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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 Surgical gowns are 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 micro-organisms, body fluids, and particulate matter.

proMedical Surgical Gowns are disposable, single use, sterile surgical gowns manufactured from non-woven spunbond-meltblown-spunbond polypropylene or spun-laced fabrics. Gowns are provided as listed below.

| No. | Model
Number | Name | Size | Category |
|-----|-----------------|---------------------------------------------|-------------------------------------|------------|
| 1 | 18-001 | OR Spunlace Gown, Standard | Medium, Large, X-large,
XX-Large | Standard |
| 2 | 18-101 | OR Spunlace Gown, with Fabric Reinforcement | Medium, Large, X-large,
XX-Large | Reinforced |
| 3 | 18-201 | OR Spunlace Gown, with Poly Reinforcement | Medium, Large, X-large,
XX-Large | Reinforced |
| 4 | 18-301 | OR SMS Gown, Standard | Medium, Large, X-large,
XX-Large | Standard |
| 5 | 18-401 | OR SMS Gown, with Fabric Reinforcement | Medium, Large, X-large,
XX-Large | Reinforced |
| 6 | 18-501 | OR SMS Gown, with Poly Reinforcement | Medium, Large, X-large,
XX-Large | Reinforced |

This document is a 510(k) clearance letter for "ProMedical Surgical Gowns". This type of document typically provides regulatory approval based on substantial equivalence to a predicate device, rather than detailed acceptance criteria and a study proving performance against those criteria.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in these specific FDA clearance letters. These details are usually part of the 510(k) submission itself, which is not publicly released in its entirety.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This means the device was found to be as safe and effective as a legally marketed predicate device, not that a new study against specific acceptance criteria for a novel device was conducted or detailed here.

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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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proMedical Products Co. LTD intends to market Non-sterile surgical gowns identified in 21 CFR 878.4040 as medical devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from the transfer of microorganisms, bodily fluids and particulate material.

Surgical Gowns

This document is an FDA 510(k) clearance letter for "Surgical Gowns" (K042111) and does not contain information about the acceptance criteria or a study proving that a device meets those criteria, as typically found in a clinical study report or a summary of safety and effectiveness (SSE).

Instead, this letter:

• Confirms substantial equivalence: It states that the device is substantially equivalent to legally marketed predicate devices.
• Specifies regulation information: It lists the regulation number, name, and product code.
• Outlines general regulatory requirements: It reminds the applicant about various FDA regulations they must comply with, such as annual registration, labeling, and good manufacturing practices.
• Includes "Indications for Use": This section describes the intended purpose of the surgical gowns (protection from microorganisms, bodily fluids, and particulate material) but does not provide specific performance metrics or acceptance criteria from a study.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone), or training set information from the provided text. This type of information would typically be detailed in the 510(k) submission itself or a separate study report, not in the FDA's clearance letter.

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proMedical Products Co. Ltd. intends to market Non-sterile surgical equipment covers which are protective barrier covers that are intended to cover equipment and provide a protective barrier for that equipment.

Non-sterile surgical equipment covers which are protective barrier covers that are intended to cover equipment and provide a protective barrier for that equipment.

The provided text is a clearance letter from the FDA for a medical device called "ProMedical Surgical Equipment Covers". It does not contain information about acceptance criteria or a study proving device performance in the way a diagnostic AI/ML device submission would.

The document pertains to a Class II device (Surgical Drape and Drape Accessories) which is a physical product designed to provide a protective barrier for surgical equipment. The FDA clearance is based on "substantial equivalence" to legally marketed predicate devices, not on a performance study against specific acceptance criteria.

Therefore, I cannot provide the requested information from this document. The questions you've asked are typically relevant for AI/ML-driven diagnostic devices that undergo rigorous performance evaluation studies, which is not the case for this type of surgical equipment cover.

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