(268 days)
The Trilogy Tissue Marker is intended for use to attach to breast tissue at the surgical breast biopsy or percutaneous breast biopsy to radiographically mark the biopsy procedure, and be permanently visible under MRI, x-ray and ultrasound.
The Trilogy Tissue Marker is a sterile, single use device comprised of a disposable delivery device preloaded with a tissue marker. The disposable delivery device includes an introducer needle comprised of a plastic molded deployment handle, a thumb slide, a 14 ga. cannula with 1 cm depth marks and a push rod. The tissue marker is preloaded in the distal end of the cannula. Trilogy tissue markers are made of a non-resorbable polymer embedded with a nitinol shape, allowing for permanent visibility under ultrasound, x-ray, and MRI. This device offers the choice of three unique tissue marker shapes (i) Ring (ii) Cross (iii) Ribbon.
The provided document is a 510(k) summary for the Trilogy Tissue Marker. It details a comparison between the subject device and a predicate device (EasyMark™ Tissue Marker) to demonstrate substantial equivalence, rather than a study about acceptance criteria for an AI device. Therefore, much of the requested information regarding AI device acceptance criteria and study design is not available in this document.
However, I can extract the information related to the device performance and the testing conducted to support its substantial equivalence with the predicate device.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not detail specific quantitative acceptance criteria or performance metrics in a readily extractable table form. Instead, it lists the types of performance tests conducted and states that the device meets "all system requirements" and is "substantially equivalent" to the predicate device.
| Performance Test Category | Device Performance (as stated in the document) |
|---|---|
| Performance Testing – Bench | Confirmed to meet all system requirements and is substantially equivalent to the predicate device. |
| Accuracy of Marker Deployment | (Implicitly meets requirements for substantial equivalence) |
| Marker Deployment Force | (Implicitly meets requirements for substantial equivalence) |
| Usability of the Device | (Implicitly meets requirements for substantial equivalence) |
| Imaging Assessment | (Implicitly meets requirements for substantial equivalence) |
| Safety and Compatibility in Magnetic Resonance (MR) Environment | (Implicitly meets requirements for substantial equivalence) |
| Tissue Marker Migration Potential | (Implicitly meets requirements for substantial equivalence) |
| Delivery Device Cannula Tensile Test | (Implicitly meets requirements for substantial equivalence) |
| Delivery Device Push Rod Tensile Test | (Implicitly meets requirements for substantial equivalence) |
| Biocompatibility | (Meets requirements for substantial equivalence) |
| Sterilization | (Meets requirements for substantial equivalence) |
| Packaging | (Meets requirements for substantial equivalence) |
| Shelf Life | (Meets requirements for substantial equivalence) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample sizes used for the "Non-Clinical Bench Performance Testing." It also does not specify data provenance (e.g., country of origin or retrospective/prospective nature), as the testing appears to be primarily bench-based (laboratory testing).
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)
This information is not applicable and not provided. The study described is not a clinical study involving expert interpretation of medical images or data from human subjects. It focuses on the physical and functional aspects of a medical device (a tissue marker).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided, as the study is not an AI performance evaluation involving multiple readers or complex ground truth adjudication.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study relates to the performance of AI systems in assisting human readers, which is not the subject of this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
A standalone performance study of an algorithm was not done. This submission is for a physical medical device (tissue marker), not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically used in AI studies (e.g., expert consensus, pathology, outcomes data) is not directly applicable here. The "ground truth" for the bench performance testing of this physical device would stem from objective measurement standards and engineering specifications. For instance, "Accuracy of Marker Deployment" would be evaluated against designed specifications for marker placement, and "Tissue Marker Migration Potential" would be assessed against defined metrics for stability.
8. The sample size for the training set
This information is not applicable and not provided, as this is not an AI device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided, as this is not an AI device.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.