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The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.

The BD Single Use, Hypodermic Syringe is a three-piece, sterile, single use hypodermic syringe with a 6% (Luer) male connector in 3ml, 5ml and 10ml Luer-Lok syringe sizes. The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The syringe barrel incorporates a male 6% (Luer) connector which is connectable to a compatible female 6% (Luer) connector. The modified BD Single Use, Hypodermic Syringe includes a new resin material in the barrel of the syringe. The syringe performance characteristics are equivalent to the predicate device.

The provided document describes the acceptance criteria and the study that proves the device meets those criteria for the BD Single Use, Hypodermic Syringe.

Here's the breakdown of the requested information:

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

The document states that the subject device met all predetermined acceptance criteria. The specific acceptance criteria are broadly described by the tests performed, and the reported performance is that the device performed in an equivalent manner to the predicate device and met the acceptance criteria.

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

The document does not explicitly state the sample sizes for each specific test (e.g., how many syringes were tested for "Break Out Force"). It mentions "design verification testing" for the performance tests and "biocompatibility evaluation" for the biological tests. The data provenance is not specified, but it can be inferred that these are prospective tests conducted on the newly designed device.

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

This information is not provided in the document. The tests performed are primarily engineering and biological tests, not clinical evaluations requiring expert interpretation of results in the traditional sense of medical image analysis or diagnostic studies. The "ground truth" here is established by adherence to recognized international standards (ISO, USP) and predefined performance specifications.

4. Adjudication method for the test set

This information is not applicable and therefore not provided. Given the nature of the tests (physical, chemical, biological), standard adjudication methods like 2+1 or 3+1 consensus, typically used for qualitative or subjective assessments (e.g., image interpretation), are not relevant. The results are quantitative measurements against predefined criteria or qualitative observations against biological safety standards.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for medical devices that involve human interpretation, particularly in diagnostic imaging and AI-assisted diagnoses. The BD Single Use, Hypodermic Syringe is a physical device for fluid aspiration/injection, and its evaluation does not involve human readers or AI assistance in this context. The document explicitly states: "Clinical testing was not required for this submission."

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

No, a standalone (algorithm only) performance study was not done. This device is not an algorithm or AI-driven system.

7. The type of ground truth used

The ground truth for this device is based on:

• Adherence to recognized international standards (e.g., ISO 7886, ISO 594, ISO 11137-2:2013, ISO 10993 series, USP ).
• Predetermined acceptance criteria for specific performance parameters (e.g., "Non-cytotoxic," "Non-hemolytic," "met acceptance criteria" for Acidity/Alkalinity/Extractable Metals).
• Equivalence to a legally marketed predicate device (K980987 BD Single Use, Hypodermic Syringe) in terms of intended use, materials, and performance characteristics.

8. The sample size for the training set

This information is not applicable and therefore not provided. This device is not an AI/ML model, so there is no concept of a "training set" in the context of its evaluation. The evaluation involves testing physical properties and biological compatibility.

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

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

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The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.

The BD Single Use, Hypodermic Syringe is a three-piece, sterile, single use hypodermic syringe with a 6% (Luer) male connector in 1ml Luer Slip. 3ml. 10ml and 20ml Luer Lok syringe sizes. The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. The syringe assembly consists of a lubricated plastic barrel with a graduated scale, a lubricated synthetic rubber stopper and a plastic plunger rod. The plunger rod is pulled along the inside of the barrel to aspirate fluids and pushed along the inside of the barrel to inject or expel fluids. The syringe barrel incorporates a male 6% (Luer) connector which is connectable to a compatible female 6% (Luer) connector. The BD Single Use, Hypodermic Syringe are provided sterile (EtO) in a syringe only configuration or with a hypodermic needle. The modified BD Single Use, Hypodermic Syringe includes a new resin material in the barrel of the syringe. The syringe performance characteristics are equivalent to the predicate device.

The provided document describes the FDA 510(k) summary for the BD Single Use, Hypodermic Syringe, focusing on its substantial equivalence to a predicate device. This is primarily a regulatory submission based on non-clinical testing and comparison to an existing device, rather than a study demonstrating clinical performance of a novel AI-powered device. Therefore, many of the requested categories related to AI studies (e.g., MRMC, standalone algorithm, training set size, expert qualifications for ground truth) are not applicable to this document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each non-clinical test. The testing was conducted by BD (Becton, Dickinson and Company) to demonstrate equivalence to a predicate device. The data provenance is internal testing performed by the manufacturer, likely in a controlled laboratory environment. The country of origin of the data is not explicitly stated but would be associated with BD's testing facilities. These were non-clinical tests, not involving human subjects or real-world patient data in the typical sense of a test set for an AI/algorithm.

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

Not applicable. For non-clinical tests like "Break Out Force" or "Cytotoxicity," the "ground truth" is established by the standardized test methods and their defined pass/fail criteria (e.g., ISO standards, equivalence to predicate device), not by clinical experts.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for clinical studies where subjective expert assessment is involved. For these non-clinical tests, the results are typically quantitative measurements compared against predefined criteria or the performance of a predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This document does not pertain to an AI device or an MRMC study. It is for a physical medical device (hypodermic syringe) demonstrating substantial equivalence through non-clinical testing.

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

No. This is not an AI/algorithm device.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on:

• Standardized Test Methods: Adherence to established international standards (e.g., ISO 10993 for biocompatibility, USP 151 for pyrogenicity).
• Predicate Device Performance: Demonstrating performance equivalent to the legally marketed predicate device (K980987 BD Single Use, Hypodermic Syringe).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

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The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.

The modified BD Single Use, Hypodermic Syringe is a three-piece single use, hypodermic syringe with a 6% (Luer) connector in 1ml Luer Slip, 3ml and 5ml Luer Lok and Luer Slip syringe sizes. The syringe assembly consists of a plastic barrel with a graduated scale, a synthetic rubber stopper, and a plastic plunger rod. The changes to the modified device from the predicate include a new synthetic stopper material and a new silicone based stopper lubricant formulation. The syringe performance characteristics are equivalent to the predicate device. The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.

The modified BD Single Use, Hypodermic Syringe are provided sterile, by either EO or an Irradiation sterilization method, in a syringe only configuration or with a pre-attached or side-by-side hypodermic needle.

The provided text describes a 510(k) summary for a BD Single Use, Hypodermic Syringe, focusing on its substantial equivalence to a predicate device and its performance characteristics. This is a medical device submission, and the "study" referred to is the design verification testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not explicitly stated in the provided text for each specific test. The document generally refers to "Design Verification tests" that were performed.
• Data Provenance: The tests were conducted as part of the "Design Verification testing" for the modified BD Single Use, Hypodermic Syringe. This is a prospective testing approach conducted by the manufacturer, Becton, Dickinson and Company, for a 510(k) submission in the USA (Franklin Lakes, NJ).

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

This section is not applicable to this type of device submission or the nature of the testing performed. The "ground truth" here is defined by meeting the specified ISO standards and biocompatibility criteria through objective physical and chemical testing, not by expert interpretation of complex data (like in image diagnosis).

4. Adjudication method for the test set

This is not applicable. The outcome of these tests are objective measurements and biological responses against defined standards, not subjective interpretations requiring adjudication.

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

This is not applicable. This submission is for a medical device (hypodermic syringe), not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI effectiveness are irrelevant here.

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

This is not applicable. As stated above, this is not an AI algorithm.

7. The type of ground truth used

The "ground truth" for the performance characteristics relies on:

• International Standards: Meeting the requirements and specifications defined by ISO 7886-1 and ISO 7886-2 for functional and chemical properties.
• Biocompatibility Standards: Meeting the criteria defined by various parts of ISO 10993 for biological safety.
• Predicate Device Equivalence: The tests also aimed to demonstrate equivalent performance to the predicate device (K980987).

8. The sample size for the training set

This is not applicable. This is not a machine learning or AI device that requires a training set.

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

This is not applicable. No training set was used.

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