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TarqoBeam is an aiming device intended to be used to verify and control correct angulation of interventional -----devices such as needles used in CT- or MRI-quided punctures, biopsies, and related procedures.

The TargoBeam is an aiming device which utilizes lasers to precisely place the correct angulation and position on interventional device such as a biopsy an needle.

Here's an analysis of the provided text regarding the TargoBeam device's acceptance criteria and study information.

It's important to note that the provided documents are a 510(k) summary and an FDA clearance letter from 1997. These documents are primarily focused on demonstrating substantial equivalence to pre-existing devices, rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics in the way modern device submissions often do.

Based on the provided text, the specific details regarding acceptance criteria and a structured study proving device performance are not explicitly available in the format requested. The documents emphasize substantial equivalence to predicate devices rather than meeting a pre-defined performance threshold through a dedicated study.

However, I can extract the available information and highlight what is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: There are no quantitative acceptance criteria (e.g., accuracy +/- X degrees, success rate > Y%) or quantified performance metrics (e.g., "The device achieved an average angular deviation of 0.5 degrees, meeting the acceptance criterion of < 1 degree"). The assessment is qualitative and comparative.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size for Test Set: Not specified. The document does not describe a formal "test set" in the context of a clinical performance study.
• Data Provenance: Not specified. There is no mention of a study involving patient data, either retrospective or prospective, or country of origin. The submission relies on a comparison to predicate devices and a description of the device's technical characteristics and intended use.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  As no formal test set or ground truth establishment process is described for performance, experts for this purpose are not mentioned. The "experts" involved would likely be the FDA reviewers assessing the substantial equivalence.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set requiring expert adjudication for ground truth is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned or implied in the provided documents. The focus is on device features and comparison to predicates.
• Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable. The TargoBeam is a physical aiming device, not an AI-assisted diagnostic or interventional tool for image interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance Study: Not applicable. The TargoBeam is an aiming device that inherently requires human interaction for its use in guiding interventional procedures. It is not an "algorithm only" device.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly defined or used in the context of a performance study in these documents. The "ground truth" for the submission is primarily the established performance and safety of the predicate devices and the technical specifications of the TargoBeam itself.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. As the TargoBeam is a physical device and not an AI/machine learning model, there is no "training set" in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.

Summary of what's provided vs. requested:

The provided documents are a regulatory submission for substantial equivalence for a physical medical device from 1997. The requirements for such submissions at that time, and for this type of device, differ significantly from the detailed clinical performance studies, AI model validation, and specific quantitative acceptance criteria that are often expected for newer, more complex devices, especially those incorporating AI or novel clinical pathways.

The "study" that proves the device meets the acceptance criteria in this context is the 510(k) submission itself, which argues that the TargoBeam is functionally equivalent, equally safe, and equally effective to legally marketed predicate devices, and therefore acceptable for market. No specific standalone clinical trial data with defined acceptance criteria and performance results are presented in these particular documents.

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