(216 days)
The PULLUP® device is designed to be used as juxtacortical fixation for ACL reconstruction.
The PULLUP® Adjustable Juxtacortical Fixation Device consists of an adjustable nonabsorbable braided loop and titanium button. The system is preloaded with traction threads. The PULLUP® Adjustable Juxtacortical Fixation Device is available in 2 versions: -PULLUP® for cortical tunnels having a diameter of 4.5 mm - PULLUP®XL for cortical tunnels having a diameter between 5 and 10 mm - The implant is supplied sterile, ready to use.
The provided document is a 510(k) premarket notification for a medical device called the PULLUP® Adjustable Juxtacortical Fixation Device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical trial to establish safety and effectiveness from scratch.
Therefore, the document does not contain the detailed information on acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device, clinical trial, or diagnostic test. Instead, it demonstrates the device's performance through non-clinical performance testing to establish equivalence to predicate devices.
Here's an analysis based on the information available in the document, framed against your requested categories, with explanations for what is not present:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with corresponding performance metrics in the way one would expect for an AI/ML device or a clinical outcome study. Instead, it makes a general statement about non-clinical performance testing:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device is as safe as predicate devices | "Non clinical performance testing demonstrated that PULLUP® device is as safe, as effective, and performs at least as safely and effectively as its predicate devices." |
| Device is as effective as predicate devices | "Non clinical performance testing demonstrated that PULLUP® device is as safe, as effective, and performs at least as safely and effectively as its predicate devices." |
| Device performs at least as safely and effectively as predicate devices | "Non clinical performance testing demonstrated that PULLUP® device is as safe, as effective, and performs at least as safely and effectively as its predicate devices." and "Verification and validation tests demonstrate that the PULLUP® device is as safe, as effective, and performs as safely and effectively as its predicate device." |
The "non-clinical performance testing" would typically involve bench testing for mechanical properties (e.g., strength, fatigue, pull-out force) designed to show equivalence to the predicate devices. The specific metrics, thresholds, and results of these tests are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and therefore not provided. The document states, "No clinical data has been presented." The performance testing mentioned is non-clinical (i.e., bench testing, not human patient 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)
This information is not applicable. Since no clinical data or human-interpreted data is referenced, there's no ground truth established by experts in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable, as there is no human interpretation of data 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
This information is not applicable. The device is a mechanical fixation device, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a mechanical fixation device; there is no algorithm involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance testing, the "ground truth" would be established by validated engineering test methods and relevant ASTM/ISO standards for mechanical testing of orthopedic implants. This often involves measuring parameters like tensile strength, cyclic loading, and pull-out strength, comparing the results of the new device against the known performance of the predicate devices under identical test conditions. Specific details are not disclosed in this summary.
8. The sample size for the training set
This information is not applicable. There is no AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable. There is no AI/ML algorithm requiring a training set.
In summary: The provided 510(k) summary is for a physical medical device. It relies on non-clinical performance testing to demonstrate substantial equivalence to predicate devices (Arthrex TightRope RT and Biomet ToggleLoc System) in terms of safety and effectiveness. It explicitly states that "No clinical data has been presented." Therefore, the detailed information requested regarding AI/ML device studies, human readers, ground truth establishment by experts, and clinical trial specifics (like sample size, data provenance, adjudication) is not relevant or available in this document.
§ 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.