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The enCircle™ Localization Device is intended for localization of non-palpable breast lesions.

The enCircle™ Localization Device is a disposable instrument consisting of a curved localization element and a needle cannula delivery system. The device is used to localize non-palpable breast lesions to facilitate surgical excision of the lesions.

The enCircle™ Localization Device is intended for the localization of non-palpable breast lesions. The submission to the FDA focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving a specific performance metric against acceptance criteria in a clinical study.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not explicitly stated. The "Testing" section mentions "In-Vitro testing." This suggests a laboratory-based evaluation of the device's physical and functional characteristics, potentially involving a certain number of device units or simulations.
• Data Provenance: Not explicitly stated. The testing was "In-Vitro," meaning it was conducted in a controlled laboratory environment, not on human subjects. This type of testing typically wouldn't involve country of origin data or be classified as retrospective/prospective in a clinical sense.

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

• Not applicable. As the testing was "In-Vitro" and focused on device performance characteristics rather than diagnostic accuracy, there was no need for expert ground truth establishment in the traditional sense of clinical image interpretation or diagnosis.

4. Adjudication Method for the Test Set:

• Not applicable. There was no clinical ground truth to adjudicate.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. An MRMC comparative effectiveness study was not conducted or mentioned. The submission relies on "In-Vitro testing" for performance comparison, not a study involving human readers or clinical cases.

6. Standalone Performance Study:

• Yes, in spirit, but not as a typical clinical standalone study. The "In-Vitro testing" compared the "performance of the enCircle™ Localization Device" (algorithm only, if applicable to a physical device) against a predicate. However, it's not a standalone in the sense of an AI algorithm's diagnostic accuracy. It's a standalone evaluation of the physical device's function.

7. Type of Ground Truth Used:

• Performance characteristics (likely engineering specifications or functional outcomes). For "In-Vitro testing," the "ground truth" would be defined by the expected functional parameters of the device (e.g., successful deployment, consistency of deployment, mechanical integrity, material properties), often against predetermined engineering specifications or the performance of a predicate device. This is distinct from clinical ground truth like pathology or expert consensus on patient data.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical medical instrument, not an AI or machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there is no training set for this type of device.

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