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BD Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.

The BD Pen Needle is designed for use with pen injectors for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. It consists of a needle, hub, and shield assembly. The BD Pen Needle is offered in a variety of needle gauge sizes (29G, 30G, 31G, and 32G) and lengths (4mm, 5mm, and 12.7mm). It is a single-use disposable device that is provided sterile. The BD Pen Needle is non-toxic and nonpyrogenic.

The provided text is a 510(k) summary for the BD Pen Needle, which is a medical device. This document is a regulatory submission to the FDA, asserting that the device is substantially equivalent to previously cleared devices. It does not describe a study proving the device meets acceptance criteria in the manner of a clinical trial or a performance study with reported metrics and statistical analyses.

Instead, the document states that the device has the "same technological characteristics as the predicate devices" and that BD has "validated the design of the subject device as part of its design control process in accordance with the Quality System Regulation." It also mentions "functional performance per ISO 11608-2: Needle-based injection systems for medical use - Requirements and test methods- Part 2: Needles." However, no specific acceptance criteria or performance results are provided in the document.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The document refers to ISO 11608-2 but does not detail what specific tests were performed, what the acceptance criteria for those tests were, or what the device's performance results were.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not a study involving expert ground truth.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable, as this is a physical medical device.
9. How the ground truth for the training set was established: Not applicable.

Summary of what is stated in the document regarding testing:

• Testing performed: "functional performance per ISO 11608-2: Needle-based injection systems for medical use - Requirements and test methods- Part 2: Needles."
• Purpose of the testing: To validate the design as part of BD's design control process and to support the compatibility of its pen needle devices with "all leading diabetes pen injectors available on the market to ensure connectivity and dose accuracy."
• Conclusion of testing: "This testing demonstrates the BD Pen Needle device meet requirements for its intended use and supports the proposed clarification."

The document focuses on demonstrating substantial equivalence based on similar technological characteristics and adherence to quality systems and relevant standards, rather than providing detailed study results against specific acceptance criteria.

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The BD SafeAssist™ Pen Needle is intended for use with pen injector devices for the injection of drugs, including insulin and exenatide.

Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.

The BD SafeAssist" safety pen needle is designed for use with pen injectors for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. The BD SafeAssist™ features a 30G needle gauge size and is offered in needle lengths of 5mm and 8mm. It is a single-use disposable device that is provided sterile (gamma irradiation sterilization). BD SafeAssist™ is non-toxic and non-pyrogenic.

The BD SafeAssist is designed to reduce occurrence of accidental needle sticks from the patient end of the needle by providing a shield that locks over the needle after use. Prior to injection, the user will attach the BD SafeAssist" to the pen injector. The shield of the BD SafeAssist" will hide the needle prior to use. As the user presses the BD SafeAssist against the skin at a 90° angle, the shield retracts to expose the needle and allows it to penetrate the skin. After injection is completed and the BD SafeAssist" is removed from the skin, the shield extends automatically and locks in place to cover the needle. The locked shield is designed to reduce the occurrence of accidental needle stick injuries. The device also features a red band indicator which provides the user visual confirmation the needle's safety mechanism has been activated. The BD SafeAssist ""should be removed from the pen and discarded after use.

The BD SafeAssist™ device comprised of modifications to the BD AutoShield™ predicate cleared under K060007. These modifications consist of design, material and labeling changes.

This document is a 510(k) Pre-Market Notification for the "BD SafeAssist™ Pen Needle". It seeks to demonstrate substantial equivalence to legally marketed predicate devices. The information provided is for regulatory clearance, not a study evaluating human reader performance with or without AI assistance. Therefore, many of the requested fields are not applicable.

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

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

The document does not explicitly present a table of acceptance criteria with corresponding performance data in the traditional sense of a clinical study assessing diagnostic accuracy or similar metrics for an AI device. Instead, it outlines non-clinical performance testing to demonstrate that the device meets requirements for its intended use and is substantially equivalent to predicate devices. The "acceptance criteria" are implied by the standards and tests performed.

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 specify a "test set" in the context of an AI study (i.e., a dataset of images/cases for evaluating algorithm performance). The testing mentioned is for the physical device's functional, sterilization, and biocompatibility properties. Therefore, "sample size" would refer to the number of physical devices or materials tested for these engineering and biological properties, not a set of clinical data. This information (specific numbers of needles tested) is not provided in the summary.

Data provenance (country of origin, retrospective/prospective) is not applicable as this is not a study using patient 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)

Not applicable. "Ground truth" in the context of an AI system's performance on clinical data is not relevant here. The ground truth for the tests performed would be established by standard accredited laboratory testing methods for functional performance, sterility, and biocompatibility.

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

Not applicable. Adjudication methods are used in clinical studies or studies involving human interpretation of data. This document describes non-clinical laboratory testing.

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 device or a diagnostic device where human reader performance would be a relevant metric. The device is a "Hypodermic Single Lumen Needle" with a safety shield.

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

Not applicable. This device does not involve an algorithm.

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

The "ground truth" for the tests performed are objective measurements based on established scientific and engineering standards (e.g., ISO standards for injection systems, sterilization, and biocompatibility). It is determined by the results of controlled laboratory experiments and chemical/biological assays, rather than expert consensus on clinical findings or pathology.

8. The sample size for the training set

Not applicable. This device does not involve AI/machine learning, and therefore there is no "training set."

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

Not applicable, as there is no training set for an AI model.

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