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Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

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

Bleomycin Sulfate (15.0 mg/ml)
Busulfan (6.0 mg/ml)
Carboplatin (10.0 mg/ml)
Cisplatin (1.0 mg/ml)
Cyclophosphamide (20.0 mg/ml)
Cytarabine (100.0 mg/ml)
Dacarbazine (10.0 mg/ml)
Daunorubicin HCl (5.0 mg/ml)
Docetaxel (10.0 mg/ml)
Doxorubicin HCl (2.0 mg/ml)
Epirubicin HCl (2.0 mg/ml)
Etoposide (20.0 mg/ml)
Fludarabine (25.0 mg/ml)
Fluorouracil (50.0 mg/ml)
Gemcitabine (38.0 mg/ml)
Idarubicin HCl (1.0 mg/ml)
Ifosfamide (50.0 mg/ml)
Irinotecan (20.0 mg/ml)
Mechlorethamine HCl (1.0 mg/ml)
Melphalan (5.0 mg/ml)
Methotrexate (25.0 mg/ml)
Mitomycin C (0.5 mg/ml)
Mitoxantrone HCl (2.0 mg/ml)
Paclitaxel (6.0 mg/ml)
Rituximab (10.0 mg/ml)
Trisenox (1.0 mg/ml)
Vincristine Sulfate (1.0 mg/ml)

The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml) : 33.8 minutes Thiotepa (10.0 mg/ml) : 128.1 minutes

Warning: Not for Use with: Carmustine, Thiotepa

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) is a Class I, patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff and single use only.

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) with sizes Medium, Large, X-Large and XX-Large are included in the submission.

The provided text describes the acceptance criteria and performance of the Nephron Nitrile Powder-Free Nitrile Examination Gloves.

Here's the requested information:

1. A table of acceptance criteria and the 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)

The document does not explicitly state the sample sizes for each test in the level of detail (e.g., number of gloves tested for each specific property or chemotherapy drug). It only refers to compliance with the standards (e.g., AQL 2.5 for freedom from holes).

The data provenance (country of origin, retrospective/prospective) is not mentioned. These are bench tests, not human trials or medical imaging data.

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 document describes bench testing of physical and chemical properties of gloves, not expert interpretation of medical images or clinical data.

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

This information is not applicable. The tests are laboratory-based and follow standardized testing protocols, which do not typically involve adjudication methods like those used for expert review of clinical cases.

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

This information is not applicable. The document describes the testing of medical examination gloves, which are physical products, not AI systems or medical imaging devices. Therefore, MRMC studies and AI assistance are irrelevant.

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

This information is not applicable. The document describes the testing of medical examination gloves, which are physical products, not algorithms.

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

The "ground truth" for these tests is defined by the technical specifications and performance requirements outlined in the referenced ASTM and ISO standards. For example:

• Physical properties (length, width, thickness, tensile strength, elongation) are measured objectively against defined numerical limits.
• Freedom from holes is assessed against an Acceptable Quality Limit (AQL), a statistical measure.
• Resistance to chemotherapy drugs is measured by detecting breakthrough time using specific analytical methods defined in ASTM D6978.
• Biocompatibility tests (irritation, sensitization, cytotoxicity, systemic toxicity) are assessed by observing biological responses in animal models or in vitro systems against established criteria for non-irritancy, non-sensitization, and non-toxicity according to ISO standards.

Essentially, the "ground truth" reflects compliance with regulatory and industry standards for glove performance and safety.

8. The sample size for the training set

This information is not applicable, as this is not a machine learning model.

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

This information is not applicable, as this is not a machine learning model.

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This sterile, single-use device is intended to be used as an accessory to medicinal nonventilatory nebulizers for respiratory therapy or for tracheal irrigation or lavage therapy.

This device is not intended for parenteral use or for preparations intended for parenteral use.

The subject device is 3mL or 5 mL Sodium Chloride Inhalation Solution USP, 0.9%. The single-use device is a color-coded (pink) blow-fill-sealed, low density polyethylene (LDPE) vial containing sterile, preservative-free, clear, colorless, aqueous solution as labeled for inhalation therapy (respiratory therapy and tracheal lavage. For respiratory therapy, Sodium Chloride Inhalation Solution USP, 0.9% is used for dilution of solutions used in nebulizers. The product contains 0.9% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives.

The provided documentation is a 510(k) premarket notification summary for Sodium Chloride Inhalation Solution USP, 0.9% manufactured by Nephron Pharmaceuticals Corporation. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing extensive clinical study results as would be required for a novel device.

Therefore, the study design and acceptance criteria outlined in the original request (which are typically for demonstrating device performance against specific metrics) are not applicable in the context of this 510(k) submission.

Here's an explanation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable.
This 510(k) is based on demonstrating substantial equivalence to predicate devices, not on meeting specific performance acceptance criteria from a clinical study. The document states: "Clinical testing is not necessary to show substantial equivalence for either safety or efficacy of intended use to the predicate devices as there are several various in vitro analytical methods (assay; fill uniformity; sterility; container integrity) and physical-chemical characteristics (solution properties; unit configuration) available which demonstrate this equivalence."

The "performance" cited is related to meeting USP monograph requirements and container criteria, not clinical outcomes.

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

Not Applicable.
No clinical test set was used for a performance study. Testing involved "various in vitro analytical methods" and analysis of "physical-chemical characteristics" to demonstrate equivalence to USP standards and predicate devices. The document does not specify sample sizes for these in vitro tests, nor is data provenance (country of origin, retrospective/prospective) relevant to these types of tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable.
No clinical test set requiring expert ground truth establishment was conducted. The equivalence is based on meeting established USP monograph criteria and comparison to predicate devices.

4. Adjudication Method for the Test Set

Not Applicable.
No clinical test set requiring adjudication was conducted.

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

Not Applicable.
No MRMC study was performed as this is a pharmaceutical accessory device, not a diagnostic or AI-assisted device. The concept of human readers improving with AI assistance is not relevant here.

6. Standalone (Algorithm Only) Performance Study

Not Applicable.
This device is a saline solution, not an algorithm or AI-based system. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

Not Applicable.
For this 510(k) submission, the "ground truth" equivalent would be the USP monograph criteria for Sodium Chloride Inhalation Solution USP, 0.9% and the established characteristics of the predicate devices. The device's components and solution are substantiated to meet these criteria.

8. Sample Size for the Training Set

Not Applicable.
There is no "training set" in the context of a 510(k) for a medical device accessory like a saline solution. The relevant "training" relates to the manufacturing process adhering to cGMP and meeting USP standards.

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

Not Applicable.
As explained above, there is no training set in the AI/machine learning sense. The "ground truth" for the device's characteristics is established by existing USP monographs and regulatory standards for pharmaceutical manufacturing and quality control, which the device aims to meet.

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To be used in conjunction with a nebulizer, the contents of these vials are for the induction of sputum production where sputum production is indicated.

The subject devices are 4mL Sodium Chloride Inhalation Solution USP, 3%, 7% or 10%. The single-use devices are a clear blow-fill-sealed, low density polyethylene (LDPE) vials containing sterile, preservative-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. Sodium Chloride Inhalation Solution USP, 3%, 7% or 10% are used in conjunction with a nebulizer. The product contains 3%, 7% or 10% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives.

The provided text is a 510(k) summary for Sodium Chloride Inhalation Solution USP, 3%, 7%, and 10%. This document is for a medical device (a saline solution for nebulizers) and primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study of the device's diagnostic or predictive capabilities.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets the acceptance criteria are not applicable in this context. The information provided heavily emphasizes that clinical testing was not necessary because the device's equivalence could be shown through in vitro analytical methods and physico-chemical characteristics.

Here’s a breakdown based on the provided text, indicating where information is not applicable:

1. A table of acceptance criteria and the 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)

• Not Applicable. The submission states: "Clinical testing is not necessary to show substantial equivalence for either safety or efficacy of intended use to the predicate devices as there are several various in vitro analytical methods (assay; fill uniformity; sterility; container integrity) and physical-chemical characteristics (solution properties; unit configuration) available which demonstrate this equivalence." Therefore, there was no "test set" in the context of clinical or diagnostic performance evaluation with human data. The "testing" referred to in the document is for product specifications and quality control.

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. No clinical or diagnostic test set was used requiring experts to establish ground truth.

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

• Not Applicable. No clinical or diagnostic test set was used.

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 not a diagnostic device involving human readers or AI.

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

• Not Applicable. This is not a device with an algorithm for standalone performance.

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

• The "ground truth," in the context of this device, refers to established USP monograph requirements and container criteria. The device is evaluated against these pre-defined specifications rather than a ground truth derived from clinical outcomes or expert consensus on patient data.

8. The sample size for the training set

• Not Applicable. There was no training set in the context of machine learning or diagnostic algorithm development. The "training" for this device would refer to the processes and controls for manufacturing and testing to meet specifications.

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

• Not Applicable. No training set was used. The "ground truth" (USP specifications, etc.) is established by recognized pharmacopeia and regulatory standards.

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