(75 days)
The EndoButton Continuous Loop is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
The EndoButton Continuous Loop consists of two components. The first is the EndoButton which is made of Titanium 6AL 4V ELI allov (ASTM F136). Its length is from 12 to 18 mm and its width is from 4 to 6 mm. It is oblong in shape with four holes through which suture is threaded. The second component is the polvester suture which is preattached to the center holes. The loop soan lengths range from 10 to 80 mm and is approximately 5 mm in diameter. The suture portion of the EndoButton Continuous Loop is made of polyester. Poly(ethylene terepthalate). The suture is prepared from fibers of high molecular weight, long chain, linear polyesters having recurrent aromatic rings as an integral component. The suture meets the applicable requirements established by the United States Pharmacopeia (U.S.P.) for non-absorbable surgical suture.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Attribute | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Tensile Strength | Equivalent to EndoButton with EndoButton Tape | "EndoButton Continuous Loop is as strong as the currently marketed EndoButton with EndoButton Tape." |
| Stiffness | Equivalent to EndoButton with EndoButton Tape | "EndoButton Continuous Loop is as strong as the currently marketed EndoButton with EndoButton Tape." |
| Cyclic Fatigue Testing | Equivalent to EndoButton with EndoButton Tape | "EndoButton Continuous Loop is as strong as the currently marketed EndoButton with EndoButton Tape." |
| Residual Tensile Strength | Equivalent to EndoButton with EndoButton Tape | "EndoButton Continuous Loop is as strong as the currently marketed EndoButton with EndoButton Tape." |
| Dimensions (EndoButton) | Width: 4-6 mm, Length: 12-18 mm (Matching predicate) | Width: 4-6 mm, Length: 12-18 mm |
| Suture Loop Span Length | 10-80 mm (Acceptable range, wider than predicate tape) | 10-80 mm |
| Material (EndoButton) | Titanium 6AL 4V ELI (ASTM F136) (Matching predicate) | Titanium 6AL 4V ELI (ASTM F136) |
| Material (Suture) | Polyester, Poly(ethylene terephthalate) (Matching predicate) | Polyester, Poly(ethylene terephthalate), meets USP for non-absorbable surgical suture |
| Sterilization | Gamma irradiation (Matching predicate EndoButton) | Gamma irradiation |
| Labeling | Sterile, Single Use Only (Matching predicate) | Sterile, Single Use Only |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size used for the tensile strength, stiffness, cyclic fatigue, and residual tensile strength tests. It only mentions "After the testing was completed."
- Data Provenance: Not specified. The study appears to be a laboratory-based equivalency testing of device components, likely conducted by the manufacturer (Smith & Nephew, Inc., Endoscopy Division). There is no mention of human subject data, country of origin, or whether it was retrospective or prospective in the context of clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable to this submission. The "ground truth" for this device's performance is based on direct physical and mechanical testing (tensile strength, stiffness, etc.) comparing it to a legally marketed predicate device, rather than expert interpretation of medical images or clinical outcomes.
4. Adjudication Method for the Test Set
- This information is not applicable. The performance evaluation was based on objective mechanical tests, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is typical for diagnostic imaging AI devices, which is not the nature of the EndoButton Continuous Loop.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- This information is not applicable. The EndoButton Continuous Loop is a surgical implant, not an AI algorithm. Its "performance" is mechanical and physical, not computational.
7. Type of Ground Truth Used
- The ground truth used was the performance of a legally marketed predicate device (EndoButton with EndoButton Tape) as determined by specific mechanical and material testing standards. The new device's performance was evaluated for equivalence against these established benchmarks. The physical properties of the materials (Titanium 6AL 4V ELI, Polyester) and their compliance with standards (ASTM F136, USP) also serve as a form of ground truth for material specifications.
8. Sample Size for the Training Set
- This information is not applicable. As this is a medical device (surgical implant) and not an AI/machine learning algorithm, there is no "training set."
9. How the Ground Truth for the Training Set was Established
- This information is not applicable, as there is no training set for this type of device.
§ 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.