Search Results

The SensiCare PI surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The SensiCare PI Surgical Gloves are disposable powder-free surgical gloves that are intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination. The gloves are made with polyisoprene and are cream in color. The SensiCare PI Surgical Gloves are available in a smooth grip and are constructed with a beaded cuff. The gloves have been tested for use with chemotherapy drugs per ASTM D6978.

This document is a 510(k) Premarket Notification for the SensiCare PI Surgical Gloves. It outlines the device's characteristics, intended use, and a comparison to a predicate device. The primary performance testing described relates to the glove's resistance to chemotherapy drugs and its physical properties.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SensiCare PI Surgical Gloves are based on compliance with specific ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards, as well as FDA regulations.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not explicitly state the exact "sample size" in terms of number of gloves tested for each individual performance test (e.g., how many gloves for tensile strength, how many for permeation). Instead, it references adherence to specific ASTM and ISO standards, which inherently include their own sampling plans and acceptance criteria. For example, ASTM D5151 for freedom from holes specifies "Inspection Level 1, AQL 1.5," which dictates the sample size based on the lot size.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of medical device testing for regulatory submission, these are typically prospective, controlled bench tests conducted in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to this type of device. The ground truth for surgical gloves, especially regarding physical properties and chemotherapy permeation, is established through objective, standardized laboratory testing against established physical and chemical metrics defined in national and international standards (ASTM, ISO). It does not involve expert consensus on subjective interpretations like image analysis or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable to this type of device. Adjudication methods (like 2+1, 3+1) are typically used in studies where human expert review is involved to establish a "ground truth" (e.g., in medical image analysis). For physical device testing, the results are objectively measured from the device directly.

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

This information is not applicable to this device. An MRMC study is relevant for diagnostic devices, particularly those involving human interpretation of data (e.g., radiologists interpreting images, often with AI assistance). This device is a surgical glove, which is a physical barrier device, and does not involve "human readers" or "AI assistance" in its direct function for diagnosis or interpretation.

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

This information is not applicable to this device, as it is a physical device and does not involve algorithms or AI.

7. The Type of Ground Truth Used

The ground truth used for this device is based on objective, quantitative measurements compliant with standardized test methods. These include:

• Standardized Physical Properties: Measurements of dimensions (length, width, thickness), tensile strength, and ultimate elongation as defined by ASTM D3577.
• Permeation Resistance: Measurement of breakthrough detection time for chemotherapy drugs as defined by ASTM D6978-05.
• Freedom from Holes: Determined by water leak tests according to ASTM D5151, with acceptance based on AQL (Acceptable Quality Level) specified in 21 CFR 800.20 and ASTM D3577.
• Biocompatibility: Results from validated in vitro or in vivo tests (like primary skin irritation and sensitization) as per ISO 10993-10 standards.

8. The Sample Size for the Training Set

This information is not applicable to this device. "Training set" refers to data used to train machine learning models. This device is a physical product and does not involve AI/ML models. Development and manufacturing of surgical gloves rely on engineering specifications and materials science, not data training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable to this device for the same reason as point 8.

Ask a specific question about this device