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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 its 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 a stereotactic mammographic imaging system 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.

SiteSelect Breast Biopsy System consists of the SiteSelect device and the Site Select table mount accessories. We have previously received clearance under 510(k) # K972328 for the 10mm and 15mm SiteSelect device. We have since received clearance under 510(k) #K993963 to expand the intended use. The Instrument Accessories have received clearance under 510(k) # K972328 and are currently on the market.

The SiteSelect device is provided sterile for single use only. It contains a Localization Needle, Localization Wire, a Stylet, and Cutting Cannula. The device is equipped with a Garrote Wire and Disc Blades to transect the specimen. The device is packaged in individual thermoformed blisters with peel off Tyvek® lid.

Here's a summary of the acceptance criteria and the study backing the SiteSelect Breast Biopsy Device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided 510(k) summary (K011575) for the 22mm SiteSelect Breast Biopsy Device does not explicitly state pre-defined acceptance criteria in terms of specific numerical thresholds for performance metrics. Instead, the study's primary goal was to demonstrate comparability to a legally marketed predicate device (the 15mm SiteSelect device).

The "acceptance criteria" can be inferred from the stated conclusions: that the 22mm device is safe for its intended use, has accurate targeting of selected tissue, captures adequate tissue specimens for histological analysis, and is comparable to the 15mm SiteSelect device with no significant variances in key clinical categories.

Table of Acceptance Criteria and Reported Device Performance (Inferred):

Study Details:

This submission describes a clinical study comparing the new 22mm SiteSelect device to the existing 15mm SiteSelect device.

1. Sample Size used for the test set and the data provenance:

   • Test Set Size: A total of 50 procedures were completed, with 25 procedures using the 22mm device and 25 procedures using the 15mm device.
   • Data Provenance: The document does not explicitly state the country of origin. It is a prospective clinical study, as procedures were "completed" for the purpose of the comparison.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not provide details on the number of experts or their qualifications for establishing the "ground truth." However, it states that "Specimens were suitable for pathological analysis," implying that pathologists (experts) would have performed this analysis.

3. Adjudication method for the test set:

   • The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The "comparable" assessment likely refers to a direct comparison of the collected data points without explicit expert adjudication of conflicting results.

4. 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:

   • No. This was a clinical study comparing two medical devices for biopsy, not an AI-based imaging study involving human readers. Therefore, an MRMC study and AI-related effect sizes are not applicable here.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This device is a manual biopsy instrument and does not involve an algorithm. Its performance is directly tied to human use in a medical procedure.

6. The type of ground truth used:

   • The ground truth primarily relates to histological analysis of the tissue specimens obtained. The study also evaluated clinical parameters like targeting accuracy, pain, and follow-up appearance, which rely on direct observation and patient reporting during the procedure and follow-up visits.

7. The sample size for the training set:

   • This was a clinical study comparing a new device size to an existing one. It is not an algorithm development study, so the concept of a "training set" in the context of machine learning does not apply.

8. How the ground truth for the training set was established:

   • As this is not an algorithm development study, the concept of establishing ground truth for a training set is not applicable. The "ground truth" for the clinical study was based on the pathological analysis of the biopsy specimens and clinical observations during the procedures and follow-up.

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