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

The BD Contoured Base 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, base, and shield assembly. The BD Contoured Base Pen Needle is offered in a 32 gauge size and 4mm length. It is a single-use disposable device that is provided sterile. The BD Contoured Base Pen Needle is non-toxic and non-pyrogenic.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device: the BD Contoured Base Pen Needle. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through a full clinical trial with novel acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria in the context of a study definitively proving the device meets those criteria for novel performance. Instead, it describes how the new device is substantially equivalent to a previously cleared device.

However, I can extract the information related to the performance tests performed to demonstrate substantial equivalence, which can be seen as meeting "requirements" rather than "acceptance criteria" in the traditional sense of a novel device proving its efficacy.

Here's an interpretation based on the provided text, structured to answer your questions where possible, and noting when the information is not applicable (N/A) or not present in the document.

Device: BD Contoured Base Pen Needle (K182320)
Predicate Device: BD Nano™ Pen Needle (K162516)
Purpose of Submission: To demonstrate substantial equivalence of the subject device to the predicate device, especially considering modifications to components like the pen needle hub, inner needle shield, and outer cover.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present "acceptance criteria" in a typical quantitative sense (e.g., "sensitivity must be >X%"). Instead, it states that the device was tested per ISO standards, and the results "passed" or "successfully demonstrated the subject device has met the requirements." The acceptance criteria are implicitly defined by the standards themselves.

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

• Sample Size for Test Set: The document simply states "Testing" and lists the tests performed. It does not specify the sample sizes for any of the non-clinical functional performance or biocompatibility tests. These details would typically be in the full test reports referenced by the submission, but are not in this summary.
• Data Provenance: The document does not specify the country of origin of the data. Given it's a US FDA submission for a US-based company (Becton, Dickinson and Company, Franklin Lakes, New Jersey), it's highly likely the testing was conducted in the US or in labs compliant with US regulatory requirements, but this is not explicitly stated. The tests are described as non-clinical (lab-based) performance and biocompatibility testing, not human clinical data.

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

• This question is not applicable to this type of submission. The ground truth for functional performance (e.g., flow rate, dose accuracy) and biocompatibility is established by the physical and chemical properties of the device and its interaction with biological systems, as measured by standardized laboratory methods (ISO standards), not by human expert consensus or interpretation of images/data. Human experts would perform the tests and analyze the results, but they are not establishing a "ground truth" in the way a radiologist establishes disease presence for an AI algorithm.

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

• This question is not applicable as there are no human-interpretable "test sets" or "ground truth" established by multiple readers that would require adjudication. The testing is laboratory-based and objective against predefined ISO standard criteria.

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 question is not applicable. The device is a physical medical device (pen needle), not an AI algorithm. There was no MRMC study, and no human readers were involved in assessing performance or effectiveness in the context of AI assistance.

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

• This question is not applicable. The device is a physical medical device (pen needle), not an algorithm.

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

• The "ground truth" is defined by the physical and chemical specifications within the relevant ISO standards (ISO 11608-2 for functional performance and ISO 10993-1 for biocompatibility). For example, "Dose Accuracy" has a defined acceptable range within ISO 11608-2; the ground truth for a given test is whether the device's measured dose delivery falls within that range. For biocompatibility, the ground truth is adherence to established biological safety limits for materials and leachables.

8. The sample size for the training set

• This question is not applicable. The device is a physical product, not an AI model that requires a training set. The engineering design process involves iteration and verification, but it's not "training" in the machine learning sense.

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

• This question is not applicable as there is no "training set" in the context of this physical device.

Summary of what the document does provide:

• It demonstrates that the BD Contoured Base Pen Needle is substantially equivalent to its predicate by showing that, despite minor design changes, it meets the same functional performance and biocompatibility requirements as defined by relevant ISO standards (ISO 11608-2 and ISO 10993-1).
• It explicitly states that no clinical study was included in the submission, reinforcing that the demonstration of substantial equivalence relied solely on non-clinical (laboratory) testing.
• The "acceptance criteria" are implicitly the requirements of the cited ISO standards, which the device "passed."

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