(28 days)
Arthrex FiberTape and TigerTape 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
- · To provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separation due to coracoclavicular ligament disruption.
The proposed Arthrex FiberTape and TigerTape Cerclage Sutures are available as flat braided sutures assembled in a loop configuration. The devices are manufactured from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE), polyester, and nylon materials. These materials are identical to those cleared in K221485 and K170206. 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. The proposed Arthrex FiberTape and TigerTape Cerclage Sutures may be used with or without the cleared Arthrex Dog Bone Button (K220947).
The provided document describes a 510(k) Premarket Notification for a medical device (Arthrex FiberTape and TigerTape Cerclage Sutures). It is a regulatory submission to demonstrate substantial equivalence to a previously cleared predicate device, not a study proving the device meets specific acceptance criteria in the manner of an AI/software device.
Therefore, most of the requested information regarding acceptance criteria, test sets, expert ground truth, MRMC studies, standalone performance, and training sets is not applicable to this type of document because the submission focuses on mechanical and biological equivalency for a physical suture device.
However, I can extract information related to the performance data and the comparison made for substantial equivalence:
Information Extracted from the Document:
- Device Name: Arthrex FiberTape and TigerTape Cerclage Sutures
- Predicate Device: K220947 Arthrex Knotless AC Repair Devices
- Reference Devices: K221485 Arthrex FiberTape and TigerTape Cerclage Sutures, K170206 Arthrex FiberTape Cerclage
- Purpose of Submission: To obtain an additional indication: "To provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separation due to coracoclavicular ligament disruption."
Given that this document is for a physical medical device (sutures) and a 510(k) submission, the traditional "acceptance criteria" and "study" framework for AI/software-based medical devices (which would involve test sets, expert ground truth, MRMC studies, etc.) does not apply directly.
Instead, the "study" proving the device meets the criteria of substantial equivalence involves performance testing to demonstrate that the new device is as safe and effective as the predicate device.
Here's how to frame the information from the document in relation to your request, highlighting what is and isn't present:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (for substantial equivalence): The new device must demonstrate similar mechanical properties and biocompatibility to the predicate device, especially for the new indication. The implied acceptance criteria are that the new device's performance in specified mechanical tests is comparable to or better than the predicate.
- Reported Device Performance:
| Performance Metric | Reported Device Performance (Arthrex FiberTape and TigerTape Cerclage Sutures) | Acceptance Criteria / Comparison to Predicate (Arthrex Knotless AC Repair Devices K220947) |
|---|---|---|
| Ultimate Load | Data was submitted | Demonstrates substantial equivalence to predicate. |
| Cyclic Displacement | Data was submitted | Demonstrates substantial equivalence to predicate. |
| Bacterial Endotoxin | Conducted per EP 2.6.14/USP | Meets pyrogen limit specifications. |
| Materials | Polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE), polyester, nylon | Identical to those cleared in K221485 and K170206 (reference devices). |
| Fundamental Scientific Technology | N/A (identical to reference devices) | Identical to predicate/reference devices. |
| Packaging, Sterility, Shelf-life, MRI Safety Labeling | N/A (identical to reference devices) | Identical to predicate/reference devices. |
2. Sample size used for the test set and the data provenance:
- The document does not specify the sample size for the mechanical tests (ultimate load, cyclic displacement, bacterial endotoxin). This information would typically be found in the full testing report, which is not part of this summary.
- Data Provenance: Not specified in terms of country of origin. The tests were likely conducted internally by Arthrex Inc. or by a contract lab. These are performance tests on the device materials/constructs, not clinical trial data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical device with objective mechanical and biological testing. There is no human "ground truth" to establish for these tests (e.g., no interpretation of images or clinical outcomes by experts to be used as ground truth).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As above, this is objective mechanical and biological testing, not 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 is for a physical surgical suture, not an AI/software device used by human readers for diagnosis or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Mechanical and Biological Properties: The "ground truth" for demonstrating substantial equivalence relies on standard, recognized testing methodologies for medical devices (ISO, ASTM standards, or equivalent) for properties like tensile strength, fatigue, and biocompatibility (e.g., endotoxin limits). There is no "expert consensus" or "pathology" in the typical sense for these types of tests.
8. The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable. This is not an AI/machine learning device.
In summary, this document is a regulatory submission for a physical medical device (suture) seeking expanded indications based on demonstrated substantial equivalence through objective mechanical and biological performance testing, rather than a study for an AI/software device that would involve the complex aspects of expert-annotated test and training datasets.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.