(72 days)
The SmartStitch® M-Connector Ultra System is indicated for use in the placement of suture(s) through soft tissue in arthroscopic and limited access procedures.
The SmartStitch M-Connector Ultra System is an orthopedic/arthroscopic instrument for mechanically delivering sutures through soft tissue based on the basic design concepts of handheld, manual suture passers. The handle is provided non-sterile. The connector and suture cartridge are sterilized by ethylene oxide. The finished products are packaged in a Tyvek® pouch inserted into a chipboard carton.
The provided text describes a 510(k) summary for the ArthroCare SmartStitch M-Connector Ultra System. This is a medical device, and the submission clarifies that no clinical or animal data were included in the submission. The device's substantial equivalence to predicate devices was demonstrated solely through non-clinical bench testing.
Therefore, most of the requested information for acceptance criteria and study details related to human performance, such as sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance, is not applicable to this particular 510(k) submission.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states: "Bench testing was performed on both the proposed and predicate devices. The test results demonstrate that the SmartStitch M-Connector Ultra System meets all design, performance, and safety specifications."
However, specific numerical acceptance criteria (e.g., tensile strength thresholds, penetration force ranges) and their corresponding reported values are not detailed in this summary. The summary only provides a general statement of compliance.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Meet all design specifications | Met |
| Meet all performance specifications | Met |
| Meet all safety specifications | Met |
| Perform as intended | Performed as intended |
| Acceptable mechanical properties | Acceptable |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified for non-clinical bench testing.
- Data Provenance: Non-clinical bench testing, conducted by the manufacturer (ArthroCare Corporation). Not applicable for country of origin or retrospective/prospective in the context of human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical data or human expert evaluation was used for this submission. Ground truth for bench testing would be defined by engineering specifications and material properties.
4. Adjudication method for the test set
Not applicable, as no clinical data or human expert evaluation was used. Adjudication methods are typically relevant for subjective human assessments.
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
No. An MRMC comparative effectiveness study was not performed as no clinical data, AI, or human reader evaluations were part of this submission. The device is a manual arthroscopic instrument, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. A standalone algorithm performance study was not performed as the device is a manual medical instrument and does not involve an algorithm.
7. The type of ground truth used
For the non-clinical bench testing, the ground truth would have been established by engineering specifications, material standards, and validated testing methodologies to assess the physical and mechanical properties of the device (tensile strength, durability, needle penetration, suture delivery mechanisms, etc.).
8. The sample size for the training set
Not applicable, as no machine learning or AI component is mentioned or relevant to this device. Bench testing does not involve training sets in the AI sense.
9. How the ground truth for the training set was established
Not applicable, as there was no training set for an AI/ML model.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). 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.