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Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution are disposable devices 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 the following chemotherapy drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution as per ASTM -D6978-05 : The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (25 mg/ml) Bendamustine HCl (5 mg/ml) Bleomycin Sulfate (15 mg/ml) Bortezomib (1 mg/ml) Busulfan (6 mg/ml) Capecitabine (26 mg/ml) Carboplatin (10 mg/ml) Carlzomib (2 mg/ml) Cetuximab (2 mg/ml) Chloroquine (50 mg/ml) Cisplatin (1 mg/ml) Cladribine (1 mg/ml) Cyclophosphamide (20 mg/ml) Cyclosporin A (100 mg/ml) Cytarabine (Cytosine) (100 mg/ml) Cytovene (Ganciclovir) (10 mg/ml) Dacarbazine (DTIC) (10 mg/ml) Dactinomycin (0.5 mg/ml) Daunorubicin HCl (5 mg/ml) Decitabine (5 mg/ml) Docetaxel (10 mg/ml) Doxorubicin HCl (2 mg/ml) Epirubicin HCI (Ellence) (2 mg/ml) Etoposide (Toposar) (20 mg/ml) Fludarabine (25 mg/ml) 5-Fluorouracil (50 mg/ml) Fulvestrant (50 mg/ml) Gemcitabine (38 mg/ml) Idarubicin (1 mg/ml) Ifosfamide (50 mg/ml) Irinotecan HCl (20 mg/ml) Leuprolide Acetate Salt (5 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) Oxaliptin (5 mg/ml) Paclitaxel (6 mg/ml) Pemetrexed (25 mg/ml) Raltitrexed (0.5 mg/ml) Retrovir (10 mg/ml) Rituximab (10 mg/ml) Temsirolimus (25 mg/ml) Topotecan HCl (1 mg/ml) Triclosan (2 mg/ml) Trisenox (1 mg/ml) Vinblastine Sulfate (1 mg/ml) Vincristine (1 mg/ml) Vinorelbine (10 mg/ml) Zoledronic Acid (0.8 mg/ml) The following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes: Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes. Thiotepa (10 mg/ml) No breakthrough up to 30.9 minutes. The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution Warning: Not for Use With: Carmustine, ThioTEPA

Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution are disposable, lavender colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves. These gloves will be available in sizes Extra Small, Small, Medium, Large and Extra Large.

The document describes the acceptance criteria and performance of the "Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution".

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Clinical Test (Modified DRAIZE-95 Test for Low Dermatitis Potential):

  • Sample Size: 204 subjects.
  • Data Provenance: Not explicitly stated, but implies a prospective study involving normal healthy human volunteers due to the nature of the Draize test. Country of origin is not mentioned.

• Non-Clinical Tests (Mechanical Properties, Permeation, Biocompatibility): The document does not specify exact sample sizes for each non-clinical test (e.g., number of gloves tested for permeation, pinholes, or physical properties). These are typically laboratory-based tests following standard protocols. Data provenance related to country of origin is not provided, but the tests refer to international standards (ASTM, ISO).

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 section is not applicable as the document describes a medical device (exam gloves) for which "ground truth" as defined for AI/diagnostic studies (e.g., expert consensus on image interpretation) is not relevant. The performance is assessed against established physical, chemical, and biological standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the type of device and tests described. Adjudication methods are typically used in clinical studies involving interpretation by multiple readers/experts to establish a definitive diagnosis or assessment, which is not the case here.

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. The device is an exam glove and not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. The device is an exam glove and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the tests conducted, the "ground truth" is defined by:

• Established industry standards and regulatory limits (e.g., ASTM D6319 for physical properties, ASTM D5151 for pinholes, ASTM D6124 for powder, ASTM D6978-05 for drug permeation, ISO 10993 for biocompatibility).
• Observed physical and chemical properties of the gloves (e.g., measured dimensions, tensile strength, elongation, residual powder, breakthrough time for drugs).
• Clinical observation of human subjects for irritation and sensitization (for the dermatitis potential test).

8. The sample size for the training set

This is not applicable. The document describes the testing of a manufactured physical device (gloves), not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable as there is no training set for this type of device.

Ask a specific question about this device

The Halyard Purple Nitrile, Powder-Free Exam Gloves are disposable devices 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 the following chemotherapy drugs and Fentanyl Citrate and Gastric Acid as per ASTM -D6978-05 :

The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:
Azacitidine (25 mg/ml)
Bendamustine HCl (5 mg/ml)
Bleomycin Sulfate (15 mg/ml)
Bortezomib (1 mg/ml)
Busulfan (6 mg/ml)
Capecitabine (26 mg/ml)
Carboplatin (10 mg/ml)
Carlzomib (2 mg/ml)
Cetuximab (2 mg/ml)
Chloroquine (50 mg/ml)
Cisplatin (1 mg/ml)
Cladribine (1 mg/ml)
Cyclophosphamide (20 mg/ml)
Cyclosporin A (100 mg/ml)
Cytarabine (Cytosine) (100 mg/ml)
Cytovene (Ganciclovir) (10 mg/ml)
Dacarbazine (DTIC) (10 mg/ml)
Dactinomycin (0.5 mg/ml)
Daunorubicin HCl (5 mg/ml)
Decitabine (5 mg/ml)
Docetaxel (10 mg/ml)
Doxorubicin HCl (2 mg/ml)
Epirubicin HCl (Ellence) (2 mg/ml)
Etoposide (Toposar) (20 mg/ml)
Fludarabine (25 mg/ml)
5-Fluorouracil (50 mg/ml)
Fulvestrant (50 mg/ml)
Gemcitabine (38 mg/ml)
Idarubicin (1 mg/ml)
Ifosfamide (50 mg/ml)
Irinotecan HCl (20 mg/ml)
Leuprolide Acetate Salt (5 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 (5 mg/ml)
Paclitaxel (6 mg/ml)
Pemetrexed (25 mg/ml)
Raltitrexed (0.5 mg/ml)
Retrovir (10 mg/ml)
Rituximab (10 mg/ml)
Temsirolimus (25 mg/ml)
Topotecan HCl (1 mg/ml)
Triclosan (2 mg/ml)
Trisenox (1 mg/ml)
Vinblastine Sulfate (1 mg/ml)
Vincristine (1 mg/ml)
Vinorelbine (10 mg/ml)
Zoledronic Acid (0.8 mg/ml)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:

Carmustine (3.3 mg/ml) No breakthrough up to 55.3 minutes.

Thiotepa (10 mg/ml) No breakthrough up to 78.8 minutes.

Warning- Not for use with Carmustine and ThioTEPA

No breakthrough was detected up to 240 minutes for Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution

The Halyard Purple Powder-Free Nitrile Exam Glove tested with Chemotherapy Drugs, Fentanyl Citrate and simulated Gastric Acid is a disposable, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination glove that are chlorinated on the donning side and are packed in a cardboard dispenser box.

The document describes the acceptance criteria and performance data for Halyard Purple Nitrile, Powder-Free Exam Gloves, which are medical gloves, not an AI-powered device. Therefore, many of the requested categories related to AI/algorithm performance (e.g., sample size for test set provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone algorithm performance, sample size for training set, ground truth for training set) are not applicable to this submission.

The information provided pertains to the physical and chemical performance of the gloves when exposed to certain substances.

Here's a breakdown of the applicable information from the provided document, restructured to address the closest relevant aspects of your request:

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

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for each test beyond indicating adherence to standard AQLs (Acceptable Quality Levels) for tests like leakage and powder content, which imply a defined statistical sampling plan according to the respective ASTM standards. The provenance of the data is from laboratory testing conducted by the manufacturer, O & M Halyard, Inc., in the context of a 510(k) premarket notification to the FDA. This is inherently prospective testing for a new device submission. Country of origin of the data is not explicitly stated but is implicitly tied to the submitting company (Alpharetta, Georgia, USA).

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, as this is a physical product being tested against chemical permeation and physical properties, not an AI/algorithm where expert consensus on interpretations is required for ground truth. The "ground truth" here is the objective measurement of chemical breakthrough time, physical dimensions, and material properties according to standardized laboratory protocols.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human interpretation or adjudication. The tests 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

Not applicable. No AI component is described in this medical device submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical product, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used for these tests is based on objective laboratory measurements in accordance with established ASTM and ISO standards for:

• Chemical permeation (breakthrough time of specific drugs through the glove material).
• Physical properties (tensile strength, elongation, dimensions).
• Freedom from defects (pinholes, residual powder).
• Biocompatibility (irritation, systemic toxicity, sensitization).

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning model.

9. How the ground truth for the training set was established

Not applicable.

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Flexaprene Green Powder-Free Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Flexaprene Green Powder-Free Exam Glove

I am sorry, but based on the provided text, I cannot provide the requested information. This document is a 510(k) clearance letter from the FDA for a medical device (Flexaprene Green Powder-Free Exam Glove). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

The document does not contain information about:

1. Acceptance criteria and reported device performance for a study. It only states the device's indications for use.
2. Sample sizes used for test sets.
3. Data provenance.
4. Number or qualifications of experts for ground truth.
5. Adjudication method.
6. MRMC comparative effectiveness study results or effect sizes.
7. Standalone algorithm performance.
8. Type of ground truth used.
9. Training set sample size.
10. How ground truth for the training set was established.

This document is a regulatory approval notice, not a study report detailing performance metrics and validation processes.

Ask a specific question about this device

The Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentany1 Citrate are disposable devices 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 the following chemotherapy drugs and Fentanyl Citrate as per ASTM -D6978-05 :

The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (25 mg/ml) Bendamustine HCl (5 mg/ml) Bleomycin Sulfate (15 mg/ml) Bortezomib (1 mg/ml) Busulfan (6 mg/ml) Capecitabine (26 mg/ml) Carboplatin (10 mg/ml) Carlzomib (2 mg/ml) Cetuximab (2 mg/ml) Chloroquine (50 mg/ml) Cisplatin (1 mg/ml) Cladribine (1 mg/ml) Cyclophosphamide (20 mg/ml) Cyclosporin A (100 mg/ml) Cytarabine (Cytosine) (100 mg/ml) Cytovene (Ganciclovir) (10 mg/ml) Dacarbazine (DTIC) (10 mg/ml) Dactinomycin (0.5 mg/ml) Daunorubicin HCl (5 mg/ml) Decitabine (5 mg/ml) Docetaxel (10 mg/ml) Doxorubicin HCl (2 mg/ml) Epirubicin HCl (Ellence) (2 mg/ml) Etoposide (Toposar) (20 mg/ml) Fludarabine (25 mg/ml) 5-Fluorouracil (50 mg/ml) Fulvestrant (50 mg/ml) Gemcitabine (38 mg/ml) Idarubicin (1 mg/ml) Ifosfamide (50 mg/ml) Irinotecan HCl (20 mg/ml) Leuprolide Acetate Salt (5 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 (5 mg/ml) Paclitaxel (6 mg/ml) Pemetrexed (25 mg/ml) Raltitrexed (0.5 mg/ml) Retrovir (10 mg/ml) Rituximab (10 mg/ml) Temsirolimus (25 mg/ml) Topotecan HCl (1 mg/ml) Triclosan (2 mg/ml) Trisenox (1 mg/ml) Vinblastine Sulfate (1 mg/ml) Vincristine (1 mg/ml) Vinorelbine (10 mg/ml) Zoledronic Acid (0.8 mg/ml)

The following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes: Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes. Thiotepa (10 mg/ml) No breakthrough up to 30.9 minutes.

The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2 ml)

Warning: Not for Use With: Carmustine, ThioTEPA

Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are disposable, lavender colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, patient examination gloves.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

Device: Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Regulatory Class: Class I (Non-Powdered Patient Examination Glove, Specialty; Fentanyl and other opioid protection glove)

Study Design Overview:

This appears to be a non-clinical performance study focusing on the physical characteristics and chemical permeation resistance of the gloves. It is a comparative study against a previously cleared predicate device (Halyard Lavender, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs). The primary method used for evaluating chemical permeation was ASTM D6978-05.

1. Table of Acceptance Criteria & Reported Device Performance

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

• Sample Size: The document does not explicitly state the specific sample sizes (number of gloves or individual tests) for each test. However, it references conformity to various ASTM and ISO standards (e.g., ASTM D6978-05, ASTM D5151-06, ASTM D6319-10, ISO 10993 parts 10 and 11), which implicitly define the required sample sizes for such tests.
• Data Provenance: The data appears to be from non-clinical, prospective laboratory testing conducted by the manufacturer (O & M Halyard, Inc.) to demonstrate compliance with recognized industry standards for medical gloves. The country of origin of the data is not explicitly stated but is implicitly associated with the manufacturer's location (Alpharetta, Georgia, USA), and the testing would adhere to international standards (ASTM, ISO).

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

• This detailed information is not provided in the 510(k) summary. For non-clinical performance and biocompatibility studies of this type (testing against standard specifications), "experts" in the traditional sense of clinical adjudication are not typically involved. The "ground truth" is established by the standardized test methods themselves and the specified acceptance criteria. The lab personnel conducting the tests would be qualified per the relevant test standards (e.g., trained technicians, chemists, biologists).

4. Adjudication Method for the Test Set:

• None in the sense of clinical image review or multi-reader evaluation. The ground truth is determined directly by the quantitative and qualitative results of the standardized physical, chemical, and biological tests as per the ASTM and ISO standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC study was not done. This device is a medical glove, and its performance evaluation relates to physical, chemical, and biological properties, not diagnostic or interpretive clinical effectiveness by human readers. Therefore, an MRMC study is not applicable.

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

• Yes, a "standalone" performance evaluation was done in the sense that the glove's resistance to chemical permeation and its physical/biological properties were tested directly, independent of human interaction during clinical use for the purpose of the test. The "algorithm" here is the glove itself and its material properties, tested in a laboratory setting.

7. The Type of Ground Truth Used:

• The ground truth is based on objective, standardized laboratory test results as defined by:
  • Consensus Standards: ASTM D6978-05 (chemical permeation), ASTM D5151-06 (pinholes), ASTM D6319-10 (physical properties, dimensions, powder), and ISO 10993 parts 10 and 11 (biocompatibility).
  • Predefined Acceptance Criteria specified in these standards (e.g., breakthrough time, AQL levels, mechanical property thresholds, irritation indices).

8. The Sample Size for the Training Set:

• Not applicable. This submission is for a physical medical device (gloves), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "development" of the glove material and design would have involved iterative testing and refinement, but this is distinct from an AI training set.

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

• Not applicable (as explained in point 8).

Ask a specific question about this device

The Halyard Purple Xtra Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are disposable devices 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 the following chemotherapy drugs and Fentanyl Citrate as per ASTM -D6978-05:
Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes
Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes
Bendamustine (5 mg/ml) No breakthrough up to 240 minutes
Bortezomib (Velcade) (1 mg/ml) No breakthrough up to 240 minutes
Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes
Busulfan (6 mg/ml) No breakthrough up to 240 minutes
Carboplatin (10 mg/ml) No breakthrough up to 240 minutes
Carfilzomib (2 mg/ml) No breakthrough up to 240 minutes
Carmustine (3.3 mg/ml) permeation occurred at 169.8 minutes
Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes
Cisplatin (1 mg/ml) No breakthrough up to 240 minutes
Cladribine (1 0 mg/ml) No breakthrough up to 240 minutes
Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes
Cytarabine HCL (100 mg/ml) No breakthrough up to 240 minutes
Cytovene (10 mg/ml) No breakthrough up to 240 minutes
Dacarbazine (10 mg/ml) No breakthrough up to 240 minutes
Daunorubicin HCL (5 mg/ml) No breakthrough up to 240 minutes
Decitabine (5 mg/ml) No breakthrough up to 240 minutes
Docetaxel (10 mg/ml) No breakthrough up to 240 minutes
Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes
Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes
Etoposide (20 mg/ml) No breakthrough up to 240 minutes
Fludarabine (25 mg/ml) No breakthrough up to 240 minutes
Fluorouracil (50 mg/ml) No breakthrough up to 240 minutes
Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes
Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes
Idarubicin (1 mg/ml) No breakthrough up to 240 minutes
Ifosfamide (50 mg/ml) No breakthrough up to 240 minutes
Irinotecan (20 mg/ml) No breakthrough up to 240 minutes
Mechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutes
Melphalan (5 mg/ml) No breakthrough up to 240 minutes
Methotrexate (25 mg/ml) No breakthrough up to 240 minutes
Mitomycin-C (0 5 mg/ml) No breakthrough up to 240 minutes
Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes
Oxaliplatin (2 mg/ml) No breakthrough up to 240 minutes
Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes
Paraplatin (10 mg/ml) No breakthrough up to 240 minutes
Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes
Pertuzumab (30 mg/ml) No breakthrough up to 240 minutes
Raltitrexed (0.5 mg/ml) No breakthrough up to 240 minutes
Retrovir (10 mg/ml) No breakthrough up to 240 minutes
Rituximab (10 mg/ml) No breakthrough up to 240 minutes
Temsirolimus (25 mg/ml) No breakthrough up to 240 minutes
Trastuzumab (21 mg/ml) No breakthrough up to 240 minutes
ThioTEPA (10 mg/ml) No breakthrough up to 240 minutes
Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes
Triclosan (1 mg/ml) No breakthrough up to 240 minutes
Trisenox (0.1 mg/ml) No breakthrough up to 240 minutes
Vincrinstine Sulfate (1 mg/ml) No breakthrough up to 240 minutes
Vinblastine (1 mg/ml) No breakthrough up to 240 minutes
Vinorelbine (10 mg/ml) No breakthrough up to 240 minutes
Zoledronic Acid (0.8 mg/ml) No breakthrough up to 240 minutes
Fentanyl Citrate (100mcg/2ml) No breakthrough up to 240 minutes

Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are disposable, purple-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, sterile patient examination gloves.

This document is a 510(k) premarket notification for Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. It describes the device's technical characteristics and performance data compared to a predicate device.

The acceptance criteria and study that proves the device meets them are related to the physical and chemical properties of the gloves and their barrier efficacy against certain hazardous substances, not an AI/ML-based medical device. Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone algorithm performance, ground truth establishment for training set) are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding the acceptance criteria and the performance studies that were conducted to support the substantial equivalence claim.

Acceptance Criteria and Reported Device Performance

The core of the acceptance criteria for these exam gloves is based on established ASTM and ISO standards for medical gloves, focusing on their physical integrity, powder content, biocompatibility, and resistance to permeation by chemotherapy drugs and fentanyl citrate.

1. Table of Acceptance Criteria and the Reported Device Performance:

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

• Non-Clinical Tests: For tests based on ASTM standards (e.g., D6319, D5151, D6124, D6978), the sample sizes are determined by the specific standard's testing methodology, often involving a certain number of gloves per batch or condition to achieve statistical significance (e.g., AQL for pinholes). The document does not explicitly state these per-test sample sizes but confirms adherence to the standards.
• Biocompatibility Tests (ISO 10993): These involve animal testing, with sample sizes determined by the ISO standards for systemic toxicity, irritation, and sensitization. The document doesn't provide the exact number of animals but states the acceptance criteria were met.
• Clinical Study (Type IV Allergic Contact Sensitization): A 204 subject study was completed.
• Data Provenance: The document does not specify the country of origin for the non-clinical or clinical test data. Given it's an FDA submission for a US-based company (O & M Halyard, Inc., Alpharetta, GA), it's highly probable the testing was conducted in the US or in labs compliant with US regulatory requirements. The studies implicitly appear to be prospective studies conducted specifically for this submission.

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

• N/A. The ground truth for this device is based on objective laboratory measurements and standardized test procedures (e.g., chemical breakthrough, physical dimensions, tensile strength, biological responses in animal/human models as per ISO/ASTM standards). It does not involve expert consensus on interpreting images or clinical cases like an AI/ML diagnostic device would.

4. Adjudication Method for the Test Set:

• N/A. Adjudication is not relevant to the nature of these physical and chemical performance tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• N/A. This is a physical product, not an AI/ML diagnostic tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are not applicable.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop):

• N/A. This is a physical product.

7. The Type of Ground Truth Used:

• The ground truth for this device's performance is established through objective, standardized laboratory measurements and biological responses to samples of the device, as defined by ASTM and ISO protocols. This includes:
  • Quantitative measurements (e.g., length, thickness, tensile strength, residual powder, breakthrough time for chemicals).
  • Qualitative observations of biological reactions in animal models (for toxicity, irritation, sensitization).
  • Clinical observations in human subjects (for allergic sensitization).

8. The Sample Size for the Training Set:

• N/A. There is no "training set" in the context of this traditional medical device. The device's manufacturing process and material composition are developed and optimized through R&D, not trained on data in a machine learning sense.

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

• N/A. As there is no training set for this type of device, this question is not applicable. The device's design and manufacturing rely on established engineering principles and material science, validated through the non-clinical and clinical testing described.

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The Halyard Sterling Nitrile Powder-Free Exam Gloves are disposable devices 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 the following chemotherapy drugs:
Arsenic Trioxide (1 mg/ml), No breakthrough up to 240 minutes Doxorubicin HCL (2 mg/ml), No breakthrough up to 240 minutes Paclitaxel (6 mg/ml), No breakthrough up to 240 minutes Azacitidine (Vidaza) (25 mg/ml), No breakthrough up to 240 minutes Epirubicin (Ellence) (2 mg/ml), No breakthrough up to 240 minutes Paraplatin (10 mg/ml), No breakthrough up to 240 minutes Bendamustine (5 mg/ml), No breakthrough up to 240 minutes Eribulin Mesylate (0.5 mg/ml), No breakthrough up to 240 minutes Pemetrexed (25 mg/ml), No breakthrough up to 240 minutes Bortezomib (Velcade) (1 mg/ml), No breakthrough up to 240 minutes Etoposide (20 mg/ml), No breakthrough up to 240 minutes Pertuzumab (30 mg/ml), No breakthrough up to 240 minutes Bleomycin sulfate (15 mg/ml), No breakthrough up to 240 minutes Fludarabine (25 mg/ml), No breakthrough up to 240 minutes Raltitrexed (0.5 mg/ml), No breakthrough up to 240 minutes Busulfan (6 mg/ml),No breakthrough up to 240 minutes Fluorouracil (50 mg/ml), No breakthrough up to 240 minutes, Retrovir (10 mg/ml) No breakthrough up to 240 minutes Carboplatin (10 mg/ml), No breakthrough up to 240 minutes Fulvestrant (50 mg/ml), No breakthrough up to 240 minutes Rituximab (10 mg/ml), No breakthrough up to 240 minutes Carfilzomib (2 mg/ml). No breakthrough up to 240 minutes Gemcitabine (38 mg/ml), No breakthrough up to 240 minutes Temsirolimus (25 mg/ml), No breakthrough up to 240 minutes Cetuximab (Erbitux) (2 mg/ml), No breakthrough up to 240 minutes Idarubicin (1 mg/ml), No breakthrough up to 240 minutes Trastuzumab (21 mg/ml), No breakthrough up to 240 minutes Cisplatin (1 mg/ml), No breakthrough up to 240 minutes Ifosfamide (50 mg/ml), No breakthrough up to 240 minutes Topotecan HCL (1 mg/ml), No breakthrough up to 240 minutes Cyclophosphamide (20 mg/ml), No breakthrough up to 240 minutes Irinotecan (20 mg/ml), No breakthrough up to 240 minutes Triclosan (2 mg/ml), No breakthrough up to 240 minutes Cytarabine HCL (100 mg/ml), No breakthrough up to 240 minutes Mechlorethamine HCL (1 mg/ml), No breakthrough up to 240 minutes Trisonex (1 mg/ml), No breakthrough up to 240 minutes Cytovene (10 mg/ml), No breakthrough up to 240 minutes Melphalan (5 mg/ml), No breakthrough up to 240 minutes Vincrinstine Sulfate (1 mg/ml), No breakthrough up to 240 minutes
Dacarbazine (10 mg/ml), No breakthrough up to 240 minutes Methotrexate (25 mg/ml), No breakthrough up to 240 minutes, Vinblastine (1 mg/ml), No breakthrough up to 240 minutes Daunorubicin HCL (5 mg/ml). No breakthrough up to 240 minutes Mitomycin-C (0.5 mg/ml), No breakthrough up to 240 minutes Vinorelbine (10 mg/ml), No breakthrough up to 240 minutes Decitabine (5 mg/ml), No breakthrough up to 240 minutes Mitoxantrone (2 mg/ml), No breakthrough up to 240 minutes Zoledronic Acid (0.8 mg/ml).No breakthrough up to 240 minutes Docetaxel (10 mg/ml), No breakthrough up to 240 minutes Oxaliplatin (2 mg/ml), No breakthrough up to 240 minutes
ThioTEPA (10 mg/ml), breakthrough detected at 37.1 minutes Carmustine (3.3 mg/ml), breakthrough detected at 22.9 minutes

The Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves are disposable devices 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 the following chemotherapy drugs:
Arsenic Trioxide (1 mg/ml), No breakthrough up to 240 minutes Doxorubicin HCL (2 mg/ml), No breakthrough up to 240 minutes Paclitaxel (6 mg/ml), No breakthrough up to 240 minutes Azacitidine (Vidaza) (25 mg/ml), No breakthrough up to 240 minutes Epirubicin (Ellence) (2 mg/ml), No breakthrough up to 240 minutes Paraplatin (10 mg/ml), No breakthrough up to 240 minutes Bendamustine (5 mg/ml), No breakthrough up to 240 minutes Eribulin Mesylate (0.5 mg/ml), No breakthrough up to 240 minutes Pemetrexed (25 mg/ml), No breakthrough up to 240 minutes Bortezomib (Velcade) (1 mg/ml), No breakthrough up to 240 minutes Etoposide (20 mg/ml), No breakthrough up to 240 minutes Pertuzumab (30 mg/ml), No breakthrough up to 240 minutes Bleomycin sulfate (15 mg/ml), No breakthrough up to 240 minutes Fludarabine (25 mg/ml), No breakthrough up to 240 minutes Raltitrexed (0.5 mg/ml), No breakthrough up to 240 minutes Busulfan (6 mg/ml),No breakthrough up to 240 minutes Fluorouracil (50 mg/ml), No breakthrough up to 240 minutes Retrovir (10 mg/ml) No breakthrough up to 240 minutes Carboplatin (10 mg/ml), No breakthrough up to 240 minutes Fulvestrant (50 mg/ml), No breakthrough up to 240 minutes Rituximab (10 mg/ml), No breakthrough up to 240 minutes Carfilzomib (2 mg/ml). No breakthrough up to 240 minutes Gemcitabine (38 mg/ml), No breakthrough up to 240 minutes Temsirolimus (25 mg/ml), No breakthrough up to 240 minutes Cetuximab (Erbitux) (2 mg/ml), No breakthrough up to 240 minutes Idarubicin (1 mg/ml), No breakthrough up to 240 minutes Trastuzumab (21 mg/ml), No breakthrough up to 240 minutes Cisplatin (1 mg/ml), No breakthrough up to 240 minutes Ifosfamide (50 mg/ml), No breakthrough up to 240 minutes Topotecan HCL (1 mg/ml), No breakthrough up to 240 minutes Cyclophosphamide (20 mg/ml), No breakthrough up to 240 minutes Irinotecan (20 mg/ml), No breakthrough up to 240 minutes Triclosan (2 mg/ml), No breakthrough up to 240 minutes Cytarabine HCL (100 mg/ml), No breakthrough up to 240 minutes Mechlorethamine HCL (1 mg/ml), No breakthrough up to 240 minutes Trisonex (1 mg/ml), No breakthrough up to 240 minutes Cytovene (10 mg/ml), No breakthrough up to 240 minutes Melphalan (5 mg/ml), No breakthrough up to 240 minutes Vincrinstine Sulfate (1 mg/ml), No breakthrough up to 240 minutes
Dacarbazine (10 mg/ml), No breakthrough up to 240 minutes Methotrexate (25 mg/ml), No breakthrough up to 240 minutes, Vinblastine (1 mg/ml), No breakthrough up to 240 minutes Daunorubicin HCL (5 mg/ml), No breakthrough up to 240 minutes Mitomycin-C (0.5 mg/ml), No breakthrough up to 240 minutes Vinorelbine (10 mg/ml), No breakthrough up to 240 minutes Decitabine (5 mg/ml), No breakthrough up to 240 minutes Mitoxantrone (2 mg/ml), No breakthrough up to 240 minutes Zoledronic Acid (0.8 mg/ml).No breakthrough up to 240 minutes Docetaxel (10 mg/ml), No breakthrough up to 240 minutes Oxaliplatin (2 mg/ml), No breakthrough up to 240 minutes
ThioTEPA (10 mg/ml), breakthrough detected at 23.9 minutes Carmustine (3.3 mg/ml), breakthrough detected at 14.8 minutes

Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves and Halyard STERLING* Nitrile Powder-Free Exam Gloves tested for Use with Chemotherapy Drugs are disposable, grey-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves that are packed in a cardboard dispenser box.

The provided document is a 510(k) summary for Halyard Sterling* Nitrile Powder-Free Exam Gloves and Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves. It details the safety and performance characteristics of these medical gloves, particularly their resistance to permeation by chemotherapy drugs.

Here’s a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The device (Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves and Halyard Sterling* Nitrile Powder-Free Exam Gloves) performance was evaluated against several standards for medical gloves and their resistance to chemotherapy drugs.

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

The document does not explicitly state the sample sizes (e.g., number of gloves tested for each drug or physical property) for the test sets. It describes the tests conducted according to the "Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs" (ASTM D6978-05), and other ASTM and ISO standards, which inherently include methodologies for sample selection.

The data provenance is not specified in terms of country of origin, nor whether it was retrospective or prospective. It refers to the testing conducted on the subject device, implying this testing occurred directly for this submission.

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

This type of information (number and qualifications of experts) is not applicable to the studies described. The "ground truth" here is established by the standardized test methods themselves, which are objective measurements of physical and chemical properties of the gloves (e.g., breakthrough time for chemotherapy drugs, presence of holes, powder content, tensile strength, biological reaction in animal models). These are not studies that require expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. The tests are based on objective, standardized measurements, not human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The device in question is a medical exam glove, and its effectiveness is determined by its physical and chemical properties under specified test conditions, not by human reader performance.

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

Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of these gloves is defined by:

• Standardized Test Methods: Adherence to established industry standards like ASTM D6978-05 for chemotherapy drug permeation, ASTM D5151-06 for hole detection, ASTM D6124-06 for residual powder, ASTM D6319-10 for physical properties, and ISO 10993 for biological evaluation.
• Objective Measurements: Direct measurements of physical properties (e.g., breakthrough time, amount of powder, tensile strength, elongation) and biological responses (e.g., systemic toxicity, irritation, sensitization).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of evaluating medical gloves through physical and chemical performance testing. This is not an AI or machine learning model.

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

Not applicable, as there is no training set for this type of device evaluation.

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The Skybreeze Zero Nitrile Powder-Free Exam 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 the following chemotherapy drugs: Cyclophosphamide (20.0 mg/ml), Doxorubicin HCl (2.0 mg/ml), Etoposide (20.0 mg/ml), 5-Fluorouracil (50.0 mg/ml), Paclitaxel (Taxol) (6.0 mg/ml), Cisplatin (1.0 mg/ml), Dacarbazine (10.0 mg/ml), Ifosfamide (50.0 mg/ml), Mitoxantrone (2.0 mg/ml), Vincristine sulfate (1.0 mg/ml), Carmustine (3.3 mg/ml), ThioTEPA (10.0 mg.ml). Warning: Not for Use with: Carmustine, ThioTEPA.

The SkyBreeze Zero Nitrile Powder-Free Exam Gloves, Tested for Use with Chemotherapy Drugs are disposable, blue-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves packed in a cardboard dispenser box.

The provided text is related to the 510(k) premarket notification for "SkyBreeze Zero Nitrile Powder-Free Exam Gloves, Tested for Use with Chemotherapy Drugs." This document outlines the safety and performance characteristics of medical exam gloves, not artificial intelligence (AI) software. As such, information regarding AI-specific criteria like multi-reader multi-case (MRMC) studies, sample sizes for AI training sets, or the number of experts for AI ground truth establishment is not present.

However, I can extract information related to the acceptance criteria and studies for the medical exam gloves as described in the document.

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

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: The document does not explicitly state the exact sample sizes (number of gloves or individual tests) for each specific test (e.g., how many gloves were tested for chemotherapy permeation, holes, etc.). However, it refers to industry standards (ASTM, ISO) which define appropriate sample sizes for such tests.
• Data Provenance: The studies were conducted by the manufacturer, O & M Halyard, Inc., to evaluate their product. The country of origin of the data is not specified, but the submission is to the U.S. FDA, implying compliance with U.S. regulatory standards. The studies are prospective in nature, as they are part of the premarket notification process for a new device.

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 information is not applicable. The product is a medical exam glove, and the "ground truth" for its performance is established through standardized laboratory testing against physical, chemical, and biological properties, not through expert human interpretation of data like in an AI study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This is not applicable as the studies involve laboratory testing and not human interpretation or adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable since the document refers to a medical device (exam gloves), not an AI algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for the device's performance is established by objective, standardized laboratory test methods and their defined pass/fail criteria. For example:

• Chemotherapy Permeation: Measured breakthrough time of specific chemicals using analytical methods.
• Hole Detection: Visual inspection or water leak test methods defined in ASTM D5151-06.
• Residual Powder: Gravimetric analysis as per ASTM D6124-06.
• Physical Properties: Mechanical testing (tensile strength, elongation) as per ASTM D6319-10.
• Biocompatibility: In vitro or in vivo tests for toxicity, irritation, and sensitization as per ISO 10993 standards.

8. The sample size for the training set:

This is not applicable as the document does not describe an AI device with a training set.

9. How the ground truth for the training set was established:

This is not applicable as the document does not describe an AI device with a training set.

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The Halyard Pink Underguard Nittile Powder-Free Exam 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 the following chemotherapy drugs:

• · Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes
• · Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes
• · Bendamustine (5 mg/ml) No breakthrough up to 240 minutes
• · Bortezomib (Velcade) (1 mg/ml) No breakthrough up to 240 minutes
• · Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes
• · Busulfan (6 mg/ml) No breakthrough up to 240 minutes
• Carboplatin (10 mg/ml) No breakthrough up to 240 minutes
• Car-filzomib (2 mg/ml) No breakthrough up to 240 minutes
• Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes
• · Cisplatin (1 mg/ml) No breakthrough up to 240 minutes
• · Cladribine (1.0 mg/ml) No breakthrough up to 240 minutes
• · Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes
• · Cytarabine HCL (100 mg/ml) No breakthrough up to 240 minutes
• Cytovene (10 mg/ml) No breakthrough up to 240 minutes
• · Dacarbazine (10 mg/ml) No breakthrough up to 240 minutes
• · Daunorubicin HCL (5 mg/ml) No breakthrough up to 240 minutes
• Decitabine (5 mg/ml) No breakthrough up to 240 minutes
• Docetaxel (10 mg/ml) No breakthrough up to 240 minutes
• · Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes
• · Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes
• Etoposide (20 mg/ml) No breakthrough up to 240 minutes
• Fludarabine (25 mg/ml) No breakthrough up to 240 minutes
• · Fluorouracil (50 mg/ml) No breakthrough up to 240 minutes
• Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes
• · Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes
• Idarubicin (1 mg/ml) No breakthrough up to 240 minutes
• · Ifosfamide (50 mg/ml) No breakthrough up to 240 minutes
• Irinotecan (20 mg/ml) No breakthrough up to 240 minutes
• · Mechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutes
• Melphalan (5 mg/ml) No breakthrough up to 240 minutes
• · Methotrexate (25 mg/ml) No breakthrough up to 240 minutes
• · Mitomycin-C (0.5 mg/ml) No breakthrough up to 240 minutes
• · Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes
• Oxaliplatin (2 mg/ml) No breakthrough up to 240 minutes
• Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes
• Paraplatin (10 mg/ml) No breakthrough up to 240 minutes
• Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes
• Pertuzumab (30 mg/ml) No breakthrough up to 240 minutes
• Raltitrexed (0.5 mg/ml) No breakthrough up to 240 minutes
• · Retrovir (10 mg/ml) No breakthrough up to 240 minutes
• · Rituximab (10 mg/ml) No breakthrough up to 240 minutes
• · Temsirolimus (25 mg/ml) No breakthrough up to 240 minutes
• Trastuzumab (21 mg/ml) No breakthrough up to 240 minutes
• · Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes
• · Triclosan (2 mg/ml) No breakthrough up to 240 minutes
• Trisonex (1.0 mg/ml) No breakthrough up to 240 minutes
• · Vincrinstine Sulfate (1 mg/ml) No breakthrough up to 240 minutes
• Vinblastine (1 mg/ml) No breakthrough up to 240 minutes
• · Vinorelbine (10 mg/ml) No breakthrough up to 240 minutes
• · Zoledronic Acid (0.8 mg/ml) No breakthrough up to 240 minutes

CAUTION: The following chemotherapy drugs and concentration showed breakthrough detected in less than 240 minutes:

• Carmustine (3.3 mg/ml) No breakthrough up to 54.7 minutes
• · ThioTEPA (10 mg/ml) No breakthrough up to 128.5 minutes

Halyard® Pink Underguard Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs are disposable, pink-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non- sterile patient examination gloves that are packed in a cardboard dispenser box.

The device described is the Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Device: Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs

Detailed Study Information:

The provided document is a 510(k) Premarket Notification summary from the FDA, evaluating the subject device against a predicate device. The "studies" are in fact non-clinical performance tests conducted against recognized international standards and ASTM methods.

2. Sample size used for the test set and the data provenance

• ASTM D6978-05 (Chemotherapy Drug Permeation): The document does not specify the exact sample size (number of gloves or replicates for each drug) used for the permeation testing for the subject device. The predicate device tested 12 drugs, while the subject device tested 52 drugs. The data provenance is not explicitly stated as country of origin, but it is implied to be laboratory testing for regulatory submission in the US (FDA). The nature of these tests is prospective for the purpose of the submission.
• ASTM D5151-06 (Holes in Medical Gloves): The document does not specify the exact sample size. It states that testing "meets the 2.5% AQL requirement," which implies a sampling plan was used according to the standard, but the specific number of gloves tested is not provided. Data provenance is implied as laboratory testing.
• ASTM D6319-10 (Physical Properties): The document mentions average tensile strength and elongation values before and after aging. The sample size for these measurements (number of gloves or test specimens) is not specified. Data provenance is implied as laboratory testing.
• ASTM D6124-06 (Residual Powder): The document notes an "average of 0.4 mg/glove." The sample size for this average is not provided. Data provenance is implied as laboratory testing.
• ISO 10993-11 (Systemic Toxicity): The test specifies "ISO Systemic Injection Test in Mice." The number of mice used is not provided. Data provenance is implied as laboratory testing.
• ISO 10993-10 (Dermal Irritation): The test specifies "ISO Indirect Primary Skin Irritation Test in Rabbits." The number of rabbits used is not provided. Data provenance is implied as laboratory testing.
• ISO 10993-10 (Dermal Sensitization): The test specifies "ISO Kligman Maximization Test." The number of animals used is not provided. Data provenance is implied as laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of submission (510(k) for a medical glove) does not involve human expert interpretation of data in the way a diagnostic AI would. The "ground truth" for these tests are the objective measurements from laboratory instruments and observations by trained technicians following standardized protocols (e.g., timing of breakthrough, physical property measurements, biological responses in animal models). Therefore, there were no "experts" establishing ground truth in the context of radiologists or similar clinical experts.

4. Adjudication method for the test set

Not applicable. As described in point 3, these are objective laboratory tests against established standards. There is no subjective interpretation or adjudication process required between multiple human readers or experts for the test results.

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 non-diagnostic physical medical device (exam glove) and does not involve AI, human readers, or medical imaging, so an MRMC study is irrelevant here.

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

Not applicable. There is no algorithm or AI component to this medical device.

7. The type of ground truth used

The "ground truth" in this context refers to the directly measured and objectively determined results from standardized laboratory tests. These include:

• Direct measurement of permeation time: For chemotherapy drugs (ASTM D6978-05).
• Observed absence/presence of leakage: For holes (ASTM D5151-06).
• Direct physical measurements: Tensile strength, elongation, glove dimensions (ASTM D6319-10).
• Direct chemical measurement: Residual powder weight (ASTM D6124-06).
• In-vivo biological observations: Mortality, signs of systemic toxicity, irritation, dermal sensitization in animal models (ISO 10993-11, ISO 10993-10).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model, so there is no "training set." The product undergoes manufacturing processes, and quality control tests (which might involve some internal data collection over time) ensure consistency, but this is distinct from training an algorithm.

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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The Immediate Stabilizing Implant (ISI) is a one-piece threaded dental implant with the abutment incorporated into the design for a single stage surgical procedure. The implant is intended to be surgically placed in the bone of the upper or lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function. Immediate loading can be obtained if implants are rigidly splinted.

Self-tapping one-piece CP Titanium threaded dental implant, with a roughened surface treatment. Available in 3.25mm, 4.0mm, and 5.0mm diameter, and in lengths of 8mm 10mm, 12mm, 14mm & 16mm.

The provided document is a 510(k) Pre-Market Notification for a dental implant (Immediate Stabilizing Implant - ISI). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and performance metrics.

Therefore, the document does not contain the requested information regarding acceptance criteria and a study proving the device meets those criteria, as it's not a clinical study report. The information about sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training sets is typically found in documentation for devices that require extensive performance validation, often through clinical or non-clinical testing that directly measures performance against pre-defined criteria.

Instead, the document focuses on comparing the ISI device's design, function, labeling, material composition, and intended use to existing predicate devices to assert substantial equivalence.

Here's a breakdown of why the requested information is absent:

1. Acceptance Criteria and Reported Device Performance: These are usually established for new devices undergoing rigorous testing for safety and efficacy. For a 510(k), the "performance" is primarily assessed against the predicate device's characteristics and historical safety/effectiveness.
2. Sample Sizes and Data Provenance: This relates to clinical or analytical studies. The 510(k) summary provided does not describe such a study.
3. Number of Experts, Qualifications, Adjudication Method: These are elements of studies involving expert review, common for diagnostic or imaging devices. This is a physical implant, not a diagnostic tool.
4. MRMC Comparative Effectiveness Study: This is specific to diagnostic aids that influence human reader performance.
5. Standalone Performance: While aspects of a device's physical/mechanical performance might be tested, a "standalone" performance in the context of an algorithm's output (as typically asked) is not relevant here.
6. Type of Ground Truth: Ground truth (e.g., pathology, outcomes data) is used to validate the accuracy or effectiveness of a diagnostic or predictive device. For a dental implant, the "effectiveness" is determined by successful integration and function, which is typically demonstrated over time in clinical use, not usually by a single ground truth in a 510(k) submission.
7. Training Set Sample Size and Ground Truth for Training Set: These are concepts related to machine learning and AI, which are not applicable to the ISI dental implant.

In summary, the provided document demonstrates substantial equivalence based on a comparison to predicate devices, not through a study with defined acceptance criteria and performance metrics in the way a diagnostic or AI-powered device would.

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"O" Company's OCO Endosseous Implant is intended to be surgically placed in the bone of the upper or lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function.

OCO Dental Implant (5.0 mm Diameter)

I am sorry, but based on the provided text, I cannot extract any information regarding acceptance criteria, device performance, results of a study, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

The document is an FDA 510(k) clearance letter for a dental implant (OCO Dental Implant, 5.0mm Diameter). It primarily focuses on:

• Device Identification: Trade/Device Name, Regulation Number, Regulation Name, Regulatory Class, Product Code.
• Clearance Determination: States that the device is "substantially equivalent" to legally marketed predicate devices.
• Regulatory Compliance: Outlines requirements for annual registration, listing, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
• Contact Information: Provides contacts for labeling regulations, promotion/advertising, and general responsibilities.
• Indications For Use: Briefly describes the intended use of the dental implant.

There is no mention of any specific study conducted by the manufacturer, acceptance criteria for performance, or any data to demonstrate the device meets such criteria. The FDA's substantial equivalence determination for this type of device (a Class III endosseous implant) typically relies on demonstrating that the new device has the same intended use, fundamental technological characteristics, and safety and effectiveness as a predicate device, often without requiring an entirely new clinical study with performance metrics in a 510(k) submission.

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