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510(k) Data Aggregation
(100 days)
THE ROBOGUIDE
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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.
| Acceptance Criteria (Inferred/Generic) | Reported Device Performance |
|---|---|
| Accurate positioning of biopsy needle | Not explicitly quantified in terms of specific metrics (e.g., error margin in mm). The text states, "the Roboguide drives a needle holder along three orthogonal axes so that the needle penetrates the precise location of the lesion." This implies accuracy is expected. |
| Use for FNA or core biopsy | "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." |
| Compatibility with X-ray/digital camera | "The Roboguide can be used with either plain film X-ray or with a digital camera." |
| Stereotactic identification | "All three units employ stereotaxis to identify the location of a breast lesion..." |
| Breast compression and immobilization | "All three units have means for compressing and immobilizing the breast during the procedure." |
| Safety mechanisms | "All three units employ safety mechanisms to assure no movement of the needle carrier during biopsy needle injection." |
| Substantial equivalence to predicate devices (Cytoguide, Mammoquide) | "The ROBOGUIDE is substantially equivalent to a combination of the Cytoguide manufactured by Phillips Medical and the Mammoquide manufactured by Elscint Ltd." and "The biopsy units of the ROBOGUIDE and the Mammoguide are identical." "The differences between the systems raise no new issues of safety or effectiveness." |
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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