Search Results

The Procedure Masks / Surgical Masks are intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Procedure Masks / Surgical Masks with Polyethylene nose wire can be used in MRI environment.

Procedure Mask / Surgical Mask, Ear loops and Tie-On. This is a single use, disposable device(s), provided non-sterile.

The provided text is a U.S. FDA 510(k) clearance letter for a Procedure Mask/Surgical Mask. It describes the device, its intended use, and states that it has been determined to be substantially equivalent to legally marketed predicate devices.

However, the document does NOT contain any information regarding the acceptance criteria, device performance testing (including details on sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details) for an AI/ML-driven device.

This document pertains to traditional medical device clearance (a surgical mask), which goes through a different evaluation process than AI/ML-driven software as a medical device (SaMD). The questions you've asked are highly relevant to the regulatory clearance of AI/ML-driven medical devices, but the provided text does not offer this information.

Therefore, I cannot fulfill your request using the given input, as the necessary information is absent.

Ask a specific question about this device

SurgiPlus Surgical Drapes are single use, disposable patient coverings intended to be used by operating room personnel during surgical and other medical procedures as protective covers to isolate surgical incision sites from microbial and other contaminations.
The SurgiPlus Surgical Drapes are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.
The drapes are classified as Level 3 or Level 4 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.

SurgiPlus Surgical Drapes are single use, disposable patient coverings. They are made of SMS base sheet with SPP with PE reinforcement or SMS base sheet. They are available in sterile and non-sterile forms.

The provided document is a 510(k) premarket notification for surgical drapes. It primarily focuses on demonstrating substantial equivalence to a predicate device based on material composition and adherence to specific AAMI (Association for the Advancement of Medical Instrumentation) standards for liquid barrier performance.

This document does not contain information about studies involving AI/ML devices, human readers, or the establishment of ground truth by experts in a clinical context. It pertains to the physical performance characteristics of a surgical drape.

Therefore, many of the requested categories are not applicable to the provided document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device claims to be classified as Level 3 or Level 4 per AAMI Standard PB70 for liquid barrier performance. The document doesn't explicitly list a table of acceptance criteria and reported performance for the device against those criteria in a comparative format. Instead, it states the classification. To fully answer this, one would need to refer to AAMI Standard PB70. However, the FDA's acceptance of the 510(k) implies that the device meets the stated AAMI levels.

The remaining questions are largely not applicable (N/A) to this 510(k) submission because it describes the physical properties and intended use of surgical drapes, not an AI/ML diagnostic or therapeutic device that would involve clinical image analysis or human-in-the-loop performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• N/A. This is a physical product (surgical drape) and the assessment relates to its material properties and barrier performance according to AAMI standards. There is no "test set" of clinical data to analyze. Testing would involve material samples for physical property assessment.

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)

• N/A. Ground truth from clinical experts is not relevant for the classification of a surgical drape based on AAMI liquid barrier performance standards. The "ground truth" would be the results of standardized physical tests performed by qualified lab personnel.

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

• N/A. No clinical "test set" requiring adjudication.

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

• N/A. This device is a surgical drape, not an AI system that assists human readers.

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

• N/A. This device is a surgical drape, not an algorithm.

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

• For the AAMI liquid barrier performance, the "ground truth" would be established by standardized laboratory testing protocols as defined by AAMI PB70. This involves objective physical measurements (e.g., hydrostatic pressure, impact penetration) rather than expert consensus on clinical data.

8. The sample size for the training set

• N/A. This is a physical product (surgical drape) and does not involve AI/ML training sets.

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

• N/A. No training set exists for this type of device.

Ask a specific question about this device

SurgiPlus Surgical Gowns are single use article of surgical apparel intended to be worn by operating room personnel during surgical and other medical procedures to protect both the medical personnel and patients from transfer of blood, body fluids, and particulate materials.

SurgiPlus Surgical Gowns are single use article of surgical apparel.

I'm sorry, but the provided text only contains a 510(k) premarket notification for a surgical gown and does not include information about acceptance criteria, study details, or performance data for a device. Therefore, I cannot generate the requested table and descriptions.

Ask a specific question about this device

The A Plus International, Inc. Solution Face Masks are designed as surgical apparel medical devices that are intended to fully cover the nose and mouth for infection control, and to be worn (for example) by operating room personnel during surgical procedures, so as to protect both the surgical patient as well as operating room personnel from transfer of microorganisms, body fluids, and particulate materials. Solution Face Masks may be used as isolation masks, procedure masks, or dental face masks, but not as combination surgical and respirator masks. Solution Face Masks are intended as single use disposable devices and not intended for reuse of any kind.

Not Found

This document is a 510(k) premarket notification acceptance letter for a medical device (face masks). It does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested.

Specifically, the document does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets, data provenance, or the number/qualifications of experts.
3. Adjudication methods.
4. Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
5. Information about standalone algorithm performance studies.
6. The type of ground truth used.
7. Sample size for the training set.
8. How ground truth for the training set was established.

This letter primarily focuses on the FDA's "substantial equivalence" determination to a legally marketed predicate device, indicating that the new device has similar technological characteristics and is safe and effective for its intended use. It does not elaborate on the specific performance studies and their results beyond stating that an equivalence determination has been made based on the submitted information.

Ask a specific question about this device