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The ROBOLITE is an automatic needle guidance system that provides means for accurate positioning of a biopsy needle of a mammography system, to enable accurate penetration to sites of detectable breast lesions.

The ROBOLITE is an automatic needle guidance system that provides means for accurate positioning of a biopsy needle of a mammography system, to enable accurate penetration to sites of detectable breast lesions. The ROBOLITE I S an attachment to and is mounted on a parent mammography system. It comprises a robotic biopsy unit and a film read out and motor control evaluation unit. After creating a stereotactic exposure of a previously detected breast lesion, the Robolite drives a needle holder along three orthogonal axes so that the needle penetrates the precise location of the lesion. The ROBOLITE can be used for fine for core biopsy by using the reqular needle aspiration (FNA) or carrier with a biopsy gun. needle with either plain film with a The ROBOLITE can be used X-ray or digital camera.

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The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria for the ROBOLITE device. The text primarily focuses on a summary of safety and effectiveness, a description of the device, and a comparison of its technological characteristics to a predicate device.

To answer your request, I would need a section of the document that specifically outlines:

1. Acceptance Criteria: Quantifiable benchmarks for performance (e.g., accuracy, precision, sensitivity, specificity).
2. Study Design and Results: Details of a study conducted to evaluate the device's performance against these criteria.

Without this information, I cannot generate the table or
address the specific questions about sample sizes, ground truth, expert involvement, or comparative effectiveness.

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I am sorry, but the provided text for the ABBOTT Advisor One-Step Pregnancy Test does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The text focuses on:

• A summary of safety and effectiveness.
• Trade name, common name, classification, and predicate device.
• Intended use and indications for the device.
• A brief physical description of the device.

To answer your request, I would need a section of the 510(k) summary (or a linked document) that specifically details:

1. Performance Metrics: Quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy against a reference method or expected hCG levels).
2. Clinical/Performance Study: A description of the study design, sample size, ground truth, and the results demonstrating that the device meets the stated criteria.

Without this information, I cannot create the table or address the specific questions you've posed.

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The ROBOGUIDE is an automatic needle guidanc system that provides means for accurate positioning of a biopsy needle of a mammography system, to enable accurate penetration to sites of detectable breast lesions. The Roboguide is an attachment to and is mounted on a parent mammography system. It comprises a robotic biopsy unit and a film read out and motor control evaluation unit. After creating a stereotactic exposure of a previously detected breast lesion, the Roboguide drives a needle holder along three orthogonal axes so that the needle penetrates the precise location of the lesion. The Roboguide can be used for fine needle aspiration (FNA) or tor core biopsy by interchanging its aspiration needle carrier with a biopsy gun holder carrier. The Roboguide can be used with either plain film X-ray or with a digital camera.

This document describes a device named ROBOGUIDE, an automatic needle guidance system for breast lesion biopsies. It is primarily a descriptive submission for substantial equivalence rather than a detailed study report with extensive performance metrics. Therefore, much of the requested information about acceptance criteria and study specifics is not explicitly provided in the given text.

Based on the provided information, here's what can be extracted and what cannot:

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

The provided text does not define specific, quantifiable acceptance criteria (e.g., accuracy thresholds, precision targets). It focuses on establishing substantial equivalence to predicate devices, implying that its performance is expected to be comparable to those devices.

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

This information is not provided in the given text. The document is a "Summary of Safety and Effectiveness" for a 510(k) submission, which often relies on comparison to predicate devices rather than new clinical study data for certain aspects. There is no mention of a specific test set, patient data, or study design.

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 information is not provided. As there's no described test set with ground truth establishment.

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

This information is not provided.

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 is not applicable and not provided. The ROBOGUIDE is described as an automatic needle guidance system, a robotic device for physical guidance, not an AI-assisted diagnostic or interpretive tool that would involve human readers improving with AI assistance. The device's function is to physically position a needle based on stereotactic localization, not to interpret images or assist radiologists in diagnostic tasks in a MRMC study context.

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

The concept of "standalone performance" in the context of an algorithm's diagnostic accuracy is not applicable here. The ROBOGUIDE is a physical robotic system. Its "performance" would likely be evaluated in terms of mechanical accuracy and precision of needle placement, not in terms of an algorithm's diagnostic output. The text does not describe any specific performance study results.

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

This information is not provided.

8. The sample size for the training set

This information is not provided. The device is a mechanical system, not a machine learning algorithm that typically requires a "training set."

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

This information is not provided. (See point 8 above).

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