specify sample sizes for any of the testing conducted on the fabric. It also doesn't mention data provenance (country, retrospective/prospective).
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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. This device is a physical product (a surgeon's vest) and its performance is evaluated through material property testing, not through expert-based interpretation of data for ground truth establishment.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for subjective evaluations often involving multiple readers or experts, which is not the case for material property testing described here.
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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 product, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical product, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the requested sense. The "ground truth" for this device would be established by standardized material testing methods and compliance with relevant industry or regulatory standards for attributes like flame resistance, fluid penetration, strength, and tearing resistance. Comparison to the predicate device's performance serves as the benchmark.
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The sample size for the training set
- Not applicable. This is a physical product being tested for material properties, not an AI model requiring a training set.
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How the ground truth for the training set was established
- Not applicable. See point 8.
Summary based on the provided text:
The document describes a 510(k) submission aiming to demonstrate substantial equivalence of the OREX Surgeon's Vest to a predicate device. The primary method of showing this equivalence relies on material testing of the OREX nonwoven fabric according to "guidance documents published for biocompatibility." The results of these tests were found to be "acceptable when compared to that of the predicate device," and in some cases "exceeded those of the predicate device." This general statement of acceptability and superiority relative to the predicate device serves as the implicit "acceptance criteria" and "performance demonstration" within the context of this regulatory submission for a physical medical device. Specific quantitative data, sample sizes, expert involvement, or AI-related metrics are not provided as they are not relevant to this type of device and submission.
§ 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.