(256 days)
To be used when stereotactically localized, large diameter, breast biopsies, identified by the placement of a needle localization wire, are desired for diagnostic sampling of a mammographic abnormality that is suspicious for malignant diseasc (i.e. usually BIRADS class 4 or 5). The ABBI* device is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of a histologic abnormality cannot be determined from its mammographic appearance. Therefore, the extent of removal of a mammographic abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled mammographic abnormality or the sampled tissue is not histologically benign, it is essential that the tissue margins be examined for completeness of removal.
The device is available in 5, 10, 15 and 20mm diameters. Device diameter should be matched to desired diameter of tissue sample for diagnosis.
The Auto Suture* ABBI* System uses stereotactic mammography to target non-palpable breast abnormalitics for biopsy. The system includes a disposable biopsy device, which uses a circular scalpel and elcctrocautcry snare to excise a diagnostic sample for diagnosis.
Here's an analysis of the acceptance criteria and study details for the Auto Suture* ABBI* System based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Endpoint: Successful histological diagnosis | 106 of 106 (100%) complete procedures were successful for a histological diagnosis. |
| Secondary Endpoint: Removal of mammographically visible abnormality | 106 of 106 (100%) procedures were successful in terms of removing a mammographically visible abnormality that had been radiographically marked for the purpose of diagnosis. |
| Secondary Endpoint (Specificity): Complete removal of mammographically visible abnormality | 102 of 106 (96.2%) procedures were completely removed, as verified by the presence of the lesion in the specimen radiograph and by its absence in the patient's post-operative mammogram of the biopsy site. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 106 patients.
- Data Provenance:
- Country of Origin: Not explicitly stated, but the submission is to the U.S. FDA, suggesting the study likely took place in the USA or North America.
- Retrospective or Prospective: Prospective study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth for the test set. However, the study focuses on "histological diagnosis" and "mammographically visible abnormality," implying the involvement of:
- Pathologists: For histological diagnosis.
- Radiologists: For identifying and confirming the removal of mammographically visible abnormalities.
4. Adjudication Method for the Test Set:
The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1) for the test set. The outcomes appear to be derived from clinical practice and standard diagnostic procedures (histological examination, mammographic review).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The Auto Suture* ABBI* System is a device for tissue excision, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone (algorithm only) performance study was not done. The ABBI* System is a physical biopsy device used by a clinician, not an algorithm operating independently. The study evaluates the device's clinical performance in human-led procedures.
7. The Type of Ground Truth Used:
The ground truth used was based on:
- Histological Examination: For diagnosing benign or malignant lesions, and determining margin status.
- Radiographic Confirmation: Via specimen radiographs and post-operative mammograms to verify the removal of the mammographically visible abnormality.
8. The Sample Size for the Training Set:
This information is not provided in the document. As this is a medical device for biopsy, not a machine learning algorithm, the concept of a "training set" for an algorithm is not directly applicable. The study data represents an evaluation of the device's performance in a clinical setting.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no mention of a "training set" in the context of an AI/machine learning model for this medical device. The "ground truth" during the clinical study was established through standard medical diagnostic procedures (histology and radiology) as described in point 7.
§ 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.