(121 days)
Acier Steel Suture is indicated for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.
Surgical Suture is indicated for use in abdominal wound closure, hernia repair, sternal closure, and certain orthopedic procedures including cerclage and tendon repair.
Acier Steel Suture is a nonabsorbable sterile surgical suture composed of 316L stainless steel.
The provided text describes a 510(k) premarket notification for Acier Sutures, which are surgical sutures. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical trials with specific acceptance criteria and performance metrics described in a traditional study report.
Therefore, many of the requested sections regarding a "study that proves the device meets the acceptance criteria" are not applicable in this context. The 510(k) submission primarily relies on demonstrating substantial equivalence through bench testing and comparison to an already approved predicate device.
Here's an breakdown based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
Not directly applicable in the format requested for a 510(k) substantial equivalence submission.
The submission states: "Functional bench testing has been conducted on the Acier sutures and the results of the testing verified that the sutures perform as designed, are suitable for their intended use."
While there would have been internal acceptance criteria for the various bench tests, these specific criteria and the detailed performance against them are not provided in the summary document. The general acceptance criterion is that the device performs as designed and is suitable for its intended use, demonstrating substantial equivalence to the predicate.
2. Sample Size Used for the Test Set and the Data Provenance
Not explicitly provided for the functional bench testing.
The text mentions "Functional bench testing has been conducted," but does not specify the sample size used for this testing or the provenance of any data (e.g., country of origin, retrospective/prospective). For bench testing, data provenance is less relevant than for clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable.
For bench testing of surgical sutures, ground truth is established through engineering and material science principles, manufacturing specifications, and comparison to a predicate device's known characteristics, not typically by human experts establishing a "ground truth" for a test set in the same way as in diagnostic imaging or clinical outcomes studies.
4. Adjudication Method for the Test Set
Not applicable.
Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or expert reviews to resolve disagreements in interpretations or diagnoses. This is not relevant for bench testing of device performance against engineering specifications.
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 submission is for a surgical suture, not an AI-powered diagnostic device. Therefore, MRMC studies and AI assistance metrics are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable.
This device is a surgical suture, not an algorithm.
7. The Type of Ground Truth Used
Device Specifications and Predicate Equivalence.
For this type of device, the "ground truth" for demonstrating performance is derived from:
- Engineering specifications and material properties of the 316L stainless steel.
- Performance characteristics (e.g., tensile strength, knot security) demonstrated through bench testing.
- Comparison of these characteristics to the predicate device (Ethicon's Ethi-Pack Surgical Stainless Steel Suture; K931271) to establish substantial equivalence.
8. The Sample Size for the Training Set
Not applicable.
This device is not an AI/ML model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
This device is not an AI/ML model, so there is no "training set" or ground truth associated with one.
Summary of 510(k) for Acier Sutures:
The 510(k) submission for Acier Sutures focuses on demonstrating substantial equivalence to a predicate device (Ethicon's Ethi-Pack Surgical Stainless Steel Suture; K931271). This is achieved through:
- Intended Use, Design, Composition, Function, Indications, Patient Population, and Performance: The applicant asserts the Acier sutures are substantially equivalent across these parameters.
- Bench Testing: Functional bench testing was conducted to verify that the sutures "perform as designed" and are "suitable for their intended use." This testing would have compared the physical and mechanical properties of the Acier sutures to established standards and/or the predicate device. The specific details of the tests, acceptance criteria, and quantitative results are not provided in this summary but would have been part of the full 510(k) submission.
- Key Differences: The application states that "Any differences between the Peters Acier sutures and its predicate device do not raise any new issues of safety and effectiveness."
The FDA's clearance letter confirms their review of the 510(k) and their determination that the device is "substantially equivalent" for the stated indications, allowing it to be marketed. The letter also specifies limitations regarding the metal used (316L stainless steel only) and requirements for maintaining documentation on vendor certification, manufacturing/quality control, and sterilization validation.
§ 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.