(24 days)
The Xclose™ Tissue Repair System is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.
The Xclose™ Tissue Repair System consists of two (2) non- absorbable braided surgical 3-0 suture and T-anchor assemblies, connected together with a loop of green 2-0 suture. The 2-0 suture loop is used to facilitate tightening, drawing the 3-0 suture assemblies together, thereby re-approximating the tissue. The device construct is composed of polyethylene terephthalate (PET) and conforms to USP requirements. The construct is provided sterile and preloaded on a disposable delivery instrument.
The provided text is related to a 510(k) submission for the Xclose™ Tissue Repair System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.
The document states:
"The modifications to the Anchor Band Suturing System were conducted in accordance with the Anulex Design Control System. Accordingly, the risk analysis identified necessary design verification and validation activities. As a result of this analysis, tensile testing was performed to confirm compliance to USP suture requirements."
This indicates that tensile testing was performed to verify compliance with USP suture requirements. While this is a verification activity, the document does not provide the specific "acceptance criteria" for tensile strength (e.g., minimum tensile strength in Newtons) or the "reported device performance" against those criteria in a tabular format. It also doesn't detail the study design for this tensile testing (e.g., sample size, methodology).
Therefore, based solely on the provided text, I cannot complete most of the requested fields. I can only infer that "USP suture requirements" were the general acceptance criteria for tensile strength, and "tensile testing was performed to confirm compliance" is the study description, but without specifics.
Here is what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: USP suture requirements (for tensile strength).
- Reported Device Performance: "Tensile testing was performed to confirm compliance to USP suture requirements." (No specific numerical performance is reported in this document beyond compliance).
| Acceptance Criteria (for Tensile Strength) | Reported Device Performance |
|---|---|
| Compliance with USP suture requirements | Confirmed compliance |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: Not specified (likely internal testing by Anulex Technologies, Inc. based in Minnetonka, MN, USA, but this is not explicitly stated as the origin of data). Not specified if retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as this is a physical device testing (tensile strength) and not an interpretive task requiring expert ground truth in the medical imaging or diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of physical device 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
- No. This is not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/imaging device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for tensile testing would be the measured tensile strength compared against the specified USP requirements. It's an objective measurement, not an expert consensus or pathology.
8. The sample size for the training set
- Not applicable. This device does not use a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.