Search Results

Powder free vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contammation between patient and examiner.

powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00ed

The provided text describes a 510(k) premarket notification for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This document focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed study data for a novel device. Therefore, much of the requested information about study design, sample sizes, and expert adjudication for an AI/algorithm-based device is not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:
The document states, "Powder free vinyl patient examination gloves, Clear(non-colored) meet requirements per ASTM D5250-06, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10." This indicates that the device underwent testing according to these established standards to demonstrate compliance.

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

• Sample Size for Test Set: Not explicitly stated. The safety and effectiveness are assessed by demonstrating compliance with referenced ASTM standards and FDA regulations for physical properties and biocompatibility. The specific sample sizes for these tests are not provided in this summary but would be detailed in the full test reports referenced by the standards (e.g., ASTM D5250-06, D6124-01).
• Data Provenance: The nature of these tests (e.g., physical property testing, biocompatibility testing) implies they are prospective tests conducted on manufactured glove samples. The country of origin of the data is not specified beyond the submitter's location in China.

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

• Not applicable. This device is a physical product (gloves), not an AI/algorithm-based diagnostic device that requires expert ground truth for interpretation of medical images or data. The "ground truth" for this device's performance is objective measurements against established engineering and biological standards.

4. Adjudication Method for the Test Set

• Not applicable. As noted above, this involves objective measurements against predefined standards, not interpretation by multiple human experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. This is not an AI-assisted diagnostic device, so an MRMC study is irrelevant.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This is a physical medical device, not an algorithm. The performance described is the inherent performance of the product itself against established standards.

7. Type of Ground Truth Used

• The ground truth for this device's performance is based on established industry standards and regulatory requirements.
  • For physical properties and dimensions: ASTM standard D 5250-06.
  • For freedom from pinholes: 21 CFR 800.20.
  • For powder residual: ASTM standard D 6124-01.
  • For biocompatibility (skin irritation and sensitization): ISO10993-10.
    These standards define the methodologies and acceptable limits for various performance metrics.

8. Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a "training set."

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

• Not applicable. As above, there is no "training set" for this type of device.

Ask a specific question about this device

Powder free vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

powder free vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0064

Here's a breakdown of the acceptance criteria and the study information based on the provided text, using the requested format.

It's important to note that this document is a 510(k) summary for a general medical device (patient examination gloves). As such, the "study" referred to is primarily non-clinical testing against established standards, not a clinical trial in the way one might think of it for drug development or complex diagnostic AI. The questions provided in the prompt are more geared towards AI/software as a medical device (SaMD) evaluations, so some sections will reflect that the information is not directly applicable or available in this type of submission.

Acceptance Criteria and Device Performance

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

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

The document does not specify the exact sample sizes used for each test. The provenance is not explicitly stated as 'country of origin of data,' but the testing standards (ASTM, FDA CFR, ISO) are international/US standards. This is non-clinical performance testing.

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. Ground truth for these physical and chemical tests is established by adhering to the methodologies described in the cited ASTM, 21 CFR, and ISO standards by qualified testers, rather than expert consensus on images or diagnoses.

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

Not applicable. This is not a human-adjudicated test set; it involves objective measurements against established technical standards.

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. This is a physical medical device (gloves), not an AI/software device. There is no concept of "human readers" or "AI assistance" in this context.

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

Not applicable. This is a physical medical device (gloves), not an AI/software device.

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

The ground truth used is based on established, objective measurement methods defined in international and US standards (ASTM D5250-00e4, 21 CFR 800.20, ASTM D6124-01, ISO10993-10) for physical properties, chemical residue, and biocompatibility.

8. The sample size for the training set

Not applicable. This is a physical medical device. There is no "training set" in the context of an algorithm or AI. Product development and manufacturing would involve quality control and process validation, but this is distinct from an AI training set.

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

Not applicable, as there is no training set for a physical medical device like this.

Ask a specific question about this device

Powdered vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0004

The provided document describes the safety and effectiveness information for "Powdered Vinyl Patient Examination Gloves, White (Non-colored)" submitted by ZIBO ZHUANGYUAN PLASTIC & RUBBER CO.,LTD. The study presented is a non-clinical evaluation comparing the device's technical characteristics against established standards.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state the specific sample size for each characteristic test (e.g., how many gloves were tested for dimensions, pinholes, etc.). It generally refers to meeting the requirements "per ASTM D5250-00", "per ASTM D6124-01", "per 21 CFR 800.20", and "ISO10993-10". These standards would define the required sample sizes for such tests.
• Data Provenance: The data is presented as a summary of non-clinical tests performed by the manufacturer, ZIBO ZHUANGYUAN PLASTIC & RUBBER CO.,LTD, located in China. The testing appears to be retrospective in nature, as it's a submission for regulatory review based on already conducted tests. The country of origin of the data is P.R.CHINA.

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

• This device is a Class I medical device (patient examination gloves). The "ground truth" for its performance is established by adherence to recognized industry standards (ASTM, FDA regulations, ISO) rather than expert consensus on individual cases.
• Therefore, there were no specific "experts" in the sense of medical professionals diagnosing conditions being used to establish a ground truth for individual items in the test set. The ground truth is the standard's specification itself, and the testing laboratories or personnel would be qualified to perform the tests according to those standards.

4. Adjudication Method for the Test Set:

• Not applicable in the context of this device and study. The evaluation focuses on meeting predefined specifications from industrial standards, not on subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret images or data, and AI assistance is being evaluated. Patient examination gloves do not involve human readers interpreting data in this manner.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Yes, in spirit, the study is standalone. The device itself (the glove) is evaluated against objective, measurable criteria defined by standards. There is no "algorithm" in a software sense, but the device's physical and biological properties are assessed in a standalone manner without human intervention influencing the outcome of the measurement beyond the testing procedure itself. The performance "meets" or "passes" the specified criteria.

7. The Type of Ground Truth Used:

• The ground truth used is primarily objective, established performance criteria and requirements defined by international and national standards (ASTM standard D 5250-00e4, 21 CFR 800.20, ASTM D6124-01, ISO10993-10). These standards specify acceptable ranges for dimensions, physical properties, pinhole rates, powder amount, and biocompatibility outcomes.

8. The Sample Size for the Training Set:

• Not applicable. This is a physical device being tested against established standards, not a machine learning algorithm that requires a "training set."

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

• Not applicable, as there is no training set for this type of device evaluation.

Ask a specific question about this device