(28 days)
Intended to implant fiducials under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.
The modified EchoTip® Ultra Fiducial Needle is generally identical to the cleared predicate device. The modified device is also composed of a delivery system (i.e., needle, sheath, handle, and stylet) with four pure gold fiducials preloaded and secured within a laser-cut track in the needle. The needle is dimpled to enhance its echogenicity, allowing the user to target tissues using endoscopic ultrasound guidance. The needle stylet is advanced to deploy the fiducials. Once deployed, the fiducials are permanent implants that serve as radiopaque reference points for future therapeutic procedures. The Intended Use and Indications for Use are identical in the modified device as is the fundamental operating principle. Modifications to this iteration of the device include minor dimensional, geometric and tolerance adjustments.
The provided text is a 510(k) summary for a medical device (EchoTip Ultra Fiducial Needle) and a clearance letter from the FDA. This type of submission is a premarket notification to demonstrate that the device is substantially equivalent to a legally marketed predicate device, rather than a clinical study proving performance against explicit acceptance criteria for a novel device.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria in the context of an AI/human-in-the-loop system. The device described is a physical medical instrument, not an AI or software device that would typically have acceptance criteria for performance metrics like accuracy, sensitivity, or specificity.
Here's why the requested information is not present:
- Acceptance Criteria and Reported Device Performance: This device is undergoing a 510(k) submission, which focuses on demonstrating "substantial equivalence" to a predicate device, not on meeting specific performance acceptance criteria for a novel technology. The "Discussion of Tests and Test Results" section states that "Cook conducted verification and validation testing specific to the risks identified to ensure that risks were mitigated and the device continued to perform as intended," but it does not list specific numerical performance criteria or results.
- Sample Size and Data Provenance (for a test set): Not applicable, as there's no diagnostic AI algorithm being tested on a "test set" of data. The "tests" mentioned are likely engineering and bench tests for the physical device.
- Number and Qualifications of Experts for Ground Truth: Not applicable for a physical device. Ground truth is usually relevant for diagnostic software where human experts label images or data.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study investigates the impact of AI assistance on human reader performance, which isn't relevant for a physical fiducial needle.
- Standalone (Algorithm-Only) Performance: Not applicable. This device is a physical instrument, not an algorithm.
- Type of Ground Truth Used: Not applicable.
- Sample Size for the Training Set: Not applicable. This device is not an AI model that requires a training set.
- How Ground Truth for the Training Set was Established: Not applicable.
In summary, the provided submission describes a physical medical device and its regulatory clearance process through substantial equivalence, not the performance evaluation of a software or AI device against acceptance criteria in a clinical study.
§ 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.