(103 days)
- The Intact® BLES with Intact® Excision XL wand and handle is indicated to provide tissue sampling of breast abnormalities
- The Intact® BLES with Intact® Excision XL wand and handle is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality
- The Intact® BLES with Intact® Excision XL wand and handle is intended to histologic examination with partial removal of a palpable abnormality
- The Intact® BLES with Intact® Excision XL wand and handle is intended to preserve lesion architecture in samples with a diameter of 12-30mm
- The Intact® BLES with Intact® Excision XL wand and handle is indicated to provide tissue samples for diagnostic sampling of breast abnormalities
- The Intact® BLES with Intact® Excision XL wand and handle is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality
- The Intact® BLES with Intact® Excision XL wand and handle is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality
- The Intact® BLES with Intact® Excision XL wand and handle is intended to preserve lesion architecture in samples with a diameter of 12-30mm
The intent of the device is to be a biopsy tool to capture a sample of breast tissue in one intact sample to preserve the tissue architecture for histologic examination. The device is a high frequency, vacuumassisted electrosurgical devices used to remove tissue by electro-surgical cutting and simultaneous capture of an incised tissue volume. The devices include the following components:
- Probe/Wand
(1a) Intact BLES Probe/wand
(1b) Intact Advance BLES Probe/wand
(1c) Intact Excise XL Probe/wand - Handle
(2) The Intact BLES Handle
(2a) Intact Excise XL Handle - Intact Medical ™ Model 3000 Controller
- Controller Power Cord Footpedal
- Table Mount
(6a) Table Mount, BLES attaches the Intact BLES Handle to a stereotactic table (Fischer and Lorad mounts).
(6b) Table Mount, Excise XL attaches the Intact Excise XL Handle to a stereotactic table (Fischer and Lorad mounts). - Vacuum Source
- Cart
The provided document describes the Intact® BLES with Intact® Excision XL wand and handle, a device used for breast tissue sampling. It discusses the device's indications for use and presents a summary of clinical literature to support its effectiveness, particularly focusing on "Complete Excision Rates."
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" with specific numerical thresholds for performance metrics. Instead, it relies on a comparison to predicate devices and a summary of clinical literature demonstrating "Complete Excision Rates" as a surrogate measure.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (from literature review) |
|---|---|---|
| Complete Excision Rate (as a surrogate for preserving tissue architecture and permitting definitive diagnosis) | The device should demonstrate the ability to achieve complete excision of breast lesions at a rate comparable to or better than established literature and predicate benchmarks, suggesting effective tissue sampling for histologic examination and preservation of lesion architecture. The stated goal is to support "partial or complete removal of an imaged abnormality" and "preserve lesion architecture." | 76% (Total BLES across 5 studies) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The "test set" in this context refers to the aggregated patient population from the five clinical literature citations. The total sample size across these studies is 224 patients.
- Data Provenance: The document explicitly states "a tabular summary of representative medical literature documenting the use of the Intact® BLES with Intact® Excision XL wand and handle." This indicates that the data is retrospective, drawn from existing published or presented clinical studies.
- One citation (Whitworth, P - 2014) mentions "Presented at: Miami Breast Meeting 2014 - Publication pending," suggesting a recent presentation.
- Other citations date from 2011 and 2013.
- The country of origin is not explicitly stated for all studies, but some authors and conference names (e.g., Miami Breast Meeting, European Congress of Radiology) suggest international or US-based origins. However, this is not definitively specified for each study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not specify the number or qualifications of experts used to establish ground truth for the individual studies summarized in the literature review. The "Complete Excision Rate" as a performance metric implies that a definitive diagnosis (ground truth) was made through histologic examination of the biopsied tissue. This would typically be performed by pathologists. However, the details on the experts for each study are not provided in this regulatory submission summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method for establishing ground truth within the summarized studies. It is implied that standard pathological assessment was used for diagnosis.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not described in this document. This device is a biopsy instrument, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is a physical biopsy device, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable. The performance metric ("Complete Excision Rate") inherently involves the human skill of the operator using the device and subsequent human pathological review.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used to assess the "Complete Excision Rate" is histologic examination (pathology). The document explicitly states: "The Intact® BLES with Intact® Excision XL wand and handle is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality." It also notes, "Whenever breast tissue is removed, histologic evaluation of the tissue is the standard of care."
8. The sample size for the training set
The document does not describe a "training set" in the context of an algorithm. This device is a physical instrument, and its development would involve engineering design, bench testing, and clinical validation. The summarized literature represents clinical experience rather than a "training set" for an AI algorithm.
9. How the ground truth for the training set was established
As there is no "training set" for an algorithm described, this question is not applicable. The ground truth for the clinical data (which serves as evidence of performance) was established through histologic evaluation (pathology).
§ 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.