(191 days)
The NeoNavia biopsy system is intended for obtaining tissue samples from both breast lesions and axillary lymph nodes for diagnostic analysis of breast abnormalities.
The FlexiPulse and VacuPulse probes are intended to provide tissue from breast lesions and axillary lymph nodes for histologic examination.
The NeoNavia biopsy system is to be used only by healthcare professionals in hospitals or healthcare facilities.
NeoNavia® biopsy system is designed to obtain tissue samples from breast lesions or axillary lymph nodes for histological evaluation. The system is composed of a base unit, a driver and two different types of sterile single use probes. Each probe type (also referred to as needle) utilizes pulses with the intention to improve precision and control when inserting and positioning the biopsy needle in a suspicious lesion. NeoNavia® must be operated together with ultrasound imaging guidance.
The provided text does not contain information about the acceptance criteria or a study that specifically proves the device meets those criteria, as typically found in clinical performance studies of AI/ML devices.
The document is a 510(k) premarket notification summary for the NeoNavia Biopsy System, which is a medical device for obtaining tissue samples. The majority of the document focuses on comparing the NeoNavia Biopsy System to predicate devices and describes various performance testing categories (sterilization, biocompatibility, software, electromagnetic compatibility, bench testing, animal testing).
Here's what can be extracted based on the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or corresponding reported device performance metrics in the format of a table as typically seen for AI/ML device performance. Instead, it describes general performance testing conducted, indicating that the device "is substantially equivalent in terms of indications for use, technology and performance to the predicate devices."
The closest to "reported performance" is the mention of animal testing where "Biopsy samples from sheep and pigs were evaluated for biopsy sample quality (gross qualitative assessment and via histopathology), acute bleeding rate, and hematoma." However, no specific numerical results or target acceptance criteria for these evaluations are provided.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: For the animal testing, the document mentions "biopsy samples from sheep and pigs." However, the exact number of animals or the total number of biopsy samples taken is not specified.
- Data Provenance: The data comes from "animal testing" involving "sheep and pigs." No information regarding country of origin or whether it was retrospective or prospective is explicitly stated, though animal testing is inherently prospective experimentation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not state the number or qualifications of experts used to establish ground truth for the animal study. It mentions that biopsy samples were evaluated via "histopathology," which implies assessment by pathologists, but no further details are given.
4. Adjudication Method for the Test Set:
No adjudication method is described for the animal study or any other part of the testing mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No MRMC comparative effectiveness study is mentioned. This device is a biopsy system, not an AI/ML diagnostic aid that would typically involve human readers interpreting images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
This question is not applicable as the NeoNavia Biopsy System is a physical device (biopsy system) and not an AI algorithm. The software mentioned has a "Moderate" level of concern, but its performance is discussed in terms of general software guidelines, not in a standalone diagnostic capacity.
7. Type of Ground Truth Used:
For the animal testing, the ground truth for biopsy sample quality was established via histopathology.
8. Sample Size for the Training Set:
This question is not applicable as the document describes a physical medical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable.
§ 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.