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MammoSTAR Biopsy Site Identifier is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future surgical procedures.

MammoSTAR Biopsy Site Identifier is a sterile, single use tissue marker consisting of pyrolytic carbon coated zirconium oxide discrete marker e that is visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT) as well as ultrasound and Magnetic Resonance Imaging (MRI) incorporated into lyophilized BiomarC Delivery Gel. MammoSTAR is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.

Based on the provided FDA 510(k) clearance letter, the "MammoSTAR Biopsy Site Identifier" is cleared without new device performance data. The clearance is based on the device being identical to its predicate device (K100994) with only one difference being an added contraindication and an extended shelf life, which was verified through testing. Therefore, there is no specific performance data from a new study presented in this document to describe or prove the device meets acceptance criteria.

The document indicates that no new performance data was required because the device is deemed identical to the predicate device, and thus, already meets the established criteria for safety and effectiveness based on the predicate's clearance.

Here's an attempt to answer your request based on the information provided and inferred within the document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this 510(k) is a "Change Being Effected (CBE) determination" where the device is considered identical to its predicate except for an added contraindication and an extended shelf-life, explicit "acceptance criteria" and "reported device performance" from a new study are not provided for the claims of equivalency in the typical sense. Instead, the acceptance criteria are implicitly met by being identical to the predicate device, which was previously deemed safe and effective.

The only "performance" mentioned that might resemble a test is the shelf-life verification.

Regarding the study proving the device meets acceptance criteria:

The document explicitly states: "No new performance data is required to support this Change Being Effected (CBE) determination." and "no clinical study is deemed necessary to support this Change Being Effected (CBE) determination since substantial equivalence has been sufficiently demonstrated."

Therefore, there is no new study described in this document that proves the device meets (newly established) acceptance criteria. The clearance is based on the device being substantially equivalent to a legally marketed predicate device (K100994) which has already met these criteria. The only change mentioned that involved verification was the extended shelf-life from 6 months to 60 months, which "has been verified." The details of this verification study (e.g., methodology, results) are not provided in this document.

Given this, the following points cannot be answered from the provided text as they relate to a new study that doesn't exist for this 510(k) submission:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. No new test set or data provenance is mentioned for device performance.

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)

• Not applicable / Not provided. No new ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided. No test set or adjudication method is described.

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

• No. This device is an "Implantable Clip" and a "Biopsy Site Identifier," not an AI diagnostic/imaging device. Therefore, an MRMC study with AI assistance is not relevant to this product.

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

• No. This is a physical implantable device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable / Not provided. No new ground truth is described.

8. The sample size for the training set

• Not applicable / Not provided. As this is not an AI/machine learning device, there is no training set mentioned.

9. How the ground truth for the training set was established

• Not applicable / Not provided. As this is not an AI/machine learning device, there is no training set mentioned.

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