(43 days)
The FASTCLOSE Sternum Closure Device is intended for use during thoracic surgery to hold and close the sternum after a sternotomy. It is designed to aid in the prevention of suture needlestick injuries.
The FASTCLOSE Sternum Closure Device has four major components: 1) a reusable instrument, 2) a single-use, disposable cartridge, 3) a single-use, disposable needle, and 4) sutures.
The cartridge containing the needle (with suture attached) is loaded onto the distal end of the device. The needle is engaged by the device's internal drive mechanism and driven through the sternum to be sutured. The suture is thus passed completely through the wound. Once the suture is in place, the device is withdrawn from the incision leaving the suture strand looped through the sternum. Additional interrupted stitches are place in the same manner and then the two ends of each suture are tied together in the usual fashion.
The provided text describes a 510(k) premarket notification for the SuturTek FASTCLOSE Sternum Closure Device. It details the device, its intended use, and a comparison to predicate devices, but it does not contain specific acceptance criteria, detailed study results, or the other requested information for the device's performance.
Based on the provided information, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document.
- Reported Device Performance: The document only states "Bench testing was performed to demonstrate that the FASTCLOSE Sternum Closure Device would perform as intended." No specific performance metrics or results are provided.
2. Sample sized used for the test set and the data provenance
- This information is not provided in the document. The document mentions "Bench testing," but no details on sample size or data provenance are included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. Bench testing typically does not involve expert-established ground truth in the same way clinical studies or image-based AI studies do.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided in the document. Adjudication methods are typically relevant for human review of data, which is not described for this device's testing.
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
- This information is not provided in the document. The device is a surgical instrument, not an AI-assisted diagnostic tool, so an MRMC study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not provided in the document. The device is a manual instrument, so "standalone" performance in the context of an algorithm is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- This information is not provided in the document. For bench testing of a surgical device, ground truth would likely refer to engineering specifications or mechanical performance metrics, but these are not detailed.
8. The sample size for the training set
- This information is not provided in the document. The device is a physical instrument, so a "training set" in the context of machine learning is not applicable.
9. How the ground truth for the training set was established
- This information is not provided in the document. As above, a "training set" is not relevant for this type of device.
Summary Table of Available Information:
| Information Category | Details |
|---|---|
| Acceptance Criteria & Reported Performance | Acceptance Criteria: Not explicitly stated. |
| Reported Device Performance: "Bench testing was performed to demonstrate that the FASTCLOSE Sternum Closure Device would perform as intended." No specific metrics or quantitative results are provided. | |
| Sample size for test set & Data provenance | Not provided. |
| Experts used for ground truth (test set) & Qualifications | Not provided. |
| Adjudication method for test set | Not provided. |
| MRMC comparative effectiveness study & Effect size | Not applicable (device is a surgical instrument, not AI-assisted). |
| Standalone (algorithm only) performance | Not applicable (device is a surgical instrument). |
| Type of ground truth used | Not provided in detail. For bench testing, it would likely involve engineering specifications or mechanical stability, but specific methods (e.g., tensile strength, fatigue testing results) are not mentioned. |
| Sample size for training set | Not applicable (device is a surgical instrument, not an algorithm). |
| How ground truth for training set was established | Not applicable. |
General Conclusion:
The provided document (a 510(k) summary) focuses on demonstrating substantial equivalence to predicate devices and describes the device's design and intended use. It confirms that "Bench testing was performed to demonstrate that the FASTCLOSE Sternum Closure Device would perform as intended," but it does not include the detailed performance data, acceptance criteria, or study methodologies that would be required to answer most of your specific questions. This level of detail is often found in the full 510(k) submission, but not typically in the publicly available summary.
§ 878.4495 Stainless steel suture.
(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.