Search Results

The Triopsy Biopsy System (instrument and needles) is intended for use in obtaining biopsies from the prostate.

The Triopsy Medical Actuator and Biopsy Needle is comprehensive system that aids in the diagnosis and treatment planning of prostate cancer. The system utilizes an actuator instrument and biopsy needle (disposable) with the intention of gathering prostate tissue and properly identifying its pathology. The needle collects full-length, unbroken apex-to-base core samples with patented ridges that hold and protect the sample's integrity. The actuator allows for variable sample lengths for each area of the prostate to be biopsied increasing accuracy and patient safety by avoiding under or overshooting.

This FDA 510(k) summary describes the Triopsy Biopsy System, consisting of the Triopsy Actuator and Triopsy Biopsy Needles, intended for obtaining prostate biopsies. The submission leverages a comparison to a predicate device, the Bard Magnum Reusable Core Biopsy Instrument & Bard Magnum Disposable Biopsy Core Needle (K934370 & K934371), to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a table of acceptance criteria with corresponding performance metrics in a clear, quantitative manner. Instead, it lists performance requirements that were verified and states that the device "successfully passed all of the results."

Inferred Acceptance Criteria based on the provided text:

The document concludes that the device is "safe, effective, and performs as well or better than the predicate device," and that "technological differences do not introduce or raise new or different questions of safety and effectiveness."

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

The document does not specify the sample size used for the verification and validation (V&V) testing (e.g., how many biopsy procedures were simulated, how many actuations were performed for mechanical durability, or how many users participated in human factors studies).

The data provenance is also not explicitly stated in terms of country of origin or whether studies were retrospective or prospective. Given the nature of performance testing (mechanical, human factors), these are typically prospective studies performed in a controlled environment (e.g., a lab or simulated clinical setting).

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

The document does not mention the use of experts to establish a ground truth for the non-clinical and human factors studies described. These types of tests typically rely on objective measurements and established standards rather than expert consensus on diagnostic outcomes. For pathological evaluation of biopsy samples, there is no mention of experts, suggesting the focus was on the physical characteristics of the sample (e.g., full-length, unbroken) rather than the diagnostic accuracy of the device in a clinical context.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method as it pertains to expert reviews of images or data to establish ground truth. The testing mentioned (depth projection, mechanical durability, etc.) would be assessed against predefined engineering specifications and performance targets, not requiring an adjudication process.

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

An MRMC comparative effectiveness study was not conducted, or at least not described in this 510(k) summary. These studies typically assess human reader performance with and without AI assistance, which is not relevant to the mechanical and usability testing described for this biopsy system.

6. Standalone Performance Study

A standalone performance study was not conducted in the sense of an algorithm-only performance to derive diagnostic metrics like sensitivity or specificity. The device is a mechanical biopsy system, not an AI or imaging-based diagnostic algorithm. The "standalone" performance here refers to the device's ability to consistently perform its intended mechanical functions (e.g., penetration, sample extraction) and meet safety requirements. The document indicates that the device's performance requirements were verified through performance testing.

7. Type of Ground Truth Used

For the non-clinical tests:

• Engineering specifications and objective measurements were used as the "ground truth" to verify performance criteria such as depth projection, mechanical durability, penetration, activation force, and sample extraction.
• For human factors studies, the "ground truth" was likely the successful and safe completion of tasks by intended users in simulated clinical scenarios, as evaluated against predefined usability criteria.

There is no mention of pathology, outcomes data, or expert consensus serving as a ground truth for diagnostic accuracy, as this submission focuses on the safety and performance of the biopsy instrument itself, not its diagnostic outcome directly.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to this submission, as the Triopsy Biopsy System is a mechanical device, not a machine learning or AI-driven system that requires training data.

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

As noted above, a training set is not applicable, so the establishment of ground truth for a training set is not relevant to this submission.

Ask a specific question about this device