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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and evan miner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00 Ed

The provided document is a 510(k) summary for the "Powder free Vinyl Examination" glove, detailing its substantial equivalence to a predicate device. It does not contain information about a study with specific acceptance criteria and detailed device performance metrics in the way that would typically be described for a diagnostic AI device.

However, based on the information provided, I can extract what is considered the "acceptance criteria" for regulatory clearance (substantial equivalence) and the "study" that supports it, even if it's not a quantitative clinical study with metrics like sensitivity, specificity, or AUC.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices seeking 510(k) clearance, the "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device. The performance is assessed by comparing technological characteristics, intended use, and safety/effectiveness.

2. Sample size used for the test set and the data provenance

The document describes a regulatory submission for a medical device (examination glove) claiming substantial equivalence to a previously cleared predicate device. This is not a study in the sense of collecting new performance data on a "test set" from patients or a specific dataset. Instead, the "test" is the comparison of the device's characteristics and performance against established standards and the predicate device.

• Sample size for the test set: Not applicable in the context of clinical data. The assessment is based on the device's design, materials, manufacturing processes, and compliance with standards. If physical testing (e.g., for tensile strength, barrier integrity) was performed, the sample sizes for those specific tests are not detailed in this summary.
• Data provenance: Not applicable. The "data" here refers to the device's specifications and comparison to the predicate, as well as adherence to standards like ASTM D5250-00 Ed. This is not clinical data from patients or a specific country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study involving expert-established ground truth for a diagnostic outcome. The "ground truth" for a medical glove's safety and effectiveness is established through compliance with recognized standards and demonstration of equivalent performance to predicate devices which have already been deemed safe and effective.

4. Adjudication method for the test set

Not applicable. There is no "test set" in the context of human interpretation or diagnostic outcomes 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

Not applicable. This is a medical glove, not an AI-powered diagnostic device. No MRMC study or AI assistance is relevant.

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

Not applicable. This is a medical glove, not an algorithm.

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

The "ground truth" for the device's safety and effectiveness relies on:

• Compliance with recognized standards: Specifically, ASTM Standard D5250-00 Ed for Vinyl Patient Examination Gloves.
• Demonstrated equivalence to a predicate device: The predicate device (Shanghai Foremost Vinyl Patient Examination Glove, Powder free, 510(k) #K971415), which was previously cleared by the FDA, serves as the benchmark for safety and effectiveness.

8. The 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. There is no training set for this device.

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

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 380,6250. Powder free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00 E4

The provided text describes a 510(k) summary for a "Powder free Vinyl Examination Glove" and focuses on establishing its substantial equivalence to a predicate device, rather than presenting a study demonstrating acceptance criteria met by the device itself in a typical AI/software context.

Therefore, many of the requested fields are not applicable to this type of submission. However, I will extract the available information and indicate where specifics about a performance study are missing.

Analysis of the Document for AI/Software Device Acceptance Criteria and Study:

The document describes a medical device, specifically a "Powder free Vinyl Examination Glove." This is a physical, disposable medical device, not an AI or software device. As such, the concept of "acceptance criteria" and "study" in the context of AI performance (e.g., accuracy, sensitivity, specificity, expert ground truth, MRMC studies, training/test sets) does not directly apply.

Instead, the submission focuses on demonstrating substantial equivalence to an existing predicate device (Shanghai Foremost Vinyl Patient Examination Glove, Powder free, 510(k) #K971415). This is a regulatory pathway for Class I and Class II devices in the US, where the new device is shown to be as safe and effective as a legally marketed device.

Table of Acceptance Criteria and Reported Device Performance (as translated for a physical device and substantial equivalence):

Missing Information (Not applicable to this type of device/submission):

The following information is primarily relevant for AI/software-based medical devices and is therefore not found in this 510(k) submission for a physical glove:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical glove. Performance is typically assessed through physical testing (e.g., tensile strength, puncture resistance, barrier integrity) against established standards (like ASTM D5250-00 E4) rather than data from a test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like a glove involves objective measurements and compliance with material standards, not expert interpretation of data.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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, as this is not an AI device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical glove, the "ground truth" would be objective measurements against an engineering standard (e.g., ASTM D5250-00 E4), not expert consensus or pathology.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device (examination glove) seeking substantial equivalence to a predicate device. It demonstrates performance by claiming adherence to an ASTM standard and direct comparison of characteristics to a previously cleared device, not through an AI-style performance study with test sets, ground truths, or expert evaluations.

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A 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.

Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Vinyl Patient Examination Glove, Powder-free, 80L YZ, conform to all requirements of ASTM Standard D5250-92 and FDA water leak test.

The provided text describes the acceptance criteria and study results for "Vinyl Patient Examination gloves, Powder-free" by SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD.

Here's the breakdown of the information requested:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: The document does not explicitly state a specific sample size for each performance test (e.g., number of gloves tested for dimensions, tensile strength, or water leak). For the Modified Draize Test, it mentions "human subjects," but no specific number.
• Data Provenance: The document does not specify the country of origin of the data. It mentions the applicant is in Shanghai, China, but this doesn't confirm the test location. The study type appears to be prospective, as the testing was done specifically for this submission.

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):

• This information is not applicable as the device is a physical medical device (gloves), not an AI/diagnostic device that requires expert ground truth establishment for interpretation. The "ground truth" is based on objective measurements and established standards (ASTM D5250-92 and FDA water leak test). For the Modified Draize Test, the interpretation of irritation and allergic contact dermatitis would be done by qualified medical professionals, but their number and specific qualifications are not detailed.

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

• This information is not applicable for this type of device and testing. Adjudication methods are typically used in studies involving subjective interpretation, like image analysis or clinical endpoint assessment. The tests performed are objective measurements against established 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:

• This information is not applicable. This is a physical medical device (gloves), not an AI or diagnostic tool involving human readers or AI assistance.

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

• This information is not applicable. This is a physical medical device (gloves), not an algorithm or AI system.

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

• The ground truth for the dimensional, physical properties, and water leak tests is based on pre-defined engineering and performance standards (ASTM D5250-92 and FDA 1000 ml water leak test). These are objective, measurable criteria.
• For the Modified Draize Test, the ground truth relates to the absence of clinically significant irritation or allergic contact dermatitis in human subjects, as interpreted by medical professionals.

8. The sample size for the training set:

• This information is not applicable. This is a physical medical device, not an AI model that requires a training set.

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

• This information is not applicable. As it's not an AI model, there is no training set or associated ground truth establishment process.

Ask a specific question about this device

A 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.

Classified by FDA's General and Plastic Surgery Device Panel as Class I, CFR 880.6250, Vinyl Patient Examination Glove, 80LYZ, powdered with an absorbable dusting starch powder, USP, Class III and conform to all requirements of ASTM Standard D5250-92 and FDA 1000 ml water leak test.

The provided text describes the acceptance criteria and performance of Vinyl Patient Examination Gloves, Powdered, submitted by SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD. This submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical trial for novel device performance. Therefore, many of the typical elements of a study proving performance against acceptance criteria (like sample sizes for test sets, expert ground truth, MRMC studies) are not applicable or not provided in the same manner as for a new, complex medical device.

However, based on the provided text, here's an analysis of the acceptance criteria and the "study" (non-clinical performance data) that demonstrates the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes (number of gloves) used for each physical and water leak test. The data provenance is implied to be from the manufacturer (Shanghai Foremost Plastic Industrial Co., Ltd.) and tested according to ASTM and FDA standards. It's an internal validation by the manufacturer. The data is most likely prospective testing conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable in the context of this device. The "ground truth" for the physical and water leak tests is established by the specified ASTM D5250-92 standard and the FDA 1000 ml water leak test protocol. These are objective measurements against defined criteria, not subjective interpretations requiring expert consensus like in image analysis or clinical diagnosis.
For the Modified Draize Test, presumably, medical professionals or dermatologists would have evaluated the human subjects, but the number and specific qualifications are not detailed.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements against a standard, not subjective assessments 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

Not applicable. This device is a physical product (gloves) and does not involve AI or human readers/interpreters in its intended use.

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

Not applicable. This is not an algorithmic device.

7. The type of ground truth used

• Physical Properties (Length, Width, Thickness, Tensile Strength, Elongation): The "ground truth" is established by the ASTM D5250-92 standard, which defines the acceptable ranges and minimums for these properties.
• Water Leak Test: The "ground truth" is defined by the FDA 1000 ml water leak test protocol, specifically aiming to meet an Acceptable Quality Level (AQL) of 4.0 with an Inspection Level of S-4.
• Biocompatibility (Modified Draize Test): The "ground truth" is the clinical observation of human subjects for the presence or absence of significant irritation or allergic contact dermatitis.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning or AI.

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

Not applicable. As there is no training set mentioned or implied for this device.

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