(119 days)
The Temno Elite Biopsy System is intended for use in obtaining biopsies from soft tissues such as liver, kidney,breast,prostate, spleen,lung,lymph nodes,thyroid,and various soft tissue masses. It is NOT intended for use in bone.
The Valved Coaxial Introducer Needle and Standard Coaxial Introducer Needles are intended for use as guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney,prostate,spleen, lung,lymph nodes,thyroid, and various soft tissue masses. It is NOT intended for use in bone.
The subject device is a single use full core biopsy device. It is available in several gauge sizes and lengths. The device has printed gauge size indicator that is color coded according to the various gauge sizes (yellow= 20G, pink= 18G, purple= 16 G, green= 14G, and blue=12G. The needles have a protective sheath.
The Temno Elite Biopsy system includes Biopsy device and has the option of including a Valved Coaxial Introducer Needle, or a Standard Coaxial Introducer Needle. The depth stop on both the Valved Coaxial Introducer Needle and the Standard Coaxial Introducer Needle is color coded to match the gauge size of the Temno Elite Biopsy system.
The Temno Elite Biopsy System is supplies sterile and is intended for single use only.
The provided text describes the Temno Elite Biopsy System, which is a medical device. The text focuses on the device's substantial equivalence to predicate devices, its indications for use, and the performance testing conducted to demonstrate its safety and efficacy.
However, the text does not contain any information about acceptance criteria and the study that proves the device meets those acceptance criteria in the context of an AI/human-in-the-loop system, image analysis, or diagnostic accuracy study. The device described is a physical biopsy instrument used for obtaining tissue samples from various soft tissues. The performance data presented refers to bench testing, biocompatibility, and sterilization, which are standard for physical medical devices, not for AI-powered diagnostic tools.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance using AI-specific metrics (e.g., sample size for test/training sets, ground truth establishment for AI, expert consensus, MRMC studies, standalone performance, effect size of human improvement with AI) because the provided document does not pertain to such a device or study.
The document discusses:
- Device: Temno Elite Biopsy System (a physical biopsy instrument)
- Indications for Use: Obtaining biopsies from soft tissues (liver, kidney, breast, prostate, spleen, lung, lymph nodes, thyroid, and various soft tissue masses).
- Acceptance Criteria/Performance Testing: These are related to the physical attributes and safety of the biopsy device itself, such as dimensional verification, tensile strength of joints, adjustable throw accuracy, multiple samples, device visibility, simulated use, biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity), and sterilization standards.
In summary, the provided text does not contain the information needed to answer the prompt regarding AI/imaging-related acceptance criteria and study data.
§ 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.