(91 days)
The Concorde Models Concorde ST Soft Tissue Biopsy Devices are intended for diagnostic sampling of soft tissue during soft tissue biopsy procedures. They are to be used for diagnostic purposes only and are not intended for therapeutic uses.
The Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices are indicated to provide soft tissue samples for diagnostic sampling of soft tissue abnormalities, including brostate, spleen, lymph nodes, and various other soft tissue abnormalities. They are designed to provide soft tissologic examination, with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from imaging appearance (ultrasound, radiographic, e.g., mammographic) of a soft tissue abnormality. 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.
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The provided text describes the FDA's 510(k) clearance for the TransMed7, LLC Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices. It focuses on regulatory and intended use information but does not contain any data or details regarding acceptance criteria, device performance, study design, or ground truth establishment for a medical device that utilizes artificial intelligence or machine learning.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as the necessary information is completely absent from the provided text.
The document is a standard FDA 510(k) clearance letter for a physical medical device (biopsy instruments), not an AI/ML-powered device. Information about acceptance criteria, performance studies, sample sizes, expert ground truth, or MRMC studies would typically be found in detailed premarket submission documents or clinical trial reports, which are not included here.
§ 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.