(196 days)
The Legends Orthopedics 5.5 mm Suture Anchors is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle, and knee.
Specific indications are as follows:
Shoulder: Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
Wrist/Hand: Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.
Foot/Ankle: Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
Elbow: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.
Knee: a Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure.
The Legends Orthopedics 2.9 mm Suture Anchor is indicated for use in soft tissue reattachment procedures.
Specific indications are as follows:
Shoulder: Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
Wrist/Hand: Scapholunate ligament reconstruction.
Elbow: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.
Knee: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament tendon repair. iliotibial band tenodesis, joint capsule closure, extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.
The Legends Orthopedics 5.5 mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee.
Specific indications are as follows:
Shoulder indications: - Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
Wrist/Hand indications: - Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.
Foot/Ankle indications: - Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
Elbow indications: - Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.
Knee indications: - Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure.
The Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) are an internal fixation device intended to aid in arthroscopic and orthopedic reconstructive procedures needing soft tissue fixation. due to injury or degenerative disease.
The subject device(s) is screw-like in shape and composed exclusively of PEEK plastic. The 5.5mm (17.5mm length) is available in both standard "knotted" and "knotless" configurations. The implantable anchor devices are available in diameters of 5.5mm (17.5mm length) and 2.9mm diameter (10mm length) and provided in sterile condition.
They 5.5mm & 2.9 Suture Anchors are provided sterile and supplied with nonabsorbable polyethylene suture. The anchor is supplied with reusable taps and guides of corresponding size.
The 5.5 knotless Suture Anchors are provided sterile no suture. Components are available in a range of sizes to meet the needs of an individual patient.
The 5.5mm suture anchor is supplied in two designs:
with USP #2 high strength non-absorbable polyethylene suture(s) intended to be knotted and Knotless without any suture and suture attachment does not require knot tying.
The 2.9mm suture anchor is supplied in two designs:
- i. with USP #2 high strength non-absorbable polyethylene suture(s) and where the anchor must be attached to the inserter before use and
- ii. where the anchors are provided preloaded on single use inserters.
The anchors are composed of polyetheretherketone (PEEK). The high strength suture is made from non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE). The implants are ethylene oxide (ETO) sterilized. All implants are supplied in sterile condition.
This document is a 510(k) Premarket Notification for a medical device, which seeks to demonstrate substantial equivalence to a predicate device. It does not contain information about a study proving the device meets acceptance criteria in the way you might expect for a digital health or AI device. Instead, it relies on demonstrating that the new device is functionally and materially similar to an already approved device.
Here's an breakdown based on the provided text, addressing your points where applicable, and noting where information is not present for this type of submission:
1. A table of acceptance criteria and the reported device performance
The document does not present "acceptance criteria" and "reported device performance" in the typical format of a study for an AI or digital health device with specific metrics like sensitivity, specificity, etc. Instead, it justifies substantial equivalence by comparing technological characteristics and adherence to recognized standards.
Here's a table summarizing the comparison to the predicate device, which serves as the basis for performance acceptance in a 510(k) of this type:
| Parameter | Acceptance Criteria (based on Predicate Device K111590) | Reported Device Performance (Legends Orthopedics Suture Anchors) | Comments |
|---|---|---|---|
| Intended Use | Indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle, and knee. | Indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle, and knee. | Identical |
| Indications for Use | Detailed list of specific indications for 5.5 mm, 2.9 mm, and 5.5 mm Knotless Suture Anchors across shoulder, wrist/hand, foot/ankle, elbow, and knee (e.g., Bankart repair, rotator cuff repair, Achilles tendon repair). | Detailed list of specific indications for 5.5 mm, 2.9 mm, and 5.5 mm Knotless Suture Anchors across shoulder, wrist/hand, foot/ankle, elbow, and knee (e.g., Bankart repair, rotator cuff repair, Achilles tendon repair). Contains minor additional indications for 2.9 mm anchor (extracapsular repair, vastus medialis obliquus (VMO) muscle advancement) which were likely also cleared for the predicate. | Identical |
| Materials | Polyetheretherketone (PEEK) for anchor, Ultra High Molecular Weight Polyethylene (UHMWPE) for suture. | Polyetheretherketone (PEEK) for anchor, Ultra High Molecular Weight Polyethylene (UHMWPE) for suture. | Identical |
| Design Features | Anchor diameters: 2.9mm and 5.5mm. Anchor geometry: 2.9mm (10mm length), 5.5mm (17.5mm length). Suture configuration: Braided multifilament (USP #2, 0.50-0.599mm). Method of fixation: Distal eyelet for knotted, through body for knotless. | Anchor diameters: 2.9mm and 5.5mm. Anchor geometry: 2.9mm (10mm length), 5.5mm (17.5mm length). Suture configuration: Braided multifilament (USP #2, 0.50-0.599mm). Method of fixation: Distal eyelet for knotted, through body for knotless. | Identical |
| Sterilization | Provided in Sterile conditions (EO Sterilization). | Provided in Sterile conditions (EO Sterilization). | Identical |
| Performance Standards | Adherence to recognized standards like ASTM F2026-17 (PEEK polymers), SP-NF M80200_04_01 (Non-absorbable Suture), USP-NF M99670_02_01 (Tensile Strength), USP-NF M99650_02_01 ( Sutures - Diameter), ISO 11135-1:2007 (Sterilization), ISO 10993-7:2008 (Ethylene oxide residuals), ISO 11607-1:2006 (Packaging), ISO 14971:2007 (Risk Management), and ASTM F543 (guideline for bone anchor testing). Also, mechanical and physical properties compared to ASTM F2026 for PEEK. | Adherence to the same recognized standards: ASTM F2026-17, SP-NF M80200_04_01, USP-NF M99670_02_01, USP-NF M99650_02_01, ISO 11135-1:2007, ISO 10993-7:2008, ISO 11607-1:2006, ISO14971:2007, ASTM F543 guideline. Mechanical and physical properties compared to ASTM F2026 for PEEK. | Same |
| Single Use/Reuse | Single Use | Single Use | Same |
| Shelf Life | 5 years | 5 years | Same |
The study that "proves the device meets the acceptance criteria" in this context is the non-clinical laboratory testing performed by "RoG Sports Medicine" (presumably to ensure consistency across batches as the predicate device manufacturer). The submission states: "Non-clinical laboratory testing was performed by RoG Sports Medicine to determine substantial equivalence. The results were reviewed and side by side comparisons were done with the identified predicate device and it demonstrated that there were no significant differences between the Legends Orthopedics Suture Anchors... and the predicate device. The results indicated that the devices were functional within their intended use."
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 provided in the document. The submission references "non-clinical laboratory testing" without specifying sample sizes for these tests, which typically involve mechanical or material characterization rather than patient data. Data provenance like country of origin or retrospective/prospective status is irrelevant for this type of submission focused on material and mechanical equivalence.
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/not provided. For a device like a suture anchor, "ground truth" established by experts in the context of clinical image interpretation or AI output is not relevant. The "ground truth" for these devices revolves around material properties and mechanical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods are typically used in studies involving subjective interpretation (e.g., radiological reads) to establish a consensus ground truth. For mechanical testing of a suture anchor, such a method is not used.
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/not provided. MRMC studies are used to evaluate AI systems in diagnostic imaging. This device is a physical surgical implant, not an AI or diagnostic imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on established material specifications, mechanical testing standards, and performance characteristics of the legally marketed predicate device. In essence, the predicate device's proven safety and effectiveness, supported by its own non-clinical data and adherence to standards, serves as the "ground truth" for comparison.
8. The sample size for the training set
This information is not applicable/not provided. This device is not an AI/ML product that would require a 'training set'.
9. How the ground truth for the training set was established
This information is not applicable/not provided. As above, no training set is relevant for this type of device.
In summary, this 510(k) submission for the Legends Orthopedics Suture Anchors demonstrates substantial equivalence by showing that the new device has identical intended use, indications for use, materials, design features, sterilization, and overall performance characteristics to a predicate device (RoG™ Sports Medicine Suture Anchor, K111590). The "study" that supports this is a series of non-clinical laboratory tests comparing the subject device to the predicate device and confirming adherence to relevant industry standards. Clinical trials were not conducted or deemed necessary for this type of submission, as the fundamental technology and performance are considered equivalent to an already approved 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.