(116 days)
The Mini TightRope™ Repair Kit is interided as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically, the Arthrex Mini TightRope™ Repair Kit is intended to provide fixation during the healing process following:
- Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
- Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and
- Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal -2nd metatarsal intermetatarsal angle.
The Mini TightRope™ Repair Kit is designed as two differently sized metal buttons and FiberWire™ suture. The buttons are pre-threaded with FiberWire suture, looped twice through the buttoriholes. A pull-through FiberWire suture is looped through one button.
Acceptance Criteria and Study for Mini TightRope™ Repair Kit
The provided document (K061925) is a 510(k) summary for a medical device called the Mini TightRope™ Repair Kit. It outlines the intended use and establishes substantial equivalence to predicate devices, rather than performing a de novo study with specific performance acceptance criteria and a detailed study validating those criteria.
Therefore, the typical structure for a study demonstrating acceptance criteria for device performance, especially in the context of AI/software or diagnostic devices, is not present in this document. This K-number filing is for a physical orthopedic implant/fixation device, and substantial equivalence is shown by demonstrating similar features, intended use, and safety/effectiveness profile to already approved devices.
However, I can extract the implied 'acceptance criteria' in the context of a 510(k) submission, which is primarily demonstrating substantial equivalence to predicate devices. The "study" in this case refers to the arguments and justifications made within the 510(k) submission itself to support this claim.
Implied Acceptance Criteria and Reported Device Performance (Based on Substantial Equivalence)
| Acceptance Criteria (Implied by 510(k) Process) | Reported Device Performance (as presented in K061925) |
|---|---|
| Similar Intended Use | The Mini TightRope™ Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. |
Specific Indications:
- Syndesmotic trauma (e.g., DRUL disruptions)
- Tarsometatarsal (TMT) injury (e.g., Lisfranc injury)
- Hallux Valgus reconstruction (reduction of 1st-2nd metatarsal intermetatarsal angle). |
| Similar Technological Characteristics/Design | The device consists of two differently sized metal buttons and FiberWire™ suture. The buttons are pre-threaded with FiberWire suture, looped twice through the buttonholes. A pull-through FiberWire suture is looped through one button. |
| Similar Materials | Metal buttons and FiberWire™ suture (implied to be similar or equivalent to predicate device materials in terms of biocompatibility and mechanical properties, though not explicitly detailed in this summary). |
| Similar Principles of Operation | Provides fixation during the healing process. Operates on the principle of a "button/suture" system for bone fixation. |
| No New Questions of Safety & Effectiveness | Arthrex states: "Any design differences between the Arthrex Mini TightRope™ Repair Kit when compared to predicate devices... are considered minor and do not raise any questions concerning safety and effectiveness. Any differences have been found to have no apparent effect on the performance, function, or intended use of the device." |
Study Details (as inferred from a 510(k) submission focused on substantial equivalence):
Given the nature of a 510(k) for a physical implant, the concept of a "test set," "ground truth," "MRMC," or "standalone algorithm performance" as typically applied to AI/software or diagnostic devices is not applicable here. The "study" is the comparison made to predicate devices.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the traditional sense for this type of device submission. There isn't an "image dataset" or "patient cohort" test set for algorithm validation. The "test" is a comparison to established predicate devices.
- Data Provenance: The "data" here refers to the known performance, safety, and regulatory history of the predicate devices:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of AI/diagnostic devices, refers to a definitive diagnosis or outcome. For this mechanical device, "ground truth" is established through engineering principles, mechanical testing (often referenced in full 510(k) submissions, but not detailed here), and the clinical history of the predicate devices. Experts involved would be product engineers, regulatory specialists, and potentially clinical consultants, but not in the context of creating a labeled test set.
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Adjudication method for the test set:
- Not applicable. There is no ambiguous "test set result" requiring adjudication. The comparison is based on objective device characteristics and intended uses.
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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 a physical orthopedic fixation device, not an AI or diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical orthopedic fixation device, not an algorithm.
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The type of ground truth used:
- The "ground truth" is implicitly the established safety and effectiveness of the predicate devices based on their prior regulatory clearance, clinical use, and documented performance (e.g., mechanical strength, biocompatibility, historical clinical outcomes).
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The sample size for the training set:
- Not applicable. There is no computational "training set" for an algorithm.
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How the ground truth for the training set was established:
- Not applicable.
§ 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.