(85 days)
Indications for the Bio-Core™ Interference Screw include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications include, but are not limited to, the following:
Shoulder: Bankart repair, SLAP lesion repair, acromio- clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Wrist/Hand: Scapholunate ligament reconstruction, ulnar/ radial collateral ligament reconstruction.
Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.
Elbow: Tennis elbow repair, ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction.
Knee: Extra-capsular repair, medial collateral ligament (MCL) repair, lateral collateral ligament (LCL) repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis reconstruction, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.
In addition to the above indications, the 7.0, 8.0, 9.0, 10.0, 11.0, and 12.0 mm screws are indicated for the following uses:
- To provide interference fixation of patellar bone- tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction;
- To provide interference fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis); and
- To provide interference fixation during posterior cruciate ligament (PCL) reconstruction.
The implant consists of a LactoSorb (85% PLLA/15% PGA) interference screw measuring in diameters from 7-12mm and in lengths from 20 to 30mm. The screw consists of a tapered tip and lattice body design. The internal drive of the screw is a cruciate shape that breaks through the minor diameter of the screw threads allowing an open lattice structure to be created. The internal drive area can be packed with autograft or allograft bone.
The provided document is a 510(k) summary for the Bio-Core™ Interference Screw, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets acceptance criteria through a specific study with defined performance metrics, as would be common for AI/ML-driven devices.
Therefore, many of the requested categories (acceptance criteria table, sample sizes for test/training, expert ground truth, adjudication, MRMC studies, standalone performance) are not applicable or cannot be extracted from this document, as they pertain to clinical or performance studies for novel device claims, which are not the primary focus of a 510(k) of this nature.
Here's an attempt to answer the questions based on the information available:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or a reported device performance table in the way one would expect for an AI/ML device. For this traditional medical device, "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices through mechanical testing.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (K041274, K993025, K991298, K941941) based on mechanical properties | "Mechanical testing was done on the Bio-Core™ Interference Screw. This testing indicated that the Bio-Core™ Interference Screw was substantially equivalent to the predicate devices." |
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 for Test Set: Not applicable. The document refers to "mechanical testing," which implies physical tests on a sample of devices, not a dataset of patient information. The number of devices tested is not specified.
- Data Provenance: Not applicable in the context of patient data. The "data" here would be the results of mechanical tests performed on the device itself.
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" in this context would generally refer to a clinical diagnosis or outcome, which is not evaluated in this 510(k) submission. Mechanical testing results are objective measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used to resolve discrepancies in expert assessments for ground truth establishment. Mechanical testing results are generally objective and do not require expert adjudication in this manner.
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 physical medical device (an interference screw), not an AI-driven diagnostic or assistive tool. Therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The relevant "truth" for this device's substantial equivalence claim is its mechanical performance as compared to predicate devices. This is established through direct measurements in a lab setting, not through expert consensus, pathology, or outcomes data in the usual sense for a 510(k) for a physical implant.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML algorithm that requires a training set and associated ground truth.
§ 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.