(85 days)
The SenoRx Biopsy Device System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
The SenoRx Biopsy Device is a percutaneous electrosurgical biopsy device which is indicated for use in providing breast tissue samples for diagnostic sampling of breast abnormalities under ultrasound guidance.
The provided text is a 510(k) summary for the SenoRx Biopsy Device System, which focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study.
Therefore, the document does not contain the requested information regarding acceptance criteria or a study proving the device meets them.
The 510(k) process primarily relies on demonstrating that a new device is "substantially equivalent" to an already legally marketed predicate device, meaning it has the same intended use and the same technological characteristics, or if it has different technological characteristics, that it does not raise new questions of safety and effectiveness and is as safe and effective as the predicate device.
Here's what can be inferred from the document regarding the information requested, and what is explicitly missing:
1. A table of acceptance criteria and the reported device performance
- Missing. The document does not define specific performance acceptance criteria for the SenoRx Biopsy Device System, nor does it report performance metrics against such criteria. The focus is on comparing its intended use, design, construction, materials, and technology to predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing. The document does not describe any clinical study or test set data. It's a regulatory submission for substantial equivalence.
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)
- Missing. As no clinical study or test set is described, there's no mention of experts or ground truth establishment for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing. No test set or related adjudication method is described.
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
- Missing. This type of study is entirely irrelevant to biopsy devices that provide tissue samples for diagnostic sampling. It's a concept typically associated with diagnostic imaging AI tools. The SenoRx device is for tissue acquisition, not image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The SenoRx Biopsy Device System is a percutaneous electrosurgical biopsy device, a physical instrument, not an algorithm. Standalone performance for an algorithm is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Missing. No ground truth is mentioned because no clinical study data is presented. The device's purpose is to provide tissue for histologic examination (pathology), which would then establish the diagnostic ground truth for the patient, but this is an outcome of using the device, not a metric by which the device itself is proven to meet acceptance criteria in this document.
8. The sample size for the training set
- Missing. As this is a physical medical device and not an AI/machine learning algorithm, the concept of a "training set" is not applicable in this context.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary of Document Content:
The document (510(k) K013641) states the following:
- Device Name: SenoRx Biopsy Device System
- Intended Use: To provide breast tissue samples for diagnostic sampling of breast abnormalities for histologic examination, with partial or complete removal of the imaged abnormality.
- Predicate Devices: Mammotome® Biopsy System (Ethicon Endo-Surgery) and Easy Guide™ Electrosurgical Access Device (SenoRx Inc.).
- Basis for Equivalence: The document asserts that the "intended use, design, construction, materials and technology are comparable to the predicate devices."
This is a standard 510(k) submission, where the primary goal is to demonstrate substantial equivalence to previously cleared devices, not to present a clinical study proving specific performance acceptance criteria for the new 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.