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510(k) Data Aggregation
(212 days)
"Skypro. Surgical Gown 6021" are intended to protect both surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 3 surgical gowns in accordance with ANSI/AAMI PB70 and used in healthcare facilities. The gown is single use, disposable, and provided sterile.
"Skypro, Surgical Gown 6021" are sterile, disposable, and intended for single use. They are fundamentally made of blue non-woven spunbond-meltblown-spunbond (SMS) polypropylene fabrics, and come in a variety of sizes (XS, S, M, L, XL, and XXL). The gown features white elastic cuffs, a hook-and-loop tap for closing the neck, and four waist belts for closing the back.
"Skypro, Surgical Gown 6021" is constructed in accordance with AAMI PB70 Level 3 specifications. The major raw material of the surgical gown is non-woven SMS polypropylene fabric, which is a trilaminate non-woven fabric with a densely packed structure (i.e., small micron pore sizes) to provide tortuous paths to block the penetration of particulate matter. The hydrophobic nature of the fabric can effectively prevent the absorption and penetration of liquids and body fluids. The joints and seam regions of the surgical gown are sealed via ultrasonic vibration- assisted welding to avoid the penetration of liquids through joints and seam stitching. The whole of the surgical gown exhibits a barrier performance of Level 3.
The provided text describes the 510(k) submission for the "Skypro, Surgical Gown 6021" and compares it to a predicate device. This document is a regulatory submission for a medical device (surgical gown), not a software-based AI/ML device. Therefore, the bulk of the questions, specifically those related to AI/ML device performance (like "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "number of experts for ground truth," or "sample size for training set"), are not applicable.
However, I can extract information related to the acceptance criteria and study proving the device meets those criteria, as well as the types of testing performed for this non-AI medical device.
Here's the relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document details various non-clinical tests and their criteria, which serve as the acceptance criteria for the surgical gown.
| Test Performed | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| ASTM F2407-20, Section 7.2 Tensile Strength (ASTM D5034-09(R17)) | To evaluate the tensile strength of the gown material | ≥ 30N | Pass (Warp yarns torn (MD): 179.7 N, Weft yarns torn (CD): 103.7 N) |
| ASTM F2407-20, Section 7.2 Seam Strength (ASTM D1683/D1683M-22) | To evaluate the tensile strength of the gown seam | ≥ 30N | Pass (Sleeve seam: 113.3 N, Armhole seam: 73.2 N, Shoulder seam: 111.1 N) |
| ASTM F2407-20, Section 7.2 Tearing Strength (ASTM D5733-99) | To evaluate the tear strength of the gown material | ≥ 10N | Pass (Warp yarns torn (MD): 53.9 N, Weft yarns torn (CD): 29.2 N) |
| ASTM F2407-20, Section 7.3 Lint Generation (ISO 9073-10:2003) | To evaluate the potential for linting of the gown | Documentation only | Pass (Side A (face): Total linting: 140.9, Coefficient of linting: 2.15; Side B (back): Total linting: 242.2, Coefficient of linting: 2.38) |
| ASTM F2407-20, Section 7.3 Evaporative Resistance (ASTM F1868-17) | To evaluate the evaporative resistance of the gown | Documentation only | Pass (0.00215 kPa·m²/W) |
| Water Resistance: Hydrostatic Pressure (AATCC 42:2017) | To evaluate the hydrostatic water resistance of the gown | ≥ 50cmH20 | Pass (Base material: > 50 cmH₂O, Sleeve Seam: > 50 cmH2O, Tie attachment with/without film: > 50 cmH₂O) |
| Water Resistance: Impact Penetration (AATCC 127:2018e) | To evaluate the water spray resistance of the gown | ≤ 1.0g | Pass (Base material: 0 g, Sleeve Seam: 0 g, Tie attachment with/without film: 0 g; No penetration can be observed) |
| ASTM F2407-20, Section 6.3 Flame Spread (16 CFR 1610) | To evaluate the flame resistance of the gown | Class 1 | Pass (Class 1) |
| Cytotoxicity Test: MEM Elution (ISO 10993-5:2009) | To evaluate the cytotoxic potential of the gown | Under conditions of the testing, non-cytotoxic | Pass (Under conditions of the testing, non-cytotoxic) |
| Sensitization Test: Kligman Maximization Test (ISO 10993-10:2021) | To evaluate the sensitization potential of the gown | Under conditions of the testing, not a sensitizer | Pass (Under conditions of the testing, not a sensitizer) |
| Primary Skin Irritation Test: Intracutaneous Injection Test (ISO 10993-10:2021) | To evaluate the skin irritation potential of the gown | Under conditions of the testing, not an irritant | Pass (Under conditions of the testing, not an irritant) |
| Sterilant Gas Residue Analysis (ISO 10993-7) | To verify low levels of residual ethylene oxide and ethylene chlorohydrin | EO: < 4 mg /device; ECh: < 9 mg / device | Pass (EO: < 4 mg /device, ECh: < 9 mg / device) |
| Seal Peel Test (ASTM F88) | To evaluate the force necessary to open the sterile barrier seals | 0.375 lbf (average) | Pass (0.375 lbf (average)) |
| Dye Migration Test (ASTM F1929) | To verify the integrity of the sterile barrier | No leakage | Pass (No leakage) |
| Simulated Aging Test (ASTM F1980) | To verify the ability of the sterile barrier to maintain integrity during its shelf life | Meets performance specifications after accelerated aging, no visually apparent change | Pass (Meets performance specifications after accelerated aging, no visually apparent change) |
| AAMI PB 70 Classification | To classify the gown's barrier performance | Level 3 | Level 3 |
| Sterility Assurance Level | To ensure microbial sterility | 10^-6 | 10^-6 |
| Shelf Life | To define the time during which the product remains safe and effective | Stated Shelf Life (e.g., 2 years) | 2 years |
2. Sample sizes used for the test set and the data provenance
The document does not specify the exact sample sizes for each non-clinical test. It refers to standard ASTM and ISO methods, which typically dictate sample sizes. The data provenance is not explicitly stated in terms of country of origin, nor is it specified as retrospective or prospective; these are standard laboratory tests on the manufactured product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is for a physical medical device (surgical gown), not an AI/ML device relying on expert interpretation for ground truth. The "ground truth" here is objective physical and chemical properties measured by standardized test methods.
4. Adjudication method for the test set
Not applicable. This is for a physical medical device. The results are from standardized laboratory testing, not subjective human-reviewed data requiring 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/ML device. No MRMC study was performed.
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
The ground truth is established through adherence to recognized international (ISO) and national (ASTM, AATCC, 16 CFR) standards and test methods for material properties, barrier performance, biocompatibility, and sterility. These are objective, measurable outcomes.
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.
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(501 days)
"Skypro, SP02 Mask (Level 3)" is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. It is intended for infection control practices to reduce the potential exposure of the wearer to blood and body fluids. It is a non-sterile, single-use, and disposable device.
"Skypro, SP02 Mask (Level 3)" is a flat-pleated surgical or procedure mask. It is composed of 4-layer spunbond/meltblown polypropylene fabrics, elastic earloops or ties, and a moldable nose clip.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: Skypro, SP02 Mask (Level 3)
Product Code: FXX
Regulation Name: Surgical apparel
Regulatory Class: Class II
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility Test: | To determine if the mask may cause adverse biological reactions. | ||
| Cytotoxicity Test (MEM Elution) | To determine if the mask may cause cytotoxic effects. | Non-cytotoxic | Non-cytotoxic |
| Sensitization Test (Kligman Max) | To determine if the mask may cause skin sensitization. | Non-sensitizing | Non-sensitizing |
| Primary Skin Irritation Test | To determine if the mask may cause skin irritation. | Non-irritating | Non-irritating |
| Fluid Resistance Test | To determine the capability of mask to resist the penetration of fluids. | Pass @ 160 mmHg | Pass |
| Particle Filtration Efficiency | To measure the filtration efficiency of mask for particulates. | ≥ 98% | 98.59% |
| Bacterial Filtration Efficiency | To measure the filtration efficiency of mask for bacteria. | ≥ 98% | 99.24% |
| Differential Pressure (Delta P) | To measure how easily air is passed, an indicator of air permeability or breathability. | < 6 mmH2O/cm² | 4.04 mmH2O/cm² |
| Flammability Test | To determine if the mask ignites easily when exposed to or used near fire or heat. | Class 1 | Class 1 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test (e.g., number of masks tested for fluid resistance, number of animals for biocompatibility). It only states that "non-clinical tests" were performed.
The data provenance is not explicitly stated in terms of country of origin of the data or whether the studies were retrospective or prospective. However, given that these are performance tests for a medical device submitted to the FDA, they are generally conducted prospectively according to established laboratory standards (e.g., GLP for biocompatibility).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided in the document. The tests performed are objective, quantitative laboratory tests (e.g., measuring filtration efficiency, pressure, or observing biological reactions) against defined standards. Therefore, "experts to establish ground truth" in the way one might for diagnostic imaging or clinical interpretation is not relevant here. The ground truth is established by the specified test methods and their measurable outcomes.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As explained above, the tests are objective laboratory measurements, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical Performance Test: No clinical testing was performed." These are non-clinical, laboratory performance tests of a surgical mask.
Therefore, there is no effect size of how much human readers improve with AI vs. without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to this device. The Skypro, SP02 Mask (Level 3) is a physical surgical mask, not an AI algorithm or a device with a software component that would involve standalone algorithm performance or human-in-the-loop performance.
7. The Type of Ground Truth Used
The ground truth for the performance tests is established by:
- Defined ASTM/ISO/FDA recognized test standards and methodologies: These standards provide objective measurement protocols and criteria (e.g., for biocompatibility, filtration, flammability).
- Quantitative measurements: For tests like Particle Filtration Efficiency, Bacterial Filtration Efficiency, and Differential Pressure, the results are numerical values obtained from calibrated equipment.
- Qualitative observations against predefined criteria: For biocompatibility, the outcomes are "non-cytotoxic," "non-sensitizing," and "non-irritating," which are determined by observing biological responses in accordance with test protocols.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a physical product (surgical mask), not an AI/ML algorithm or a system that requires a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As mentioned above, there is no training set for this type of device.
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(387 days)
The Skypro, SP01 Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The mask is a single use, disposable device, provided non-sterile.
Skypro, SP01 Mask, is a flat pleated procedure or surgical mask. It is 3 layers and composed of Polypropylene and Meltblown, with elastic earloops or Ties in either knitted polyester/lycra or non-woven polyester and A malleable nosepiece is placed within the bindings for comfort and individualized fir around the wearer's nose.
The provided text is a 510(k) summary for the Skypro, SP01 Mask, which is a surgical mask. It doesn't describe an AI/ML device, a comparative effectiveness study involving human readers, or the establishment of ground truth by medical experts. The acceptance criteria and performance data relate to the physical and functional characteristics of the mask itself, not an algorithm's performance.
Therefore, many of the requested categories are not applicable to the provided document. I will fill in the relevant information based on the document and explicitly state when a criterion is not applicable.
Here's the breakdown of the acceptance criteria and the study information for the Skypro, SP01 Mask:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Predicate Device K141875) | Reported Device Performance (Skypro, SP01 Mask) |
|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | Pass @120mmHg | Pass @120mmHg |
| Particulate Filtration Efficiency (ASTM F2299) | 99.4% | 99.28% |
| Bacterial Filtration Efficiency (ASTM F2101-07) | 99.76% | 99.66% |
| Differential Pressure (MIL-M-36954C) | 3.33 mm H2O/cm² | 3.72 mm H2O/cm² |
| Flammability Class (16 CFR Part 1610) | Class 1 | Class 1 |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic | Non-cytotoxic |
| Biocompatibility (Sensitization) | Non-sensitization | Non-sensitization |
| Biocompatibility (Primary Skin Irritation) | Non-irritating | Non-irritating |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. The document refers to "test data submitted," implying that samples were tested according to the respective ASTM and MIL standards.
- Data Provenance: Not specified in terms of country of origin of the data or if it was retrospective or prospective. It is assumed to be testing conducted specifically for this device submission.
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. This device is a physical medical supply (surgical mask), and its performance data are based on standardized laboratory tests, not expert interpretation of medical images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As per point 3, there is no expert adjudication involved in determining the performance of a surgical mask based on physical and filtration characteristics.
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 document pertains to a surgical mask, not an AI/ML device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This document pertains to a surgical mask, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Standardized Test Methods: The "ground truth" for the device performance is established by the results of standardized laboratory tests (e.g., ASTM F1862 for fluid resistance, ASTM F2299 for particulate filtration, ASTM F2101-07 for bacterial filtration, MIL-M-36954C for differential pressure, 16 CFR Part 1610 for flammability, and ISO 10993 for biocompatibility). These methods define the criteria for passing or failing each test.
8. The sample size for the training set:
- Not Applicable. This document pertains to a surgical mask, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As per point 8, there is no training set for this device.
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