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proMedical Products Co. LTD intends to market sterile surgical drapes identified in 21 CFR 878.4370 as device made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

proMedical Products Co. LTD intends to market Sterile surgical equipment covers which are protective barrier covers that are intended to be used to cover surgical equipment and provide a protective barrier for that equipment.

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This document is a 510(k) premarket notification approval letter for ProMEDICAL Surgical Drapes and Surgical Equipment Covers. It confirms that the devices are substantially equivalent to legally marketed predicate devices.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to a specific performance study (like clinical trial results for an AI/ML device).

Instead, it refers to the general requirements for surgical drapes and equipment covers, implying that the acceptance criteria would be related to material properties, sterility, and barrier function as required by the relevant FDA regulations (21 CFR 878.4370). The "study" here is essentially the manufacturer's demonstration that their device meets these general requirements and is substantially equivalent to existing devices, evidenced by the 510(k) submission.

Therefore, I cannot provide the requested information in the format of a table describing acceptance criteria and reported device performance, nor details about sample sizes, experts, adjudication methods, or MRMC studies, as these aspects are not present in the provided text.

The information provided is specific to regulatory approval for a medical device (surgical drapes and equipment covers) based on substantial equivalence, and not a performance study as would be conducted for a diagnostic AI device.

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proMedical Products Co. LTD intends to market Non-sterile surgical drapes identified in 21 CFR 878.4370 as device made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination

Non-sterile Disposable Surgical Drapes made of natural or synthetic material.

The provided text is related to a 510(k) premarket notification for "Non-sterile Disposable Surgical Drapes." This document focuses on the regulatory clearance for a medical device (surgical drapes), and as such, it does not contain information about product performance acceptance criteria or a study proving its performance in the way a diagnostic or AI-driven device would.

The 510(k) process for devices like surgical drapes primarily involves demonstrating "substantial equivalence" to a predicate device. This is achieved through comparisons of material, manufacturing processes, intended use, and conformance to relevant industry standards (e.g., for sterility, barrier properties, tensile strength, etc.), rather than clinical performance metrics like accuracy, sensitivity, or specificity.

Therefore, most of the requested information (items 1-9) cannot be extracted from this document because it describes a different type of regulatory submission and product.

Here's a breakdown of what can be extracted or inferred, and why the other points are not applicable:

1. A table of acceptance criteria and the reported device performance

• Not applicable / Not present in this document. For surgical drapes, acceptance criteria would typically relate to physical properties (e.g., fluid resistance, tensile strength, linting, flammability, cytotoxicity) and manufacturing standards (e.g., sterility assurance level if sterile, biocompatibility). These specifics are not detailed in this high-level regulatory summary. The document states "substantial equivalence" to predicate devices, implying it meets similar performance standards, but doesn't list them.

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 / Not present. Clinical performance studies with test sets are not typically required or described for 510(k) submissions of devices like surgical drapes. The "testing" would involve laboratory-based characterization of materials.

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 / Not present. Ground truth establishment by experts is relevant for diagnostic devices interpreting complex data (like medical images). It does not apply to surgical drapes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not present. Adjudication relates to resolving discrepancies in expert interpretations, which is not relevant here.

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 / Not present. MRMC studies are for evaluating diagnostic accuracy, especially with AI assistance. This device is a surgical drape, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable / Not present. This applies to AI algorithms, not physical medical devices like drapes.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not applicable / Not present. Ground truth is not a concept applied in the same way for these types of devices. Compliance with industry standards and material specifications would be the "truth" here.

8. The sample size for the training set

• Not applicable / Not present. Training sets are used for machine learning models. This is a physical product.

9. How the ground truth for the training set was established

• Not applicable / Not present. See point 8.

Summary regarding the provided document:

This 510(k) notification focuses on establishing "substantial equivalence" of "proMedical Surgical Drapes" to already legally marketed predicate devices (Primeline (Primaguard) surgical drapes (K021864) and Medline (Proxima) surgical drapes (K964142)). The FDA determined this equivalence, allowing the device to be marketed. The information typically found in such a submission (but not fully detailed in this letter) would include:

• Intended Use: "Non-sterile surgical drapes ... intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination."
• Classification: Class II, product code KKX, regulation number 878.4370.
• Comparison to Predicates: The 510(k) submission would have contained detailed comparisons of the device's material properties, design, manufacturing processes, and performance characteristics (e.g., barrier properties, fluid resistance, strength) to the predicate devices, likely citing adherence to recognized consensus standards. However, these specific details are not present in the provided excerpts.

In conclusion, the provided text does not describe acceptance criteria and a study proving device performance in the context of diagnostic accuracy or AI performance, as it pertains to a different class and type of medical device undergoing a different regulatory pathway.

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