(29 days)
FairFix QT Adjustable Button is intended to be used with single ended graft, during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery when a Ø4.5 mm tunnel is realized.
FairFix Extenders are intended to be used in association with FairFix QT Adjustable Button during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery with a Ø6 - 11 mm tunnel.
The FairFix QT Adjustable Button is a Medacta SportsMed device line extension providing a new adjustable loop solution meant for use with single-end graft during knee ligament reconstruction surgery (i.e. ACL, PCL).
The subject device consists of a metal elongated button with a pre-assembled, nonabsorbable adjustable suture loop, a graft tape to be coupled with the graft, a pulling suture (blue) to pull the construct through the bone tunnel and a flipping suture (white) to flip the button once the extracortical side has been reached.
The device is provided with two needled whipstitch sutures allowing implant graft connection and all the components are pre-assembled on a dedicated card, aiming to facilitate device handling.
The provided FDA 510(k) summary (K223795) describes the FairFix QT Adjustable Button, which is a medical device for knee ligament reconstruction. It states that no clinical studies were conducted, and the substantial equivalence determination is based on non-clinical performance testing.
Therefore, the requested information regarding acceptance criteria, study details, expert qualifications, and ground truth establishment, which are typically derived from clinical studies or extensive performance validation against clinically relevant metrics, cannot be fully extracted from this document as it focuses on demonstrating substantial equivalence through non-clinical testing and comparison to a predicate device.
However, I can provide the available information:
1. A table of acceptance criteria and the reported device performance:
The document summarizes the performance testing conducted to support substantial equivalence but does not explicitly present a table of quantitative acceptance criteria alongside reported device performance. It mentions "PERFORMANCE TESTING" aimed at a "Substantial Equivalence Assessment" between the FairFix QT Adjustable Button and the predicate "FairFix Adjustable Button".
2. Sample size used for the test set and the data provenance:
The document mentions "performance testing was conducted to written protocols" but does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical studies were conducted, and therefore no expert-established ground truth for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical studies were conducted that would involve an adjudication method for a test set.
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 mechanical implant, not an AI-assisted diagnostic tool. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a mechanical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not explicitly stated in terms of clinical ground truth. The "performance testing" would have used engineering specifications and physical test results as the "ground truth" for evaluating mechanical properties.
8. The sample size for the training set:
Not applicable. This pertains to machine learning models, which are not relevant to this device.
9. How the ground truth for the training set was established:
Not applicable.
Summary of Available Information from the Provided Text:
The document focuses on demonstrating that the FairFix QT Adjustable Button is substantially equivalent to a predicate device (FairFix Adjustable Button System, K203259) through non-clinical performance testing.
- Acceptance Criteria & Performance: The document states that "performance testing was conducted to written protocols" for a "Substantial Equivalence Assessment." It lists a few categories of non-clinical tests: Performance Testing (comparison to predicate), MR safety, Pyrogenicity (Bacterial endotoxin test, Pyrogen test), Biocompatibility, and Shelf-life evaluation. No specific quantitative acceptance criteria or detailed performance results are provided in this summary.
- Study Type: Non-clinical (laboratory/bench-top) studies.
- Sample Size: Not specified for any of the non-clinical tests.
- Ground Truth: For the non-clinical tests, the "ground truth" would be established by validated test methods and engineering specifications.
- Clinical Studies: No clinical studies were conducted. Therefore, there is no information on expert review, human-in-the-loop performance, or clinical outcomes data.
§ 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.