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The NAVIRFA Scope is intended to provide physicians with the trajectory information of needle instruments when used in conjunction with medical ultrasound. Instruments used with the NAVIRFA Scope may include an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or an ablation needle.

The device is intended to be used interventional procedures that already use ultrasound devices for visualization. The device is intended for prescription use only.

The NAVIRFA Scope utilizes an optical camera and supporting software to integrate the trajectory information of needle instruments towards improving interventional procedures.

The NAVIRFA Scope is fixed onto an ultrasonic transducer. The camera observes and detects the motion of a needle with an attached tracking marker (NAVIRFA Tracking Kit). The needle position is calculated and mapped onto a real-time ultrasonic image via NAVIRFA software.

The NAVIRFA Scope is compatible with the existing ultrasound system Smartus Ext-1m/3m, TELEMED (K163121).

The information provided in the document focuses on the substantial equivalence of the NAVIRFA Scope to a predicate device, rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria for image analysis or diagnostic performance. Instead, it describes bench testing for performance characteristics, specifically accuracy, to support its intended use.

Here's a breakdown of the available information based on your request:

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

The document does not explicitly present a table of acceptance criteria followed by quantitative device performance against those criteria. It states: "Data of accuracy was collected and showing that the NAVIRFA Scope could accurately achieve its intended use." However, specific numerical values for accuracy or other performance metrics, and the acceptance thresholds for these metrics, are not provided.

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 mentions "Bench testing was conducted to evaluate the performance characteristics of NAVIRFA Scope." It does not specify the sample size (e.g., number of tests, number of needles, number of simulated procedures) used for this bench testing. There is no information regarding the data provenance (e.g., country of origin, retrospective or prospective nature) as it refers to bench testing rather than clinical 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)

This is not applicable as the testing described is "bench testing" and not a study involving human interpretation of medical images or diagnoses. Ground truth, in this context, would likely refer to engineered precision or known values in a laboratory setting, not expert consensus on medical findings.

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

This is not applicable for bench testing. Adjudication methods are typically used in clinical studies involving multiple human readers for diagnostic accuracy.

5. If a multi-reader multicase (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

The document explicitly states: "No clinical data was collected to support a substantial equivalence determination." Therefore, no MRMC comparative effectiveness study was conducted with human readers or AI assistance.

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

The document mentions "Bench testing was conducted to evaluate the performance characteristics of NAVIRFA Scope. Data of accuracy was collected and showing that the NAVIRFA Scope could accurately achieve its intended use." This bench testing would be considered a standalone performance evaluation of the device's ability to provide trajectory information, as it doesn't involve human interpretation loops. However, specific metrics of "standalone" performance are not quantified beyond a general statement of "accuracy."

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

Given it was "bench testing" for a needle tracking system, the ground truth would most likely be precisely measured or known physical positions and trajectories of needles in a controlled experimental setup, rather than expert consensus, pathology, or outcomes data, which are relevant to clinical diagnostic accuracy. The document does not explicitly state the specific method used to establish this ground truth.

8. The sample size for the training set

The document does not mention any training set size. The context is a 510(k) submission focused on substantial equivalence based on performance characteristics, and there is no indication that the device utilizes machine learning or AI that would require a distinct training set in the conventional sense for image interpretation. The "proprietary software algorithms" are used for optical detection and mapping, which may or may not involve machine learning models that require training data.

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

As no training set is mentioned or implied to be used for machine learning models that generate diagnostic outputs, this information is not provided.

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