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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Gloves were tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric acid and Xylazine in Fentanyl Citrate in accordance with ASTM D6978-05 Standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.

Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate is a Class I patient examination glove and specialty chemotherapy gloves, that made from synthetic nitrile latex. They are pink color, non-sterile, powder-free, fingertip textured, ambidextrous with beaded cuff, and single use only, and come in different sizes- XS, S, M, L, XL and XXL.

The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been been tested for biocompatibility and permeability to chemotherapy drugs, Fentanyl Citrate, Gastric Acid and Xylazine in Fentanyl Citrate.

This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for a medical device submitted for FDA 510(k) clearance.

The device in question is Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate.

Acceptance Criteria and Device Performance Study

The acceptance criteria for this device are primarily based on established industry standards for medical examination gloves and specific permeation resistance tests for various chemical substances. The study conducted to prove the device meets these criteria is a series of non-clinical performance tests.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes (number of gloves) used for each individual test. However, it indicates that the tests were conducted according to established ASTM and ISO standards, which typically specify appropriate sample sizes for such tests to ensure statistical validity.

The data provenance is through non-clinical testing performed in accordance with recognized international and national standards (ASTM, ISO). This implies the data were prospectively generated for the purpose of this submission. The country of origin of the data is not specified, but the use of international standards suggests a globally accepted testing methodology.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable (N/A) as the device is a physical product (medical glove) and the performance is evaluated through objective, standardized laboratory tests (e.g., measuring permeation time, tensile strength, dimensions) rather than expert interpretation of images or clinical data. There is no "ground truth" established by human experts in the context of diagnostic accuracy for this type of device.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) for the same reason as above. Adjudication methods like 2+1 or 3+1 are relevant for studies involving human interpretation (e.g., radiology reads) where discrepancies need to be resolved. The tests performed for this device are objective measurements.

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 (N/A). This document pertains to the clearance of a physical medical device (gloves), not an AI algorithm or a diagnostic imaging device that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This information is not applicable (N/A). As mentioned, this is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective, quantitative measurements obtained through standardized laboratory testing methodologies (ASTM and ISO standards). For example:

• Permeation: Measured breakthrough time of specific chemicals through the glove material.
• Physical Properties: Measured tensile strength, elongation, length, width, and thickness.
• Biocompatibility: Observed biological responses (e.g., irritation, sensitization, systemic toxicity) in controlled in-vitro or in-vivo (animal) tests as per ISO standards.
  This is not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather on direct physical and chemical testing.

8. The Sample Size for the Training Set

This information is not applicable (N/A). This device is a manufactured product that undergoes performance and biocompatibility testing. There is no "training set" in the context of machine learning. The manufacturing process is designed and validated to consistently produce gloves meeting the specified criteria.

9. How the Ground Truth for the Training Set was Established

This information is not applicable (N/A) as there is no training set for this device. The "ground truth" for the device's design and manufacturing is derived from the established standards (ASTM, ISO) that define the performance characteristics expected of such gloves. Quality control during manufacturing ensures conformity to these standards.

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Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:

• Arsenic Trioxide (1 mg/ml)
• Bendamustine, (5 mg/ml)
• Blenoxane (15 mg/ml)
• Bleomycin (15 mg/ml)
• Bortezomib (1 mg/ml)
• Busulfan (6 mg/ml)
• Carboplatln (10 mg/ml)
• Carfilzomib (2 mg/ml)
• Cetuximab (2 mg/ml)
• Cisplatin (1 mg/ml)
• Cyclophosphamide (Cytoxan) (20 mg/ml)
• Cytarabine (100 mg/ml)
• Dacarbazine (DTIC) {10 mg/ml)
• Daunorubicin {5 mg/ml)
• Decitabine (5 mg/ml)
• Docetaxel (10 mg/ml)
• Doxorubicin HCL (2 mg/ml)
• Ellence (2 mg/ml)
• Erbitux (2 mg/ml)
• Eribilin Mesylate (0.5 mg/ml)
• Etoposide (Toposar) (20 mg/ml)
• Fludarabine (25 mg/ml)
• Fulvestrant (50 mg/ml)
• Gemcitabine (Gemzar) (38 mg/ml)
• Idarubicin (1 mg/ml)
• Ifosfamide (IFEX) (50 mg/ml)
• Irinotecan (20 mg/ml)
• Mechlorethamine HCL (1 mg/ml)
• Melphalan (5 mg/ml)
• Methotrexate (25 mg/ml)
• Mitomycin C (0.5 mg/ml)
• Mitoxantrone (2 mg/ml)
• Oxaliplatin (2 mg/ml)
• Paclitaxel (Taxol) (6 mg/ml)
• Paraplatin (10 mg/ml)
• Pemetrexed Disodium (25 mg/ml)
• Pertuzumab (30 mg/ml)
• Raltitrexed (0.5 mg/ml)
• Rituximab (Rituxan) (10 mg/ml)
• Temsirolimus (25 mg/ml)
• Thiotepa (10 mg/ml)
• Topotecan HCL (1 mg/ml)
• Trastuzumab (21 mg/ml)
• Trisenox (1 mg/ml)
• Velcade (1 mg/ml)
• Vinblastine (1 mg/ml)
• Vinorelbine (10 mg/ml)

Carmustine (3.3 mg/ml) permeation occurred at 60.0 minutes.

The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:

• Fentanyl Citrate Injection (100 mcg/2 ml)
• Gastric Acid Fluid/Fentanyl Citrate Injection Mix (50/50 Solution)

Caution: Testing showed a minimum breakthrough time of 60.0 minutes with Carmustine.

The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes:

• Cytovene (10 mg/ml)
• Retrovir (10 mg/ml)
• Triclosan (2 mg/ml)
• Zoledronic Acid (0.8 mg/ml)

Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable, 12"purple-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, nonsterile patient examination gloves.

The provided text is an FDA 510(k) clearance letter and summary for a medical glove, not an AI-powered medical device. Therefore, many of the requested fields related to AI study design (like "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "number of experts," etc.) are not applicable and cannot be found in the document.

However, I can extract the acceptance criteria and performance data for the glove based on the provided information, focusing on the non-clinical and clinical tests described.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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The SImmetry+ System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The SImmetry+ System consists of sterile packaged fully threaded titanium Implants designed to transfix the sacrum and ilium, providing stability for bony fusion. The surgical implants are available in various sizes to accommodate patient anatomy. Implants have major diameters ranging from 9.5mm-14.5mm, in 1mm increments. Implant lengths in 5mm increments range from 30mm to 110mm. All devices are additively manufactured from Titanium Alloy (Ti-6Al4V ELI).

This 510(k) clearance letter pertains to the SImmetry+ System, a device for sacroiliac joint fusion (a metallic bone fixation fastener). Unlike a clearance for a software device or AI/ML system, this document focuses on the physical and mechanical performance of the implantable device.

Therefore, the requested information regarding acceptance criteria and study that proves the device meets the acceptance criteria specifically in the context of AI/ML performance metrics (like sensitivity, specificity, MRMC studies, expert consensus on images, etc.) is not applicable to this type of medical device clearance.

The provided document describes:

• Device Type: A physical, implantable device (fully threaded titanium implants for sacroiliac joint fusion).
• Acceptance Criteria (Implicitly): Demonstrated through non-clinical performance testing against specific ASTM standards. These standards define the expected mechanical properties (e.g., static and dynamic cantilever testing, axial pullout, torsional properties, driving torque).
• Study Proving Acceptance: "Non-clinical testing data" was submitted, including:
  • Static and dynamic cantilever testing per ASTM F2193
  • Axial pullout testing per ASTM F543
  • Torsional properties testing per ASTM F543
  • Driving torque testing per ASTM F543
  • Additive manufacturing characterization

Summary of Requested Information based on the provided document:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Mechanical performance standards defined by ASTM F2193 and ASTM F543, and additive manufacturing characterization. (Specific numerical thresholds are not provided in this public clearance letter, but would have been part of the confidential submission.)
   • Reported Device Performance: The document states that SiVantage completed non-clinical testing and the data demonstrates substantial equivalence. This implies the device met the performance criteria outlined in the standards.

2. Sample sizes used for the test set and the data provenance: Not applicable. The "test set" here refers to physical implants subjected to mechanical testing, not a dataset of patient information for AI/ML evaluation.

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 a physical implant is established by engineering measurements against defined material and mechanical standards.

4. Adjudication method for the test set: Not applicable. Mechanical testing results are objective measurements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human interpretation of medical images, often with AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI/ML algorithm performance.

7. The type of ground truth used:

   • For the physical device: Engineering specifications, material properties, and mechanical performance standards (ASTM F2193, ASTM F543).

8. The sample size for the training set: Not applicable. The "training set" concept applies to AI/ML model development. For a physical device, manufacturing processes are refined, but there isn't a "training set" in the AI sense.

9. How the ground truth for the training set was established: Not applicable for a physical device.

In conclusion, this FDA 510(k) clearance is for a conventional mechanical implant, not an AI/ML powered device. Therefore, many of the questions asked, which are highly relevant for AI/ML device clearances, do not apply to the details provided in this document. The "proof" of meeting acceptance criteria for this device rests on its physical and mechanical characteristics meeting established engineering standards and showing substantial equivalence to existing predicate devices based on those characteristics.

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The glove is disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves were tested for use with Chemotherapy drugs, Fentanyl and Gastric acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.

Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)

The provided document is a 510(k) premarket notification approval letter for Nitrile Powder-Free Exam Gloves. It details the device's substantial equivalence to existing predicate devices and lists the results of permeation tests for various chemotherapy drugs, opioid fentanyl citrate, and simulated gastric acid.

However, the document does not describe a study involving an AI/software medical device requiring ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies. The "acceptance criteria" discussed in this document relate to the gloves' resistance to permeation by specific chemicals, measured in "Minimum Breakthrough Detection Time."

Therefore, based solely on the provided text, it is not possible to answer the questions related to AI/software device performance, expert ground truth, adjudication methods, or MRMC studies.

Here's an attempt to answer the questions based on the information available in the document, acknowledging that most questions are not applicable to this type of device:

Acceptance Criteria and Device Performance for Nitrile Powder-Free Exam Gloves

The study presented here is a series of permeation tests conducted to determine the resistance of Nitrile Powder-Free Exam Gloves to various hazardous substances, specifically chemotherapy drugs, opioid fentanyl citrate, and simulated gastric acid. The acceptance criteria are implicit in the detailed breakthrough detection times, aiming to demonstrate the gloves' barrier properties against these substances. The tests were performed in accordance with ASTM D6978-05 standards.

1. Table of Acceptance Criteria and Reported Device Performance:

The document directly states the "Minimum Breakthrough Detection Time" for each substance for both the Light Blue and Dark Blue gloves. The implicit acceptance criterion would be that the gloves demonstrate a sufficiently long breakthrough time (ideally >240 minutes) for safe handling, or to clearly identify substances for which the gloves are not suitable. The reported performance is the actual measured breakthrough time.

Light Blue Glove Performance:

Note: Warnings are explicitly provided for Carmustine and ThioTEPA due to extremely low permeation times.

Dark Blue Glove Performance:

Note: Warnings are explicitly provided for Carmustine and ThioTEPA due to extremely low permeation times.

2. Sample Size and Data Provenance for the Test Set:
The document does not explicitly state the sample size (number of gloves tested for each substance) used for these permeation tests. It only lists the test results. The data provenance is stated as being tested "in accordance with ASTM D6978-05 standards," which implies a standardized laboratory testing setting. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth:
This section is not applicable to this type of device and study. The "ground truth" here is the physical measurement of chemical permeation, which is determined by laboratory instrumentation and protocols defined by the ASTM standard, not by human expert interpretation or consensus.

4. Adjudication Method for the Test Set:
This section is not applicable. Adjudication methods like "2+1" or "3+1" are used in studies involving human readers/experts evaluating data (e.g., medical images) to establish a consensus ground truth. In this study, the "ground truth" is a direct physical measurement.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This section is not applicable. MRMC studies are performed for AI/software devices where human readers interpret medical data, often comparing human performance with and without AI assistance. This document describes chemical permeation tests of gloves, not a diagnostic or prognostic medical device involving human interpretation.

6. Standalone (Algorithm Only) Performance:
This section is not applicable. This refers to the performance of an AI algorithm without human intervention. The device in question is a physical glove, not an algorithm.

7. Type of Ground Truth Used:
The "ground truth" for this study is a physical measurement of chemical permeation through the glove material, determined by laboratory testing protocols as defined by the ASTM D6978-05 standards. It is not derived from expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set:
This section is not applicable. This study does not involve a training set as it's not an AI/machine learning model development context.

9. How the Ground Truth for the Training Set was Established:
This section is not applicable for the reasons stated above.

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Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves were tested for use with Chemotherapy drugs, Fentanyl, Gastric acid and Xylazine in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.

Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate is a Class I patient examination glove and specialty chemotherapy gloves, that made from synthetic nitrile latex. They are non-sterile, powder-free, fingertip textured, ambidextrous with beaded cuff, blue colored nitrile gloves featuring an inner coating of hyaluronic acid and single use only. There are six different sizes- XS, S, M, L, XL and XXL. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs, opioid Fentanyl Citrate, simulated Gastric Acid and Xylazine per ASTM D6978-05.

The provided document is a 510(k) clearance letter from the FDA for Nitrile Powder-Free Exam Gloves. It details the device's characteristics, indications for use, and a comparison with predicate and reference devices, as well as a summary of non-clinical testing.

However, the nature of this medical device (examination gloves) means that the provided information does not include the typical "study that proves the device meets the acceptance criteria" in the context of an AI/ML powered device for diagnostic or prognostic purposes, which is what your questions #2 through #9 are geared towards.

For examination gloves, the "acceptance criteria" are based on physical properties, biocompatibility, and permeation resistance to certain chemicals, assessed through laboratory testing, not clinical studies involving patient data or expert interpretation.

Therefore, I will answer the questions that are applicable to the provided document and explicitly state when a question is not applicable.

Acceptance Criteria and Device Performance for Nitrile Powder-Free Exam Gloves

1. A table of acceptance criteria and the reported device performance

Chemotherapy and Other Drug Permeation Minimum Breakthrough Detection Times:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes (e.g., number of gloves tested for each physical or chemical property) for the non-clinical tests. It only states that testing was conducted. Data provenance (e.g., country of origin, retrospective/prospective) is not provided as these are laboratory tests of a manufactured product, not data collected from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for glove performance tests (physical properties, biocompatibility, chemical permeation) is established by adherence to standardized testing methodologies (e.g., ASTM, ISO standards) and measurable outcomes, not by expert consensus or interpretation in the way it is for diagnostic AI.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical imaging studies or similar diagnostic contexts where expert consensus is required for labeling data. This does not apply to the laboratory testing of gloves.

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 type of study is relevant for AI-powered diagnostic or screening tools that assist human interpreters. The device in question is examination gloves, which do not involve human readers interpreting cases or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical product (gloves), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is based on direct measurements and observations derived from standardized laboratory tests (e.g., tensile strength, elongation, hole detection, chemical permeation) defined by recognized industry standards (ASTM, ISO).

8. The sample size for the training set
Not applicable. The device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established
Not applicable. The device is not an AI/ML algorithm.

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The SimpleStitch Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue (e.g., closure and healing of ESD/EMR sites, and closing of fistula, perforation or leaks).

The SimpleStitch Suturing System ("SimpleStitch SS") is a sterile, single patient-use device that enables endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract using a flexible endoscope. The system includes the following components: SimpleStitch Suture Device, SimpleStitch Suture Cartridge, and SimpleStitch Suture Cinch. The SimpleStitch SS is designed for compatibility with single-channel endoscopes (gastroscopes and colonoscopes) with a minimum working channel inner diameter of 2.8mm. During use, the suturing device/suture cartridge is mounted to the endoscope's exterior; the cinching device goes through the endoscope's working channel. The SimpleStitch SS is available with a USP 2-0 and USP 0 nonabsorbable polyester suture. Tissue is secured using a cinch anchor once tissue approximation is complete.

This FDA 510(k) clearance letter and summary is for a physical medical device (SimpleStitch Suturing System), not an AI/Software as a Medical Device (SaMD). Therefore, the information typically requested for AI/SaMD performance studies (such as acceptance criteria for algorithm performance, sample size for test sets with ground truth, number of experts for ground truth, MRMC studies, standalone performance, training set details, etc.) is not applicable here.

The document focuses on demonstrating substantial equivalence to a predicate device (OverStitch Endoscopic Suturing System) through:

• Comparison of Technological Characteristics: Showing similarities in intended use, indications for use, principle of operation, materials, and design.
• Performance Data: Primarily bench testing (dimensional verification, functionality, destructive testing, side-by-side comparison with predicate, usability, packaging, shelf-life), biocompatibility, MRI safety, and an animal (swine) survival study.

There is no mention of an algorithm or AI model, nor any associated acceptance criteria, ground truth establishment, or statistical performance metrics typically associated with AI/SaMD.

Therefore, I cannot provide the requested information regarding acceptance criteria and study proof in the context of an AI/SaMD for this document.

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The glove is disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves were tested for use with Chemotherapy drugs, Fentanyl and Gastric acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.

Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) is a Class I patient examination glove and specialty chemotherapy gloves, that made from synthetic nitrile latex. They are non-sterile, powder-free, fingertip textured, ambidextrous with beaded cuff, and single use only, and come in different sizes- XS, S, M, L, XL and XXL.

The provided [K243441](https://510k.innolitics.com/search/K243441) document is a 510(k) premarket notification for Nitrile Powder-Free Exam Gloves. This type of device is a Class I medical device and does not involve AI or complex algorithms requiring human-in-the-loop studies or ground truth established by experts.

Therefore, most of the requested information regarding AI/algorithm performance, human reader studies, and expert-established ground truth is not applicable to this document. The "device" in this context is a physical examination glove, not an AI-powered diagnostic tool.

The acceptance criteria and performance are related to the physical properties and barrier efficacy of the gloves, not to analytical or diagnostic performance of an algorithm.

However, I can extract the relevant acceptance criteria and reported performance for the physical glove testing:

Acceptance Criteria and Reported Device Performance

As the device is a physical medical glove and not an AI/software device, the acceptance criteria and performance relate to its physical and chemical barrier properties.

Table of Acceptance Criteria and Reported Device Performance:

Detailed Permeation Performance (Minimum Breakthrough Detection Time in minutes):

(Light Blue Glove)

Warning: Do not use Light Blue glove with Carmustine (16.6 minutes) and ThioTEPA (44.9 minutes).

(Dark Blue Glove)

Warning: Do not use Dark Blue glove with Carmustine (21.5 minutes) and ThioTEPA (17.9 minutes).

Regarding the other requested information (which is not applicable to this physical device):

• 2. Sample size(s) used for the test set and the data provenance: Not explicitly stated as "sample size" in a statistical sense for AI. Testing involves physical samples of gloves manufactured for the purpose of meeting ASTM standards. Data provenance is implied to be from laboratory testing according to the listed ASTM and ISO standards.
• 3. Number of experts used to establish the ground truth...: Not applicable. Ground truth for physical properties and chemical permeation is established by standardized laboratory testing procedures (e.g., measuring dimensions, tensile strength, or breakthrough time), not by expert consensus on images or medical data.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication is not relevant for objective laboratory measurements.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable. This is a physical product, not an AI or imaging device that would involve human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device is based on objective measurements and established physical/chemical standards (e.g., ASTM, ISO), not expert medical interpretation or clinical outcomes data in the context of an AI device.
• 8. The sample size for the training set: Not applicable. There is no training set as this is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable. There is no training set.

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The simpli-COLLECT STI Test is a test system intended for in vitro detection and identification of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) in home-collected specimens. The specimens are shipped to a clinical laboratory for testing using the Alinity m STI Assay with the automated Alinity m System for the direct, qualitative detection and differentiation of ribosomal RNA from CT, DNA from NG, ribosomal RNA from TV, and ribosomal RNA from MG, to aid in the diagnosis of disease(s) caused by infection from these organisms. The assay may be used to test the following self-collected specimens from symptomatic and asymptomatic individuals for the following analytes:

• · CT: vaginal swabs, female urine and male urine .
• NG: vaginal swabs, female urine, and male urine .
• . · TV: vaginal swabs, female urine and male urine
• . • MG: vaginal swabs and male urine

The simpli-COLLECT STI Test contains all the necessary components for the selfcollection and transport of urine from male and female patients (simpli-COLLECT Urine Collection Kit) or vaginal swabs from female patients (simpli-COLLECT Swab Collection Kit) in their home, or in similar environments. The simpli-COLLECT Collection Kits may also be used to self-collect specimens in a clinic.

The simpli-COLLECT STI Test is a test system intended for in vitro detection and identification of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) in home-collected specimens (simpli-COLLECT Urine Collection Kit [09N93001] and the simpli-COLLECT Swab Collection Kit [09R02-001]).

This test system uses the Alinity m STI Assay (cleared under K202977 and K222379) for real time RT-PCR to amplify and detect Chlamydia trachomatis (CT) ribosomal RNA sequences, Neisseria gonorrhoeae (NG) genomic DNA sequences, Trichomonas vaginalis (TV) ribosomal RNA sequences, Mycoplasma genitalium (MG) ribosomal RNA sequences, and human genomic DNA sequences that have been extracted from vaginal swab specimens or male and female urine specimens.

The Alinity m STI assay requires two separate assay-specific kits as follows:

• . Alinity m STI AMP Kit (09N17-095), which consists of multi-well amplification plates containing lyophilized, unit-dose RT-PCR amplification/detection reagents, and multi-well activator plates containing liquid, unit-dose activation reagents (MgC12. TMAC, and KC1). The intended storage condition for the Alinity m STI AMP Kit is 2°C to 8°C.
• . Alinity m STI CTRL Kit (09N17-085), which consists of negative controls and positive controls, each supplied as liquid in single-use tubes. The intended storage condition for the Alinity m STI Control Kit is -15°C to -25°C.

The steps of the Alinity m STI assay consist of sample preparation. RT-PCR assembly, amplification/detection, and result calculation and reporting. All stages of the Alinity m STI assay procedure are executed automatically by the Alinity m System. No intermediate processing or transfer steps are performed by the user. The Alinity m System is designed to be a random-access analyzer that can perform the Alinity m STI assay in parallel with other Alinity m assays on the same instrument.

Nucleic acids from specimens are extracted automatically on-board the Alinity m System using the Alinity m Sample Prep Kit 1, Alinity m Lysis Solution, Alinity m Ethanol Solution or Alinity m Bottle for Ethanol Use filled with Ethanol supplied by customers, and Alinity m Diluent Solution. The Alinity m System employs magnetic microparticle technology to facilitate nucleic acid capture, wash, and elution. The resulting purified nucleic acids are then combined with the liquid unit dose activator reagent, lyophilized unit-dose Alinity m STI amplification reagents, and Alinity m Vapor Barrier Solution, and transferred by the instrument to an amplification/detection module for reverse transcription, PCR amplification, and real-time fluorescence detection.

Assay controls are tested at or above an established minimum frequency to help ensure that instrument and reagent performance remain satisfactory. During each control event, a negative control and a positive control are processed through sample preparation and RT-PCR procedures that are identical to those used for specimens. Assay controls are used to demonstrate proper sample processing and assay validity. The CTRL kit configuration includes 12 vials at 0.47 mL of both the Alinity m STI Negative CTRL and Alinity m STI Positive CTRL.

The Alinity m STI amplification reagents include primers and probes that amplify and detect the single copy human gene, ß-globin. Amplification and detection of the ß-globin gene demonstrates proper sample processing and adequate sample input. In addition, an exogenous internal control (containing an armored RNA sequence) is included in the lyophilized Alinity m STI amplification reagents and is used to confirm that no PCR inhibitors are present in the sample. The ß-globin control and internal control are both used to demonstrate assay validity. The AMP kit configuration includes 4 trays (96 tests per tray) of both an AMP TRAY 1 and ACT TRAY 2. The AMP Kit provides sufficient reagents for 384 tests.

The simpli-COLLECT Urine Collection Kit is used to collect, stabilize, and transport male urine specimens for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae. Trichomonas vaginalis, and Mycoplasma genitalium, and female urine specimens for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Each kit can be used to collect 1 urine specimen. The collected specimens are intended for testing with the Alinity m STI assay. The simpli-COLLECT Urine Collection Kit contains the following components: 1 Abbott Sample Collection pack, which contains 1 Alinity m Sample Tube with Liguid Buffer and 1 Transfer Pipette, 1 Tube and Bag Label Sheet, 1 Urine Cup/Urine Collection Cup, 1 simpli-COLLECT Urine Collection Kit Patient Instructions For Use, 1 Biohazard Bag with Absorbent Pad, 1 Tube and Cap Holder, and 1 simpli-COLLECT Urine Collection Kit Box.

The simpli-COLLECT Swab Collection Kit is used to collect, stabilize, and transport vaginal swab specimens for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium. Each kit can be used to collect 1 vaginal swab specimen. The collected specimens are intended for testing with the Alinity m STI assay. The simpli-COLLECT Swab Collection Kit contains the following components: 1 Abbott Swab Collection pack, which contains 1 Alinity m Sample Tube with Liguid Buffer and 1 Specimen Collection Swab, 1 Tube and Bag Label Sheet, 1 Biohazard Bag with Absorbent Pad, 1 Tube and Cap Holder, 1 simpli-COLLECT Swab Collection Kit Patient Instructions For Use, and 1 simpli-COLLECT Swab Collection Kit Box.

Here's a breakdown of the acceptance criteria and study information for the simpli-COLLECT STI Test, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details the performance in terms of usability and absence of interference, rather than specific quantitative diagnostic accuracy metrics (like sensitivity/specificity) for the simpli-COLLECT STI Test itself. The diagnostic accuracy is implicitly covered by the reference to the cleared Alinity m STI Assay (K202977 and K222379).

2. Sample Size Used for the Test Set and Data Provenance

• Human Factors Study:

  • Sample Size: 223 participants.
  • Data Provenance: Prospective, simulated home environment study conducted in the United States.

• Interference Study:

  • Sample Size: Not explicitly stated as a number of "samples" but involved testing 11 potential hand contaminants diluted into negative or positive swab and urine matrices. The number of replicates for each condition is not specified in this summary.
  • Data Provenance: Laboratory study, likely conducted internally by Abbott Molecular.

• Clinical Performance (Reference to K202977 & K222379):

  • The document states that "Performance characteristics of the Alinity m STI assay with swab and urine specimens were established in a multicenter clinical study conducted in the United States to support the clearance of K202977 and K222379." The sample sizes for these previous clearances are not detailed in the provided K243410 summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not directly stated for the specific studies presented in this document (Human Factors and Interference).

• For the Human Factors study, "ground truth" was evaluated by observing participants' actions and evaluating packaged samples for errors based on laboratory accessioning criteria. This doesn't involve medical experts establishing diagnostic ground truth.
• For the Interference study, "ground truth" refers to the known positive or negative status of the spiked matrices, against which assay performance (presence/absence of interference) was assessed. This is laboratory-controlled.
• For the underlying Alinity m STI assay (K202977 and K222379), clinical studies would have involved a gold standard for establishing ground truth, likely including culture, other cleared NAATs, and/or clinical diagnosis, but the details are not available in this summary.

4. Adjudication Method for the Test Set

This information is not explicitly provided for the studies in this summary.

• For the Human Factors study, "difficulties were noted" and "packaged samples were then evaluated for errors according to the laboratory accessioning criteria." This suggests an objective assessment based on predefined criteria rather than a multi-expert adjudication of clinical diagnoses.
• For the Interference study, it's a technical and controlled laboratory experiment, not requiring adjudication in the clinical sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Improvement with AI vs. without AI Assistance

This is not applicable as the simpli-COLLECT STI Test is a molecular diagnostic test system for in vitro detection, not an AI-assisted diagnostic imaging or interpretation device. Therefore, no MRMC study or AI assistance effect size is mentioned or relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This is not applicable in the context of an "algorithm only" performance. The simpli-COLLECT STI Test is a collection and transport system intended to be used with the Alinity m STI Assay, which performs the actual detection. The Alinity m STI Assay operates automatically on the Alinity m System (an automated instrument), so its "standalone" performance would be its analytical and clinical performance as an automated assay, which was established in K202977 and K222379. The current submission focuses on the collection and transport component for home use.

7. The Type of Ground Truth Used

• Human Factors Study: Ground truth was based on pre-defined protocol steps for correct specimen collection and packaging, and laboratory accessioning criteria for evaluating collected samples.
• Interference Study: Ground truth was established by preparing matrices with known positive (spiked with target organisms) or negative status, and then adding interfering substances at defined concentrations.
• For the Alinity m STI Assay (from referenced K202977 and K222379): Likely clinical diagnosis, culture, and/or comparison to other legally marketed nucleic acid amplification tests (NAATs). The specific details are not in this summary.

8. The Sample Size for the Training Set

• Human Factors Study: 223 participants used as the test set. There isn't a separate "training set" mentioned for this usability evaluation. The design presumably refined the kit instructions prior to this summative study, but specific training set details are not provided.
• Interference Study: No explicit "training set" concept applies here; it's a validation experiment.
• For the Alinity m STI Assay (from referenced K202977 and K222379): Not detailed in this summary.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there's no explicitly defined "training set" for the type of studies presented here for the simpli-COLLECT STI Test. For the underlying Alinity m STI Assay, the ground truth for its training and validation would have been established through methods applicable to clinical diagnostic assays, as mentioned in point 7.

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The SIMEOX 200 airway clearance device is intended to promote airway clearance and to improve bronchial drainage by enhancing mobilization of bronchial secretions via high frequency oscillatory vibrations and intermittent negative pressure to the airway during exhalation. The device is intended to be prescribed for use in patients capable of independently generating cough.

SIMEOX 200 is intended for use in the home, hospital, and other healthcare institutions by individuals weighing at least 23 Kg.

The SIMEOX 200 Airway Clearance Device consists of a portable generator and a single patient use expiratory kit. The patient inhales from the ambient environment, naturally and independent of the device, and then exhales into the device mouthpiece. During the patient's exhalation, the SIMEOX 200 generates a pneumatic vibration throughout the airway. This vibration, applied at 6 Hz or 12 Hz via negative pressure pulses, disseminates throughout the bronchial tree in order to decrease mucus viscosity and increase secretion mobility. During or after therapy, the patient can clear the secretions by coughing independently.

This document describes the FDA's 510(k) clearance for the SIMEOX 200 Airway Clearance Device. It primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications and non-clinical performance testing.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of human-in-the-loop performance, AI assistance, or expert-based ground truth establishment for diagnostic purposes.

The document states:

• "Performance verification testing was conducted on the bench with the SIMEOX 200 Airway Clearance Device to demonstrate the subject device performs to its pre-specified requirement specifications, which align with those of the predicate devices."
• "The SIMEOX 200 device also went through comprehensive software verification and validation testing to confirm the device operates within specification."
• "Testing demonstrated the SIMEOX 200 performed as intended and was safe and effective."
• "A human factors validation study was conducted with simulated first-time use of the product in adult users and dyads of children with caregivers. The study concluded that the device is safe for its intended users."

This indicates that the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and safety performance specifications, rather than clinical performance metrics typically associated with AI/diagnostic devices (like sensitivity, specificity, or reader improvement).

Therefore, I cannot populate the requested table and study details as they are not present in the provided text. The document describes a medical device (Airway Clearance Device), not an AI or diagnostic device that would typically involve the type of acceptance criteria and studies you've outlined.

The acceptance criteria implied are the device's ability to meet its pre-specified parameters (e.g., pressure range, oscillation frequencies) and demonstration of safety and effectiveness through bench testing, software validation, and human factors validation.

Here's a summary of the information that is available, reframing it in the context of device performance rather than AI/diagnostic performance:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other requested information, it is largely not applicable or not provided for this type of device and submission:

2. Sample size used for the test set and the data provenance:
* Test Set: Not explicitly stated in terms of a "test set" for performance metrics like sensitivity/specificity. Performance testing was "on the bench" and included software V&V and human factors simulation.
* Data Provenance: Not applicable for this type of technical/safety validation. The human factors study involved "simulated first-time use," but details about participant numbers or demographic provenance are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* This is not relevant for this device's 510(k) submission, as it's not a diagnostic device requiring expert interpretation for ground truth.

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, as this is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable, as this is not an AI/algorithm-driven device in the sense of image analysis or diagnostic prediction. Its "performance" is based on its physical and software operation parameters.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* "Ground truth" in this context refers to the pre-defined engineering specifications and safety standards (e.g., pressure measurements, frequency measurements against a calibrated standard, successful execution of software functions, successful completion of simulated tasks in human factors). It's not a clinical or diagnostic ground truth.

8. The sample size for the training set:
* Not applicable. This device does not use machine learning that requires a "training set."

9. How the ground truth for the training set was established:
* Not applicable.

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The SimpleSnip Suture Cutter is intended to cut sutures during all flexible endoscopic procedures.

The SimpleSnip Endoscopic Suture Cutter is sterile, single patient-use device intended to cut sutures during flexible endoscopic procedures. The cutting device goes through the working channel of the endoscope and is compatible with flexible endoscopes with a minimum channel diameter of 2.8mm. The device is available in two working lengths: 160cm working length for gastroscopes and 230 cm working length for colonoscopes. The device consists principally of a proximal handle assembly, a catheter with core wire, and a blade to cut the suture. Once the SimpleSnip device is inserted in the working channel of the endoscope, the blade is advanced from the catheter, the suture is captured within the blade such that when the blade is pulled back toward the catheter the suture is cut. The blade is rotatable to allow easy suture capturing and cutting.

I am sorry, but the provided text does not contain information about acceptance criteria and a study proving a device meets these criteria. The document is an FDA 510(k) clearance letter for the SimpleSnip Endoscopic Suture Cutter, detailing its substantial equivalence to a predicate device. It includes information about the device description, indications for use, comparison with a predicate device, and performance/biocompatibility/sterilization testing conducted.

Specifically, it states:

• "No clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device." This means there isn't a clinical study with acceptance criteria and reported performance in the context of human data.
• The performance data mentioned is primarily bench testing and functional testing, as well as comparative testing against the predicate device for certain mechanical aspects (rotation, actuation, bending stiffness). These tests are designed to verify specifications and show equivalence, not necessarily to meet pre-defined clinical performance acceptance criteria against human outcomes.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance for a clinical study.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone algorithm performance.
7. Type of ground truth for a clinical study.
8. Sample size for a training set.
9. How ground truth for the training set was established.

This document focuses on demonstrating substantial equivalence through non-clinical data and comparison to a predicate device, which is common for 510(k) submissions where clinical studies are not deemed necessary.

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