(38 days)
SiteSelect is a disposable, single use, diagnostic device used to obtain localized large core biopsies of breast tissue of a mammographic abnormality, identified by the placement of a needle/ localization wire, which is suspect to be malignant. The SiteSelect device is intended to provide tissue for histological examination with partial or complete removal of imaged lesions. The scope of a histological abnormality is not able to be determined from it's mammographic appearance. Therefore, it is essential that the tissue margins be examined for margin involvement and completeness of removal in cases where the tissue sample is not found to be benign.
SiteSelect is to be used in conjunction with stereotactic mammographic imaging systems capable of determining position of lesion within breast tissue.
This device is used in conjunction with the SiteSelect Instrument Accessories, which are mounted on a stereotactic table and used with a stereotactic mammographic imaging system.
The SiteSelect device, a disposable breast biopsy device, is substantially equivalent to like devices in commercial distribution. These devices are marketed by Imagyn Surgical and United States Surgical Corporation (USSC).
SiteSelect, Imagyn Surgical, and USSC devices are all used to obtain biopsies within breast tissue. These devices are used in conjunction with instrument accessories which are used to mount the devices on a stereotactic table. These devices are used with stereotactic mammographic imaging systems.
The construction, materials, sterilization, and method of operation of the SiteSelect devices are identical to the Imagyn Surgical SiteSelect devices currently on the market.
The major difference between SiteSelect and USSC ABBI devices is that the ABBI device removes tissue in route to and including the target area. The SiteSelect device obturates up to the lesion, leaving intact the tissue in route to the target area.
The provided text describes the SiteSelect breast biopsy device and its 510(k) submission for market clearance. It focuses on demonstrating substantial equivalence to existing devices and presents a clinical summary. However, it does not explicitly define acceptance criteria for device performance in the context of diagnostic accuracy, nor does it present a study specifically designed to prove the device meets such criteria with quantitative metrics like sensitivity or specificity.
The clinical summary describes the device's usage and outcomes in a patient cohort, but this is presented as an evaluation of the device for use in removing abnormalities for diagnostic evaluation, rather than a test against pre-defined performance thresholds.
Here's an analysis of the provided information, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit acceptance criteria are provided in the document for diagnostic performance metrics (e.g., sensitivity, specificity, PPV, NPV). The document's purpose is to demonstrate substantial equivalence and usability, not to establish diagnostic performance against specific targets.
The "device performance" in the clinical summary relates to the ability to obtain tissue and the subsequent histological findings.
| Acceptance Criteria (Not explicitly stated for diagnostic accuracy) | Reported Device Performance (Clinical Summary) |
|---|---|
| e.g., Sensitivity of X%, Specificity of Y% | 87 patients underwent SiteSelect stereotactic breast biopsy. |
| e.g., Successful tissue acquisition rate of X% | 12 patients (14%) were diagnosed with malignant lesions. |
| e.g., Margin status for malignancies | Of the 12 malignant lesions: 2 (16.7%) had negative margins, 7 (58.3%) had margin involvement, and 3 (25%) were undetermined. |
| All patients with malignancies were treated with a surgical procedure after the SiteSelect procedure. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 87 patients.
- Data Provenance: The study was a "multi-center, non-randomized study" collected from "3 sites." The country of origin is not specified, but the FDA submission suggests it was likely
conducted in the United States. The study was prospective as it involved patients undergoing procedures to evaluate the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used to establish the ground truth. It states that "malignant lesions" were "diagnosed," which implies pathological examination. The qualifications of these experts (e.g., pathologists) are not provided.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set. Diagnosis of malignancy would typically come from a pathology report, which serves as the ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described focuses on the device's ability to obtain biopsies and the subsequent diagnostic findings, not on comparing reader performance with or without AI assistance. The SiteSelect device is a physical biopsy tool, not an AI-assisted diagnostic tool for image interpretation.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, this is not applicable. The SiteSelect is a physical medical device (a disposable breast biopsy device), not an algorithm or AI. Therefore, a standalone study of an algorithm's performance is not relevant in this context. The clinical summary describes its use in conjunction with human healthcare providers.
7. The Type of Ground Truth Used
The ground truth for the diagnosis of malignancy was pathology (histological examination), as indicated by the statement "diagnosed with malignant lesions" and the subsequent "surgical procedure after diagnostic SiteSelect procedure," implying confirmation of the diagnosis.
8. The Sample Size for the Training Set
Not applicable. The SiteSelect device is a physical, disposable breast biopsy device, not a machine learning model or algorithm that requires a training set. The clinical study described is for evaluating the device's use in tissue acquisition and diagnosis in patients.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, this is a physical device, not an AI model, and therefore does not have a "training set" in the context of machine learning.
§ 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.