(20 days)
The EleVation™ Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities.
The instrument 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 ELEVATION™ Breast Biopsy System is a handheld, self-contained, single insertion, multiple sample vacuum-assisted biopsy device and is intended to be used with ultrasound guidance. The device can obtain and store multiple samples with a single insertion probe. The components of the system are designed to operate safely when used together for diagnostic sampling a breast biopsy procedure. The device consists of a battery-powered, reusable driver and a disposable probe with a sample container.
I am sorry, but the provided text does not contain the information required to answer your request regarding acceptance criteria and a study proving a device meets them. The document is an FDA 510(k) clearance letter for the EleVation Breast Biopsy System, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Here's why the information you're looking for is not present:
- No Clinical Study Details: The document explicitly mentions "non-clinical tests" (e.g., Sampling Reliability, Prime/Pierce Reliability, System Lifetime Reliability, etc.) to demonstrate substantial equivalence. There is no mention of a clinical study involving human patients, AI assistance, human readers, or ground truth established by experts/pathology/outcomes data.
- No Acceptance Criteria Table with Performance: While "Performance Testing Summary" is a section, it lists the types of tests performed (e.g., "Sampling Reliability", "Needle Requirements") but does not provide quantitative acceptance criteria or corresponding reported device performance values for these non-clinical tests.
- No Information on AI/Human Reader Performance: The device is a mechanical biopsy system, not an AI-powered diagnostic tool. Therefore, questions about MRMC studies, human reader improvement with AI, or standalone algorithm performance are not applicable to this document.
- No Training/Test Set Details: Since no clinical study involving data sets is described, there's no information about sample sizes for training or test sets, data provenance, or methods for establishing ground truth.
In summary, this document is a regulatory clearance for a physical medical device based on non-clinical engineering and performance testing comparing it to a predicate device, not a report on a clinical trial or AI algorithm validation.
§ 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.