(52 days)
The GeniCon Clip Applier and implantable clips are intended for use during laparoscopic procedures for the purpose of approximating soft tissue, closing off vessels and other structures in order to stop bleeding or to connect internal tissues to aid in healing.
The Genicon Clip Applier is a disposable device with a plastic handle and a working shaft that is approximately 32cm in length. Within the shaft are 20 titanium clips. The handle of the instrument is depressed and a titanium clip, which resides in the distal iaw of the instrument. is pressed together around whatever structure is within the jaw of the instrument.
The GeniCon Clip Applier is a disposable device used in laparoscopic procedures for approximating soft tissue, closing off vessels and other structures to stop bleeding, or connecting internal tissues to aid in healing.
Here's an analysis of its acceptance criteria and the study that proves its performance:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Integrity and Durability | 1. Stress/Exposure Testing | Successfully performed (implied, no specific metrics provided) |
| Functional Safety | 2. Cleaning/Disinfection/Sterilization Testing | Successfully performed (implied, no specific metrics provided) |
| Clinical Efficacy | Ability to approximate soft tissue | Effective for its intended use (implied by substantial equivalence) |
| Ability to close off vessels and other structures | Effective for its intended use (implied by substantial equivalence) | |
| Ability to stop bleeding | Effective for its intended use (implied by substantial equivalence) | |
| Ability to connect internal tissues to aid in healing | Effective for its intended use (implied by substantial equivalence) |
Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific performance metrics against pre-defined acceptance criteria. The "Performance" section lists general categories of testing but does not provide quantitative results or explicit acceptance thresholds. The conclusion states that the device is "effective for its intended use" based on these tests and design characteristics.
2. Sample Size and Data Provenance
The document does not describe a clinical study with a "test set" in the conventional sense of human or animal subjects for evaluating clinical effectiveness. The performance tests mentioned ("Stress/Exposure Testing" and "Cleaning/Disinfection/Sterilization Testing") appear to be laboratory-based validation tests performed on the device itself. Therefore, information regarding sample size used for a test set, countries of origin of data, or retrospective/prospective nature is not applicable in this context.
3. Number of Experts and Qualifications for Ground Truth
For the performance tests described (Stress/Exposure, Cleaning/Disinfection/Sterilization), the concept of "ground truth" derived from expert consensus on medical images or pathology is not applicable. These are engineering and sterilization validation tests. The results would likely be evaluated against pre-defined engineering specifications or industry standards by qualified technical personnel rather than medical experts establishing a diagnostic ground truth.
4. Adjudication Method
As there is no described clinical study involving human assessment of outcomes or imaging, an adjudication method like 2+1 or 3+1 is not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was mentioned. The 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device through technological characteristics and performance testing, rather than a direct comparison of human reader performance with and without AI assistance. Therefore, information on effect size of human reader improvement with AI assistance is not applicable.
6. Standalone Performance Study
The document describes "performance tests" on the GeniCon Clip Applier itself. These tests (Stress/Exposure, Cleaning/Disinfection/Sterilization) are essentially evaluations of the standalone device's physical and functional properties. However, these are not clinical standalone performance studies in terms of diagnostic accuracy or a specific clinical endpoint typically seen with AI-powered devices. The clinical effectiveness is inferred through substantial equivalence to a predicate device.
7. Type of Ground Truth Used
For the described performance tests (Stress/Exposure, Cleaning/Disinfection/Sterilization), the ground truth would be based on:
- Engineering specifications: For stress/exposure testing, ensuring the device meets predefined strength, durability, and material integrity criteria.
- Regulatory standards: For cleaning/disinfection/sterilization, ensuring the device meets established standards for sterility and biocompatibility.
There is no mention of ground truth derived from expert consensus (beyond the designers/engineers establishing specifications), pathology, or outcomes data for these specific tests.
8. Sample Size for the Training Set
Since the GeniCon Clip Applier is a medical device (surgical clip applier) and not an AI/machine learning algorithm, the concept of a "training set" for an algorithm is not applicable.
9. How Ground Truth for the Training Set Was Established
As there is no AI/machine learning component or a "training set" in the context of this device, this question is not applicable.
§ 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.