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The device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. For breast biopsy this product is for diagnosis only - not for therapeutic use.

The PreciseCore™ Biopsy Device is a sterile, disposable device which features a stainless steel cutting cannula and stylet. The device is comprised of a plastic housing that contains the mechanically actuated components. The stylet of the device is stationary, therefore acquiring tissue without an advancement of the needle set beyond the visualized tip.

This 510(k) submission (K093399) for the PreciseCore™ Biopsy Device primarily focuses on demonstrating substantial equivalence to a predicate device through performance testing. However, it does not provide detailed acceptance criteria, specific performance metrics in a tabular format, or a comprehensive study report with the kind of information typically requested (e.g., sample sizes for different sets, ground truth establishment details, expert qualifications, MRMC studies).

Here's an analysis based on the provided text, highlighting what is and is not present:

Acceptance Criteria and Device Performance (Based on available information)

The document states: "Performance testing confirms that the quality of samples obtained with the PreciseCore™ Biopsy Device is equivalent to that of the predicate device." This implies the acceptance criterion was "equivalence in sample quality" to the predicate, but no specific metrics or thresholds are provided.

Missing Information (Based on the provided text):

The provided 510(k) summary does not contain the following details:

1. Sample sizes used for the test set and the data provenance: There is no mention of a specific clinical "test set" in terms of patient or tissue samples. The performance testing appears to be functional or mechanical, comparing the device's output (sample quality) to a predicate.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as there isn't a described "test set" requiring expert ground truth establishment in the context of clinical images or diagnostic outcomes. The "quality of samples" likely refers to characteristics like length, integrity, or cellularity, evaluated by laboratory personnel or pathologists, but no specifics are given.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for the reasons above.
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: This is not applicable. The device is a physical biopsy instrument, not an AI-powered diagnostic or imaging tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This is not applicable, as it is a physical biopsy device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): While the "quality of samples" would likely refer to histopathological evaluation, the specific method of establishing this ground truth for the comparison is not detailed.
7. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

Summary of Study (Based on provided text):

The submission relies on a "Performance Testing Summary" to demonstrate substantial equivalence.

• Study Design/Purpose: To confirm that the quality of samples obtained with the PreciseCore™ Biopsy Device is equivalent to that of the predicate device (K994272 – Promex Automated Core Biopsy Device, Inrad® AccuCore Single Action Core Biopsy Device, and US Biopsy SABD).
• Methodology (General): "Performance testing" was conducted. While no specifics are given, for a biopsy device, this typically involves mechanical testing (e.g., penetration force, firing reliability) and potentially benchtop testing on tissue phantoms or ex vivo tissue to assess core length, integrity, and cellular yield when compared to the predicate device.
• Data Provenance: Not specified, but likely laboratory/benchtop testing rather than clinical data from a specific country.
• Result: The testing "confirms that the quality of samples obtained with the PreciseCore™ Biopsy Device is equivalent to that of the predicate device."

Conclusion:

The K093399 submission successfully demonstrated substantial equivalence for the PreciseCore™ Biopsy Device by asserting that its performance testing confirmed sample quality equivalent to its predicate. However, it lacks the detailed breakdown of acceptance criteria, specific performance metrics, and clinical study information (like sample sizes, ground truth establishment, expert qualifications, or MRMC studies) that would be expected for an AI/ML device or a device requiring detailed clinical validation data. This is typical for 510(k)s for predicate-based medical devices where the equivalence is often shown through functional, mechanical, and benchtop testing rather than extensive clinical efficacy trials.

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