(70 days)
The Omnisonics Resolution® Thrombectomy System is intended for use in the treatment of thrombosed synthetic dialysis access grafts.
The Resolution Thrombectomy System is a portable acoustic energy system for the treatment of thrombosed synthetic dialysis access grafts. The system is comprised of three major components: (1) the disposable Resolution 360° Therapeutic Wire, (2) the reusable Handpiece/Cable Assembly, and (3) the multiuse Generator. Accessories include the Resolution Torque Wrench and Resolution Irrigation Tubing Set.
The provided text describes a 510(k) premarket notification for the OmniSonics Resolution® Thrombectomy System. This is a medical device, and 510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a standalone study with detailed performance metrics.
Therefore, the document does not provide the detailed information requested in your prompt regarding acceptance criteria, specific device performance numbers, sample sizes, expert qualifications, adjudication methods, or multi-reader multi-case studies.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" as clear quantifiable metrics for the device's performance. Instead, it claims "substantial equivalence" to predicate devices. The "performance" is generally described as:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices for Thrombus Removal | "demonstrated through clinical studies that the Resolution Thrombectomy System is substantially equivalent to the predicate devices with respect to removal of thrombus within synthetic dialysis access grafts" |
| Safety & Biocompatibility | "results of mechanical bench testing, biocompatibility testing and in vivo animal testing support that the Resolution Thrombectomy System is substantially equivalent to the predicate devices." |
2. Sample sized used for the test set and the data provenance
- Test set sample size: Not specified. The document only mentions "clinical studies" in a general sense.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified. The document does not detail how the results of the "clinical studies" were evaluated or by whom.
4. Adjudication method for the test set
Not specified.
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
Not applicable. This device is a thrombectomy system, not an AI-assisted diagnostic or imaging device. There is no mention of "human readers" or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (thrombectomy system), not an algorithm or software. It is intended for use by a clinician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not explicitly stated. Given the nature of a thrombectomy system, "outcomes data" related to successful thrombus removal and patient recovery would be the most relevant ground truth in a clinical study.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of what the document focuses on:
The document is a 510(k) summary, which aims to establish "substantial equivalence" to legally marketed predicate devices. It relies on:
- A comparison of technological characteristics (indications for use, sterilization methods, product design, materials, labeling, packaging, and principles of operation).
- General mention of "clinical studies" demonstrating equivalence in thrombus removal.
- "Mechanical bench testing, biocompatibility testing and in vivo animal testing" to support safety and equivalence.
It does not provide a detailed report of a clinical trial with specific performance metrics, sample sizes, or ground truth establishment methods typically associated with proving a device meets predefined acceptance criteria for novel performance claims.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).