(118 days)
Arthrex FiberTape and Tiger Tape Cerclage sutures and Arthrex Radiopaque FiberTape Cerclage sutures are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.
When used as bone fixation cerclage the sutures are intended for:
- · Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty)
- · Sternotomy indications including the "rewiring" of osteomized sternums
- · Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring
- · Treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft)
- · Repair of long bone fractures due to trauma or reconstruction
- · Provide fixation during the healing process following syndesmotic trauma. such as fixation of acromioclavicular separation due to coracoclavicular ligament
- · Spinal applications including sublaminar and intrafacet wiring of the spinal column
The Arthrex Radiopaque FiberTape Cerclage sutures are non-absorbable braided sutures composed of Ultra High Molecular Weight Polyethylene (UHMWPE) which incorporates Bismuth Trioxide (Bi2O3), and Polyester yarns over a core of suture also made with Ultra High Molecular Weight Polyethylene (UHMWPE) with Bismuth Trioxide (Bi2O3), and Polyester. Dyes include D&C Blue No. 6. The UHMWPE is naturally yellow due to the addition of Bismuth Trioxide (Bi2O3). The sutures are assembled on an ABS loader. The sutures may also contain a FiberLink shuttling suture that is used for passing only.
The Arthrex FiberTape and TigerTape Cerclage Sutures are non-absorbable braided sutures composed of Ultra High Molecular Weight Polyethylene, polyester, and possibly nylon yarns over a core of FiberWire or TigerWire Suture (each made of UHMWPE and polyester). FiberTape differs from TigerTape in color and materials. FiberTape is blue/white suture consisting of UHMWPE and polyester. TigerTape suture is white/black consisting of UHMWPE, polyester, and nylon. Additional materials include cyanoacrylate at the suture ends which are cut off during the procedure. Dyes include D&C Blue No. 6 and Logwood Black. For the loop assembly the looped end of the suture is tied as a hitch over a sheath that secures a double loop or tied over the post of an ABS loader.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Arthrex FiberTape and TigerTape Cerclage Sutures and Arthrex Radiopaque FiberTape Cerclage Sutures:
Device: Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures
The provided document is a 510(k) Premarket Notification summary, indicating a submission to expand and align the indications for the Arthrex Radiopaque FiberTape Cerclage Sutures and Arthrex FiberTape & TigerTape Cerclage Sutures. The primary purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices.
Based on the available text, the study presented focuses on demonstrating mechanical equivalence and biocompatibility, not clinical performance with human-in-the-loop for diagnostic accuracy. Therefore, several of the requested sections (e.g., MRMC studies, expert qualifications, adjudication methods, training set details) are not applicable or cannot be extracted from this document, as they pertain to AI/diagnostic device performance studies.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device must achieve) | Reported Device Performance (How the device performed) |
|---|---|
| Mechanical Performance: Dynamic Tensile Fatigue Testing (5 million cycles in fluid) | "The submitted testing data, dynamic tensile fatigue testing in fluid for 5 million cycles, demonstrates that the Arthrex Radiopaque FiberTape Cerclage and Arthrex FiberTape & TigerTape Cerclage sutures are substantially equivalent to the primary predicate Kinamed SuperCable Iso-Elastic Cerclage System (K181749) and secondary predicate Arthrex FiberTape and TigerTape Cerclage sutures (K232755)." |
| Biocompatibility/Pyrogenicity: Meet pyrogen limit specifications | "Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the devices meet pyrogen limit specifications." |
| Equivalence to Predicates: Same intended use, materials, fundamental scientific technology, design, packaging, sterility, shelf-life, and MRI safety labeling. | "Compared to the secondary predicate Arthrex FiberTape and TigerTape Cerclage sutures (K232755), and reference device Arthrex Radiopaque FiberTape Cerclage sutures (K230976), the subject Arthrex Radiopaque FiberTape Cerclage and Arthrex FiberTape & TigerTape Cerclage sutures have the same intended use, materials, fundamental scientific technology, design, packaging, sterility, shelf-life, and MRI safety labeling." |
2. Sample Size Used for the Test Set and Data Provenance
The document describes mechanical testing and biocompatibility testing, not a clinical study on patient data.
- Mechanical Testing: The sample size for dynamic tensile fatigue testing is not explicitly stated in terms of the number of sutures tested, only the duration/cycles (5 million cycles). The provenance of the "test set" (i.e., the sutures themselves) would be from the manufacturer (Arthrex Inc.).
- Biocompatibility (Bacterial Endotoxin): The sample size for this testing is also not explicitly stated (e.g., how many units were tested), only the method.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a surgical suture, not a diagnostic device requiring expert interpretation of results to establish ground truth from a test set. The validation relies on engineering and biological testing standards.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the context of diagnostic interpretation requiring adjudication.
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 device is a surgical suture, not an AI-assisted diagnostic tool.
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
- Mechanical Performance: The "ground truth" is defined by established engineering standards for suture performance (e.g., ability to withstand 5 million fatigue cycles) and substantial equivalence to predicate devices with a known safety and effectiveness profile. This is typically determined by physical measurements and adherence to pre-defined mechanical property specifications.
- Biocompatibility/Pyrogenicity: The ground truth is defined by established biological safety standards (e.g., EP 2.6.14/USP pyrogen limits) to ensure the device does not cause adverse biological reactions.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, no AI model or training set is applicable here.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.