(24 days)
The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
The device is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed 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 Sanarus Centrica Rotational Core Biopsy System consists of a sticking probe, tissue cutter, control unit and specimen container. The sticking probe is operated by the control unit and utilizes cold temperatures at its tip to enqage the tissue to be sampled. The tissue cutter is coaxially mounted around the sticking probe and is used to core the tissue specimen. The tissue cutter will be available in several gauge sizes and lengths.
Here's an analysis of the provided text regarding the Sanarus Centrica™ Rotational Core Biopsy System, addressing your specific questions.
Important Note: The provided text is a 510(k) premarket notification for a medical device. These notifications generally focus on demonstrating substantial equivalence to a predicate device, rather than comprehensive de novo clinical studies with detailed acceptance criteria and performance metrics against a gold standard. Therefore, some of your requested information (like specific effect sizes for MRMC studies, acceptance criteria for algorithm-only performance, and detailed sample sizes for training sets) might not be explicitly present or will be framed in the context of equivalence rather than absolute performance.
Acceptance Criteria and Study Details for the Sanarus Centrica™ Rotational Core Biopsy System
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (Reference to Predicate) |
|---|---|
| Equivalence in Sample Quality (Implicit) | "Testing confirms that the quality of samples obtained with the Sanarus Centrica Rotational Core Biopsy System is equivalent to the predicate device." |
| Same Indications for Use (Explicit) | "The Sanarus Centrica Rotational Core Biopsy System has the same indications for use... as the predicate device." |
| Similar Technological Characteristics (Explicit) | "The Sanarus Centrica Rotational Core Biopsy System has... technological characteristics as the predicate device." |
| Same Patient Contact Components & Materials (Explicit) | "The patient contact components and component materials for obtaining core biopsy samples in both the new and predicate device are the same." |
| Equivalent Packaging & Sterilization (Explicit) | "The packaging materials, packaging configurations, sterilization methods and sterility assurance level are also equivalent." |
| No New Questions of Safety & Effectiveness (Implicit) | Based on the above points, "does not raise significant new questions of safety and effectiveness." |
Explanation: The "acceptance criteria" here are primarily focused on demonstrating substantial equivalence to a previously cleared predicate device (Sanarus Core Tissue Biopsy System, K021137). There are no specific quantitative performance metrics (e.g., sensitivity, specificity, or specific tissue yield) provided for the new device on its own, beyond the qualitative statement of "equivalent" sample quality. The study's main goal was to show that the new device is as safe and effective as the predicate.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated in the provided text. The text only mentions "Testing confirms" without detailing the size of the test samples or the number of biopsies conducted.
- Data Provenance: Not explicitly stated. There is no mention of the country of origin of the data or whether it was retrospective or prospective. Given the nature of a 510(k) for a biopsy device comparing to a predicate, it's likely pre-clinical (e.g., bench testing, cadaveric, or animal studies) or a limited clinical comparison, but the specifics are not disclosed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. If histological sample quality was assessed, it would typically involve pathologists, but their number and specific qualifications are not mentioned in this summary.
4. Adjudication Method for the Test Set:
- Not explicitly stated. There is no information provided about how any disagreements in assessment of sample quality (if such assessments were made by multiple experts) were resolved.
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:
- No, an MRMC comparative effectiveness study was not done.
- No effect size could be determined as this is a biopsy device, not an AI-powered diagnostic imaging tool involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone (algorithm only) study was not done. This device is a mechanical biopsy system; it does not involve an algorithm or AI.
7. The Type of Ground Truth Used:
- The primary "ground truth" reference appears to be the performance of the predicate device. The study aims to demonstrate that the new device's "quality of samples" is "equivalent" to that obtained by the predicate device.
- For assessing the quality of the bioptic samples themselves, it is highly probable that histology/pathology would be the ultimate ground truth, as the device's purpose is to "provide breast tissue samples for diagnostic sampling... for histologic examination." However, the text does not detail the specific assessment methodology.
8. The Sample Size for the Training Set:
- Not applicable/Not explicitly stated. This is a mechanical device, not a machine learning algorithm that requires a "training set" in the context of AI. The "testing" mentioned is likely related to engineering specifications and performance characteristics, and comparative sample quality.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As noted above, there is no "training set" in the sense of an AI model for this device.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.