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The Polyisoprene Surgical Gloves are sterile and single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination.

Device Description

The proposed device is Polyisoprene Surgical Gloves, sterile and disposable devices. The proposed devices are made of polyisoprene. The proposed device is white. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D3577.

AI/ML Overview

The provided document is a 510(k) summary for Polyisoprene Surgical Gloves, which are a Class I medical device. The document does not describe an AI/ML-enabled device or an diagnostic device requiring an MRMC study or AI-specific acceptance criteria.

The acceptance criteria provided in the document relate to the physical and biological characteristics of the surgical gloves as per various ASTM and ISO standards, and the "study" is a series of non-clinical performance tests confirming the gloves meet these established standards.

Therefore, I cannot extract information related to AI/ML device performance, sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or training set details as these are not relevant to the product described in the input.

However, I can extract the acceptance criteria and performance data for the Polyisoprene Surgical Gloves as presented in the document.

Acceptance Criteria and Reported Device Performance (for Polyisoprene Surgical Gloves)

1. Table of Acceptance Criteria and Reported Device Performance

No.	Name of the Test Methodology / Standard	Purpose	Acceptance Criteria	Reported Device Performance
1	ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Skin Sensitization.	Assesses possible contact hazards released from medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization.	Skin Sensitization Test: provided grades less than 1, otherwise sensitization.	All grades are 0. All animals were survived, and no abnormal signs were observed during the study.
2	ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation	Assesses possible contact hazards released from medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization.	Skin Irritation Test: If the primary irritation index is 0-0.4, the response category is Negligible. 0.5-1.9 means slight, 2-4.9 means moderate, 5-8 means severe.	The primary irritation index is 0. The response of the proposed device was categorized as negligible under the test condition.
3	ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity	Describes test methods to assess the in vitro cytotoxicity of medical devices.	The viab.% of the 100% extract of the test article is the final result, and if viability is reduced to <70% of the blank, it has cytotoxic potential.	Viab.% of 100% test article extract is 6.1%. It means the proposed device have potential toxicity to L-929 in the MTT method.
4	ISO 10993-11: 2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity	To evaluate the potential for medical device materials to cause adverse systemic reactions.	Within the monitoring period (72 h), if the toxicosis response of testing group is not greater than that of control group, the testing sample is regarded as acceptable.	There was no evidence of systemic toxicity from the extract.
5	ISO 10993-7 standards for EO/ECH residual testing	Specifies allowable limits for residual ethylene oxide (EO).	Limit (< 24 h) EO 4 mg; ECH 9 mg. Prolonged (> 24 h < 30 d) EO 60 mg/30 d; ECH 60 mg/30 d.	EO residue: ≤ 4mg in the first 24h; ≤ 60mg in the first 30d; EO residue shall also ≤ 10ug/g; ECH residue: ≤ 9mg in the first 24h; ≤ 60mg in the first 30d.
6	ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves	Designed to determine the amount of residual powder (or filter-retained mass) found on medical gloves.	powder residue limit of 2.0 mg	0.1mg/glove
7	ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. 12/23/2019	Covers the detection of holes in medical gloves.	Samples number: 200 gloves; AQL: 1.5 (ISO 2859); Criterion ≤7 gloves for water leakage.	0 glove water leakage found
8	ASTM D5712-15 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method	Intended to test NR, latex, and elastomeric materials for residual protein content.	Have a recommended aqueous soluble protein content limit of 200 ug/dm²	52ug/dm²
9	ASTM D3577-19, Standard Specification for Rubber Surgical Gloves	Intended as a reference to the performance and safety of rubber surgical gloves.	Dimensions: -6.5: width 83±6mm, Length ≥265 mm -7: width 89±6mm, Length ≥265 mm -7.5: width 95±6mm, Length ≥265 mm -8: width 102±6mm, Length ≥265 mm Thickness: -Finger ≥0.10 mm -Palm ≥0.10 mm -Cuff ≥0.10 mm Physical properties: ● Before aging ● Tensile strength ≥17MPa ● Ultimate Elongation ≥ 650% ● Stress at 500% Elongation ≤ 7.0 MPa ● After Accelerated Aging ● Tensile strength ≥12MPa ● Ultimate Elongation ≥ 490%	Dimensions: 6.5: width: 83-84 mm, Length 280-289 mm Thickness: Finger 0.230-0.260 mm, Palm 0.188-0.207 mm, Cuff 0.137-0.151 mm 7: width 91-93 mm, Length 271-278 mm Thickness: Finger 0.211-0.241 mm, Palm 0.181-0.193 mm, Cuff 0.133-0.144 mm 7.5: width 96-98 mm, Length 273-280 mm Thickness: Finger 0.218-0.237mm, Palm 0.180-0.192 mm, Cuff 0.136-0.146 mm 8: width 103-105 mm, Length 268-283 mm Thickness: Finger 0.221-0.272 mm, Palm 0.189-0.212 mm, Cuff 0.143-0.153 mm Physical properties: Before aging -Tensile strength 25.2-30.9 MPa -Ultimate Elongation 721% - 777% -Stress at 500% Elongation 6.5-7.0 MPa After Accelerated Aging -Tensile strength 23.0-29.0 MPa -Ultimate Elongation 680% - 716%

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

Holes in Medical Gloves (ASTM D5151-19): 200 gloves were sampled for this specific test.
Other tests (Biological, Chemical, Physical property tests): The document does not specify a distinct "test set" sample size for each individual test beyond the 200 gloves for hole detection. Standard methodologies like ISO and ASTM usually define sample sizes for their respective tests, which are implicitly followed.
Data Provenance: Not specified, but the applicant company is Puyang Linshi Medical Supplies Co., Ltd. in China, suggesting the testing was likely conducted in China or by labs cooperating with them. The document does not state if the data is retrospective or prospective; it describes non-clinical performance testing.

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

Not applicable. This device is surgical gloves, not a diagnostic device requiring expert interpretation for ground truth. Ground truth is established by physical and chemical test results against international standards.

4. Adjudication Method for the Test Set:

Not applicable. This is not an image-based diagnostic or AI/ML device requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, this type of study is not applicable to surgical gloves. It is typically conducted for diagnostic devices (e.g., AI in radiology).

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

Not applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used:

The ground truth is established by adherence to recognized international standards and test methodologies (e.g., ISO 10993 series for biological evaluation, ASTM D6124, D5151, D3577 for physical and chemical properties). This involves laboratory measurements and observations based on predefined criteria.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable, as there is no training set for this device.

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