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• · The Intact® Gen2 System is indicated to provide tissue sampling of breast abnormalities.
• · The Intact® Gen2 System is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.
• · The Intact · Gen2 System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
• The Intact Gen2 System is intended to preserve lesion architecture in samples with a diameter of 12–30 mm. .

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 highfrequency, vacuum-assisted electrosurgical device used to remove tissue by electrosurgical cutting and simultaneous capture of an incised tissue volume. The device includes the following components:

1. Probe/Wand
   Intact® Gen2 Probe/wand (Sizes: 12mm, 15mm, 20mm and 30mm)
2. Handle
3. Gen2 Controller with Power Cord and Foot Pedal
4. Table Mount
5. Cart

The provided text describes a 510(k) premarket notification for the Intact Gen2 System, which is a biopsy instrument. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than a study proving the device meets specific acceptance criteria based on diagnostic performance metrics. Therefore, many of the requested details about acceptance criteria, performance metrics (like sensitivity, specificity), ground truth, and expert involvement are not available in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a "Verification Testing Summary Table" for comparing the proposed Intact Gen2 System with its predicate device (Intact BLES System). The acceptance criteria are generally "Pass," indicating that the device met the requirements of the specified standards. The performance is reported as "Pass" for both the proposed and predicate devices in most categories, with comments often stating "Equivalent."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "extensive bench and animal testing" but does not specify the sample size used for these tests.
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data provided. The testing appears to be primarily laboratory-based (bench and animal testing).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not available in the provided text. Since the study focuses on engineering and performance characteristics (like energy delivery and thermal artifacts) using bench and animal models, the concept of "ground truth" established by clinical experts (like radiologists) for diagnostic performance is not applicable in the context described.

4. Adjudication Method for the Test Set

This information is not available. Given the nature of the testing described (bench and animal studies for electrosurgical properties), an adjudication method in the context of clinical interpretation by multiple readers is not relevant.

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

There is no mention of an MRMC comparative effectiveness study in this document. The device is a biopsy instrument, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is an electrosurgical biopsy instrument, not an algorithm, and it requires human operation.

7. The Type of Ground Truth Used

For the "Bench Performance Verification Test" and "Thermal Artifact Verification Testing," the ground truth implicitly refers to:

• Measurement of energy delivered to biopsy tissue samples.
• Assessment of thermal artifacts in biopsy tissue samples.
  These are objective, measurable physical properties, likely evaluated using standard laboratory techniques and instruments, rather than clinical ground truth like pathology or outcomes data. The document states the goal was to demonstrate equivalence to the predicate device in these aspects.

8. The Sample Size for the Training Set

This is not applicable. The device is a biopsy instrument and does not involve AI or machine learning models that require a "training set."

9. How the Ground Truth for the Training Set was Established

This is not applicable for the reasons stated above.

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• 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:

1. Probe/Wand
   (1a) Intact BLES Probe/wand
   (1b) Intact Advance BLES Probe/wand
   (1c) Intact Excise XL Probe/wand
2. Handle
   (2) The Intact BLES Handle
   (2a) Intact Excise XL Handle
3. Intact Medical ™ Model 3000 Controller
4. Controller Power Cord Footpedal
5. 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).
6. Vacuum Source
7. 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.

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).

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The Intact Excision XL is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.

The Intact® Excision XL is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.

The Intact Excision XL is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpable or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Intact System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histologic evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Not Found

This 510(k) summary for the Intact Excision XL device does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document is a standard 510(k) submission, primarily focusing on:

• Identifying the device and its manufacturer.
• Stating its intended use.
• Establishing substantial equivalence to predicate devices (Intact BLES and Intact® Advance).
• Providing the FDA's formal letter of clearance for marketing.

Therefore, I cannot provide the requested information from the provided text. The submission for this device did not include a new clinical study to demonstrate performance against specific acceptance criteria. Instead, it relies on substantial equivalence to existing legally marketed devices.

To answer your request, I would need a document detailing a clinical performance study with acceptance criteria.

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The intact™ BLES is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.

The intact™ BLES is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.

The intact™ BLES is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpable or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the intact™ BLES may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histologic evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Common or Usual Name: Electrosurgical Generator
Trade or Proprietary Name: intact™ Breast Lesion Excision System (BLES)
Classification Name: Electrosurgical Cutting & Coagulation Device & Accessories (21 C.F.R. § 878.4400) Biopsy Instrument (21 C.F.R. § 876.1075)

This document does not contain information on acceptance criteria or a study proving the device meets acceptance criteria. The provided text is a 510(k) summary for the intact™ Breast Lesion Excision System (BLES), detailing its name, submitter, predicates, and intended use. It also includes an FDA letter confirming substantial equivalence. There is no performance study data or acceptance criteria outlined.

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