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Clearview Plus Bone and Vertebral Body Biopsy Needles are intended for use by a physician performing bone or vertebral body biopsy using a coring (cutting) or aspiration technique.

The Clearview Bone and Vertebral Body Biopsy Needles consist of a cannula/stylet assembly in 11 and 13 gauge configurations. The needles have a useable length of 4.565 in (11.6 cm).

The modified Clearview Plus Bone and Vertebral Body Biopsy Needles consist of a cannula/stylet assembly and are available in an 11 gauge configuration. The additional components include:

• . 10cc VacLok syringe
• Luer cap .
• 13.5 gauge inner cannula (useable length 5.355 in, 13.6 cm) .

The needles useable length of 4.565 in (11.6 cm) is the same for the original design and for the modified design. The modified product and the original product are both provided sterile and for single use only.

This is a 510(k) summary for a medical device (Clearview Plus Bone and Vertebral Body Biopsy Needles), not a study demonstrating algorithm performance. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics for AI/ML devices is not applicable.

The document describes the device, its intended use, and argues for its substantial equivalence to a predicate device (Clearview Bone and Vertebral Body Biopsy Needles, K011206). Substantial equivalence means the device is as safe and effective as a legally marketed device that does not require premarket approval. The "acceptance criteria" here refers to the regulatory criteria for demonstrating substantial equivalence, not performance metrics of an algorithm.

Here's a breakdown of what information can be extracted or inferred based on the provided text, and what cannot:

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

The provided document does not contain quantitative acceptance criteria or performance data in the way one would expect for an AI/ML device. For a 510(k) submission like this, "acceptance criteria" would primarily relate to demonstrating that the new device shares the same intended use, technological characteristics, and safety/effectiveness profiles as a legally marketed predicate device. The "reported device performance" is essentially the finding of "substantial equivalence."

Acceptance Criteria for 510(k) (Inferred for this type of submission):

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

Not applicable. This is a 510(k) for a physical medical device, not an AI/ML algorithm that would undergo a test set evaluation. The decision of substantial equivalence is based on comparing the device and its documentation to a predicate, not on clinical performance data from a test set in the context of an algorithm.

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. No "ground truth" establishment in the context of an algorithm's performance on a test set is discussed. The "experts" involved would be the FDA reviewers and the manufacturer's regulatory team.

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

Not applicable. No test set for algorithm performance.

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 not an AI-assisted device.

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

Not applicable. This is a physical biopsy needle.

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

Not applicable. No ground truth in the context of an algorithm's performance. The "ground truth" for this submission is that the predicate device is already legally marketed and considered safe and effective.

8. The sample size for the training set

Not applicable. No training set for an algorithm.

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

Not applicable. No training set for an algorithm.

In summary, the provided document describes a regulatory submission (510(k)) for a physical medical device. It is not an AI/ML device and therefore the questions pertaining to acceptance criteria and study designs relevant to AI/ML algorithms are not applicable to this text. The "study" here is essentially the comparison and justification provided by the manufacturer (Parallax Medical, Inc.) to the FDA for demonstrating substantial equivalence to a predicate device.

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