(98 days)
The Arthrex Mini TightRope and Mini TightRope FT are intended as adjuncts in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are intended to provide fixation during the healing process following:
- Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
- Tarsometatarsal (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 Arthrex Mini TightRope and the Mini TightRope FT, when used for fixation of bone-to-bone or soft-tissue-to-bone, are intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of the thumb metacarpal by providing stabilization between the base of the first and second metacarpals when the trapezium has been excised due to osteoarthritis. The Mini TightRope and Mini TightRope FT are also indicated for use as adjuncts in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.
The Mini TightRope devices are designed in two basic configurations: two metal buttons and a pre-threaded FiberWire suture and; one metal button, one bioabsorbable suture anchor.
The provided text describes the Arthrex Mini TightRope devices and their intended use, but it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically associated with AI/ML device evaluations.
Instead, this document is a 510(k) premarket notification for a medical device (Mini TightRope) seeking clearance for an expanded indication. The evaluation for this type of device relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than meeting quantitative performance metrics against a defined acceptance criterion through a study as would be seen for an AI/ML diagnostic or prognostic tool.
Therefore, many of the specific points requested (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for training set) are not applicable to this type of traditional medical device submission based on the provided text.
Based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| Predicate Device Similarity: Basic design features and intended uses are the same as the predicate (Mini TightRope, K090107). | The Arthrex Mini TightRope family of devices is substantially equivalent to the predicate devices, in which the basic design features and intended uses are the same. |
| Mechanical Strength (Shear & Tensile): Adequate for the desired proposed indication of Hematoma Distraction Arthroplasty (HDA). | The submitted mechanical testing data demonstrates that the shear and tensile strength of the predicate devices are adequate for the desired proposed indication. |
| Clinical Efficacy (Literature Review): Supports the use for HDA. | The submitted clinical literature review demonstrates the same. |
| Safety and Effectiveness: No new questions concerning safety and effectiveness compared to the predicate device for the new indication. | The modifications to the indications for use of the predicate devices are considered minor and do not raise questions concerning safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. This submission is based on demonstrating substantial equivalence to a predicate device and mechanical testing, not a clinical study on a patient test set in the conventional sense for AI/ML. The "mechanical testing data" would refer to laboratory tests on the device itself.
- Data Provenance: The document does not specify the origin of the mechanical testing data.
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. No ground truth establishment for a patient "test set" is described for this device as it's a mechanical device, not an AI/ML diagnostic.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No human adjudication for a test set is described.
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 a mechanical surgical implant, not an AI/ML imaging or diagnostic device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a mechanical surgical implant, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is established through mechanical testing data (shear and tensile strength) and clinical literature review to support its adequacy for providing stabilization as an "adjunct in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty."
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not Applicable. There is no "training set" and associated ground truth establishment for this type of device.
§ 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.