(77 days)
The Bard® Mission® Disposable Core Biopsy Instrument is intended for use in obtaining biopsy samples from soft tissues such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and various soft tissue tumors.
The subject device BARD® MISSION® Disposable Core Biopsy Instrument is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The plunger is color coded according to the various gauge sizes, e.g. yellow = 20 gauge, pink = 18 gauge, purple = 16 gauge, and green = 14 gauge.
The provided text describes the 510(k) submission for the Bard® Mission® Disposable Core Biopsy Instrument. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and biocompatibility.
Crucially, this document does not contain information about a study involving AI assistance, multi-reader multi-case (MRMC) studies, or the establishment of ground truth by human experts for an algorithm's performance. The device in question is a physical medical instrument for obtaining biopsy samples, not a diagnostic imaging AI or similar software.
Therefore, many of the requested criteria regarding AI performance, human reader improvement, expert consensus, and ground truth establishment for a diagnostic algorithm are not applicable to this document.
However, I can extract information related to the device's acceptance criteria and performance based on the non-clinical (bench) testing described in the 510(k) summary.
Here's a breakdown of the available information:
1. Table of acceptance criteria and the reported device performance:
The document states: "The subject device, BARD® MISSION® Disposable Core Biopsy Instrument, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."
While specific numerical acceptance criteria and their corresponding reported performance values are not explicitly detailed in a table, the document lists the in vitro tests performed and generally states that the device "performed as expected."
| Acceptance Criteria Category (Derived from Tests Performed) | Reported Device Performance |
|---|---|
| Number of Samples (ability to collect samples) | Performed as expected |
| Penetration Depths (accuracy of needle penetration) | Performed as expected |
| Stylet / Cannula to Handle Tensile Strength (durability) | Performed as expected |
| Corresponding Working Needle Length and Cutting Cannula OD, and Stylet/Cannula Working Needle Lengths (dimensional accuracy) | Performed as expected |
| Integrity of the Sterile Barrier (sterility maintenance) | Performed as expected |
| Performance After Ship Testing (durability during transport) | Performed as expected |
| Needle Protection After Shipping and Storage (safety and integrity) | Performed as expected |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact numerical sample sizes for each
in vitrotest. It broadly refers to "the subject device BARD® MISSION®" being tested. - Data Provenance: The tests are described as "in vitro tests," meaning they were performed in a lab setting (bench testing) rather than on human or animal subjects. The provenance is internal testing performed by C.R. Bard. The document does not specify a country of origin for these specific tests, but the submission is to the US FDA. The testing is
prospectivein the sense of being performed for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document describes the performance of a physical biopsy instrument through bench testing, not a diagnostic algorithm requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" for these engineering tests would simply be the objective measurements and adherence to specifications.
4. Adjudication method for the test set:
- Not Applicable. As above, this is about physical instrument performance tests, not diagnostic interpretations requiring adjudication.
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:
- Not Applicable. This is a physical core biopsy instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm.
7. The type of ground truth used:
- For the physical tests, the "ground truth" is based on engineering specifications, measurements, and established testing protocols (e.g., ISO 10993-1 for biocompatibility). There is no "expert consensus" or "pathology" in the sense of interpreting images for diagnosis.
8. The sample size for the training set:
- Not Applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an AI model.
In summary, the provided document focuses on the substantial equivalence of a physical medical device (biopsy instrument) based on non-clinical (bench) performance testing and biocompatibility, as opposed to the performance of a diagnostic AI algorithm.
§ 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.