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510(k) Data Aggregation
(285 days)
The AAMI4 Isolation Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The proposed AAMI4 Isolation Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB 70:2012, Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The AAMI4 Isolation Gown is a single use, disposable medical device provided non-sterile.
The proposed device, AAMI4 Isolation Gown, is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The proposed device is a single use, disposable medical device provided non-sterile. There is one model of AAMI4 Isolation Gown: 4015T. And the proposed AAMI4 Isolation Gown is available in one product size: U. The barrier protection level for AAMI4 Isolation Gown meets AAMI Level 4. The proposed device consists of five components: 1) Basic Gown, 2) Belt, 3) Cuff, 4) Hook-and-loop Velcro and 5) Seam Sealing Tape. The gown is made of polypropylene and polyethylene laminating. The gown is blue in color.
The provided document is a 510(k) summary for a medical device called "AAMI4 Isolation Gown." This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe a study involving human readers or AI assistance. Therefore, information regarding human readers, AI assistance, effect size, standalone algorithm performance, and sample size for training sets is not available in this document.
Here's the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Flammability | To evaluate the flammability of the test sample in accordance with 16 CFR Part 1610. | Meets Class 1 requirements | Class 1 |
| Hydrostatic pressure | To determine the hydrostatic pressure of the test sample in accordance with AATCC 127: 2017. | >50 cm | Gown sleeve: 188 cmH₂OSleeve seam: 80 cmH₂OBody-sleeve seam: 65 cmH₂OGown body: 199 cmH₂OBelt attachment: 74 cmH₂O |
| Water impact | To determine the hydrostatic pressure of the test sample in accordance with AATCC 127: 2017. (Note: The purpose description seems to be a typo and should likely refer to water impact.) | ≤1.0 g | Gown sleeve: 0gSleeve seam: 0gBody-sleeve seam: 0gGown body: 0gBelt attachment: 0g |
| Breaking strength | To evaluate the breaking strength of the test sample in accordance with ASTM D 5034:2009(2017). | >20 N | MD: Mean 87.3 NCD: Mean 66.7 N |
| Tearing strength | To evaluate the tearing strength of the test sample in accordance with ASTM D5587:2015(2019). | >20 N | MD: Mean 31.6 NCD: Mean 22.9 N |
| Linting | To evaluate the linting of the test sample in accordance with ISO 9073-10:2003. | Log10(particle count) < 4 | Log10(lint count): Mean 2.5 |
| Seam strength | To evaluate the seam strength of the test sample in accordance with ASTM D1683/D1683M: 2017(2018). | >50 N | Mean 70.9 N |
| Viral barrier (resistance to bacteriophage Phi-X174) | To evaluate the resistance to bacteriophage penetration in accordance with ASTM F1671/F1671M-13. | No bacteriophage penetration | No bacteriophage penetration |
| Cytotoxicity | To evaluate the cytotoxicity of the test sample in accordance with ISO 10993-5 Third edition 2009-06-01. | Viability ≥ 70% of blank; 50% extract viability ≥ 100% extract viability. | The viability was ≥70% of the blank. The 50% extract had higher viability than 100% extract. Proposed device was non-cytotoxic. |
| Sensitization | To evaluate the sensitization of the test sample in accordance with ISO 10993-10 Third Edition 2010-08-01. | Non-sensitizing | The proposed device was non-sensitizing. |
| Irritation | To evaluate the irritation of the test sample in accordance with ISO 10993-10 Third Edition 2010-08-01. | Non-irritating | The proposed device was non-irritating. |
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 for each test. It refers to "test sample" for each methodology. The tests were performed in accordance with international and US standards. The manufacturer is Hubei Xinxin Non-woven Co., Ltd. from Xiantao, Hubei, China. The data provenance is non-clinical laboratory testing; it does not involve human data, thus the terms "retrospective" or "prospective" are not applicable.
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. The ground truth for these non-clinical tests is established by the specified industry and regulatory standards, not by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a non-clinical performance and biocompatibility study, not a clinical study requiring human 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
No, an MRMC comparative effectiveness study was not done. This document does not describe studies involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This document describes the testing of a physical medical device (an isolation gown), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth for the performance tests (Flammability, Hydrostatic pressure, Water impact, Breaking strength, Tearing strength, Linting, Seam strength, Viral barrier) is defined by the technical specifications and requirements within the referenced industry standards (e.g., 16 CFR Part 1610, AATCC 127, ASTM D5034, ISO 9073-10, ASTM D1683/D1683M, ASTM D5587, ASTM F1671/F1671M-13).
The ground truth for the biocompatibility tests (Cytotoxicity, Sensitization, Irritation) is defined by the requirements and methodologies within the ISO 10993 series of standards (ISO 10993-5, ISO 10993-10).
8. The sample size for the training set
Not applicable. This document describes the testing of a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a physical medical device.
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(205 days)
The surgical masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to bloody fluids. This is a single-use, disposable device, provided non-sterile.
XX0009 Ear loop Level: Level 1, Level 2 and Level 3
XX0008 Tie-on Level: Level 1, Level 2 and Level 3
XX0006 Tie-on with shield Level: Level 1, Level 2 and Level 3
XX0005 Ear loop with shield Level: Level 1, Level 2 and Level 3
The surgical masks are single use, flat-pleated masks that are provided in blue. The outer and inner layers of the mask are made of spunbond polypropylene. The middle filter is made of one layer of meltblown polypropylene filter. The Surgical Masks are available in four types due to different configurations, including ear loop, tie-on, ear loop with shield and tie-on with shield. Detail configurations of them are presented in Table 1 Surgical Masks Description. The ties are made of spunbond polypropylene and the ear loops are made of spandex. The shield is made of PET. The nose piece is made of iron wire and polypropylene. Users can adjust the nose piece according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The proposed devices are provided in non-sterile. The proposed devices contain four (4) types of masks: XX0009, XX008, XX0006 and XX0005. Each of these types have three different levels, level 2, and level 3. Therefore, the proposed devices have 12 models in toto, and detailed model information is provided in Table 1.
The provided text is a 510(k) Summary for Surgical Masks (K212120), focusing on demonstrating substantial equivalence to a predicate device (K160269) through non-clinical testing. It does not describe a study involving an AI (Artificial Intelligence) or medical imaging device, nor does it involve a multi-reader multi-case (MRMC) study. Therefore, many of the requested details, such as human reader improvement with AI assistance, ground truth establishment for AI training/test sets, or the number of experts for adjudication, are not applicable to this document.
However, I can extract the relevant information regarding the acceptance criteria and the study that proves the device meets those criteria, specifically for the surgical masks.
Acceptance Criteria and Device Performance for Surgical Masks (Based on Non-Clinical Tests)
1. Table of Acceptance Criteria and Reported Device Performance
The non-clinical tests were conducted to verify that the proposed device met all design specifications. The performance levels (Level 1, Level 2, Level 3) refer to classifications defined by ASTM F2100: 2019 "Standard Specification for Performance of Materials Used in Medical Face Masks."
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Particulate Filtration Efficiency (PFE) | Determines the particle filtration efficiency (PFE) of the test article (ASTM F2299/F2299M-03 (2017)) | Level 1: ≥95%Level 2: ≥98%Level 3: ≥98% | Level 1: Pass at 96.17%Level 2: Pass at 98.95%Level 3: Pass at 99.06% |
| Bacterial Filtration Efficiency (BFE) | Determines the bacterial filtration efficiency (BFE) of the test article using a biological aerosol of Staphylococcus aureus (ASTM F2101: 2019) | Level 1: ≥95%Level 2: ≥98%Level 3: ≥98% | Level 1: Pass at 96.80%Level 2: Pass at 98.90%Level 3: Pass at 99.04% |
| Differential Pressure | Measures the breathability of the mask (EN 14683:2019+AC: 2019 Annex C) | Level 1: <5.0 mmH₂O/cm²Level 2: <6.0 mmH₂O/cm²Level 3: <6.0 mmH₂O/cm² | Level 1: Pass at 4.0 mmH₂O/cm²Level 2: Pass at 5.1 mmH₂O/cm²Level 3: Pass at 5.2 mmH₂O/cm² |
| Flammability | Determines the flammability of the mask material (16 CFR Part 1610) | Class 1 | Class 1 |
| Resistance to Penetration by Synthetic Blood | Evaluates the effectiveness of the sample from possible exposure to blood and other body fluids (ASTM F1862/F1862M: 2017) | Level 1: No penetration at 80 mmHgLevel 2: No penetration at 120 mmHgLevel 3: No penetration at 160 mmHg | Level 1: Pass at 80 mmHgLevel 2: Pass at 120 mmHgLevel 3: Pass at 160 mmHg |
| Cytotoxicity | Evaluates the cytotoxicity of the test sample (ISO 10993-5:2009) | Viability ≥ 70% of the blank; 50% extract viability ≥ 100% extract viability | Viability ≥ 70% of the blank; 50% extract had higher viability than 100% extract. Proposed device was non-cytotoxic. |
| Sensitization | Evaluates the sensitization potential of the test sample (ISO 10993-10:2010) | Non-sensitizing | Under the conditions of the study, the proposed device was non-sensitizing. |
| Irritation | Evaluates the irritation potential of the test sample (ISO 10993-10:2010) | Non-irritating | Under the conditions of the study, the proposed device was non-irritating. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size (number of masks or material samples) used for each non-clinical test. These tests are typically conducted on a statistically significant number of samples per batch or according to the specific standard's requirements, but the exact count is not detailed in this summary.
The provenance of the data is that these are non-clinical laboratory test results performed to demonstrate compliance with recognized consensus standards (ASTM, ISO, EN, CFR). The tests were performed for a Chinese manufacturer (Hubei Xinxin Non-woven Co., Ltd.) for submission to the U.S. FDA. The data is implicitly prospective testing conducted specifically for this regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. These are physical and biological performance tests on a device (surgical masks), not image-based diagnostic tests or AI performance evaluations requiring expert radiologists or similar medical professionals for ground truth establishment. The "ground truth" for these tests is defined by the objective measurement results according to the specified standard methods.
4. Adjudication Method for the Test Set
Not applicable. This is not a study that requires human adjudication of subjective data. The results are based on objective, standardized laboratory measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This submission is for surgical masks, not an AI or imaging device that would typically involve a human-in-the-loop diagnostic task.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (surgical mask), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance of the surgical masks is established by objective, standardized laboratory measurements performed according to internationally recognized consensus standards (e.g., ASTM, ISO, EN). For biocompatibility, it's the biological response observed based on in-vitro (cytotoxicity) and in-vivo (irritation, sensitization) assays against defined criteria.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI model, and therefore, it does not have a "training set" in the context of machine learning.
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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