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The BD U-500 Insulin Syringe is intended for the subcutaneous injection of U-500 insulin for patients requiring more than 200 units per day.

The U-500 Insulin Syringe is a standard single use 0.5mL plastic syringe intended for the injection of U-500 insulin into the subcutaneous tissue. It features a 31G needle and 6 mm needle length with unique U-500 scale markings on the syringe barrel. The U-500 syringe also features a green needle shield and a green U-500 symbol. It is a single use, sterile, nontoxic syringe. The fluid path of the syringe is sterile and non-pyrogenic.

This document pertains to a 510(k) premarket notification for a medical device, specifically the BD U-500 Insulin Syringe. The information provided describes the device, its intended use, comparison to a predicate device, and the non-clinical performance testing conducted to demonstrate substantial equivalence.

Here's an analysis of the provided text in relation to your request:

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

Other acceptance criteria for functional performance (from ISO 8537, but specific values not detailed):

• Device functional performance at time-zero and shelf-life (e.g., plunger force, break loose force, etc., though not explicitly stated with values in this summary). The summary states "met requirements."

Other acceptance criteria for various tests (specific values not detailed):

• Device material biocompatibility per ISO 10993-1. The summary states "met requirements."
• Human factor evaluations per ANSI/AAMI/IEC 62366-1. The summary states "met requirements."
• Device sterilization per ISO 11737. The summary states "met requirements."
• U-500 Insulin Stability. The summary states "met requirements."
• Extractables and Leachables Testing. The summary states "met requirements."
• Sterility Assurance Level (SAL): 10^-6. The summary states the subject device has an SAL of 10^-6, which matches the predicate.

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

The document primarily discusses non-clinical (laboratory) testing. It does not specify sample sizes (e.g., number of syringes tested) for each test or the country of origin of the data. The testing would be considered prospective, as it involves testing newly manufactured devices according to established protocols.

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 device is not an AI/ML or diagnostic device that requires expert review for "ground truth" establishment in the typical sense. The "ground truth" for the performance tests (e.g., volumetric accuracy) would be established by the physical measurements themselves, compared against the specified ISO standards.

Human factors evaluations (per ANSI/AAMI/IEC 62366-1) likely involved user studies or expert review to assess usability and identify potential use errors, but the number and qualifications of individuals involved in these evaluations are not specified in this summary.

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

Not applicable for this type of non-clinical device performance testing. Adjudication methods are typically used in clinical studies or for diagnostic/interpretive devices where expert agreement is needed to establish a reference standard.

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 physical medical device (insulin syringe), not an AI/ML-driven diagnostic or image analysis system. No "human readers" or "AI assistance" are involved in its performance assessment.

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

Not applicable. This is a physical medical device.

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

For the volumetric accuracy and other functional tests, the "ground truth" is defined by the objective, measurable criteria set forth in recognized international standards (e.g., ISO 8537) and internal company specifications. For biocompatibility, it's defined by ISO 10993. For sterility, it's defined by ISO 11737.

8. The sample size for the training set

Not applicable. This is a physical device, and the testing described is performance verification/validation, not the training of an AI/ML model.

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

Not applicable. As above, this document does not describe the training of an AI/ML model.

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