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The hypodermic Pinpoint™ GT Needle is intended for the injection into or the withdrawal of body fluids from parts of the body below the surface of the skin. The needle is to be used with syringes for general purpose fluid injection. The needle tip is echogenic and may be used with ultrasound to provide a visual representation of the needle tip throughout the insertion, medication administration and aspiration process.

Bard Access Systems, Inc's hypodermic Pinpoint™ GT Needles are designed to inject medication or aspirate fluid. The hypodermic Pinpoint™ GT Needles contain a magnet which emits a passive magnetic field that can be detected by ultrasound systems equipped with Pinpoint™ GT Needle Technology. The hypodermic Pinpoint™ GT Needles, when used with an ultrasound system equipped with Pinpoint™ GT Needle Technology, creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion, medication administration and aspiration process. There are four (4) hypodermic Pinpoint™ GT Needle configurations included in this submission, as shown in the table below.

The provided document describes the hypodermic Pinpoint™ GT Needle and its journey through FDA 510(k) premarket notification. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new performance claim or the efficacy of an AI algorithm. Therefore, many of the requested elements pertaining to AI model validation (e.g., sample size for training set, number of experts for ground truth, MRMC study, effect size of AI assistance) are not applicable to this document.

The document outlines acceptance criteria primarily through a list of performance tests designed to show the device meets engineering and safety standards, and is substantially equivalent to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study (verification and validation tests) as provided in the document:

Acceptance Criteria and Reported Device Performance

The document states: "The subject device configurations met all predetermined acceptance criteria derived from the above listed verification tests and demonstrated substantially equivalent performance as compared to the cited predicate device."

This implies that for each performance test listed, there were predefined acceptance criteria, and the device successfully met them. However, the specific quantitative acceptance criteria and the numerical reported device performance are not explicitly detailed in the provided text. Instead, the document lists the types of tests conducted and the standards utilized, indicating that the device passed these tests.

Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The study design is described as "Verification and validation tests... designed and performed in accordance with Design Controls as per 21 CFR §820.30." The tests conducted are listed in the table above, referencing various ISO and ASTM standards, as well as USP standards and internal protocols.

Information Not Applicable or Not Provided in the Document:

Many of the requested details are specific to the validation of AI/ML algorithms and are not relevant to the approval of a physical medical device like this needle, which underwent a 510(k) submission based on substantial equivalence.

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

   • Sample Size: Not explicitly stated for each test, but implied to be sufficient for demonstrating compliance with the referenced standards (e.g., ISO, ASTM). The document lists four needle configurations (18G x 2.75", 19°; 21G x 3", 30°; 22G x 2", 30°; 24G x 1.5", 30°) which would have been tested.
   • Data Provenance: Not specified, but generally, device performance testing is conducted by the manufacturer (Bard Access Systems, Inc. in Salt Lake City, Utah) in controlled laboratory environments. This would be prospective testing on manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like a needle is established through engineering and material science measurements against predefined specifications, not expert consensus on interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for physical device testing. Test results are objective measurements against 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: Not applicable. This device is a hypodermic needle, not an AI diagnostic tool. The "echogenic" feature simply means it's visible on ultrasound, and the optional "passive magnet" feature works with a separate "Pinpoint™ GT Needle Technology" system (which is explicitly stated as "not the subject of this submission"). The needle itself does not involve AI assistance to human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device involved engineering specifications, material properties, and performance standards (e.g., tensile strength, dimensional accuracy, biocompatibility, leakage).

8. The sample size for the training set: Not applicable. There is no AI model being trained as part of this submission.

9. How the ground truth for the training set was established: Not applicable. There is no AI model being trained as part of this submission.

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