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510(k) Data Aggregation
(85 days)
Disposable Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Isolation Gowns meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Isolation Gowns are single use, disposable medical devices; provided non-sterile.
Disposable Isolation Gown is designed for the medical personnel using in medical environment, not intended for use in the operating room. The employed material is a polypropylene and polyethylene (PP+PE) compound non-woven fabric. The color of the gown is blue. The gown has long sleeves with cuffs and neck fasten belts. There are seam tapes above the sleeves and where the sleeves meet the body. The seam tape is ethylene-vinyl acetate (EVA). The material of cuff is polyester and it is elastic.
The body and sleeve of the Disposable Isolation Gowns are constructed from a blue PP+PE compound non-woven fabric and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a Disposable Isolation Gown. The Disposable Isolation Gown is a single use, disposable medical device.
Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:
Device: Disposable Isolation Gown (K223467)
1. A table of acceptance criteria and the reported device performance:
| Test Name | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Seam strength (sleeve seam) | To evaluate the strength of the sleeve seam | ≥30N per standard F2407-20 for level 3 | Pass |
| Tensile strength (Media Direction & Cross Direction) | To evaluate the tensile strength of the test sample | ≥30N per standard F2407-20 for level 3 | Pass |
| Tear strength (Media Direction & Cross Direction) | To evaluate the tear resistance of the test sample | ≥10N | Pass |
| Hydrostatic pressure test (front, sleeve, sleeve seam, shoulder seam, back) | To evaluate the hydrostatic barrier property of the gown | ≥50cmH2O AQL: 4% (32 of 32 samples pass each location) | Pass |
| Lint and other particles generation in the dry state (material) | To evaluate the linting resistance of the test sample | Critical area≤4.0; Less critical area≤ 4.0 | Pass |
| Lint and other particles generation in the dry state (sleeve seam) | To evaluate the linting resistance in the dry state of the sleeve seam | Critical area≤4.0; Less critical area≤ 4.0 | Pass |
| 2-year accelerated aging (AAMI PB70:2012 - AATCC 42 Water impact & AATCC 127 Hydrostatic pressure) | To demonstrate performance stability throughout the shelf life | Meets all AAMI PB70 performance requirements; AATCC 42 ≤ 1.0 g; AATCC 127 ≥ 50 cm H2O | Pass |
| 2-year accelerated aging (ASTM F3352 - Tensile strength, Tear strength, Seam Strength, Lint generation) | To demonstrate performance stability throughout the shelf life (additional parameters) | ASTM D5034 ≥ 30 N (Machine direction and cross direction); ASTM D5733 ≥ 10 N (Machine direction and cross direction); ASTM D1683 ≥ 30 N; ISO 9037-10 Coef. of linting ≤ 4.0 | Pass |
| Flammability | To evaluate the flame resistance of the test sample | Class I | Pass |
| Water impact resistance (front, sleeve, sleeve seam, shoulder seam, back) | To evaluate the water impact barrier property of the gown | ≤1.0g AQL: 4% (32 of 32 samples pass each location); Level 3 per standard ANSI/AAMI PB70:2012 | Pass |
| Cytotoxic potential | To evaluate the cytotoxic potential of the gown | Under the conditions of the study, the device is not cytotoxic | Pass |
| Irritation | To evaluate the irritation property of the gown | Under the conditions of the study, the device is not an irritant | Pass |
| Sensitization | To evaluate the sensitization property of the gown | Under the conditions of the study, the device is not a sensitizer | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size:
- For Hydrostatic pressure test and Water impact resistance, the acceptance criteria state "32 of 32 samples pass each location." This implies a sample size of 32 for these specific tests.
- Specific sample sizes for other non-clinical tests (e.g., seam strength, tensile strength, tear strength, lint generation, flammability, biocompatibility) are not explicitly stated in this document beyond the general "sample" or "test sample." However, these types of tests typically involve testing multiple units or specimens to ensure reproducibility and statistical validity according to the referenced standards.
- Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Given that the manufacturer is based in China, it is highly probable that the testing was conducted there. All tests described are non-clinical tests, which are typically conducted in a controlled laboratory setting (i.e., not on human subjects), and thus the retrospective/prospective distinction is not applicable in the same way it would be for a clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the studies are entirely non-clinical (laboratory-based performance and material property testing). There are no human experts establishing a "ground truth" for diagnostic or clinical interpretation. The "ground truth" for these tests comes from adherence to established international and national standards (e.g., ASTM, ISO, AAMI, AATCC, CPSC CFR) for material properties and barrier performance.
4. Adjudication method for the test set:
- This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., image reading) where there might be disagreement among experts. Since these are non-clinical, objective laboratory tests against pre-defined numerical or qualitative criteria, there is no need for 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:
- No, an MRMC comparative effectiveness study was not conducted. This device is a disposable isolation gown, and the submission focuses on its physical and barrier properties, not on an AI-assisted diagnostic or interpretive tool that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm-only performance study was not conducted. This device is manufactured personal protective equipment (PPE), not software or an AI algorithm. The performance evaluation is based on material and product testing against established engineering and safety standards.
7. The type of ground truth used:
- The "ground truth" for these non-clinical tests is based on established testing standards and regulatory requirements. This includes:
- Material properties: Tensile strength, tear strength, seam strength, lint generation, flammability, all measured against specific ASTM and ISO standards with predefined passing criteria.
- Barrier performance: Hydrostatic pressure and water impact resistance, measured against AAMI PB70:2012 (Level 3) and AATCC standards.
- Biocompatibility: Cytotoxicity, irritation, and sensitization, measured against ISO 10993 standards with "not cytotoxic," "not an irritant," and "not a sensitizer" as the ground truth.
- Shelf-life stability: Demonstrated by meeting all performance requirements after accelerated aging, with the original acceptance criteria serving as the ground truth for stability.
8. The sample size for the training set:
- This information is not applicable as the device is a physical product (disposable isolation gown), not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithms.
9. How the ground truth for the training set was established:
- This information is not applicable for the reason stated above.
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(104 days)
Disposable Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Isolation Gowns meet the requirements of AAMI Level 3 barrier protection for a surgical isolation gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Isolation Gowns are single use, disposable medical devices, provided non-sterile.
Disposable Isolation Gowns are designed for the medical personnel using in medical environment, not intended for use in the operating room. The employed material is Polypropylene(PP) non-woven with polyethylene(PE) lamination. It is a kind of Non- Reinforced isolation gown. The sleeve and body of the Disposable Isolation Gowns are constructed from a blue PP&PE (non-woven fabric, PE lamination) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical isolation gown. The Disposable Isolation Gowns are single use, disposable medical device that will be provided in a variety of non-sterile packaging configurations with 6 sizes, S,M,L,XL,XXL,and XXXL.
The provided text describes the acceptance criteria and performance data for a medical device, specifically Disposable Isolation Gowns. However, it is not an AI/ML powered medical device. Therefore, the requested information pertaining to AI/ML model performance, such as sample sizes for test sets, data provenance, expert consensus for ground truth, MRMC studies, or training set details, is not applicable to this document.
The document focuses on demonstrating the substantial equivalence of the proposed isolation gowns to a legally marketed predicate device based on their physical properties, barrier performance, and biocompatibility.
Here's the relevant information that can be extracted, presented in the requested format where applicable:
Acceptance Criteria and Reported Device Performance for Disposable Isolation Gowns
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Performance Tests | ||
| Seam strength | $\ge$ 30N (7lbf) per standard F2407-20 | Pass |
| Breaking strength | $\ge$ 30N (7lbf) per standard F2407-20 | Pass (Mean Result MD: 85.6N, CD: 77.3 N) |
| Tear strength (N) | $\ge$ 20N | Pass (Mean Result MD: 29.9N, CD: 18.43N) |
| Lint and other particle generation in dry state | Critical area $\le$ 4.0, Less critical area $\le$ 4.0 | Pass |
| Flammability | Class I per 16 CFR Part 1610 | Pass |
| Liquid Barrier Performance Tests (AAMI Level 3) | ||
| Water proof property (material, seam) | $\le$ 1.0g AQL: 4%, Level 3 per standard ANSI/AAMI PB70:2012 (AATCC42-2017) | Pass |
| Static hydrostatic resistance | $\ge$ 50 cmH2O per standard ANSI/AAMI PB70:2012 (AATCC 127-2018) | Pass |
| Biocompatibility Endpoints Assessment | ||
| Cytotoxicity | Non-Cytotoxic | PASS |
| Irritation | Non-Irritating | PASS |
| Sensitization | Non-Sensitizing | PASS |
Points 2-9 are not applicable as this is not an AI/ML medical device submission.
- 2. Sample size used for the test set and the data provenance: Not applicable. The tests are for physical and biological properties of the gowns, not an AI/ML model. The testing is based on standard methods for material properties. The provenance is internal testing by the manufacturer (Xiamen Probtain Medical Technology Co., Ltd. in China).
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical and biological tests is defined by established international standards (ISO, ASTM, AATCC, CPSC).
- 4. Adjudication method for the test set: Not applicable. Results are quantitative measurements against defined 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: Not applicable. This is not an AI/ML device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- 7. The type of ground truth used: For physical and barrier performance, the "ground truth" is defined by the acceptance criteria specified in the referenced industry standards (e.g., AAMI PB70:2012, ASTM, ISO, AATCC, CPSC 16 CFR). For biocompatibility, it's the biological response observed under standardized test conditions (e.g., non-cytotoxic, non-irritating, non-sensitizing).
- 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
In summary: The provided document is a 510(k) submission for a non-AI/ML medical device (disposable isolation gowns). The "study" proving the device meets acceptance criteria consists of a battery of non-clinical, laboratory-based tests of the product's physical, barrier, and biocompatibility properties, demonstrating compliance with recognized standards. The concept of an "AI/ML model" and associated metrics (training/test sets, human readers, ground truth creation for AI) does not apply to this submission.
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(56 days)
Disposable Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Isolation Gown meets the requirements of AAMI Level 3 barrier protection for a surgical isolation gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Isolation Gowns are single use, disposable medical devices, provided sterile.
Disposable Isolation Gowns are designed for the medical personnel use in medical environment, not intended for use in the operating room. The employed material is Polypropylene(PP) non-woven with polyethylene(PE) lamination. It is a kind of Non- Reinforced isolation gown. The Disposable Isolation Gowns are constructed from a blue PP&PE (non-woven fabric, PE lamination) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical isolation gown. The Disposable Isolation Gowns are blue color, sterilized by ethylene oxide gas , single use, disposable medical device that will be provided in a variety of sterile packaging configurations with 6 sizes, S,M,L,XL,XXL,and XXXL
The provided document describes the acceptance criteria and the results of non-clinical tests for the "Disposable Isolation Gowns" (K223411) from Xiamen Probtain Medical Technology Co., Ltd.
Here's the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Item | Test Standard | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Seam strength | ASTM D1683M-17 Standard Test Method for Failure in Sewn Seams of Woven Fabrics. | ≥30N (7lbf) per standard F2407-20 for level 3 | PASS (89.86 N, average from 10 samples) |
| Breaking strength | ASTM D5034-09 (2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) | ≥30N (7lbf) per standard F2407-20 for level 3 | PASS (MD: 90.92 N, CD: 77.06 N, average from 10 samples) |
| Tear strength (N) | ASTM D5587-15, Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure | ≥10N | PASS (MD: 31.89 N, CD: 19.2 N, average from 10 samples) |
| Lint and other generation in the dry state | ISO 9073-10: 2003 Textiles - Test Methods for Nonwovens - Part 10: Lint and Other Particles Generation in the Dry State | Log10(particle count) < 4 | PASS (1.8, average from 10 samples) |
| Flammability | CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles | Class I | PASS (Class I) |
| Water Penetration Resistance | AATCC 42-2013, Impact Penetration Test | ≤1.0g AQL: 4% Level 3 per standard ANSI/AAMI PB70:2012 for level 3 | PASS (≤1.0g) |
| Static hydrostatic resistance | AATCC 127-2014, Water Resistance: Hydrostatic Pressure Test | ≥50 cmH2O per standard ANSI/AAMI PB70:2012 for level 3 | PASS (≥50 cmH2O) |
| EO and ECH sterilization residual | ISO 10993-7:2008 Ethylene oxide sterilization residuals | EO ≤ 4mg/d, ECH ≤ 9mg/d | PASS (EO ≤ 4mg/d, ECH ≤ 9mg/d) |
| Biocompatibility: Cytotoxicity | ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity (The test was performed under the conditions of the study, the device extract was not cytotoxic.) | Non-Cytotoxic | PASS (Under the conditions of the study, the device is non-cytotoxic.) |
| Biocompatibility: Irritation | ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization (The test was performed under the conditions of the study, the non-polar and polar device extracts were not found to be an irritant.) | Non-Irritating | PASS (Under the conditions of the study, the device is non-irritating.) |
| Biocompatibility: Sensitization | ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization (Under conditions of the study, the non-polar and polar device extracts were not found to be a sensitizer.) | Non-Sensitizing | PASS (Under the conditions of the study, the device is non-sensitizing.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Mechanical/Physical Tests: For most mechanical and physical tests (Seam strength, Breaking strength, Tear strength, Lint and other generation), the results are reported as an "Average result from 10 samples."
- Sample Size for Biocompatibility Tests: Not explicitly stated but generally follows ISO 10993 standards which define sample sizes.
- Data Provenance: The tests were conducted to verify that the proposed device met design specifications. The document does not specify the country of origin of the testing data beyond listing the applicant's address in Xiamen, Fujian, China. The studies are non-clinical (laboratory-based performance and safety tests), not related to patient data, so "retrospective or prospective" does not apply in the typical sense.
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 product is a medical device (isolation gown), not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for these tests is established by adherence to recognized international and national standards (e.g., AAMI, ASTM, ISO, CPSC). The experts involved would be laboratory technicians and engineers who are qualified to perform these specific standard tests, but their specific number or qualifications are not detailed in this submission as it's not relevant for this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically for clinical studies or studies involving human readers/interpreters. This document describes non-clinical laboratory testing of a physical product against established performance standards. Therefore, an adjudication method is not applicable and not mentioned.
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 device is a disposable isolation gown, not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This is not an algorithmic device. The "standalone" performance here refers to the physical gown's performance against defined standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is defined by the acceptance criteria specified in recognized industry standards (e.g., AAMI PB70:2012, ASTM D1683M-17, ISO 10993). Therefore, it's a standards-based ground truth.
8. The sample size for the training set
This is a physical medical device (isolation gown) undergoing non-clinical performance and biological safety testing, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithms.
9. How the ground truth for the training set was established
As explained in point 8, there is no training set for this type of device.
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(97 days)
The StringKing Disposable Isolation Gown is intended to protect health care personnel and health care patients from the transfer of microorganisms, body fluids and particulate material. These gowns are not intended for use in the operating room. The StringKing Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The String King Disposable Isolation Gown is a single use, disposable medical device and is provided non-sterile.
Disposable, single-use isolation gown. The StringKing Disposable Isolation Gown is made of blue polyethylene and serves as a barrier to the transfer of microorganisms, body fluids and particulate material. The gowns feature hook and loop neck closure with a strap for fastening the back of the gown. The gown sleeves have thumb-loops to keep sleeves from sliding when donning the gown. The gowns are available in Large sizes. The gowns are non-sterile, single-use devices.
This document describes the premarket notification (510(k)) for the StringKing Disposable Isolation Gown (K212633). This is a disposable medical device intended to protect healthcare personnel and patients from the transfer of microorganisms, body fluids, and particulate material. It is a Class II device and is not intended for use in the operating room.
Here's an analysis of the provided information regarding acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70) for Level 3 barrier protection, along with other physical performance and biocompatibility standards.
| Test Category | Specific Test (Standard) | Acceptance Criteria (Predicate Device K202310 Performance, if available/relevant) | Reported Device Performance (StringKing Disposable Isolation Gown) | Result |
|---|---|---|---|---|
| Barrier Protection | ANSI/AAMI PB70:2012 | Level 3 | Meets Level 3 requirements | Same (Meets Level 3) |
| Barrier Protection | Water Resistance: Hydrostatic Pressure Test - AATCC 127:2017 (cm) | Passed at ≥ 50cm (Predicate Chest: Mean = >151, Min = 155, Max = >155; Sleeve Seam: Mean = >165, Min = 171, Max = >173) | Fabric (body): Mean 170.33, Min 128.87, Max 196.87; Sleeve: Mean 126.60, Min 54.83, Max 189.40; Armhole: Each lot tested had less than 4 failures, meeting AQL 4.0. | Both passed at ≥ 50cm |
| Barrier Protection | Water Resistance: Impact Penetration Test - AATCC 42 | Passed at ≤ 1.0g (Predicate Chest: Mean = <0.1, Min = <0.1, Max = .5; Sleeve Seam: Mean = <0.1, Min = <0.1, Max = <0.1) | Fabric (body): Mean 0.01, Min 0.00, Max 0.11; Sleeve: Mean 0.03, Min 0.01, Max 0.38; Armhole: Mean 0.02, Min 0.00, Max 0.16 | Both passed at ≤ 1.0g |
| Physical Properties | Flammability of Clothing Textiles - 16 CFR Part 1610 (a) | Class I (average > 3.5 seconds) | Mean 5.41, Min 1.63, Max 7.87 | Class 1: average > 3.5 seconds. Both passed. |
| Physical Properties | Tear Resistance - ASTM D1004* | Predicate: Max Load (lbf): Mean = 1.04, Min = .95, Max = 1.17; Max Extension (in): Mean = 1.01, Min = .91, Max = 1.10 | N/A (Not tested as this method is not required by ANSI/AAMI PB70:2012 or ASTM F2407-20) | Subject device not tested as not required by relevant standards. |
| Physical Properties | General Tensile Testing - ASTMD882* | Predicate: Breaking Factor (lbf/in): Mean = 6.66, Min = 4.87, Max = 9.20; Tensile (Max) (MPa): Mean = 24.8, Min = 19.7, Max = 33.4; Tensile (Break) (MPa): Mean = 21.5, Min = 15.9, Max = 33.4; Elongation (%): Mean = 1061, Min = 945, Max = 1327; Modulus (MPa): Mean = 91.1, Min = 2.58, Max = 117 | N/A (Not tested as this method is not required by ANSI/AAMI PB70:2012 or ASTM F2407-20) | Subject device not tested as not required by relevant standards. |
| Physical Properties | Trap Tear ASTM D5587-15 | Passed at ≥2.3lbf (Predicate: Mean = 5.10, Ind Min = 3.2, Ind Max = 7.0) | Length: Mean 3.80, Min 3.18, Max 4.46; Width: Mean 6.88, Min 6.26, Max 7.58 | Both passed at ≥2.3lbf |
| Physical Properties | Grab Tensile CD ASTM D5034 | Passed at ≥7lbf (Predicate: Mean = 21.95, Ind Min = 20.60, Ind Max = 23.30) | Length: Mean 23.75, Min 20.54, Max 25.91; Width: Mean 19.63, Min 17.10, Max 21.59 | Both passed at ≥7lbf |
| Physical Properties | ASTM D1683 Seam Strength | Predicate: Not included in 510k summary; assumed to meet relevant standards for its performance. | Sleeve: Mean 11.95, Min 6.48, Max 18.18; Armhole: Mean 12.30, Min 6.95, Max 17.41 | Subject device passed at ≥7lbf; predicate data not provided. |
| Biocompatibility | Cytotoxicity: ISO 10993-5:2009 | Non-Cytotoxic (Predicate: Pass: ISO 10993-1) | Pass (Grade 0: non-cytotoxic) | Same (Pass) |
| Biocompatibility | Skin Irritation: ISO 10993-10:2010(R)2014 | Non-Irritating (Predicate: Pass: ISO 10993-1) | Negligible (pass) (Specimen: 0.0 non-irritating) | Same (Pass) |
| Biocompatibility | Skin Sensitization: ISO 10993-10:2010(R)2014 | Non-Sensitizing (Predicate: Pass: ISO 10993-1) | No sensitization noted (pass) (Specimen: 0.0 non-sensitizing) | Same (Pass) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific numerical sample size for each individual test. However, it provides mean, min, and max values for various physical tests, implying multiple samples were used for each. For the hydrostatic pressure and impact penetration tests, the results include mean, min, and max values for "Fabric (body)", "Sleeve", and "Armhole", suggesting multiple measurements across different regions of the gown. For the armhole hydrostatic pressure, it mentions "Each lot tested had less than 4 failures", indicating testing across lots.
- Data Provenance: The tests were non-clinical performance data and biocompatibility tests. The document does not specify the country of origin where the tests were explicitly conducted. It is implied that these are lab-based tests. The data is retrospective in the sense that it was generated for the purpose of this 510(k) submission, based on the manufactured device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This device is a physical product (disposable isolation gown), not an AI/software device requiring human expert annotation for "ground truth". The "ground truth" for this device is established by its physical and biological performance against standardized, internationally recognized test methods (e.g., AAMI, AATCC, ASTM, ISO, CPSC).
- Therefore, the concept of "experts" to establish ground truth in the traditional sense of image interpretation or clinical diagnosis is not applicable here. The "experts" verifying the device's performance would be qualified lab technicians and engineers performing the standardized tests, and subsequently regulatory reviewers from the FDA.
4. Adjudication Method for the Test Set
- Not applicable. This is not an observational study requiring adjudication of interpretations. The tests are objective measurements of physical and biological properties.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those incorporating AI, where human readers (e.g., radiologists) interpret cases with and without AI assistance. This document pertains to a disposable physical medical device (isolation gown), not a diagnostic or AI-assisted device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
- Not applicable. This is a physical medical device, not an algorithm or software. The term "standalone performance" typically refers to the performance of an AI algorithm independent of human interaction.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established by objective, standardized measurements and laboratory testing results as defined by:
- ANSI/AAMI PB70:2012 (Liquid Barrier Performance Classification)
- AATCC 127:2017 (Water Resistance: Hydrostatic Pressure Test)
- AATCC 42 (Water Resistance: Impact Penetration Test)
- 16 CFR Part 1610 (Flammability of Clothing Textiles)
- ASTM D5587-15 (Tearing Strength of Fabrics by Trapezoid Procedure)
- ASTM D5034 (Breaking Strength and Elongation of Textile Fabrics (Grab Test))
- ASTM D1683 (Failure in Sewn Seams of Woven Fabrics)
- ISO 10993-5:2009 (Biological Evaluation - In-Vitro Cytotoxicity)
- ISO 10993-10:2010(R)2014 (Biological Evaluation - Irritation and Delayed-Type Hypersensitivity)
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI-based device, so there is no "training set" in the context of data used to train an algorithm. The device's manufacturing processes would be subject to quality control, but this is distinct from a "training set" for an AI model.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no "training set" in the AI/ML context for this physical device.
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