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The BD Plastipak™ Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.

The BD Plastipak™ Syringe is a three-piece, single use, sterile, hypodermic syringe with a 6% (Luer) male connector in 20 mL and 50 mL eccentric luer slip tip configurations. The BD Plastipak™ 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 BD Plastipak™ Syringe is provided sterile by Ethylene Oxide Gas (ETO) sterilization method.

The provided text is a 510(k) Clearance Letter for a medical device (BD Plastipak™ Syringe). It details the device's characteristics, intended use, and comparison to a predicate device. However, it does not describe an AI/ML-driven medical device or a study involving human readers or expert consensus for ground truth establishment.

The document discusses bench performance testing and biocompatibility tests for a physical device (syringe), not a software or AI-based diagnostic tool. Therefore, many of the requested criteria (like sample size for test/training set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types) are not applicable to this specific submission.

Despite the irrelevance of some questions to the provided document, I will structure the answer based on the questions asked, indicating "Not Applicable" or providing the information that is present in the document.

Here's an analysis of the provided 510(k) clearance letter in the context of the requested information about acceptance criteria and study data:

This 510(k) clearance letter pertains to a physical medical device, the BD Plastipak™ Syringe, not an AI/ML-driven diagnostic or image analysis tool. As such, many of the typical acceptance criteria and study methodologies applicable to AI models (e.g., ground truth established by experts, MRMC studies, training/test set sizes for algorithms, human reader improvement with AI assistance) are not relevant or described in this document.

The "study" referenced in the document primarily consists of non-clinical performance and biocompatibility testing to demonstrate the substantial equivalence of the new syringe (with a changed barrel resin) to a previously cleared predicate syringe.

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "The subject device met all the predetermined acceptance criteria for the above listed performance and biocompatibility tests." However, it does not explicitly list the quantitative acceptance criteria or the specific numerical performance results for each test. It only lists the tests performed and the standards they adhere to.

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

• Sample Size for Test Set: Not specified in the provided document. The tests are "bench performance testing" on various syringe units.
• Data Provenance: Not specified, but generally, bench testing for physical devices is conducted in a controlled lab environment by the manufacturer. It is non-clinical.
• Retrospective or Prospective: Not applicable for this type of physical device testing.

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

• Not Applicable. Ground truth for this physical device testing is established through standardized laboratory test methods and measurements against international or internal specifications, not by human experts interpreting clinical data.

4. Adjudication Method for the Test Set

• Not Applicable. (See point 3)

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. This is not an AI/ML device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or is relevant.

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

• No. This is not an AI/ML device. Therefore, no standalone algorithm performance was assessed. The performance tests are for the physical syringe itself.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on measurements against established engineering specifications and international standards (e.g., ISO, ASTM, USP) for physical and material properties (e.g., force, leakage, volume accuracy, biocompatibility reactions). It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device. There is no concept of a "training set" in the context of the reported non-clinical bench testing for a physical syringe.

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

• Not Applicable. (See point 8)

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The BD Plastipak ™ Syringe is intended for single use by health care professionals for general purpose fluid aspiration/injection.

The 3mL and 20mL BD Plastipak™ Syringe is a three-piece, single use, sterile or bulk non-sterile (BNS) hypodermic syringe with Luer Slip or male 6% (Luer Lock) connection, which are connectable to a compatible female 6% (Luer) connector. The syringe assemblies consist of a lubricated polypropylene barrel with a graduated scale, a lubricated thermoplastic elastomer stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The barrel scale of the BD Plastipak™ Syringe incorporates a scale graduated in units of milliliters.

The BD Plastipak™ Syringe is provided sterile by Irradiation or Ethylene Oxide Gas (EtO) sterilization methods in a syringe only configuration or with a BD Hypodermic Needle, BD SafetyGlide™ Hypodermic Needle or BD Eclipse™ Hypodermic Needle. The BD Plastipak™ Syringe is also provided in a bulk nonsterile, syringe only configuration.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the BD Plastipak™ Syringe.

Here's a 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

The document does not specify the exact sample sizes for each test in the test set. It mentions "non-clinical/design verification testing" was performed, indicating a test set was used to verify each of the listed criteria against the established standards (e.g., ISO, USP). The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature, but it implies internal testing by Becton, Dickinson and Company.

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 "ground truth" for this type of device (syringe) is typically established by adherence to recognized international and national standards (ISO, USP, PH Eur.) rather than expert consensus on individual cases.

4. Adjudication method for the test set

This information is not applicable and not provided. The testing involves objective measurements against established standards, not interpretation by experts 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

A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices involving human interpretation (e.g., medical imaging AI), which is not the nature of a syringe.

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

This is not applicable as the device is a physical medical instrument (syringe), not an algorithm or AI system. The tests are focused on the physical and functional performance of the syringe.

7. The type of ground truth used

The ground truth for this device's performance is based on established international and national standards and specifications, such as ISO 7886 (Syringes for medical use), ISO 11135 (Sterilization of health care products - Ethylene oxide), ISO 11137 (Sterilization of health care products - Radiation), ISO 10993 (Biological evaluation of medical devices), USP (United States Pharmacopeia), and PH Eur. (European Pharmacopoeia). These standards define acceptable parameters and testing methodologies.

8. The sample size for the training set

This information is not applicable. The BD Plastipak™ Syringe is a manufactured medical device, not a machine learning model, so there is no "training set" in the context of data for an algorithm. The design and manufacturing process would involve internal testing and validation, but not a training set as understood in AI/ML.

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

This information is not applicable for the reasons stated in point 8.

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