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510(k) Data Aggregation
(89 days)
(Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)
Regulation Number: 21 CFR 878.4040
Device Classification Name:** Surgical Apparel
Product Code: FXX
Regulation Number: 21 CFR 878.4040
Classifications: Class II, 21 CFR 878.4040 - Surgical Apparel
Predicate device
**Primary
use only. | provided non-sterile. | |
|---|---|---|---|
| Regulation Number | Class II, 21 CFR 878.4040
| Class II, 21 CFR 878.4040 | Class II, 21 CFR 878.4040 | Same |
| Mask Style | Vitaform: Fish-shaped
Vitaform Procedural Masks are intended to be worn to protect both the patient and the healthcare worker from transfer of microorganisms, body fluids, and particulate material. They are single-use and intended for use in infection control practices to reduce potential exposure to blood and body fluids.
Vitaform Procedural Mask (henceforth referred to as "Vitaform")
The Vitaform Procedural Mask is a single-use, three-layered, fish-shaped surgical mask with ear loops and an aluminum nose piece. The inner and outer layers are made of spunbond polypropylene, and the middle filter layer consists of meltblown polypropylene. The ear loops are made of PET and Spandex material, and worn around the ears to keep the mask close to the face. The nose piece is a flexible aluminum strip that is fitted over the nose so that the mask conforms better to the user's face.
The Vitaform Procedural Mask is provided in the color blue. It is non-sterile and intended to be a single-use, disposable medical device.
Vitaform Procedural Mask with Shield (henceforth referred to as "Vitaform-FS")
The Vitaform Procedural Mask with Shield is a single-use, fish-shaped surgical mask with ear loops and an aluminum nose piece. The inner and outer layers are made of spunbond polypropylene, and the middle filter layer consists of meltblown polypropylene. The insertion layer that provides structural support is made of thermal-bonded polypropylene. The ear loops are made of PET and Spandex material, and is worn around the ears to keep the mask close to the face. The nose piece is a flexible aluminum strip that is fitted over the nose so that the mask conforms better to the user's face. The mask also contains a face shield (FS) made from a polyethylene terephthalate film, and an anti-reflective flap. The face shield is welded to the upper half of the mask to cover the upper part of the face.
The Vitaform Procedural Mask with Shield is provided in the color blue. It is non-sterile and intended to be a single-use, disposable medical device.
N/A
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(156 days)
: K250082**
Trade/Device Name: Procedure mask/Surgical mask/Face mask
Regulation Number: 21 CFR 878.4040
Identification of Predicate Device
K220194 Procedure mask/Surgical mask/Face mask; 21 CFR 878.4040 FXX
K223232 Procedure mask/Surgical mask/Face mask; 21 CFR 878.4040 FXX Mask, Surgical (For level 3).
| 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Indications for Use | The Procedure mask/Surgical
| 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Indications for Use | The Procedure mask/Surgical
The Procedure mask/Surgical mask/Face 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 to blood and body fluids. This is a single-use, disposable device, provided non-sterile.
The subject device is a three-layer, single-use, flat-pleated mask. The inner and outer layers of the mask are made of polypropylene nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The subject device is available in one type, ear loop. The ear loops are made of polyester and spandex. The ear loops model is held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The nose clip is made of Iron and polypropylene. Users can adjust the nose clip 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 ear loop masks are available in two size, 17.5 × 9.5 cm and 14.5 × 9.5 cm. And the colors for the ear loop mask are yellow, blue and white. The ear loop masks are available in level 1, level 2 and level 3 masks based on ASTM F2100-23. This is a single-use, disposable device, provided non-sterile.
The provided document is a 510(k) Clearance Letter for a medical device: Procedure mask/Surgical mask/Face mask. This type of document, specifically the "Summary of Non-Clinical Test" section, details the performance characteristics required for the device to meet regulatory standards.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Important Note: The provided document is for a medical mask, not an AI-powered diagnostic device. Therefore, many of the typical questions regarding AI/software performance studies (e.g., sample size for test set, number of experts, adjudication, MRMC studies, training set details, ground truth for AI) are not applicable to this submission. The "study" here refers to physical and biological performance testing of the mask material itself.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are based on established standards like ASTM F2100-23, ASTM F1862/F1862M-24, ASTM F2101-23, EN 14683:2019+AC:2019, 16 CFR Part 1610, and ISO 10993 series. The table below summarizes these criteria and the reported performance:
Table 1: Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Resistance to Penetration by Synthetic blood (ASTM F1862/F1862M-24) | To evaluate the effectiveness of the test article from possible exposure to blood and other body fluids. | Level 1: No penetration at 80 mmHgLevel 2: No penetration at 120 mmHgLevel 3: No penetration at 160 mmHg | Yellow mask (Level 1): Pass at 80 mmHgWhite mask (Level 1): Pass at 80 mmHgBlue mask: Level 1: Pass at 80 mmHg, Level 2: Pass at 120 mmHg, Level 3: Pass at 160 mmHg |
| Particulate Filtration Efficiency (ASTM F3502-24) | To determine the particle filtration efficiency (PFE) of the test article. | Level 1: ≥ 80%Level 2: ≥ 85%Level 3: ≥ 85% | Yellow mask (Level 1): greater than 80% efficiencyWhite mask (Level 1): greater than 80% efficiencyBlue mask (Level 1): greater than 80% efficiencyBlue mask (Level 2): greater than 85% efficiencyBlue mask (Level 3): greater than 85% efficiency |
| Bacterial Filtration Efficiency (ASTM F2101-23) | To determine the bacterial filtration efficiency (BFE) of the test article. | Level 1: ≥ 95%Level 2: ≥ 98%Level 3: ≥ 98% | Yellow mask (Level 1): greater than 95% efficiencyWhite mask (Level 1): greater than 95% efficiencyBlue mask (Level 1): greater than 95% efficiencyBlue mask (Level 2): greater than 98% efficiencyBlue mask (Level 3): greater than 98% efficiency |
| Differential Pressure (EN 14683:2019+AC:2019 Annex C) | To determine the differential pressure of the test article. | Level 1: < 5.0 mmH₂O/cm²Level 2: < 6.0 mmH₂O/cm²Level 3: < 6.0 mmH₂O/cm² | Yellow mask (Level 1): less than 5.0 mmH₂O/cm²White mask (Level 1): less than 5.0 mmH₂O/cm²Blue mask (Level 1): less than 5.0 mmH₂O/cm²Blue mask (Level 2): less than 6.0 mmH₂O/cm²Blue mask (Level 3): less than 6.0 mmH₂O/cm² |
| Flammability (16 CFR Part 1610) | To evaluate the flammability of the test article. | Class 1 | Yellow mask (Level 1): Class 1White mask (Level 1): Class 1Blue mask: Level 1: Class 1, Level 2: Class 1, Level 3: Class 1 |
| Cytotoxicity (ISO 10993-5:2009) | To evaluate the cytotoxicity of the test article. | The cell culture test system is suitable if the observed responses to the negative control is grade 0 and to the positive control is at least grade 3. The sample meets the requirements of the test if the response to the sample is not greater than grade 2. | Under the conditions of this study, the cytotoxicity result was grade 0. The test article would be considered no cytotoxic potential. The negative controls, blank controls, and the positive controls performed as anticipated. |
| Sensitization (ISO 10993-10:2021) | To evaluate the sensitization of the test article. | Grades of 1 or greater in the test group generally indicated sensitization, provided grades of less than 1 are seen in the control animals. If grades of 1 or greater were noted in control animals, the reactions of test animals which exceeded the most severe reaction in control animals are presumed to be due to sensitization. | Under the conditions of this study, the guinea pig showed no sensitization reaction after the induction of test extracts and the positive rate is 0%. There was no evidence that the test article extracts would cause sensitization on guinea pig. |
| Irritation (ISO 10993-23:2021) | To evaluate the irritation of the test article. | The cumulative irritation indices in the range of 0 to 0.4 were determined to be in the irritation response category of "Negligible". | Under the conditions of the test, the cumulative stimulus value is 0.0, the test article caused no skin irritation to rabbits. The test article met the test requirements. |
Study Details (Applicable to Face Mask Device)
Given that the device is a medical face mask, the "study" primarily consists of non-clinical, laboratory-based performance and biocompatibility testing, not clinical trials or AI performance evaluations as would be done for software.
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in terms of number of masks or test replicates for each test, but standard test methodologies (e.g., ASTM F1862/F1862M-24, ASTM F2101-23) typically specify a minimum number of samples. The results are given for specific "lots" (e.g., Yellow mask (Level 1), White mask (Level 1), Blue mask (Level 1, 2, 3)), implying that multiple samples from these production lots were tested.
- Data Provenance: Not explicitly stated. The manufacturer is Winner Medical Co., Ltd. from Shenzhen, China. This indicates the testing was likely conducted in China or by labs accredited to perform these standards. The tests are "Non clinical tests," meaning they are laboratory experiments rather than human subject or retrospective studies.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For this type of device (medical mask), "ground truth" is established by adherence to validated, objective, and standardized laboratory test methodologies and measurements, not by expert human interpretation (like in imaging for AI). The tests measure physical and biological properties directly.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for human interpretation tasks (e.g., reading medical images) where there can be inter-reader variability. These are objective, quantitative laboratory tests.
-
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 a physical medical device (mask), not an AI-powered diagnostic tool. MRMC studies are used to assess the performance of AI systems in combination with human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device (mask), not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective Laboratory Measurements/Standards. The "ground truth" for this device is based on the objective measurements obtained through the specified ASTM, EN, CFR, and ISO standards (e.g., bacterial filtration efficiency percentage, differential pressure values, absence of penetration by synthetic blood, flammability class, cellular toxicity grading, sensitization response). These are empirical, quantitative, and qualitative results from standardized test protocols.
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The sample size for the training set:
- Not Applicable. This is a physical device being tested against performance standards, not an AI/ML algorithm that requires a "training set."
-
How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an algorithm is involved.
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(246 days)
with SO SOFT* Lining and SO SOFT* Earloops, WrapAround Visor (47147)
Regulation Number: 21 CFR 878.4040
Mask and Procedure Mask |
| Device Product Code and Classification Name | FXX Class II, 21 CFR §878.4040
FXX | Same |
| FDA Classification | Class II | Class II | Same |
| Regulation Number | 21 CFR 878.4040
| 21 CFR 878.4040 | Same |
| Common Name | Surgical Mask | Surgical Mask | Same |
| **Device Trade
The Fluidshield* 3 Surgical Mask(s) and Fluidshield* 3 Procedure Mask(s) are 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. Fluidshield* 3 Surgical Masks(s) and Fluidshield* 3 Procedure Face Mask(s) are single use, disposable device(s), provided non-sterile.
The subject device(s) are ASTM F2100 Level 3 (orange in color) Surgical and Procedure Mask(s). The Fluidshield* 3 Surgical Mask(s)s and Fluidshield* 3 Procedure Masks family of products are a four-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties while the Procedure Masks are provided with earloops. A malleable nosepiece is placed within the bindings to conform around the wearer's nose. The Fluidshield* 3 Surgical Mask(s)s and Fluidshield* 3 Procedure Mask(s) family will be provided in designs with and without a protective visor. The Fluidshield* 3 Surgical Mask(s) and Fluidshield* 3 Procedure Mask(s) family are single use, disposable devices, provided non-sterile.
This document describes the FDA 510(k) clearance for several Fluidshield® 3 Surgical and Procedure Masks. However, it does not contain the level of detail regarding study design, sample sizes, ground truth establishment, or expert qualifications that would be present in a comprehensive study report for an AI/software device. The information provided is typical for a medical device clearance describing performance characteristics and compliance with standards, not for an AI comparative effectiveness or standalone study.
Based on the provided text, here's what can be extracted and what cannot:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Face Mask Performance | ASTM F2100 Level 3 | Pass (28800, 28804, 47137, 48207) - Implies all models meet Level 3 |
| Bacterial Filtration Efficiency | ≥98% | Pass |
| Particulate Filtration Efficiency | ≥98% | Pass |
| Differential Pressure | <6.0 mmH₂O/cm² | Pass |
| Fluid Resistance | 160 mmHg | Pass |
| Flammability | Class 1 | Pass |
| Biocompatibility | (Not specified in table) | Pass (28800, 28804, 47107, 48207) - Implies all models meet standard |
| Cytotoxicity | Non-cytotoxic | Pass |
| Sensitization | Non-sensitizing | Pass |
| Irritation | Non-irritant | Pass |
Study Details (Based on available information in the document)
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document. The document lists "Pass" for various tests, but does not detail the number of masks or samples tested for each criterion.
- Data Provenance: Not specified. The tests are non-clinical (laboratory-based) tests of the physical properties and performance of the mask materials and construction. They are not based on patient data, but rather on material testing.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/software device study involving expert interpretation of data. The "ground truth" here refers to the quantitative results of standardized non-clinical material performance tests, performed by laboratory personnel according to the specified ASTM and ISO standards.
-
Adjudication method for the test set:
- Not applicable. The performance is measured against objective, standardized physical testing methods rather than subjective expert consensus requiring adjudication.
-
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 is for the premarket notification (510(k)) of physical medical devices (surgical masks), not an AI/software as a medical device (SaMD). Therefore, no MRMC study or AI performance evaluation was conducted.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/software device.
-
The type of ground truth used:
- The "ground truth" for the performance claims of these masks is based on standardized non-clinical laboratory testing results as defined by the ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards listed (e.g., ASTM F2100, ASTM F2101, ASTM F2299, ASTM F1862, 16 CFR Part 1610, ISO 10993). These are objective, measurable physical properties and biocompatibility assessments.
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The sample size for the training set:
- Not applicable. This is not an AI/software device and therefore does not involve training sets.
-
How the ground truth for the training set was established:
- Not applicable. No training set is involved.
Summary of the Study:
The "study" referenced in this document is a series of non-clinical laboratory tests to demonstrate that the Fluidshield® 3 Surgical and Procedure Masks meet established performance standards for medical face masks, specifically ASTM F2100 Level 3. These tests evaluate properties such as bacterial filtration efficiency, particulate filtration efficiency, differential pressure (breathability), fluid resistance, flammability, and biocompatibility (cytotoxicity, sensitization, irritation).
The conclusion states that the nonclinical tests demonstrate the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, forming the basis for its 510(k) clearance for market.
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(197 days)
92653
Re: K243522
Trade/Device Name: ViVi® Toga Premium
Regulation Number: 21 CFR 878.4040
PRODUCT CODE / DEVICE:
FYA – Gown, Surgical
REGULATION NUMBER AND DESCRIPTION:
21 CFR 878.4040
Innovation Gmbh | |
| 510(k) Number | K243522 | K192194 | K222214 | |
| Registration Number | 21 CFR 878.4040
| 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Device Class | Class II | Class II | Class II | Same
The ViVi® Toga Premium is a component of the ViVi® System and is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
The ViVi® Toga Premium is a one-piece head and body cover that is worn by healthcare professionals. The ViVi® Toga Premium is a component of the ViVi® Surgical Helmet System and worn over the air-exchanging surgical helmet. The ViVi® Toga Premium is used with the ViVi® Helmet or the ViVi® Helmet HPL (High Power LED) with Light Emitting Diode (LED) light to provide a barrier between the operating environment and the surgical personnel to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
ViVi® Toga Premium is designed and has been tested to meet the applicable AAMI PB70 standards for level 4 compliance. The AAMI standard does not cover apparel for the head, face, and eyes. Therefore, the hood area and the lens are exempt from classification under this standard.
The provided FDA 510(k) clearance letter for the ViVI® Toga Premium is for a Class II surgical apparel device. This document primarily details the substantial equivalence of the ViVi® Toga Premium to a predicate device based on non-clinical performance data. It explicitly states that "No clinical evaluation is necessary for this device."
Therefore, this document does not describe a study involving an AI/Machine Learning (ML) algorithm with a test set, ground truth, expert adjudication, or MRMC studies. The device is a physical product (surgical toga/gown), and its "performance" is related to its physical properties and barrier capabilities, not diagnostic or predictive accuracy.
Given the information provided, it's not possible to fulfill the request for acceptance criteria and study details related to an AI/ML device. The "study" mentioned in the document refers to non-clinical laboratory testing of material properties.
However, I can extract the acceptance criteria and the "reported device performance" based on the provided document as it relates to this specific physical device.
Acceptance Criteria and Reported Device Performance for ViVi® Toga Premium (Surgical Apparel)
Based on the provided FDA 510(k) clearance letter for the ViVi® Toga Premium, the acceptance criteria and reported device performance relate to its physical properties and barrier capabilities, as it is a surgical apparel device and not an AI/ML device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the standards and tests performed, with "PASS" indicating successful compliance.
| Property or Characteristic | Test Method / Standard | Acceptance Criteria (Implied) | Reported Device Performance (ViVi® Toga Premium) |
|---|---|---|---|
| Flammability of clothing textiles | 16 CFR 1610 | Class 1 compliant | Class 1 compliant PASS |
| Biocompatibility: Cytotoxicity | ISO 10993-5 | Compliant | Compliant PASS |
| Biocompatibility: Sensitization | ISO 10993-10 | Compliant | Compliant PASS |
| Biocompatibility: Irritation | ISO 10993-23 | Compliant | Compliant PASS |
| Tear Resistance | ASTM D5587 | Compliant | Compliant PASS |
| Tensile Strength | ASTM D5034 | Compliant | Compliant PASS |
| Seam Strength | ASTM F88/F88M | Compliant | Compliant PASS |
| Laser Resistance | ISO 11810:2015 | Compliant | Compliant PASS |
| Linting (Lint and other particles generation in the dry state) | ISO 9073-10:2005 | Compliant | Compliant PASS |
| Water Vapor Transmission rate | ASTM E96/E96M-24A | Compliant | Compliant PASS |
| Barrier Performance (Liquid) | ANSI/AAMI PB70:2012; ASTM F1671/F1671M | Level 4 compliant | Compliant Level 4 PASS |
| Sterilization Assurance Level (SAL) | Not explicitly detailed by test method but stated as requirement | 10⁻⁶ | 10⁻⁶ |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (number of garments or material samples) used for each individual non-clinical test. The testing is reported as "tests were conducted and completed," indicating standard laboratory evaluations.
- Data Provenance: Not applicable in the context of clinical data. The tests are material and performance tests conducted in a laboratory setting. No geographical origin of "data" in the sense of patient data is mentioned, as this is a physical product. The manufacturer is THI Total Healthcare Innovation GmbH, based in Austria. The predicate device manufacturer is Zimmer Surgical, Inc.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This device is surgical apparel, and its "performance" is assessed through standardized physical and biological material testing, not through expert human interpretation of data like images or clinical outcomes. There is no "ground truth" in the diagnostic AI sense.
4. Adjudication Method for the Test Set
- Not applicable. As described above, there is no expert adjudication process for this type of device. Performance is determined by meeting pre-defined regulatory standards and test method specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study is a type of clinical study used to evaluate the performance of diagnostic devices (often imaging-based AI) by comparing the accuracy of multiple human readers with and without AI assistance across multiple cases. This does not apply to a surgical apparel device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
- Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
- Not applicable in the context of AI/ML. The "ground truth" for this device's performance is derived from established international and national standards (e.g., ISO, ASTM, ANSI/AAMI, CFR), which define objective physical and chemical properties and test methodologies. Meeting these standards serves as the "truth" for device functionality.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This is not an AI/ML device and does not have a training set or associated ground truth.
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(222 days)
Trade/Device Name:** Dream Medi Sterile Surgical Gown (SurgicalGownUL)
Regulation Number: 21 CFR 878.4040
XXL
3.0 Classification
Production code: FYA - Gown, Surgical
| Regulation number: 21CFR 878.4040 |
|---|
| Regulatory Classification |
| Regulation Number |
| 21 CFR 878.4040 |
| Product Code |
| Device Name |
The Dream Medi Sterile Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter.
In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile.
Dream Medi Surgical Gowns are made from SMS material. They are full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. They provide AAMI Level-3 protection.
The Level 3 Gowns have five different sizes: Small (S), Medium (M), Large (L), Extra Large (XL), Extra Extra Large (XXL).
SMS is a multi-ply material consisting of layers of spunbond and meltblown polypropylene.
The body is made from 44g Blue SMS and the sleeve is made from 54g Blue SMS. Sleeve opening is made from pure polyester. The collar closure is made from dacron. All gowns are sterilized with ethylene oxide.
This document, a 510(k) Clearance Letter, describes the regulatory approval of a surgical gown (Dream Medi Sterile Surgical Gown), not a medical device that relies on complex algorithms, image analysis, or AI. Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-driven device (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable to this document.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance of the surgical gown against established standards for protective apparel, as detailed in Section 8.0 "Summary of Non-Clinical Testing."
Here's a breakdown of the relevant information from the provided document, addressing the prompt as best as possible given the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
| Purpose | Test | Acceptance Criteria (from AAMI Level 3) | Reported Device Performance (Results) |
|---|---|---|---|
| Impact Penetration | AATCC 42 | Level 3, ≤1.0 g | Pass |
| Hydrostatic Resistance | AATCC 127 | Level 3, ≥50 cm | Pass |
| Tensile strength | ASTM D5034 | ≥30 N (≥ 7 lbf) | Pass |
| Tear resistance | ASTM D5587 | ≥10 N (≥ 2.3 lbf) | Pass |
| Seam strength | ASTM D1683 | ≥30 N (≥ 7 lbf) | Pass |
| Lint and Other particles generation in the dry state | ISO 9073-10 | Log 10 < 4 | Pass |
| Flammability testing | 16 CFR Part 1610 | Class 1 | Pass |
| Biocompatibility cytotoxicity | ISO 10993-5 | Non-cytotoxic | Pass |
| Biocompatibility irritation | ISO 10993-23 | Non-irritant | Pass |
| Biocompatibility Sensitization | ISO 10993-10 | Non-sensitizing | Pass |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify the exact sample size for each non-clinical test. However, these tests are typically performed on a statistically representative number of units according to the respective ASTM, AAMI, and ISO standards (e.g., a certain number of specimens cut from gowns for tensile strength, tear resistance, etc.).
- Data Provenance: The tests were performed to confirm the device met design specifications and acceptance criteria. The document states the manufacturer is Dae Myung Chemical Co., Ltd. in Vietnam. The testing itself is non-clinical, meaning it's laboratory-based performance testing rather than patient data. It is inherently "prospective" in the sense that the gowns were produced and then tested to confirm properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For a surgical gown, "ground truth" is established by the standardized test methods themselves (e.g., AATCC 42 for impact penetration, ISO 10993-5 for cytotoxicity). These are objective measurements following established protocols, not subjective interpretations by human experts in the way that ground truth for medical image analysis would be.
4. Adjudication method for the test set
- Not Applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in human expert interpretations (e.g., in radiology studies). For physical product testing against objective criteria, there is no such adjudication method. Results are either within the specified limits ("Pass") or not.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. This type of study involves human readers (e.g., radiologists) interpreting cases with and without AI assistance to measure improvement in diagnostic accuracy or efficiency. It is entirely irrelevant for a sterile surgical gown.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This concept applies to AI algorithms. A surgical gown has no algorithm.
7. The type of ground truth used
- Standardized Test Methods and Biocompatibility Assessment: The "ground truth" here is adherence to the performance requirements specified in recognized industry standards (e.g., AAMI PB70, ASTM, ISO, 16 CFR Part 1610) for fluid barrier protection, physical strength, flammability, and biocompatibility. These are objective, measurable properties.
8. The sample size for the training set
- Not Applicable. There is no "training set" for a surgical gown. The device is manufactured, and select samples are tested for quality control and regulatory submission.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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(159 days)
Trade/Device Name: Medline Level 4 Surgical Gown with Breathable Sleeves Regulation Number: 21 CFR 878.4040
Classification Panel: | General & Plastic Surgery |
| Regulation Number: | 21 CFR 878.4040
|
| Regulation Number | 21 CFR 878.4040
| 21 CFR 878.4040
The Medline Level 4 Surgical Gown with Breathable Sleeves is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Medline Level 4 Surgical Gown with Breathable Sleeves meets the Level 4 requirements of ANSI/AAMIPB70:2022 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
The Medline Level 4 Surgical Gown with Breathable Sleeves is also sold in a non-sterile version to repackagers/kitting entities, to be sterilized using the validated ethylene oxide sterilization method according to ISO 11135-1 in its final finished form, as a kit component.
The Medline Level 4 Surgical Gown with Breathable Sleeves is a single-use, sterile, disposable medical device that is provided in a variety of sizes (Large, X-Large, 3X-Large, 3X-Large and X-Long (only Sirus)) and styles (Sirus, Aurora and Eclipse). The Medline Level 4 Surgical Gown with Breathable Sleeves is constructed from nonwoven SMS (spunbond, meltblown, spunbond), a poly-fabric reinforcement on the chest front panel, and a breathable film (Polyester ether and polyester) for the sleeves. Each gown is designed with a hook and loop closure at the neck, ties at the waist, knitted cuffs at the end of the sleeves as well as a transfer tab for ease in donning. The Medline Level 4 Surgical Gown with Breathable Sleeves has been tested according to ANSI/AAMI PB70:2022 and meets AAMI Level 4 barrier level protection for a surgical gown.
This document describes the performance testing for the Medline Level 4 Surgical Gown with Breathable Sleeves (K242844), a surgical apparel device. The information provided is based on non-clinical testing only, as no clinical testing was performed for this 510(k) submission.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Standard | Standard Title | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ISO 10993-5 Cytotoxicity | ISO MEM Elution Using L-929 Mouse Fibroblast Cells | Non-cytotoxic | Pass - Non-cytotoxic |
| ISO 10993-23 Irritation | ISO Intracutaneous Irritation Test | Non-irritating | Pass - Non-irritating |
| ISO 10993-10 Sensitization | ISO Guinea Pig Maximization Sensitization Test | Non-sensitizing | Pass - Non-sensitizing |
| ASTM F1671 | Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens | 4.0 AQL | Pass |
| AATCC 42 | Water Resistance: Impact Penetration Test | ≤4.5 g | Pass |
| AATCC 127 | Water Resistance: Hydrostatic Pressure Test | ≥50 cmH20 | Pass |
| ASTM D5034-09 (2013) | Breaking Strength and Elongation of Textile Fabrics (Grab Test) | ≥20 N | Pass |
| ASTM D5587-15 | Tearing Strength of Fabrics by Trapezoid Procedure | ≥20 N | Pass |
| ASTM D1683 | Standard Method for Failure in Sewn Seams of Woven Apparel Fabrics | ≥20 N | Pass |
| 16 CFR 1610 | Flammability of Clothing Textiles | Meets Class 1 Requirements | Pass |
| ASTM E96 | Water Vapor Transmission of Materials | Reinforced Outside Material >800 g/m²/24 hrs | Pass |
| Sleeve Material >1200 g/m²/24 hrs | Pass | ||
| ANSI/AAMI PB70:2022 | Liquid Barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. | Meets ANSI/AAMI PB 70:2012 Level 3 and Level 4 Liquid Barrier requirements | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical tests conducted to verify design specifications. For each test listed in the table, the "Results" column indicates a "Pass," meaning the acceptance criteria were met.
- Sample Size: The specific sample sizes for each non-clinical test (e.g., number of fabric specimens tested for ASTM F1671) are not detailed in this summary. The 510(k) summary typically provides a high-level overview, and the detailed test reports (which FDA reviews) would contain this information.
- Data Provenance: The tests are generally performed by accredited testing laboratories or the manufacturer's own qualified labs. The document does not specify the country of origin of the data. Given it's an FDA submission, the tests would typically adhere to recognized international standards like ISO and ASTM. These are prospective tests performed specifically to support the regulatory submission of this new device.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. For this type of medical device (surgical gowns), "ground truth" is established through adherence to standardized, objective performance tests (e.g., measuring water resistance, breaking strength, biocompatibility). These are not studies that rely on expert interpretation of images or clinical outcomes to establish ground truth in the way an AI diagnostic device would.
4. Adjudication Method for the Test Set:
- None. Adjudication methods (like 2+1, 3+1) are relevant for studies involving human interpretation or clinical endpoints, often in the context of diagnostic accuracy or clinical trials. As this is a non-clinical performance evaluation against objective standards, no adjudication method is used. The results are quantitative measurements interpreted against pre-defined thresholds.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (especially those involving image interpretation by human readers) to assess how an AI algorithm impacts reader performance. The Medline Level 4 Surgical Gown is a protective apparel, not a diagnostic device, and its performance is evaluated through physical and material property tests, not human reader studies.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This question typically pertains to AI/ML software as a medical device (SaMD). The Medline Level 4 Surgical Gown is a physical medical device. Its performance is inherent in its material properties and manufacturing, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is established by objective, quantitative measurements against published national and international standards. This includes:
- Biocompatibility Standards: ISO 10993 series (Cytotoxicity, Irritation, Sensitization).
- Barrier Performance Standards: ASTM F1671 (blood-borne pathogens), AATCC 42 (impact penetration), AATCC 127 (hydrostatic pressure), and ANSI/AAMI PB70:2022 (overall liquid barrier performance classification).
- Material Strength Standards: ASTM D5034 (breaking strength), ASTM D5587 (tearing strength), ASTM D1683 (sewn seam failure).
- Other Performance Standards: 16 CFR 1610 (flammability), ASTM E96 (water vapor transmission/breathability).
The "ground truth" is therefore the measured physical and chemical properties of the gown, compared against the predefined acceptance criteria of these standard test methods.
8. The Sample Size for the Training Set:
- Not Applicable. The concept of a "training set" is relevant for machine learning algorithms. This device is a manufactured product, not an AI algorithm. Its design and manufacturing process would involve material selection and engineering, not machine learning training.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.
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(129 days)
Texas 76205
Re: K242689
Trade/Device Name: AAMI Level 4 Protective Gown Regulation Number: 21 CFR 878.4040
The AAMI Level 4 Protective 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 AAMI Level 4 Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012 - Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities; but has an open back which is non-protective.
The AAMI Level 4 Protective Gown is a single use, disposable medical device and is provided non-sterile.
The AAMI Level 4 Protective Gown is a single use, disposable medical device and is provided non-sterile. It has an open back which is non-protective.
This document is a 510(k) clearance letter for an AAMI Level 4 Protective Gown. It is not a study report for a diagnostic device or an AI/software-as-a-medical-device (SaMD) product. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies is not applicable to this document.
The document states that the device "meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012 - Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities". This indicates the performance standard the device is intended to meet, but it doesn't provide the detailed acceptance criteria or a study write-up in the format requested for a software device.
In summary, the provided text does not contain the information necessary to answer the specific questions about acceptance criteria, study design, and performance metrics as it pertains to a diagnostic or AI device. It is a regulatory clearance for a physical medical device (a protective gown).
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(82 days)
Re: K242502
Trade/Device Name: Aurelia Surgical Mask ASTM Level-3 (2130) Regulation Number: 21 CFR 878.4040
General Hospital
- Product Code: FXX
- Submission Type: Traditional 510(k)
- Regulation Number: 21 CFR §878.4040
| 21 CFR 878.4040
| 21 CFR 878.4040
Aurelia Surgical Masks ASTM Level-3 (2130) is intended for use to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device and provided non-sterile
The Aurelia Surgical Masks ASTM Level 3 are constructed with three layers of nonwoven polypropylene. The direct body contact materials include polypropylene, polyurethane, and nylon. The indirect body contacting materials include polypropylene and aluminum wire coated with melt-blown polypropylene embedded within the three layers.
The provided text is a 510(k) summary for the Aurelia Surgical Mask ASTM Level-3 (2130). It details the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device, rather than a study proving a device meets AI/ML acceptance criteria.
Therefore, many of the requested data points (like sample size for test/training sets in an AI/ML context, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for training) are not applicable to this document. This document describes the testing of a physical medical device (a surgical mask) against established performance standards for such devices.
Here's a breakdown based on the provided text, focusing on the relevant information:
Acceptance Criteria and Device Performance for Aurelia Surgical Mask ASTM Level-3 (2130)
This section describes the performance testing of a physical product (surgical mask) against established standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM F2101-19 | Bacterial Filtration Efficiency | ≥ 98% | 99% (Pass) |
| ASTM F2299/F2299M-03(2017) | Sub-micron Particulate Filtration Efficiency | ≥ 98% | 99% (Pass) |
| EN 14683:2019, Annex C | Differential Pressure (Breathability) | <6 H2O/cm² | 5.5 H2O/cm² (Pass) |
| ASTM F1862/F1862M-17 | Resistance to penetration by synthetic blood | 160 mmHg | 160 mmHg (Pass) |
| 16 CFR Part 1610 | Flame Spread | Class 1 | Class 1 (Pass) |
| ISO 10993-5 | Cytotoxicity | Non-toxic | Non-cytotoxic (Pass) |
| ISO 10993-10 | Irritation | Non-irritating | Not an irritant (Pass) |
| ISO 10993-10 | Sensitization | Non-sensitizing | Not a sensitizer (Pass) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of masks) used for each individual test. It refers to "non-clinical tests" conducted to verify design specifications. The data provenance is implied to be from laboratory testing related to the device manufacturer (Supermax Healthcare Canada), rather than patient data. The tests are "non-clinical" and therefore do not involve retrospective or prospective human subject data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This is not an AI/ML diagnostic device requiring expert consensus for ground truth on medical images or conditions. The "ground truth" here refers to the physical properties and performance metrics of the surgical mask, established through standardized laboratory testing methods (e.g., measuring filtration efficiency, pressure differential).
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human readers or interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML medical device.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The ground truth is based on established objective performance standards and test methods (e.g., ASTM F2101-19 for Bacterial Filtration Efficiency, ISO 10993 for biocompatibility). These standards define what constitutes a "pass" or "fail" for the specified performance characteristics of a medical face mask.
8. Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is involved for this type of device.
In summary, this document is a regulatory submission for a physical medical device (surgical mask), providing evidence of its performance against established industry standards. It does not pertain to the development or validation of an AI/ML diagnostic or therapeutic device.
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(198 days)
China
Re: K240916
Trade/Device Name: Surgical Face Mask (Tie on/ Ear loops) Regulation Number: 21 CFR 878.4040
Tie-on (17.5cm×9.5cm) |
3.0 Classification
Production code: FXX Regulation number: 21CFR 878.4040
| 21 CFR 878.4040
| 21 CFR 878.4040
Surgical Face Mask 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 use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non sterile.
The Surgical face mask is single use, three-layer, flat-pleated style with ear loops/ties and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the straps are made of nonwoven fabrics, the middle layer is made of melt blown fabrics.
The model of proposed device, tie-on, is held in place over the user's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene.
The model of proposed device, ear loops, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.
The ties/ear loops are not made with natural rubber latex. The nose piece on the layers of face mask is to allow the user to fit the face mask around their nose, which is made of Polypropylene with iron core. The Surgical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
This document is a 510(k) summary for a Surgical Face Mask. It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria (ASTM F2100-23 Level 3) | Reported Performance |
|---|---|---|
| Performance Testing | ||
| Bacterial filtration efficiency (BFE) (%) | ≥98 | 99.7%-99.9% (Pass) |
| Differential pressure (mmH2O/cm²) | <6.0 mmH2O/cm² | 3.2-3.7 mmH2O/cm² (Pass) |
| Sub-micron particulate filtration efficiency at 0.1 micron, % (PFE) | ≥85 | 97.16-99.52% (Pass) |
| Resistance to penetration by synthetic blood, Minimum pressure | 29 of 32 test articles passed at 160mmHg | 32 of 32 test articles Pass (at 160mmHg, implied) |
| Flame spread | Class 1 | 32 of 32 test articles Pass (Class 1, implied) |
| Biocompatibility Testing | ||
| Cytotoxicity (ISO 10993-5) | Viability < 70%, it has a cytotoxic potential. (Acceptance if no cytotoxic potential) | Tie on: 91.0%; Ear loops: 70.5% (No potential toxicity) |
| Irritation (ISO 10993-23) | Primary Irritation-Index ≤ 2.0 (Response category Negligible) | Primary irritation indexes of both polar and non-polar test groups were 0. (No skin irritation) |
| Sensitization (ISO 10993-10) | Provided grades less than 1, otherwise sensitization. (Acceptance if no sensitization) | Skin sensitization rates of both polar and non-polar extract groups were 0%. (No sensitization) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual performance test (BFE, differential pressure, PFE). However, for Resistance to penetration by synthetic blood and Flame spread, it states that 32 test articles were used.
The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. Given this is a 510(k) submission for a Chinese manufacturer (Xiantao Daoqi Plastic Co., Ltd.) and tests are cited against international (ISO) and US (ASTM) standards, the testing was likely conducted in laboratories, possibly in China or other accredited facilities. The nature of these tests (bench testing) implies they are prospective assessments of product samples.
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 to this type of submission. The ground truth for these medical device tests (surgical face mask performance and biocompatibility) is established by adherence to recognized international and national standards (ASTM, ISO). These standards define specific methodologies and acceptance criteria. No human experts are involved in establishing "ground truth" in the way they would for a diagnostic AI study. The "experts" are the technicians performing the standardized tests and interpreting the results against the defined criteria.
4. Adjudication method for the test set
This information is not applicable. The tests are objective measurements against predefined criteria in recognized standards. There is no adjudication process involving multiple human observers or adjudicators for these types of physical and chemical tests.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI-powered clinical decision support systems, not for a physical device like a surgical face mask.
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 AI/algorithm-based device. The device is a physical surgical face mask.
7. The type of ground truth used
The "ground truth" for this device is established by objective measurements and assessments against recognized performance and biocompatibility standards (ASTM F2100-23, ASTM F2101-23, ASTM F1862/F1862M-17, ISO 10993-5, ISO 10993-23, ISO 10993-10). These standards define the acceptable range of physical properties and biological responses for surgical masks.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI or machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth for a training set.
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(163 days)
Trade/Device Name: Stryker Steri-Shield 8 Surgical Hoods and Togas Regulation Number: 21 CFR 878.4040
FYA- Gown, SurgicalFXY- Hood, Surgical |
| Classification Regulation | CFR 878.4040
Brandingname, lineextension |
| ProductClassification/Regulation | Class II21 CFR 878.4040
Surgical Apparel | Class II21 CFR 878.4040Surgical Apparel
The Stryker Steri-Shield 8 disposables, including all hood and toga models, are components of the Stryker Steri-Shield 8 Personal Protection System and are intended to protect the patient, healthcare personnel, and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganism and particulate material. The Stryker Steri-Shield 8 disposables are sterile, disposable, single-use only devices.
The Stryker Steri-Shield 8 Surgical Protective Equipment consist of Stryker Steri-Shield 8 Surgical Hoods and Steri-Shield 8 Surgical Togas.
The Stryker Steri-Shield 8 Surgical Hood is a single piece device that covers the user's head, neck, and shoulder region and is intended to be worn with commercially available sterile surgical gowns. The Steri-Shield 8 Hoods are available with Standard (NPA), Peel Away (PA) and Anti-Reflective (AR) face shield options.
The Stryker Steri-Shield 8 Surgical Togas are a single piece device that covers the user's head, neck, arms, torso, and upper legs region. The Stryker Steri-Shield 8 Surgical Togas is offered in three configurations: Steri-Shield 8 Pullover Togas, Steri-Shield 8 Zippered Togas, and Steri-Shield 8 Tie Back Togas.
The Stryker Steri-Shield 8 Surgical Hoods and Togas is a medical device intended to protect the patient, healthcare personnel, and operating room personnel against contamination, exposure to infectious bodily fluids, and the transfer of microorganisms and particulate material. The device is sterile, disposable, and for single-use only.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| Barrier Performance (Gown - Critical Zone Level 4 Protection) | |
| ASTM F1671 testing - BVB & Sleeve Seam | Passes requirements for PB70 Level 4 protection |
| Barrier Performance (Gown - Non-Critical Zone) | |
| AATCC Test Method 42 Per AAMI/ANSI PB70 | Passes AATCC Test Method 42 (< 4.5g) |
| Barrier Performance (Hood - Exempt) | |
| All materials and seams | Non-protective (meets acceptance criteria as intended) |
| Physical Performance | |
| Flammability per 16 CFR Part 1610 (Class 1) | Class 1 requirements met |
| Water Spray Impact per AATCC 42 (Water Penetration ≤ 4.5 g) | Water Penetration ≤ 4.5 g |
| Synthetic Blood per ASTM F1862 (No visible penetration) | No visible penetration |
| Fabric Viral Penetration per ASTM F1671 (no detectable (< 1 PFU/mL)) | No detectable (< 1 PFU/mL) |
| Particulate Filtration Efficiency per ASTM F2299 (≥ 95%) | ≥ 95% |
| Bacterial Filtration Efficiency per ASTM F2101 (≥ 95%) | ≥ 95% |
| Particle Release per ISO 9073-10 (Lint Count ≤ 4.0 (Log10, Upper Quartile)) | Lint Count ≤ 4.0 (Log10, Upper Quartile) |
| Air Permeability per ASTM D737 | Better or equivalent to predicate product |
| Tear Strength per ASTM D5587 (≥ 2.3 lbf) | ≥ 2.3 lbf |
| Tensile Strength per ASTM D5034 (≥ 7.0 lbf) | ≥ 7.0 lbf |
| Seam Strength per ASTM D1683 (≥ 7.0 lbf) | ≥ 7.0 lbf (Predicate was ≥ 6.0 lbf, so this is an improvement or meets threshold) |
| Evaporative Resistance per ASTM F1868 | Better or equivalent to predicate product |
| Light Transmittance and Haze per ASTM D1003 | Better or equivalent to predicate product |
| Perforation Tear Strength Testing (Stryker Internal Testing) (0.15 lbf < Tear Force ≤ 1.5 lbf) | 0.15 lbf < Tear Force ≤ 1.5 lbf |
| Biocompatibility | |
| Human Factors and Usability | Product is found to be safe and effective for the intended users, uses and use environment |
| Noise and Speech Interference Levels | Better or equivalent to predicate product |
| Carbon Dioxide (CO2) Testing (Inhale CO2 ≤ 5000ppm per OSHA Exposure Limits) | Inhale CO2 ≤ 5000ppm |
| ISO 10993-1, -5, -10, -23, -11 (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity) | Cytotoxicity – MEM Grade ≤ 2; Sensitization – Sensitization response ≤ 0; Irritation – Intracutaneous Reactivity ≤ 1.0; Acute Systemic Toxicity – No signs of toxicity, no weight loss in excess of 10% (Note: Cytotoxic response in one test article was mitigated by in vivo testing and chemical characterization) |
| ISO 10993-17 (Toxicological risk assessment) | Assessment performed |
| ISO 10993-18 (Chemical characterization of medical device materials) | Characterization performed |
| Sterilization | |
| Finished (Terminal) Product Sterilization Method (SAL 10-6 Terminally sterilized via Ethylene Oxide (EO)) | SAL 10-6 Terminally sterilized via Ethylene Oxide (EO) in accordance with ISO 11135, Half cycle overkill method |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes for each test mentioned (e.g., number of hoods or togas tested for flammability, water resistance, etc.). The tests are described as "Performance Data (Non-Clinical Tests)," indicating that they were conducted in a laboratory setting on product samples. The data provenance is not specified beyond being generated by Stryker Instruments as part of their 510(k) submission. Given the nature of performance testing for surgical apparel standards, these tests are typically conducted on representative samples of the manufactured devices.
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. The acceptance criteria for the Stryker Steri-Shield 8 Surgical Hoods and Togas are based on recognized industry standards (e.g., ASTM, AATCC, ISO, 16 CFR) for material properties and device performance, not on expert interpretations of outcomes.
4. Adjudication method for the test set:
This information is not applicable as the acceptance criteria are based on objective, quantifiable measurements from recognized standards, not subjective assessments 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:
This information is not applicable. The device is a surgical hood and toga, not an AI-assisted diagnostic or imaging device that would involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
This information is not applicable. The device is a physical product (surgical apparel), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device is based on established, quantifiable metrics and pass/fail criteria defined by recognized national and international standards for medical textiles, barrier materials, and biological safety. Examples include:
- Physical properties (e.g., tear strength, tensile strength, air permeability).
- Barrier effectiveness against fluids, synthetic blood, viruses, and particulates.
- Biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity).
- Flammability.
- CO2 levels within the hood.
These "ground truths" are objective measurements against defined thresholds in the standards.
8. The sample size for the training set:
This is not applicable as the device is a physical product and not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable as the device is a physical product and not an AI/ML algorithm.
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