(69 days)
The Steelex Sternum Set is indicated in abdominal surgery, for orthopedic procedures (tendon operations and cerclages), hernia surgery and sternal closure. It is designed to remain inside the patient.
The Steelex Sternum Set consists of a corrosion resistant steel monofilament suture with a specially designed HRS needle for the sternum closure. The set consists of a combination of 2 or 4 steel wite monofilaments armed with a tapercut round bodied needle fixed or rotating. The wire for Steelex Sternum Set is made of stainless steel 316L (ASTMF138) and the needle is made of stainless steel 302, 420 or 420F (ASTMF899). The needle sizes for Steelex Sternum Set are available in the USP sizes 3, 4, 5, 6 and 7.
The provided text is a 510(k) summary for the Steelex Sternum Set, a medical device. It describes the device, its intended use, and its substantial equivalence to other legally marketed devices. However, it does not contain information about acceptance criteria, detailed study designs, or performance metrics in a way that would allow for a comprehensive answer to your request.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document mentions "All required testing per USP for Steelex Sternum Set were completed." This implies compliance with USP standards, which would have performance criteria, but they are not detailed here. | "Biomechanical testing results demonstrate the Steelex Sternum Set is substantially equivalent to other suture systems currently on the market." |
Missing Information:
- Specific quantitative acceptance criteria (e.g., tensile strength, knot security, degradation rates).
- The exact numerical performance results of the Steelex Sternum Set against those criteria.
2. Sample size used for the test set and the data provenance
Missing Information: The document does not specify the sample size used for the biomechanical testing mentioned, nor does it provide information on data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing Information: This information is not relevant to this type of device submission. The "ground truth" for a surgical suture would typically be defined by established material science and biomechanical standards, not expert consensus on interpretations.
4. Adjudication method for the test set
Missing Information: Not applicable to this type of device or study.
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
Missing Information: This is not applicable. The Steelex Sternum Set is a surgical suture, not an AI-powered diagnostic or assistive device where MRMC studies with human readers would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing Information: Not applicable for this device.
7. The type of ground truth used
- Type of Ground Truth: Established industry standards (USP - United States Pharmacopeia) for surgical sutures and performance of legally marketed predicate devices.
8. The sample size for the training set
Missing Information: This is not applicable for this type of device. There isn't a "training set" in the context of material performance testing for a suture.
9. How the ground truth for the training set was established
Missing Information: Not applicable for this type of device.
Summary of Study Information Provided in the Document:
- Study Purpose: To demonstrate substantial equivalence of the Steelex Sternum Set to predicate devices.
- Study Type: Biomechanical testing.
- Methodology: "All required testing per USP for Steelex Sternum Set were completed." (Implies adherence to USP standards for surgical sutures).
- Performance Outcome: "Biomechanical testing results demonstrate the Steelex Sternum Set is substantially equivalent to other suture systems currently on the market."
- Predicate Devices:
The document is a regulatory summary focused on demonstrating equivalence for market clearance, rather than a detailed scientific publication of a specific study with all the granular details about acceptance criteria and sample sizes. The "performance data" section is very brief, stating that USP testing was completed and biomechanical testing showed substantial equivalence.
§ 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.