(88 days)
The Rubicor Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedure. The Rubicor Breast Biopsy Device is to be used for diagnostic purposes only and is not intended for therapeutic uses.
Rubicor Breast Biopsy Device
The provided text describes the 510(k) premarket notification for the Rubicor Breast Biopsy Device, focusing on its substantial equivalence to predicate devices rather than detailed performance studies with acceptance criteria, human readers, or ground truth.
Therefore, many of the requested categories cannot be populated from the given information.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not specify quantitative acceptance criteria for the device's performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC). Instead, it refers to general safety and effectiveness.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device materials meet biocompatibility standards. | "The materials used in the Rubicor Breast Biopsy Device meets the requirements of ISO 10993-1." (Implicitly, this is met). |
| Effectiveness: Device can perform its intended function of diagnostic sampling of breast tissue. | "Results of in-vitro testing demonstrate that the Breast Biopsy Device is safe and effective for its intended use." (General statement, no specific metrics provided). |
| Substantial Equivalence: Device is substantially equivalent to legally marketed predicate devices. | "Based on the intended use, product, performance and biocompatability information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices." (FDA concurred as per the letter). |
2. Sample size used for the test set and the data provenance
- The document mentions "in-vitro testing," but does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document as it focuses on device functionality and material safety, not diagnostic performance studies involving expert interpretation of results for ground truth.
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 device is a biopsy device, not an AI diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers using this device is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a biopsy device, not an algorithm or AI. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The text states "Results of in-vitro testing demonstrate that the Breast Biopsy Device is safe and effective for its intended use." This implies ground truth would be related to the physical characteristics of the tissue samples obtained (e.g., size, integrity, ability to be pathologically analyzed), but the specific type of ground truth (e.g., histological verification of tissue presence, size of biopsy core, cellular viability) is not detailed. It is not a diagnostic device relying on expert consensus or pathology on images, but a device to acquire tissue for pathology.
8. The sample size for the training set
- Training set information is not applicable as this is a physical medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Ground truth for a training set is not applicable for this physical device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.