(48 days)
The Anchor Band Suturing System is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.
The Anchor Band Suturing System consists of a non-absorbable braided surgical suture and T-anchor, both of which are composed of polyethylene terephthalate (PET). The suture, which conforms to U.S.P. 2-0, and T-anchor assembly are provided sterile and preloaded on a disposable delivery instrument. The instrument's needle facilitates placement of the suture by positioning the T-anchor in the sub-layer of the tissue.
The provided text describes a 510(k) premarket notification for the "Anchor Band Suturing System." This submission focuses on establishing substantial equivalence to existing predicate devices, rather than presenting a performance study with detailed acceptance criteria of the type typically seen for new AI/algorithm-driven devices.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies is not present in the provided document. The submission relies on biocompatibility and bench testing to support safety and effectiveness and concludes substantial equivalence based on intended use, technological characteristics, materials, and performance compared to predicate devices.
Here's a breakdown of what can be extracted based on the provided text, and what information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of specific performance metrics or thresholds. | "Biocompatibility and bench testing were completed and support the safety and effectiveness of the Anchor Band Suturing System." (This is a general statement, not specific performance data.) |
| Substantial equivalence to predicate devices in intended use, technological characteristics, materials, and performance. | "The Anchor Band Suturing System is substantially equivalent in intended use, technological characteristics, materials and performance to the predicate devices." |
2. Sample size used for the test set and the data provenance
- Not available. The document mentions "bench testing" but does not provide details on sample sizes or data provenance for any specific performance tests. This submission is for a medical device (suturing system), not a software/AI device, and therefore the concept of a "test set" in the context of an algorithm's performance isn't applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not available. This information is relevant for studies involving human interpretation or consensus, typically for AI or diagnostic devices. The submission for the Anchor Band Suturing System does not describe such a study.
4. Adjudication method for the test set
- Not applicable/Not available. Similar to point 3, this is not relevant for the type of device and submission 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
- No. An MRMC study is not mentioned as this device is not an AI/software-driven diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm.
7. The type of ground truth used
- Not applicable/Not available. The submission focuses on physical characteristics, biocompatibility, and mechanical performance through bench testing, not on a "ground truth" for diagnostic accuracy.
8. The sample size for the training set
- Not applicable/Not available. The concept of a "training set" applies to machine learning algorithms, which are not relevant to this device.
9. How the ground truth for the training set was established
- Not applicable/Not available. The concept of a "training set" and "ground truth" in this context does not apply to the Anchor Band Suturing System.
§ 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.