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510(k) Data Aggregation
(81 days)
A surgeon's glove is a disposable device intended for medical purpose that is worn on surgeon's hands during surgical operations to prevent contamination between patient surgeon's
Latex Surgeon's Gloves Pre-Powdered Sterile
The provided document is a 510(k) summary for "Latex Surgeon's Gloves Pre-Powdered Sterile" from PT. MAJA AGUNG LATEXINDO. It details the device's characteristics, performance criteria, and a statement that the performance data meets these criteria.
Here's an analysis to extract the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Before ageing) | Acceptance Criteria (After ageing at 70°C 168 hrs) | Reported Device Performance (Implied) |
|---|---|---|---|
| Dimensions: | Meets ASTM D 3577 Standard | ||
| Length mm (min.) Sizes | 265 | N/A | Reported as meeting criteria |
| Palm Width mm (for sizes) | $83 \pm 6$ to $108 \pm 6$ | N/A | Reported as meeting criteria |
| Thickness 1. Cuff mm (min) | 0.10 | N/A | Reported as meeting criteria |
| Thickness 2. Palm mm(min) | 0.10 | N/A | Reported as meeting criteria |
| Thickness 3. Finger Tip mm | 0.10 | N/A | Reported as meeting criteria |
| Physical Properties: | Meets ASTM D 3577 Standard | ||
| Tensile Strength | 24 Mpa (min) | 18 Mpa (min) | Reported as meeting criteria |
| Ultimate Elongation | 750 % (min.) | 560 % (min.) | Reported as meeting criteria |
| Stress at 500 % Elongation | 5.5 (max) | N/A | Reported as meeting criteria |
| Performance Requirements: | |||
| Watertight (Holes) | AQL 1.5 | N/A | Meets FDA pin hole requirement |
| Dimensions | AQL 4.0 | N/A | Reported as meeting criteria |
| Physical Properties | AQL 4.0 | N/A | Reported as meeting criteria |
| Sterility | Not Acceptable for Fails Sterility | N/A | Meets the sterility assurance level |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not explicitly state the sample size used for the test set. It refers to "Inspection Level S-4" and "S-2" and "AQL" values for performance characteristics, which imply sampling plans were used according to standards like ASTM or ISO, but the exact number of units tested is not provided.
- Data Provenance: The data appears to be from the manufacturer, PT. MAJA AGUNG LATEXINDO, based in Indonesia. The nature of the data (retrospective or prospective) is not specified, but it represents testing conducted to demonstrate compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The established ground truth for performance characteristics is based on objective measurements and adherence to ASTM D 3577 and FDA requirements, rather than expert consensus on subjective findings.
4. Adjudication method for the test set
This information is not provided in the document. Given the objective nature of the tests (dimensions, tensile strength, elongation, watertightness, sterility), an adjudication method in the context of expert review would likely not be applicable. The results would be a direct measurement against the specified criteria.
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
- No MRMC study was done. This device is a physical product (latex surgeon's gloves), not an AI-assisted diagnostic or therapeutic tool. Therefore, a study comparing human reader performance with or without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. As the device is a physical product, there is no algorithm or AI component to perform in a standalone manner.
7. The type of ground truth used
The ground truth used for this device is based on objective measurement against established industry standards and regulatory requirements.
- ASTM D 3577 Standard: For dimensions and physical properties.
- FDA pin hole requirement: For watertightness.
- Sterility Assurance Level: For sterility.
These are well-defined, quantitative standards.
8. The sample size for the training set
- Not applicable. This device is a physical product; there is no machine learning model or algorithm that requires a "training set" in the conventional sense. The product design and manufacturing processes are likely informed by industry experience and engineering principles rather than a data-driven training set.
9. How the ground truth for the training set was established
- Not applicable. As explained above, there is no training set for this type of device. The "ground truth" for ensuring the quality of the manufacturing process would be established through quality control procedures, adherence to Good Manufacturing Practices (GMP), and material specifications, all designed to meet the performance standards.
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(164 days)
Surgeon's Glove is a medical device intended to be worn by operating room personnel during surgery to protect a surgical wound from contamination.
Class 1- Surgeon's Gloves (Pre-Powdered) 79KGO that meets all the requirements of ASTM D 3577 - 91. Type 1 - Gloves compounded primarily from Natural Rubber Latex.
The device being described is a Surgeon's Glove manufactured by SRI ANUSHAM RUBBER INDUSTRIES PRIVATE LIMITED. The acceptance criteria and performance data are primarily based on the ASTM D3577-91/95 specifications for latex surgeon's gloves.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria (ASTM D3577-95) | Reported Device Performance (SARI Value) | Result |
|---|---|---|---|
| Dimensions | |||
| Length (various sizes) | 245 mm minimum (size 5.5), 265 mm minimum (sizes 6-9) | 270-272mm (all sizes) | Meets |
| Width (various sizes) | Varies by size (e.g., 70 +/- 6 mm for 5.5, 114 +/- 6 mm for 9) | Consistent with ASTM ranges (e.g., 68mm for 5.5, 112mm for 9) | Meets |
| Thickness | 0.1mm minimum at cuff, palm, and finger | 0.12mm (cuff), 0.16mm (palm), 0.19mm (finger) | Meets |
| Physical Properties | |||
| Tensile Strength (Before Ageing) | 24 mpa min. | 31 mpa (SARI Value), 29 mpa (Performance Test Data) | Meets |
| Elongation at Break % (Before Ageing) | 750% min. | 950-975% (SARI Value), 850% (Performance Test Data) | Meets |
| Tensile Strength (After Ageing) | 18 mpa min. | 22 mpa | Meets |
| Elongation at Break % (After Ageing) | 560% min. | 850-900% (SARI Value), 800% (Performance Test Data) | Meets |
| Modulus at 500% Elongation (Before Ageing) | 5.5 mpa (max) | 3.4 mpa | Meets |
| Performance Requirements (AQL) | |||
| Freedom from Holes | AQL 1.5 | AQL 1.5 (SARI) | Meets |
| Dimensions | AQL 4 | AQL 4 (SARI) | Meets |
| Physical Property | AQL 4 | AQL 4 (SARI) | Meets |
| Other Properties | |||
| Powder Content | Not explicitly stated in ASTM, but implied compliance through SARI value. (ASTM D3577-95 typically specifies maximum powder residue) | 120 +/- 20 mg per glove (SARI Value for Powder Content) | Meets |
| Protein Content | FDA Requirement: Value not fixed | 80 +/- 20 ppm | Meets (no fixed requirement) |
| Moisture Content | FDA Requirement: Value not fixed | 0.8% (SARI Value/Maximum for Performance Test Data) | Meets (no fixed requirement) |
| Bio-compatibility | Biologically Compatible (FDA Requirement) | Biologically Compatible | Meets |
| Sterility | NA (as per SARI) | "Fails Sterility" is a defect, not a performance metric for the device itself (AQL level "As per IP" for SARI, "As per USP" for ASTM is listed). The document doesn't explicitly state the glove is sterile, but rather that sterility failure is a defect. | N/A (implied that if claimed sterile it meets standard, but not explicitly stated as a performance criteria metric) |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves for tensile strength testing, number of gloves for hole testing). It refers to "SARI Value" and "Performance Test Data," suggesting internal testing by the manufacturer.
- Data Provenance: The data is retrospective, generated by SRI ANUSHAM RUBBER INDUSTRIES PRIVATE LIMITED, a company located in Nagercoil, Tamil Nadu, S. India. It represents their internal testing results for the purposes of a 510(k) submission to the FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The ground truth is established by adherence to a recognized international standard, ASTM D3577-91/95, which defines the specifications for surgeon's gloves. The "Pioneer Manikandan Buildings" entity appears to be the manufacturer, not an expert panel for ground truth assessment.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This type of study does not involve human expert adjudication in the traditional sense. The device's performance is objectively measured against a predefined technical standard (ASTM D3577).
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
- MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not done. This is a technical performance study for a physical medical device (surgeon's gloves), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a physical product (surgeon's gloves), not an algorithm or software. Its performance is measured directly through physical and chemical tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The ground truth is established by existing regulatory standards and technical specifications, specifically the ASTM D3577-91/95 for latex surgeon's gloves. This standard defines the required physical and chemical properties.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. There is no "training set" in the context of this device's evaluation, as it is not a machine learning model. The manufacturer would have internal quality control and manufacturing processes that produce gloves meeting the specifications, but this isn't a "training set" in the AI sense.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable (as per point 8). The manufacturing process and quality control would be geared towards consistent production of gloves that adhere to the ASTM D3577 standards.
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(71 days)
The surgeon's gloves are sterile gloves worn by surgeons, healthcare workers or similar personnel during surgical procedures to prevent contamination between the user and the patient.
Surgeon's Gloves or Surgical Gloves. Anatomical in shape. Hand Specific (Left or Right). Available in sizes 6, 6½, 7, 7½, 8, 8½, 9. Made from Natural Rubber Latex, Sulphur, Zinc Oxide, ZDEC, ZDBC, Titanium Dioxide, Antioxidant (Styrenated Phenol), and Absorbable Corn Starch. Designed to comply with the physical measurements of ASTM D 3577.
The provided document describes a 510(k) submission for Surgeon's Gloves (SUR-G GLOV®) and focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for an AI-based device. Therefore, many of the requested elements for an AI device study (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable and not present in this document.
However, the document does contain information regarding the performance characteristics of the gloves, which can be interpreted as acceptance criteria based on the ASTM D 3577 standard.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is compared against the ASTM D 3577 (91) standard. This standard serves as the acceptance criteria for various physical characteristics of surgeon's gloves.
| Characteristics | Acceptance Criteria (ASTM D 3577 (91)) | Reported Device Performance (SUR-G GLOV®) |
|---|---|---|
| Width Size | ||
| 6 | $76 \pm 6$ | $76 \pm 3$ |
| 6½ | $83 \pm 6$ | $83 \pm 3$ |
| 7 | $89 \pm 6$ | $90 \pm 3$ |
| 7½ | $95 \pm 6$ | $95 \pm 3$ |
| 8 | $102 \pm 6$ | $103 \pm 3$ |
| 8½ | $108 \pm 6$ | $109 \pm 3$ |
| 9 | $114 \pm 6$ | $115 \pm 3$ |
| Length (min) | 265 | 280 |
| Thickness | ||
| Palm mm | 0.10 | $0.21 \pm 0.02$ |
| Finger mm | 0.10 | $0.23 \pm 0.02$ |
| Cuff mm | 0.10 | $0.21 \pm 0.02$ |
| Tensile Strength Min | ||
| (Unaged) | 24 Mpa | 27 Mpa |
| (Aged) | 18 Mpa | 24 Mpa |
| Elongation @ break | ||
| (Unaged) | 750% min | 830% |
| (Aged) | 560% min | 800% |
| Modulus @ 500 % elongation (max.) | 5.5 Mpa | 4.0 Mpa |
| External powder level | NA (Not Available in ASTM standard) | $80 \pm 25$ mg |
| Internal powder level | NA (Not Available in ASTM standard) | $90 \pm 25$ mg |
2. Sample sized used for the test set and the data provenance
The document states "A test certificate of the above is in Appendix B." but Appendix B is not provided in the extracted text. Therefore, the specific sample sizes used for testing these performance characteristics are not available. The data provenance (country of origin, retrospective/prospective) is also not available from the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. This is a physical device (surgical gloves), and its performance is measured against established engineering and material standards (ASTM D 3577), not by expert interpretation or ground truth derived from expert consensus.
4. Adjudication method for the test set
Not Applicable. As per point 3, the assessment is against a standard, not expert 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 not an AI-based device, and therefore, 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 not an AI algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance is adherence to the ASTM D 3577 standard for surgical gloves, which defines acceptable physical properties.
8. The sample size for the training set
Not Applicable. This is not an AI device that requires a training set. The gloves are manufactured and tested against specifications.
9. How the ground truth for the training set was established
Not Applicable. No training set is relevant for this device. The "ground truth" (i.e., the standard specifications) for manufacturing and testing are established by ASTM International.
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