(71 days)
The Salute Fixation System is indicated for use in a variety of laparoscopic / endoscopic or open surgical procedures for fixation of prosthetic material and approximation of tissue.
A minor modification has been made to the Salute staples in that a coating has been added to the surface of the staples. A reusable surgical instrument with integral disposable cartridge for placing coated stainless steel constructs. This instrument may be used laparoscopically with 5mm trocars.
This 510(k) premarket notification for K014286 describes a minor modification to an existing Endoscopic stapler and staple system (Salute Fixation System) by adding a coating to the surface of the staples.
Crucially, the provided document does NOT contain specific acceptance criteria, performance data, or detailed study information required to populate most of the requested fields. This submission relies on substantial equivalence to predicate devices (ProTack™ laparoscopic stapler and Ethicon staples) which also use a similar coating.
Therefore, many of the requested fields cannot be answered from the provided text.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not mentioned in the document. The submission is focused on demonstrating substantial equivalence based on a minor modification (adding a coating) that is already present in predicate devices, rather than presenting new performance data against specific criteria. | Not mentioned in the document. No specific performance metrics (e.g., tensile strength, biological compatibility, or staple deployment success rate) are provided for the modified device or the predicate devices. The claim is that the modification "will not change the intended use of the device in any way." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not mentioned.
- Data provenance: Not mentioned.
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)
- Not applicable as no specific test set or ground truth establishment process is described for this submission. The submission relies on equivalence to existing devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no specific test set or adjudication process is described.
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 surgical stapler, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a surgical stapler, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable as no specific ground truth for performance evaluation is described. The basis for clearance is substantial equivalence to legally marketed predicate devices, implying that the established safety and effectiveness of those predicates extend to this modified device.
8. The sample size for the training set
- Not applicable. This submission is for a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.