(27 days)
The MultiFIX S Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulelabral reconstruction, biceps tenodesis, and deltoid repair
Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon reattachment
Knee: Exira-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction. ITB tenodesis; patellar ligament and tendon avulsions
The MultiFIX S Knotless Fixation System (MultiFIX S) is an implantable bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The MultiFIX S is a knotless fixation device, meaning that manually tying surgical knots is not necessary for the fixation of suture to tissue.
The MultiFIX S consists of two primary parts: an implantable bone anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool.
The entire product is packaged in a tray with a Tyvek® Iid, and the finished product is sterilized by irradiation. Both the anchor and inserter are designed for single use only.
The provided text describes the MultiFIX S Knotless Fixation System, which is a medical device. The document is a 510(k) premarket notification summary submitted to the FDA. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics for a novel AI device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in this document because it pertains to a different type of medical device evaluation (AI/software-as-a-medical-device), not a substantially equivalent hardware device.
The document states: "No clinical or animal data are included in this submission." and "Bench testing was performed on both the proposed and predicate devices. The test results demonstrate that the proposed MultiFIX S meets its design, performance, and safety specifications."
This means the evaluation was based on non-clinical (bench) testing and comparison of technological characteristics to a previously cleared device (K140604).
Here's an overview of the information that is available:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a specific table of acceptance criteria with numerical targets and reported performance. Instead, it states broadly that "The test results demonstrate that the proposed MultiFIX S meets its design, performance, and safety specifications." and "Based on the test results, the proposed device performs as intended and mechanical properties are substantially equivalent to the predicate device when used in accordance with labeling."
The "Comparison of Technological Characteristics" table (on page 5 of the document) highlights the similarities between the predicate and proposed device, implying that the proposed device met acceptance criteria by being "Same" as the predicate for most characteristics, or providing acceptable alternatives (e.g., additional qualified suture threads).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size: Not specified. The document only mentions "Bench testing was performed."
- Data provenance: Not applicable in the context of clinical/patient data, as it's bench testing.
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. Ground truth as typically defined in AI/diagnostic studies is not relevant for this type of bench testing for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There was no expert-based adjudication in the context of this submission.
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:
- No MRMC study was done. This device is a surgical fixation system, not an AI diagnostic tool that human readers would interact with.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For bench testing, the "ground truth" would be engineering specifications and validated test methods (e.g., tensile strength, fixation strength) according to established standards. This is not explicitly detailed but is implied by "meets its design, performance, and safety specifications."
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.