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510(k) Data Aggregation
(64 days)
Cardinal Health 200, LLC
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Not Found
This document is a 510(k) clearance letter for Cardinal Health Nitrile Exam Gloves. While it confirms the device is substantially equivalent to legally marketed predicate devices, it does not contain information about acceptance criteria or a study design in the typical format of an AI/ML device submission.
This type of device (nitrile exam gloves) is a physical medical device, not a software device or an AI/ML product. The "acceptance criteria" and "study" described in the input prompt are typically associated with the evaluation of performance claims for AI/ML algorithms, which involve metrics like accuracy, sensitivity, specificity, and rigorous testing on curated datasets.
Here's what can be extracted and inferred from the provided text, acknowledging that it doesn't align with the detailed AI/ML study request:
1. A table of acceptance criteria and the reported device performance:
The closest information provided is the permeation resistance to chemotherapy drugs as tested per ASTM D6978. This acts as a performance standard for this specific "indication for use."
| Chemotherapy Drug and Concentration | Acceptance Criteria (Implicit) | Reported Device Performance (Minimum Breakthrough Detection Time in Minutes) |
|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | (Implied to be > 30.1 minutes for safe use, but warning issued) | 30.1 |
| Cisplatin (1.0 mg/ml) | (Implied to be > 240 minutes for safe use) | >240 |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | (Implied to be > 240 minutes for safe use) | >240 |
| Cytarabine (100 mg/ml) | (Implied to be > 240 minutes for safe use) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | (Implied to be > 240 minutes for safe use) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | (Implied to be > 240 minutes for safe use) | >240 |
| Etoposide (20.0 mg/ml) | (Implied to be > 240 minutes for safe use) | >240 |
| Fluorouracil (50.0 mg/ml) | (Implied to be > 240 minutes for safe use) | >240 |
| Ifosfamide (50.0 mg/ml) | (Implied to be > 240 minutes for safe use) | >240 |
| Methotrexate (25 mg/ml) | (Implied to be > 240 minutes for safe use) | >240 |
| Mitomycin C (0.5 mg/ml) | (Implied to be > 240 minutes for safe use) | >240 |
| Mitoxantrone (2.0 mg/ml) | (Implied to be > 240 minutes for safe use) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | (Implied to be > 240 minutes for safe use) | >240 |
| Thiotepa (10.0 mg/ml) | (Implied to be > 50.5 minutes for safe use, but warning issued) | 50.5 |
| Vincristine Sulfate (1.0 mg/ml) | (Implied to be > 240 minutes for safe use) | >240 |
Note: The "acceptance criteria" here are implied by the testing standard ASTM D6978 and the explicit warnings for drugs with low permeation times. For most drugs, " >240 minutes" appears to be the desired performance, and the device meets this for the majority. For Carmustine and Thiotepa, where performance is lower, specific warnings are issued.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The ASTM D6978 standard would dictate the number of gloves tested.
- Data Provenance: Not specified, but generally for such testing, it would be laboratory testing conducted according to the ASTM standard. It's not "country of origin of data" in the sense of patient data, nor is it retrospective or prospective as it's a materials performance test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a diagnostic device requiring expert interpretation of medical images or data. The "ground truth" here is the physical permeation time measured by laboratory equipment following the ASTM D6978 standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This refers to consensus building among experts for tasks like image labeling or diagnosis, which is not relevant for glove permeation testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. The device is a physical medical glove, not an AI/ML diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical medical glove, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth is the measured breakthrough detection time for each chemotherapy drug, obtained through standardized laboratory testing (ASTM D6978).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
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(122 days)
Cardinal Health 200, LLC
Cardinal Health™ SMARTGOWN™ Surgical Gown with ASSIST™ Instrument Pockets 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. The gowns meet the barrier protection requirements of AAMI Level 4 per ANSI/ AAMI PB70 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities. The Cardinal Health™ SMARTGOWN™ Surgical Gown with ASSIST™ Instrument Pockets is a single use, disposable medical device provided sterile and non-sterile. Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user
Not Found
This FDA 510(k) clearance letter pertains to a surgical gown, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not present in the provided text.
The document discusses the regulatory clearance of a physical medical device: Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets.
Here's what the document does provide regarding the device and its compliance:
- Regulation Number: 21 CFR 878.4040
- Regulation Name: Surgical Apparel
- Regulatory Class: Class II
- Product Code: FYA
- Intended Use: 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.
- Performance Standard: The gowns meet the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities. This reference to AAMI Level 4 and ANSI/AAMI PB70 is the primary "acceptance criterion" mentioned, indicating the device's barrier performance.
Since this is a traditional medical device, not an AI/ML product, the questions related to AI/ML specific criteria (sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable here.
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(229 days)
Cardinal Health 200, LLC
Monoject Magellan Insulin Safety Syringes are intended for delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.
The Monoject™ Magellan™ Insulin Safety Syringe consists of a piston syringe with a permanently attached needle, and safety shield designed to extend, fully cover, and permanently lock over the needle when activated by a fingertip or thumb to reduce the occurrence of accidental needle sticks. The device is provided sterile and is intended for single use only. An orange needle cap indicates for use with insulin. The barrel of the syringe is graduated for measuring a prescribed dose. The syringe is intended for use immediately after filling and is not intended to contain or store insulin for extended periods of time.
The provided text is a 510(k) summary for a medical device (Monoject Magellan Insulin Safety Syringe). It details the device's characteristics, intended use, and comparison to a predicate device to establish substantial equivalence.
However, this document does not contain any information about an AI/ML-driven device or its acceptance criteria and study results. The device described is a physical medical device (syringe), not a software or AI/ML product.
Therefore, I cannot fulfill the request to describe acceptance criteria and associated study results for an AI/ML device based on the provided text. The questions posed (e.g., sample size for test set, number of experts, MRMC study, standalone performance, training set data) are relevant to the evaluation of AI/ML models, but the provided document is not about such a device.
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(471 days)
Cardinal Health 200, LLC
Cardinal Health™ Protexis™ PI Blue with Neu-Thera™ Surgical Gloves are powder-free surgeon's gloves that are disposable devices made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
In addition, these gloves have been tested for resistance to permeation of various chemotherapy drugs per ASTM D6978, "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."
powder-free surgeon's gloves that are disposable devices made of synthetic rubber
The provided text describes the 510(k) clearance for "Cardinal Health™ Protexis™ PI Blue with Neu-Thera™ Surgical Gloves". This document primarily focuses on the regulatory clearance for a physical medical device (surgical gloves) and its resistance to chemotherapy drug permeation. It does NOT describe an AI/ML-driven medical device, an algorithm's performance, or any associated clinical study involving human readers or expert ground truth establishment for such an algorithm.
Therefore, I cannot fulfill your request for information related to acceptance criteria and studies for an AI device. The questions you've asked are specifically tailored for AI/ML device evaluations (e.g., sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance).
Based on the provided document, the "acceptance criteria" and "study" are related to the physical properties of the surgical gloves as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria and reported performance for these surgical gloves, as detailed in the "Indications for Use" section, relate to their resistance to permeation by various chemotherapy drugs. This is assessed by reporting the minimum breakthrough detection time.
| Chemotherapy Drug | Acceptance Criteria (Conceptual) | Reported Device Performance (min. breakthrough detection time in minutes, 0.01 µg/cm²/min) |
|---|---|---|
| Carmustine (3.3 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | 18.5 |
| Cisplatin (1 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| Cyclophosphamide (20 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| Doxorubicin HCl (2 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| Etoposide (20 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| 5-Fluorouracil (50 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| Methotrexate (25 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| Mitomycin C (0.5 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| Paclitaxel (6 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| Thiotepa (10 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | 24.4 |
| Vincristine Sulfate (1 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
Explanation of the Study:
The study proving the device meets its performance claims is referenced as testing "per ASTM D6978, 'Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.'" This is a standardized laboratory test protocol aimed at evaluating the barrier properties of medical gloves against hazardous drugs.
I cannot answer the following questions because the document pertains to a physical medical device (gloves) and not an AI/ML-driven device:
- 2. Sample sized used for the test set and the data provenance: Not applicable to a physical glove's chemical resistance test in the context of AI.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for gloves is defined by the chemical testing method.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for glove performance is established through standardized chemical permeation testing, not expert consensus or medical outcomes.
- 8. The sample size for the training set: Not applicable. This is a manufactured product, not an AI model.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document clearly indicates a regulatory submission for surgical gloves, with performance claims related to their chemical resistance. It does not contain any information about an AI/ML device or its associated clinical and technical studies related to AI model evaluation.
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(115 days)
Cardinal Health 200, LLC
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves have been tested for resistance to permeation of various chemotherapy drugs per ASTM D6978, "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."
Nitrile Blue Powder-Free Examination Gloves
This document is a 510(k) Premarket Notification from the FDA regarding "Nitrile Blue Powder-free Examination Gloves." It is a clearance letter, not a study report for an AI/ML medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and performance studies of a device related to AI, image analysis, or similar technologies.
The document only provides information about the chemical permeation resistance of the gloves to various chemotherapy drugs.
Thus, I cannot fulfill your request for the following reasons:
- No AI/ML Device: The device described (nitrile examination gloves) is a physical medical device, not a software or AI/ML-based device.
- No Performance Study Data of the Type Requested: The document details the results of ASTM D6978, which is a chemical permeation test, not a performance study involving test sets, expert readers, ground truth, or MRMC analysis for an AI algorithm.
- No Acceptance Criteria for AI/ML Performance: The "acceptance criteria" presented are minimum breakthrough times for chemotherapy drugs, not metrics like sensitivity, specificity, AUC, or other measures common for AI/ML diagnostic tools.
Therefore, I cannot extract the information asked for in points 1-9 of your prompt from the provided text.
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(121 days)
Cardinal Health 200, LLC
Cardinal Health™ SMARTGOWN™ Breathable Surgical Gown and Cardin™ SMARTGOWN™ AIR Breathable Surgical Gown are 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. The gowns meet the barrier protection requirements of AAMI Level 4 per AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities. The Cardinal Health™ SMARTGOWN™ Breathable Surgical Gown and Cardinal Health™ AIR Breathable Surgical Gown are single use, disposable medical devices provided sterile and non-sterile.
Cardinal Health™ SMARTGOWN™ Breathable Surgical Gown and Cardinal Health™ SMARTGOWN™ AIR Breathable Surgical Gown are single use, disposable medical devices provided sterile and non-sterile.
The provided text is a 510(k) premarket notification for surgical gowns, which are physical medical devices. This type of FDA submission focuses on demonstrating substantial equivalence to a predicate device through performance testing of the physical properties and barrier protection of the gowns.
Therefore, the concepts of acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training sets are not applicable in the context of this document. These concepts are relevant to the evaluation of AI/ML-driven software as a medical device (SaMD) or devices that incorporate such software, which rely on data analysis and interpretation.
The document describes the performance criteria for the surgical gowns, which are based on physical barrier protection standards.
Here's the relevant information from the document related to "acceptance criteria" and "device performance":
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meet the barrier protection requirements of AAMI Level 4 per AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities. | The gowns meet the barrier protection requirements of AAMI Level 4 per AAMI PB70:2012. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not detailed in the provided document. The 510(k) summary (which is typically a separate document) or the full submission would contain details about the specific tests performed (e.g., synthetic blood penetration, hydrostatic pressure, impact penetration) and the number of samples tested to demonstrate AAMI Level 4 compliance. This involves physical testing of the gowns, not analysis of medical image data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth for surgical gowns is established through standardized laboratory testing protocols, not by expert medical interpretation.
4. Adjudication Method
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is relevant for diagnostic or interpretive AI/ML devices.
6. Standalone Performance Study
Not applicable in the context of a physical surgical gown. The "standalone performance" of the gown refers to its ability to meet the AAMI Level 4 barrier standards independently, which is what the submission attests to.
7. Type of Ground Truth Used
The "ground truth" for surgical gowns is defined by the objective, quantifiable results of standardized physical tests according to AAMI PB70:2012. This involves tests for fluid resistance, microbial barrier properties, etc.
8. Sample Size for the Training Set
Not applicable. Surgical gowns are physical devices; there is no "training set" in the AI/ML sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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(109 days)
Cardinal Health 200, LLC
The Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Closed Back, are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling, and administration.
The closed back gowns are single use, disposable medical devices provided sterile and non-sterile. The non-sterile, closed back gowns are not intended for use in the operating room.
The Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Open Back, are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling, and administration.
The open back gowns are single use, disposable medical devices provided non-sterile. The open back gown is nonprotective in the back. The open back gowns are not intended for use in the operating room.
The Cardinal Health™ ChemoPlus™ Full Coverage Closed Back and Open Back Gowns are classified as Class II medical devices under Regulation 21 CFR 878.4040, General & Plastic Surgery Panel, FDA product code FYA, Surgical Gown.
The ChemoPlus™ Full Coverage Closed Back and Open Back Gowns are made of a laminate with adhesive taped seams. Both closed and open back gowns have a hook and loop closure at the back of the neck and a waist tie feature to secure the gown to the body of the user. The sleeves of the gown have knit cuffs sewn onto the end of the sleeve at the user's wrists to keep the sleeves in place on the wearer. The entire gown including the gown sleeves are made of the same material and utilize the same manufacturing processes.
The provided text is a 510(k) Summary for the Cardinal Health™ ChemoPlus™ Full Coverage Gowns, indicating that these are medical devices subject to FDA regulation. The document describes non-clinical performance testing for these gowns.
It's important to note that this document pertains to physical medical devices (gowns), not an AI/ML powered device or a software as a medical device (SaMD). Therefore, many of the typical acceptance criteria and study components relevant to AI/ML devices (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not applicable in this context.
The study described is a series of non-clinical, laboratory-based performance tests conducted on the gowns themselves, adhering to specific industry standards.
Here's the information from the document relevant to acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Standards Type | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Liquid Barrier | |||
| AATCC 42 | Spray Impact | Water Resistance | PASS |
| AATCC 127 | Hydrostatic Pressure | Water Resistance | PASS |
| ANSI/AAMI PB70:2012 AAMI Level 3 | Liquid Barrier Performance | Water Resistance (AAMI Level 3 requirements) | PASS |
| Chemical Permeation | |||
| ASTM F739-12 | Permeation of Liquids and Gases through Protective Clothing | Chemical Permeation Under Continuous Contact | PASS (>480 minutes breakthrough for specified chemotherapy drugs with no permeation detected at minimum detectable permeation or 0.1 µg/cm²/min) |
| Material Properties | |||
| ASTM D3776/D3776M-17 | Weight of Woven Fabric | Material Weight | PASS |
| ASTM D5034 - 9 2017 | Grab Tensile, Peak Stretch, and Peak Energy – Nonwovens | Tensile Strength | PASS |
| ASTM 1683-17 (2018) | Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics | Seam Strength | PASS |
| ASTM D5587-15 (2019) | Standard Test Method for Tearing Strength of Fabrics by the Trapezoid Procedure | Trapezoid Tear | PASS |
| NWSP 160.1 | Resistance to Linting of Nonwoven Fabrics (Dry) | Particulate | PASS |
| Flammability | |||
| 16 CFR 1610 | Standard for the Flammability for Clothing Textiles | Flammability (Meet Class I) | PASS |
| Biocompatibility | |||
| ISO 10993-5:2009 | ISO MEM Elution Cytotoxicity | Cytotoxicity (Non-cytotoxic) | PASS |
| ISO 10993 10:2010 | ISO Indirect Primary Skin Irritation Test | Irritation (Non-irritating) | PASS |
| ISO 10993-10:2010 | Guinea Pig Maximization Test | Sensitization (Non-sensitizing) | PASS |
| Sterilization Residuals | |||
| ISO 10993-7:2008 (R) 2012 | EO Sterilization Residuals (Sterile Catalog Numbers) | EO and ECH Residuals | PASS |
Study Proving Acceptance Criteria:
The study involved "Non-Clinical Performance Testing" of the Cardinal Health™ ChemoPlus™ Full Coverage Gowns (both closed and open back). This testing was conducted according to various recognized industry standards (AAMI, ASTM, AATCC, NWSP, CFR, ISO) to evaluate specific properties of the gowns. The results for all tests, as reported in the document, uniformly indicated "PASS," demonstrating that the proposed devices meet the acceptance criteria for their intended use.
Specific details for the chemical permeation test (ASTM F739-12) include:
- Chemotherapy drugs tested: Carmustine, Cisplatin, Cyclophosphamide, Cytarabine Hydrochloride, Dacarbazine, Daunorubicin Hydrochloride, Doxorubicin Hydrochloride, Etoposide, Fluorouracil, Ifosfamide, Methotrexate, Mitomycin C, Mitoxantrone, Paclitaxel, Thiotepa, Vincristine Sulfate.
- Reported performance: Average standardized breakthrough time for all tested chemotherapy drugs was ">480 minutes."
- Detection limit: No permeation was detected at either the minimum detectable permeation or 0.1 µg/cm²/min for any of the tested drugs.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests are non-clinical, material performance tests, where "sample size" would refer to the number of gown material specimens tested according to the specific test standard's requirements, rather than patient data. Data provenance (country, retrospective/prospective) is not relevant for this type of materials testing.
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 not applicable. The "ground truth" for material performance criteria is established by the accepted scientific and engineering principles embedded in the referenced ASTM, ISO, AAMI, etc., standards, and the measurement equipment used for testing. It does not involve human expert consensus in the way an AI/ML medical image analysis device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the evaluation is based on objective measurements against defined technical standards, not subjective human interpretations.
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 is not applicable. This is not an AI/ML device, nor does it involve human readers or diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for these tests is defined by the objective measurement protocols and acceptance limits set forth in the various referenced international and national standards (e.g., AATCC 42, ASTM F739-12, ISO 10993-5:2009). For example, chemical permeation is measured directly using analytical methods, not expert consensus or pathology.
8. The sample size for the training set
This is not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. This is not an AI/ML device that requires a training set or ground truth for training.
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(94 days)
Cardinal Health 200, LLC
The Cardinal Health™ Level 3 surgical masks with Anti-Fog Foam Strip are intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health™ Level 3 surgical masks are single use, disposable devices provided non-sterile.
The Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip is a four-layer mask constructed of 1 layer of nonwoven polyester/polyethylene blend (inner facing), 1 layer of nonwoven polyolefin melt blown (filter media), 1 layer of nonwoven polyester/polyethylene blend (middle layer), and 1 layer polyolefin spunbond material (outer facing). The four layers of the mask body are collated and sonically welded around the edges to enclose the filter media. The mask is provided with nonwoven polyolefin ties attached by ultrasonic welding. A malleable nosepiece is placed within the binding for comfort and individualized fit around the wearer's nose. The Anti-Fog Foam Strip is intended to minimize fogging.
The provided text describes the acceptance criteria and the study conducted for the Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip (K192374).
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Purpose | Acceptance Criteria per ASTM F2100-11 Level 3 (AQL = 4.0%) | Reported Device Performance (Test Results) | Average Performance |
|---|---|---|---|---|
| ASTM F1862 Synthetic Blood | Determine synthetic blood penetration resistance | 160 mmHg | Pass (31/32) | N/A |
| ASTM F2101 BFE | Determine the bacterial filtration efficiency | ≥ 98% | Pass (32/32) | 99.7% |
| ASTM F2299 PFE at 0.1 micron | Determine sub-micron particulate filtration efficiency | ≥ 98% | Pass (32/32) | 99.2% |
| Mil-M-36954C Delta P | Determine breathing resistance or differential pressure |
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(203 days)
Cardinal Health 200, LLC
The Cardinal Health™ Poly-Coated Open-Back 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 proposed Cardinal Health™ Poly-Coated Open-Back 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 Cardinal Health™ Poly-Coated Open-Back Protective Gowns is a single use, disposable medical device provided non-sterile.
The Cardinal Health™ Poly-Coated Open-Back Protective Gown is a Class II medical device under the FDA product code of FYC, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The device description of the Cardinal Health™ Poly-Coated Open-Back Protective Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and Guidance for Industry and FDA Staff: Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings, issued on December 9, 2015.
The Cardinal Health™ Poly-Coated Open-Back Protective Gown consists of a laminate (blue spunbond polypropylene coated with polyethylene) throughout the body of the gown (including sleeves). The sleeves have a thumbhook cuff formed into the sleeve or have a knit cuff sewn onto sleeve for keeping the sleeves in place on the wearer. The collar has a neck removal feature and the belt ties are integrated into the body. These gowns are non-sterile, single use, disposable gowns that are packaged in pastic bags and/or dispenser boxes. These gowns are offered in blue and come in both Universal and XX-Large sizes.
The document describes the non-clinical performance testing of the Cardinal Health™ Poly-Coated Open-Back Protective Gown. It evaluates the device against specific acceptance criteria and details the study methods used.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Element of Comparison | Specification (Acceptance Criteria) | Reported Device Performance (Mean (min/max)) |
|---|---|---|
| Basis Weight (ASTM D3776/D3776M-17) | 39.0 gsm min (average) | |
| 42.0 gsm target | ||
| 45.0 gsm max (average) | 43.3 (39.9 / 46.1) gsm (Sleeve and Body material) | |
| Tensile Strength, CD (ASTM D5034-17) | 5.8 lb min (individual) | |
| 3.5 lb min (average) | 14.2 (12.6 / 16.1) lb | |
| Tear Strength, MD (ASTM D5587-15) | 6.7 lb min (individual) | |
| 2.8 lb min (average) | 6.0 (4.4 / 7.5) lb | |
| Flammability (CPSC, Part 1610) | Class 1 | Class 1 |
| Hydrostatic Head (AATCC 127:2017) | 140 cmH20 target | |
| 100 cmH20 min (individual) | >130 (130 / >130) cmH20 |
51 (51 / >51) inH20 |
| Viral barrier (ASTM F1671-13) | Pass | Pass |
| Liquid Barrier Performance Classification Properties (ANSI/AAMI PB70:2012 / ASTM F1671) | Meets AAMI Level 4 performance requirements | All areas tested meet Level 4 performance requirements |
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing per ISO-10993-1 | Non-cytotoxic, non-irritating, non-sensitizing and met requirements per ISO-10993-1 |
2. Sample size used for the test set and the data provenance
- Liquid Barrier Performance Classification Properties: Testing was performed using 3 lots and 32 samples per lot in each critical zone area (body or sleeve, and heat sealed seam(s)).
- Other tests (Basis Weight, Tensile Strength, Tear Strength, Hydrostatic Head): The document provides mean and min/max values, but a specific sample size for these individual tests beyond the "Finished Good Test Results" is not explicitly stated.
- Data Provenance: The document implies that the testing was conducted internally by the manufacturer, Cardinal Health, or by a contracted lab. The data is presented as "Finished Good Test Results" for the "Subject Device: Cardinal Health™ Poly-Coated Open-Back Protective Gown." This data would be considered prospective as it's generated specifically for the device submission. The country of origin for the data is not specified, but the submission is to the U.S. FDA by a company based in Illinois, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The tests described are non-clinical performance tests that use standardized methodologies (e.g., ASTM, AATCC, ISO standards) to measure physical and barrier properties. These types of tests do not typically involve human expert interpretation or "ground truth" in the same way clinical studies or diagnostic device evaluations would. The "ground truth" is established by the test method itself and the specified performance criteria. Therefore, no human experts were used to establish ground truth for this test set in the context of diagnostic interpretation.
4. Adjudication method for the test set
Not applicable. As noted above, these are non-clinical, objective performance tests following standardized methods, not subjective clinical 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
Not applicable. This is a submission for a protective gown, which is a physical medical device, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant or presented.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used
The ground truth for the non-clinical performance tests is based on predefined objective standards and specifications (e.g., AAMI Level 4 for barrier protection, specific tensile strength values, flammability classes). These standards define what constitutes a "pass" or "fail" for each characteristic.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, and therefore there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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(223 days)
Cardinal Health 200 LLC
The Cardinal Health™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:
· Gravity steam at 250°F/121°C for 30 minutes.
· Pre-vacuum steam at 270°F/132°C for 4 minutes.
• 100% ethylene oxide (EO) with a concentration of 725-735 mg/l at 131°F/55°C and 40%-80% relative humidity for 60 minutes.
- · Advanced Sterilization Products (ASP) STERRAD® 100S system.
· Advanced Sterilization Products (ASP) STERRAD® NX system, Standard and Advanced Cycles.
· Advanced Sterilization Products (ASP) STERRAD® 100NX System, Standard, Flex, Express and Duo Cycles.
· Advanced Sterilization Products (ASP) STERRAD® 200 System.
• Lumen, Non Lumen, and Flexible Cycles in the STERIS V-PRO® 1 Plus, STERIS V-PRO® maX and STERIS V-PRO® 60 Low Temperature Sterilization Systems.
· TSO3 STERIZONE® VP4 System Cycle 1 (Refer to Table 5 for load)
The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used.
Cardinal Health™ Sterilization Wraps are made from 100% polypropylene spunbondmeltblown-spunbond (SMS) nonwoven fabric. The sterilization wrap is provided in six different material basis weights (models) of four product offerings in various dimensions. Cardinal Health™ Sterilization Wrap, Single Layer is comprised of a single sheet or one layer of SMS fabric. Cardinal Health™ Sterilization Wrap, Dual Layer and Cardinal Health™ Sterilization Wrap, TwoColor are comprised of two single layer sheets of SMS fabric ultrasonically bonded along two opposing sides. The wrap design allows for use of the sequential or simultaneous double-wrapping technique per recommendations from ANSVAAMI ST79:2017 and allows for a sterilized pack to be opened aseptically. All models utilize the same material technology. These products are a single-use device and for over-the-counter use only.
The Cardinal Health™ Sterilization Wrap is intended to enclose medical devices for sterilization and maintain their sterility until use. The device has been tested against various sterilization methods and loads.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilant Penetration | Negative for growth | Negative for growth (tested per ANSI/AAMI TIR 12, ANSI/AAMI ST79/A4) |
| Maintenance of Package Sterility | Negative for growth (Microbial Aerosol Challenge) | Negative for growth (tested per ANSI/AAMI TIR12, ANSI/AAMI ST79 A1&A2) |
| Event Related Shelf Life | No growth (for specified durations depending on sterilization method) | 365 days for Pre-vacuum steam, Gravity steam, EO, STERRAD® 100S, STERRAD® NX, STERRAD® 100NX, VPRO 1, VPRO 1 Plus, VPRO maX, VPRO 60, VP4; 30 days for STERRAD® 200 (tested per ANSI/AAMI TIR12, ANSI/AAMI ST79 A1&A2) |
| Biocompatibility - Irritation | Negligible irritant | Negligible irritant (tested per ISO 10993-10) |
| Biocompatibility - Leachability | Non-Aged: Extract Appearance: Clear, free of color; pH: Comparable to negative control | Non-Aged: Extract Appearance: Clear, free of color; pH: Comparable to negative control (tested per ISO 6588-2) |
| Aged 30 days: Extract Appearance: Clear, free of color; pH: Comparable to negative control | Aged 30 days: Extract Appearance: Clear, free of color; pH: Comparable to negative control (tested per ISO 6588-2) | |
| Biocompatibility - Residuals | None detected | None detected (tested per ISO 10993-7) |
| Sterilization Efficacy | Negative for growth | Negative for growth (tested per ANSI/AAMI TIR 12, ANSI/AAMI ST79/A4) |
| Material Compatibility (Physical Properties) | Compatible (i.e., integrity of wrap properties not compromised after sterilization and storage) | Compatible (tested for Basis weight, Air permeability, Material burst strength, Grab Tensile strength, Trapezoidal Tear strength, Hydrostatic Pressure per ASTM standards) |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes various validation studies performed for different sterilization methods and wrap models. The studies involved a range of loads, including medical instruments with different geometries, lumens, flexible endoscopes, towels, drapes, and metal mass. The specific sample sizes for each test set (e.g., number of wrapped packages, number of sterilization cycles) are not explicitly stated as numerical values in the provided text.
The data provenance is not explicitly stated in terms of country of origin, nor whether it was retrospective or prospective. Given that it is a 510(k) submission for a medical device and describes "Performance testing," it is implied to be prospective testing conducted in a controlled environment to validate the device's claims.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not specify the number or qualifications of experts used to establish the "ground truth" for the test set. The nature of the device (sterilization wrap) and the tests performed (microbial growth, physical properties, biocompatibility) suggest that the "ground truth" would be established through laboratory analyses and adherence to standardized testing protocols (e.g., ANSI/AAMI, ISO, ASTM), rather than expert consensus on subjective observations.
4. Adjudication Method for the Test Set:
An adjudication method is not mentioned, as it is not typically applicable to the type of objective, quantitative testing (e.g., microbial growth, physical property measurements) described for this device.
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 was not done. This type of study is irrelevant for a sterilization wrap, which is a physical device, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
A standalone performance study was not done. This term is applicable to AI algorithms, not physical medical devices like sterilization wraps. The performance evaluation focuses on the physical and microbiological properties of the wrap itself.
7. The Type of Ground Truth Used:
The ground truth used for these studies is based on:
- Microbial Growth/Sterility: Absence of microbial growth, determined by standard microbiological culture techniques after sterilization and shelf-life challenges.
- Physical Properties: Quantitative measurements of material characteristics (e.g., weight, air permeability, tensile strength, tear strength, burst strength, hydrostatic pressure) compared against defined specifications before and after sterilization.
- Biocompatibility: Absence of detectable residuals, clear and pH-neutral extracts, and negligible irritant response as determined by standardized ISO tests.
8. The Sample Size for the Training Set:
A training set is not applicable to this device. This concept relates to machine learning models, whereas the Cardinal Health™ Sterilization Wrap is a physical product evaluated through traditional laboratory and material science testing.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this device.
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