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510(k) Data Aggregation
(72 days)
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.
The subject device is a non-sterile, single-use, and flat pleated mask with ear loops and a Nose piece. The product is manufactured with three layers, the inner and outer layer is made of polypropylene spunbond, the middle layer is made of melt blown polypropylene. The elastic ear loops are not made with natural rubber latex. The Nose piece in the layers of the face mask is to allow the user to fit the face mask around their nose, which is made of polyethylene coated iron wire. The mask will be provided in black and blue color, the colorant for the model 0868F is Carbon black (CAS No.1333-86-4), and for the model 0866F is Pigment Blue 15 (CAS No.147-14-8). The model 0866F will be provided in blue and labeled in Level 3, the model 0868F will be provided in black and labeled in Level 1.
The provided document is a 510(k) Premarket Notification for a Surgical Mask. It details the device's technical specifications, intended use, and a comparison to predicate devices, along with performance and biocompatibility testing. The document does not describe an AI/ML-driven medical device, but rather a traditional medical device (a surgical mask).
Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, training set details) for an AI/ML device is not applicable to this document.
The document focuses on demonstrating substantial equivalence to predicate devices through physical and performance testing, rather than through a clinical study involving AI/ML performance metrics.
Here's a breakdown of the information that is available related to the device's performance, as per the tables in the document, interpreted as "acceptance criteria" and "reported performance" for a surgical mask:
1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML)
The document presents performance data for two models of the surgical mask (0868F and 0866F), which align with different performance levels (Level 1 and Level 3, respectively, based on ASTM F2100 standards).
| Test Item | Acceptance Criteria (Level 1 for 0868F) | Reported Performance (0868F) | Acceptance Criteria (Level 3 for 0866F) | Reported Performance (0866F) |
|---|---|---|---|---|
| Performance Testing | ||||
| Fluid Resistance (ASTM F1862) | Pass at 80 mmHg | Pass at 80 mmHg | Pass at 160 mmHg | Pass at 160 mmHg |
| Particulate Filtration Efficiency (PFE, ASTM F2299) | ≥ 95% (at 0.1 µm) | Pass (≥ 95%) | ≥ 98% (at 0.1 µm) | Pass (≥ 98%) |
| Bacterial Filtration Efficiency (BFE, ASTM F2101) | ≥ 95% | Pass (≥ 95%) | ≥ 98% | Pass (≥ 98%) |
| Differential Pressure (ΔP, EN 14683 / ASTM F2100) | < 5.0 mm H2O/cm² | Pass (< 5.0 mm H2O/cm²) | < 6.0 mm H2O/cm² | Pass (< 6.0 mm H2O/cm²) |
| Flammability (16 CFR Part 1610) | Class 1 | Class 1 | Class 1 | Class 1 |
| Biocompatibility Testing | ||||
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Pass | Non-cytotoxic | Pass |
| Irritation (ISO 10993-10) | Non-irritating | Pass | Non-irritating | Pass |
| Sensitization (ISO 10993-10) | Non-sensitizing | Pass | Non-sensitizing | Pass |
Points 2-9 (Specific to AI/ML Device Study Design) are Not Applicable:
Since this document describes a surgical mask and not an AI/ML device, the following points are not addressed:
- 2. Sample sized used for the test set and the data provenance: Not applicable. Performance is evaluated on physical samples of the mask, not a data test set.
- 3. Number of experts used to establish the ground truth... and their qualifications: Not applicable. Ground truth for a surgical mask is based on standardized physical and chemical tests, not expert interpretation of AI outputs.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. This is for evaluating changes in human diagnostic performance with AI assistance.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for a surgical mask's performance is established by the standardized test methods themselves (e.g., ASTM F1862 for fluid resistance, ASTM F2101 for BFE).
- 8. The sample size for the training set: Not applicable. There is no AI model to train.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document details the regulatory clearance for a traditional medical device (surgical mask) based on established performance standards and biocompatibility, rather than a clinical study of an AI/ML device.
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(96 days)
The Medical nitrile examination gloves (Model: SH001) is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The subject device is a powder-free nitrile examination glove, provided as a non-sterile and disposable device. The subject device is mainly made from nitrile and there are four sizes, includes small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is Butadiene-Acrylonitrile Copolymers (CAS No.9003-18-3) and Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface with textured fingertips and a rolled rim at the cuff edge. The Medical nitrile examination gloves meet the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided text describes the acceptance criteria and performance data for "Medical nitrile examination gloves (Model: SH001)" to demonstrate substantial equivalence to a predicate device for FDA 510(k) clearance. This is a Class I medical device and the data provided is for non-clinical performance testing, primarily mechanical and biocompatibility tests, not an AI/Software-as-a-Medical-Device (SaMD) study.
Therefore, many of the requested items related to AI/SaMD studies (e.g., human-in-the-loop performance, expert ground truth, adjudication methods, multi-reader multi-case studies, training/test set sample sizes for AI, etc.) are not applicable to this submission focusing on physical product characteristics of examination gloves.
I will provide the information that is applicable from the provided text.
Acceptance Criteria and Device Performance for Medical Nitrile Examination Gloves (Model: SH001)
The device, Medical nitrile examination gloves (Model: SH001), underwent non-clinical performance testing to demonstrate its safety and effectiveness, primarily adhering to the ASTM D6319-19 standard. The study aimed to show substantial equivalence to a predicate device (K203593).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (Standard) | Test Purpose | Acceptance Criteria | Reported Device Performance (Test Results) | Conclusion |
|---|---|---|---|---|
| ASTM D6319-19 - Physical Dimensions Test | To determine the width, length, and thickness of the gloves | Width:S: 80±10 mmM: 95±10 mmL: 110±10 mmXL: 120±10 mmLength:S: ≥220 mmM/L/XL: ≥230 mm | Lot Batch 20210723C1:Width: S: 79-84mm, M: 93-97mm, L: 104-107mm, XL: 112-115mmLength: S: 231-235mm, M: 234-238mm, L: 237-240mm, XL: 238-243mmLot Batch 20210719A1:Width: S: 80-83mm, M: 93-96mm, L: 104-107mm, XL: 112-116mmLength: S: 231-235mm, M: 235-238mm, L: 237-240mm, XL: 239-243mmLot Batch 20210726A0:Width: S: 79-83mm, M: 94-97mm, L: 104-107mm, XL: 112-116mmLength: S: 232-235mm, M: 235-238mm, L: 237-240mm, XL: 238-243mm | Passed (for all 3 lots) |
| ASTM D6319-19 - Thickness Test | To determine the thickness of the gloves | Finger: ≥0.05mmPalm: ≥0.05mm | For all three lots (S/M/L/XL): Finger min: 0.13mm, Palm min: 0.13mm | Passed (for all 3 lots) |
| ASTM D6319-19 - Physical Properties (Tensile Strength & Ultimate Elongation) | To determine tensile strength and ultimate elongation before and after accelerated aging | Before Aging:Tensile Strength: ≥14MpaUltimate Elongation: ≥500%After Aging:Tensile Strength: ≥14MpaUltimate Elongation: ≥400% | For all three lots:Before Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥500%After Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥400% | Passed (for all 3 lots) |
| ASTM D6319-19 (ASTM D5151-11) - Freedom from Holes (Water Tight) | To determine the holes in the gloves | AQL 2.5 | For all three lots: Pass at AQL 2.5 | Passed (for all 3 lots) |
| ASTM D6319-19 (ASTM D6124-11) - Residual Powder | To determine the residual powder in the gloves | < 2.0 mg/glove | Lot Batch 20210723C1: 0.17 mg/gloveLot Batch 20210719A1: 0.23 mg/gloveLot Batch 20210726A0: 0.18 mg/glove | Passed (for all 3 lots) |
| ISO 10993-10 - Skin Irritation | To evaluate potential intracutaneous reactivity | Under the conditions of the study not an irritant | Under the conditions of study not an irritant | Passed |
| ISO 10993-10 - Skin Sensitization | To determine skin sensitization potential | Under the conditions of study not a sensitizer | Under the conditions of the study not a sensitizer | Passed |
| ISO 10993-11:2017 - Acute Systemic Toxicity | To evaluate for acute systemic toxicity | Under the conditions of the study no systemic toxicity | Under the condition of acute systemic toxicity test, the test article did not show acute systemic toxicity in vivo. | Passed |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The document refers to "Lot Batch of 20210723C1," "Lot Batch of 20210719A1," and "Lot Batch of 20210726A0" for physical dimensions, tensile strength, elongation, freedom from holes, and residual powder tests. While specific numbers of gloves per batch are not provided in this summary, the testing was done on multiple production lots.
- Data Provenance: The manufacturing company, Jiangxi SanHao Medical Instruments Co.,Ltd, is located in China. The testing data would originate from their internal testing or qualified third-party labs, likely within China, as part of their manufacturing and quality control process. The nature of the testing is retrospective from manufactured batches to demonstrate compliance.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable: This is not an AI/SaMD study requiring expert interpretation of medical images or data. Ground truth for physical properties (e.g., dimensions, tensile strength) is established by standardized measurement methods according to ASTM and ISO standards, using calibrated equipment and trained technicians.
4. Adjudication Method for the Test Set
- Not Applicable: As this involves physical and chemical property testing of gloves, adjudication methods typically used for expert disagreement in medical image interpretation are not relevant. Test results are objective measurements against predefined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable: This is not an AI/SaMD study. No human readers or AI assistance for diagnostic tasks are involved.
6. Standalone Performance (AI algorithm only without human-in-the-loop performance)
- Not Applicable: This is not an AI/SaMD device. The "device" is a physical medical glove. The performance presented is "standalone" in the sense that it is the performance of the physical product itself under various specified tests, without human decision-making assistance beyond standard testing procedures.
7. Type of Ground Truth Used
- Objective Measurements against Standard Specifications: The ground truth for the device's performance is established by objective measurements (e.g., length in mm, tensile strength in MPa, powder content in mg/glove) that are compared against predefined numerical acceptance criteria specified in recognized industry standards (ASTM D6319-19, ASTM D5151-11, ASTM D6124-11, ISO 10993-10, ISO 10993-11). For biocompatibility, the ground truth is the biological response (e.g., "not an irritant," "not a sensitizer," "no systemic toxicity") observed in animal models, as per ISO standards.
8. Sample Size for the Training Set
- Not Applicable: There is no "training set" in the context of device performance testing for a physical product like examination gloves. The manufacturing process is designed to consistently produce gloves meeting the specifications, and the tests are for verification/validation, not for training a model.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: As there is no training set for a physical product, this question is not relevant.
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