Search Results
Found 146 results
510(k) Data Aggregation
(222 days)
Dream Medi Sterile Surgical Gown (SurgicalGownUL)
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 |
Ask a specific question about this device
(159 days)
Medline Level 4 Surgical Gown with Breathable Sleeves
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.
Ask a specific question about this device
(133 days)
ProPel SG3 Surgical Gown
ProPel SG3TM Surgical Gown is 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.
The reusable Propel Surgical Gown is provided non-sterile and must be sterilized before use. Stertlization parameters are as follows:
Prevacuum Steam Sterilization: 132°C/270°F (temperature)/ 4 minutes (exposure time)/15 minute (dry time)
The ProPel SG3TM Surgical Gown is a reusable, woven surgical gown that provides an ANSI /AAMI PB70:2022 Level 3 Liquid Barrier Performance Barrier using 100% polyester with silicone coating in the critical zone. The critical zone inner ply and back of the surgical gown is made of polyester with electrostatic dissipative yarn (graphene) and silicone coating. The gown has polyester mesh and vented cape on the back panels of the gown for ventilation. The ProPel SG3TM Surgical Gown may undergo up to 60 reprocessing cycles.
The ProPel SG3™ Surgical Gown is available in small, medium, large, extra large (XL), 2XL and 3XL. The device will be sold as a non-sterile surgical gown that is to be laundered, sterilized and processed by the healthcare facility prior to first use and after each subsequent use.
The provided text describes the non-clinical testing performed on the ProPel SG3™ Surgical Gown to demonstrate its equivalence to a predicate device. It is important to note that this is a 510(k) submission, which aims to show substantial equivalence, not necessarily a study proving clinical effectiveness in the same way a new drug or high-risk device might.
Here's the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Test Method/Applicable Standard(s) | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Tensile Strength | ASTM D5034/ASTM F2407-20 | ≥ 30 N (≥ 7 lbf) | PASS |
| Tear Strength | ASTM D5587/ASTM F2407-20 | ≥ 10 N (≥ 2.3 lbf) | PASS |
| Seam Strength | ASTM D1683/ASTM F2407-20 | ≥ 30 N (≥ 7 lbf) | PASS |
| Hydrostatic Resistance | AATCC Method 127/ANSI/AAMI PB70 | ≥ 50 cm per AAMI PB70 for Level 3 | PASS |
| Impact Penetration | ATCC Method 42/ANSI/AAMI PB70 | ≤ 1.0 g per AAMI PB70 for Level 3 | PASS |
| Lint Generation | ISO 9073-10 | --- (No explicit quantitative acceptance criteria listed; qualitative comparison) | Coefficient for linting is 3 for both predicate and subject device |
| Flammability | 16 CFR 1610 | Pass Class I Flammability | PASS (Class I) |
| Snap Strength | ASTM D4846-96 | Fasteners provide peel strength of ≤ 1.5 lbf (easy doff) and shear force ≥ 4.5 lbf (secure) | PASS |
| Evaporative Resistance | ASTM F1868-17 | Evaporative resistance of critical zone (average of 3 specimens) ≤ 350 Pa m²/W; evaporative resistance of the back mesh (2-ply average of 3 specimens) ≤ 5 Pa m²/W | PASS |
| Critical Zone Fabric Weight Testing | ASTM D3776/D3776M-20 | --- (No explicit acceptance criteria; result is a specific measurement) | Gown critical zone fabric construction weighs less than 7.83 OSY |
| Use Life Tracking | --- | QCM label is legible and RFID Chip can be read at the beginning and end of use life (after 60 reuses) | PASS |
| Cytotoxicity | ISO 10993-5 | Less than/equal to grade 2 (mild reactivity) | PASS |
| Sensitization | ISO 10993-10 | No evidence of causing delayed dermal contact sensitization | PASS |
| Irritation | ISO 10993-23 | No erythema, no edema | PASS |
| Pyrogenicity | USP /ISO 10993-11 | Temperature rise within acceptable limits | PASS |
| Acute Systemic Toxicity | ISO 10993-11 | No mortality or evidence of systemic toxicity | PASS |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to non-clinical testing of the physical and biological properties of the surgical gown material and design. For each test, "specimens" or "gowns" would be used as samples. However, the exact sample size (N) for each specific test (e.g., number of gowns for tensile strength, number of fabric pieces for hydrostatic resistance, number of biological samples for cytotoxicity) is not explicitly stated in this summary. For Evaporative Resistance, it mentions "average of 3 specimens".
The data provenance (country of origin, retrospective/prospective) is not provided in this document. Given that it's non-clinical testing of a manufactured product, it is likely that the testing was performed in a controlled laboratory environment, but the location is not specified.
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 is a non-clinical, laboratory-based study for a surgical gown. It does not involve medical imaging, diagnosis, or clinical decision-making by human experts where "ground truth" would be established by referring radiologists or other clinicians. The "ground truth" or "acceptance criteria" for these tests are based on established national and international standards (like ANSI/AAMI, ASTM, ISO, AATCC, 16 CFR, USP), which reflect a consensus of scientific and technical experts in materials science, biology, and medical device regulations. Therefore, this question is not applicable in the context of this device and study type.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since this is non-clinical laboratory testing against predefined, objective standards, an adjudication method like 2+1 or 3+1 (typically used for resolving discrepancies in expert interpretations) is not applicable. The 'adjudication' is inherent in the test method itself, where results are measured objectively and compared against numerical acceptance criteria in a pass/fail manner.
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
A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study is performed for diagnostic devices, particularly those involving human interpretation (e.g., radiologists reading images). This device is a surgical gown, which is a physical barrier protection device. Therefore, an MRMC study and effects related to human reader improvement with AI assistance are not applicable. The document explicitly states "SUMMARY OF CLINICAL TESTING Not Applicable", further confirming no clinical effectiveness study (which would include MRMC) was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of an AI algorithm without human involvement. Since the device is a surgical gown and not an AI-powered diagnostic or assistive tool, this question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance claims of the surgical gown is based on established national and international standards and test methods. These standards define measurable physical and biological properties (e.g., tensile strength, tear strength, barrier performance, biocompatibility) and their respective acceptance criteria.
8. The sample size for the training set
This question typically applies to machine learning or AI models. Since this is non-clinical testing of a physical medical device (surgical gown), there is no "training set" in the context of an AI algorithm. The gown samples tested were used to demonstrate compliance with the specified performance standards.
9. How the ground truth for the training set was established
As there is no "training set" for an AI algorithm in this context, this question is not applicable. The "ground truth" for evaluating the gown's performance was established by recognized industry standards and test methodologies.
Ask a specific question about this device
(270 days)
GCI Surgical Gown
GCI surgical gown is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 2 barrier classification.
GCI Surgical Gowns are intended to be used during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate materials. The gown is available in multiple sizes. They are provided non- sterile and intended to be sterilized prior to use. They are reusable up to 75 uses. Per ANSI/AAMI PB70 Liquid barrier performance and classification of protective apparel intended for use in health care facilities, the proposed devices meet the requirements for 2, as indicated by their labeling.
This document describes the non-clinical performance testing of the GCI Surgical Gown to demonstrate its substantial equivalence to a legally marketed predicate device (K211422).
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Flammability | Meets Class 1 Requirements | Meets Class 1 Requirements |
| Water Resistance: Hydrostatic Pressure | Water Resistant ≥20 cm | Water Resistant ≥20 cm |
| Water Resistance: Impact Penetration | ≤1.0 g water | ≤1.0 g water |
| Breaking / Bursting Strength | ≥20 N | >20 N |
| Tearing Strength | ≥20 N | >20 N |
| Seam Strength | ≥20 N | >20 N |
| Linting | Log10 |
Ask a specific question about this device
(185 days)
Disposable Surgical Gown
Disposable 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 material. This surgical gown meets the requirements of AAMI Level 3/Level 4 barrier protection for a surgical gown per ANSU AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices; provided sterile.
Disposable Surgical Gown
This document is a 510(k) clearance letter for a Disposable Surgical Gown. It is a regulatory document addressing the substantial equivalence of the device to a predicate device, not a study report for a medical AI/ML device.
Therefore, the requested information about acceptance criteria, study details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details for an AI/ML device is not applicable to this document.
The document discusses:
- The device name: Disposable Surgical Gown
- Regulation Number: 21 CFR 878.4040
- Regulatory Class: Class II
- Product Code: FYA
- Indications for Use: "Disposable 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 material. This surgical gown meets the requirements of AAMI Level 3/Level 4 barrier protection for a surgical gown per ANSU AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices; provided sterile."
The acceptance criteria mentioned for the surgical gown are related to its physical performance as a barrier: "meets the requirements of AAMI Level 3/Level 4 barrier protection for a surgical gown per ANSU AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70)." However, this document does not provide a study detailing how these criteria were met or the specific results.
Ask a specific question about this device
(126 days)
Surgical Gown (40083)
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 material. This surgical gown meets the requrements of AAMI Level 3 barrier protection for a surgical gown per ANSI/A AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices, provided sterile.
The proposed device Surgical Gown is model 40083, its body, sleeve and belt are made of SSMMS non-woven material, and cuff is made of cotton. The proposed device is available in XS, S, M, L, XL, 2XL, 3XL sizes. This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012. The proposed devices are disposable medical devices and provided in sterile and blue color.
This document is a 510(k) Premarket Notification from the FDA regarding a Surgical Gown. It evaluates the device's substantial equivalence to a legally marketed predicate device. The information provided is primarily focused on the physical and barrier performance characteristics of the surgical gown, not an AI/Software as a Medical Device (SaMD) product.
Therefore, most of the requested information regarding AI/SaMD performance criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone algorithm performance," and "training set details," is not applicable to this submission.
However, I can extract the relevant information regarding the surgical gown's acceptance criteria and the studies proving it meets those criteria:
Device: Surgical Gown (Model 40083)
Intended Use: To be worn by operating room personnel during surgical procedures to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. It meets AAMI Level 3 barrier protection.
Acceptance Criteria and Reported Device Performance:
| Test Item | Test Standard | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Seam Strength | ASTM D1683M-17 | ≥30N (7lbf) per standard F2407-20 for Level 3 | PASS: 68.46 N (Average result from 30 samples) |
| Breaking Strength | ASTM D5034-09 (2017) | ≥30N (7lbf) per standard F2407-20 for Level 3 | PASS: MD: 120.61N, CD: 88.19N (Average result from 30 samples) |
| Tear Strength (N) | ASTM D5587-15 | ≥20N | PASS: MD: 60.03N, CD: 39.78N (Average result from 30 samples) |
| Lint and other generation in the dry state | ISO 9073-10:2003(E) | Log10(particle count) |
Ask a specific question about this device
(212 days)
Skypro, Surgical Gown 6021
"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: |
Ask a specific question about this device
(170 days)
Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series),
Disposable Surgical Gown (Level 4, MF2105 Series)
Disposable Surgical Gown (Level 3, MF2103 Series)/ Disposable Surgical Gown (Level 3, MF2104 Series)/ Disposable Surgical Gown (Level 4, MF2105 Series) is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is single use, disposable and supplied sterile.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, MF2103 Series and MF2104 Series met the requirements for Level 3 classification, MF2105 Series met the requirements of Level 4 classification.
Not Found
This document is a 510(k) premarket notification from the FDA, specifically concerning the substantial equivalence determination for Disposable Surgical Gowns. It clarifies that the device is found substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about an AI/ML-based medical device, its acceptance criteria, or the study that proves it meets those criteria. The device in question is a physical product (surgical gowns), and the assessment is based on physical barrier performance standards (ANSI/AAMI PB70:2012), not on AI/ML algorithm performance.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, including details like:
- A table of acceptance criteria and the reported device performance: Not applicable as the "performance" here refers to physical barrier properties, not algorithmic output.
- Sample sizes used for the test set and the data provenance: Not applicable. Testing for surgical gowns involves physical property tests (e.g., liquid barrier, particulate material transfer), not data sets.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical product like a surgical gown is established by standardized physical testing methods, not expert consensus on data.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is relevant for AI-assisted image interpretation, not physical products.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable in the context of AI/ML. The "ground truth" for the gowns is their adherence to ANSI/AAMI PB70:2012 standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document focuses on the regulatory clearance for a medical device (surgical gowns) based on their physical barrier performance against industry standards, not on an AI/ML algorithm's diagnostic or analytical performance.
Ask a specific question about this device
(89 days)
Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)
The 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. This is a single use, disposable device, provided sterile.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Surgical Gown and Reinforced Surgical Gown met the requirements for Level 3 classification.
The proposed device Surgical Gown its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The proposed device is available in S(110×130cm), M(120×140cm), L(130×150cm), XL(140×160cm), XXL(150×170cm), XXXL(155×180cm) sizes . This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.
The proposed device Reinforced Surgical Gown is its body, sleeve and belt are made of SMMS nonwoven material, and cuff is made of cotton. The reinforced and critical zone is front chest and sleeves. This zone is reinforced with PP/PE composite breathable film. The proposed device is available in S(110×130cm), M(120×140cm), L(130×150cm), XL(140×160cm), XXL(150×170cm), XXXL(155×180cm) sizes. This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.
The proposed devices are disposable medical devices and provided in sterile.
The provided FDA 510(k) summary for the Surgical Gown and Reinforced Surgical Gown details the device's technical specifications and non-clinical testing for substantial equivalence to a predicate device, rather than an AI/ML-driven medical device. Therefore, the information requested regarding acceptance criteria, study methodologies, and performance related to AI/ML device evaluation (such as sample sizes for test/training sets, expert consensus, MRMC studies, or ground truth establishment) is not applicable to this document.
The document focuses on the physical and barrier properties of surgical gowns. Here is a summary of the acceptance criteria and performance as presented in the non-clinical testing section:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Seam strength | ASTM D1683M-17 | ≥30N (7lbf) per standard F2407-20 for level 3 | PASS (59.21 N average from 30 samples) |
| Breaking strength | ASTM D5034-09 (2017) | ≥ 30N (7lbf) per standard F2407-20 for level 3 | PASS (MD: 144.87N, CD: 88.89N average from 30 samples) |
| Tear strength (N) | ASTM D5587-15 | ≥ 10N | PASS (MD: 69.61N, CD: 32.25N average from 30 samples) |
| Lint and other generation in dry state | ISO 9073-10:2003(E) | Log10(particle count) |
Ask a specific question about this device
(168 days)
Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
The Sterile Triplex Surgical Gown (S, M, L, XL, XXL, is a sterile single-use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
They have been tested and are classified as Level 4 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding a Sterile Triplex Surgical Gown. It clears the device for marketing due to its substantial equivalence to legally marketed predicate devices.
The information provided in the document is about the regulatory clearance for a physical medical device (surgical gown) based on its performance in barrier tests, not an AI/ML medical device. Therefore, the questions about acceptance criteria for an AI/ML model, test sets, ground truth establishment, expert adjudication, MRMC studies, and training sets are not applicable to this document.
The document states:
- Trade/Device Name: Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
- Regulation Number: 21 CFR 878.4040
- Regulation Name: Surgical Apparel
- Regulatory Class: Class II
- Product Code: FYA
- Indications for Use: To protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
- Performance Claim: "They have been tested and are classified as Level 4 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities."
Since the request is specifically about a study proving device performance using AI/ML-related metrics, and this document pertains to a physical sterile gown, I cannot extract the requested information.
Ask a specific question about this device
Page 1 of 15