(90 days)
Indications for the LactoSorb® Screw Anchor with Lactocarbonate Suture includes the use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows.
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: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair.
The LactoSorb® Screw Anchor's are resorbable suture anchors used to reattach soft tissue to bone. The anchors consist of a screw portion and a head portion engages with the bone while the head portion provides a means to drive the anchor into the bone.
Lactocarbonate Suture, undyed (white) or dyed (violet), is a synthetic resorbable sterile surgical suture. The suture is a braided size 2 suture.
The Biomet LactoSorb® Screw Anchor with Lactocarbonate Suture (K032072) did not include a study to prove acceptance criteria for device performance. Instead, the submission relies on non-clinical testing for biocompatibility and functionality to demonstrate substantial equivalence to predicate devices.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility (General requirement for implantable devices) | "Results indicated that the device was highly biocompatible." |
| Functionality (Ability to perform intended use) | "Results indicated that the device... was functional within its indicated uses." |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. No clinical test set was used.
- Data Provenance: Not applicable. Non-clinical (laboratory) testing was performed. The document doesn't specify the country of origin for the lab testing, but the applicant is based in the USA. The testing was prospective for the purpose of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set requiring expert ground truth was performed.
4. Adjudication method for the test set
Not applicable. No clinical test set was performed.
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 surgical implant, not an AI-assisted diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical implant, not an algorithm.
7. The type of ground truth used
For the non-clinical testing, the "ground truth" was established by standard laboratory methods and specifications for biocompatibility and functional performance for resorbable sutures and anchors.
8. The sample size for the training set
Not applicable. No algorithm or AI component requiring a training set is involved with this device.
9. How the ground truth for the training set was established
Not applicable. No algorithm or AI component requiring a training set is involved with this device.
Study Proving Acceptance Criteria:
The study that "proves the device meets the acceptance criteria" is described as:
- Nonclinical Testing: "Nonclinical laboratory testing was performed to determine substantial equivalence. Biocompatibility and Functionality testing was conducted to assess the safety and effectiveness of Lactocarbonate suture (L-lactide / trimethylene carbonate, dyed and undyed. Results indicated that the device was highly biocompatible and was functional within its indicated uses."
This indicates that the manufacturer performed in-house or contracted laboratory tests to assess critical material properties and mechanical performance relevant to the device's intended use and biological interaction. The specific details of these tests (e.g., test standards, number of samples, specific quantitative results) are not provided in this 510(k) summary but would have been part of the full submission.
Absence of Clinical Testing:
The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This means the FDA's clearance was based solely on the non-clinical (laboratory) evidence and the device's substantial equivalence to previously cleared predicate devices with established safety and effectiveness.
§ 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.