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510(k) Data Aggregation
(88 days)
POLYMER THREADED ANCHOR / SUTURE COMBINATION
This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of non-absorbable synthetic sutures.
The PeBA Series Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indications:
Shoulder:
-
- Bankart lesion repairs
-
- SLAP lesion repairs
- Acromio-clavicular separation repairs 3.
- Rotator cuff tear repairs 4.
- Capsular shift or capsulolabral reconstructions 5.
- Biceps tenodesis 6.
- Deltoid repairs 7.
Foot and Ankle:
-
- Hallux Valgus repairs
- Medial or lateral instability repairs/reconstructions 2.
- Achilles tendon repairs/reconstructions 3.
- Midfoot reconstructions 4.
- Metatarsal ligament/tendon repairs/reconstructions 5.
Elbow, Wrist, and Hand:
- Scapholunate ligament reconstructions 1.
- Ulnar or radial collateral ligament reconstructions 2.
- Tennis elbow repair 3.
- Biceps tendon reattachment 4.
Knee:
1.
- Extra-capsular repairs:
- a. medial collateral ligament
- lateral collateral ligament b.
- c. posterior oblique ligament
- Iliotibial band tenodesis 2.
- Patellar realignment and tendon repairs, including vastus medialis 3. oblivious advancement
The Cinch Threaded Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency. The Cinch Threaded Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indication:
Urinary: Bladder Neck Suspension
The proposed device, Polymer Threaded Anchor/Suture Combination, is a pre-packaged, sterile device composed of a suture anchor, anchor inserter, and non-absorbable sutures. The device is used to secure soft tissue to bone. The device is pre-packaged so that the suture is looped through the anchor eyelet and the anchor/suture is installed in the inserter. The device is single use. The device can be used for open and arthroscopic procedures. These components are packaged together sterile in double mylar/tyvek pouches or formed trays.
The Polymer Threaded Anchor is a polyacetal screw designed to be screwed into a hole in bone chosen by the surgeon as a site for anchoring soft tissue to bone. The anchor consists of a threaded portion to engage bone, an eyelet to retain suture, and a drive means to couple the device to the inserter. The anchor is referred to by its major diameter of the largest thread). The sizes included in this submission are 2.8 mm, 4.0 mm, 5.0 mm, and 6.5 mm.
The suture used in the proposed device is a braided polyester suture. The suture is multifilament, braided, non-absorbable poly(ethylene terephthalate) surgical suture meeting USP requirements.
The Insertion Device is a manual surgical instrument comprised of a handle and shaft. The handle is constructed from polypropylene and serves as the interface between the surgeon's hand and the device. The shaft serves the functions of transferring the torque from the surgeon's hand to the anchor.
Materials:
Anchor: Polyacetal
Inserter: Piston and Sleeve: Stainless Steel, Handle: Polypropylene
Suture: multifilament, braided, non-absorbable poly(ethylene terephthalate) surgical suture from Surgical Specialties
Here's a breakdown of the acceptance criteria and study information for the Polymer Threaded Anchor / Suture Combination, based on the provided text:
Acceptance Criteria and Device Performance
The provided document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing. The acceptance criteria are implicitly defined by showing superior or equivalent performance to the predicate devices and meeting general design objectives.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Pullout Strength | Proposed Device: All four proposed devices (2.8 mm, 4.0 mm, 5.0 mm, and 6.5 mm Polymer Threaded Anchors) provide higher pullout strength than the predicate ROC device (Innovasive 2.8mm and 3.5mm ROC Suture Bone Fastener). |
| Predicate ROC device (Innovasive 2.8mm and 3.5mm ROC Suture Bone Fastener): Implicitly lower than the proposed device. | |
| Anchor/Suture Interface (Suture Break Strength) | Proposed Device (2.8 mm Polymer OBL Anchor): Provides higher suture break strength than USP listed Knot Break Strength. |
| Design Criteria: To create a lesser stress riser in the suture than a knot. (The 2.8mm anchor is considered the worst-case scenario due to its smallest head). | |
| Material Equivalence | The proposed device uses Polyacetal for the anchor. This is a modification from OBL's previous "PeBA Anchor/Suture Combination" which used Titanium alloy. Innovasive's "ROC Bone Fastener" also uses Polyacetal, thereby demonstrating material equivalence to a predicate. The suture is braided polyester, meeting USP requirements and already marketed in other devices. |
| Design, Usage, and Function Equivalence | The proposed device is stated to be the same as the predicate "PeBA Anchor/Suture Combination" in terms of design, usage, and function, with the material change being the primary modification. Both use a threaded anchor, an eyelet for suture, and an inserter. |
| Sterilization Method | Both the proposed device and the Innovasive predicate device can be EtO sterilized. |
| Indications for Use | The device is cleared for the same indications as the PeBA Series and Cinch Series Anchor/Suture Combinations, covering various orthopedic repairs in the shoulder, hand/wrist/elbow, foot/ankle, and knee, as well as bladder neck suspension. |
Study Details
2. Sample Size and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The text mentions "All four of the proposed devices" for pullout strength testing and "the 2.8 anchor" for suture interface testing, implying multiple tests were performed for each, but the exact number of samples per device/test is not provided.
- Data Provenance: The studies were conducted internally by Orthopaedic Biosystems Ltd., Inc. (OBL) as part of their 510(k) submission. The data is retrospective in the sense that the testing was performed specifically to support the regulatory submission. The country of origin for the testing would presumably be the US, where OBL is located.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
Not applicable. This is a medical device (implantable anchor/suture system, not an AI/diagnostic software) submission, and the "ground truth" for mechanical performance is established through physical testing against defined material properties and biomechanical measures (e.g., load to failure, USP standards). Expert opinion is typically not used to establish "ground truth" for such mechanical tests, though engineering expertise would be involved in designing and interpreting the tests.
4. Adjudication Method (Test Set)
Not applicable. As described above, the "ground truth" is based on direct physical measurements and comparison to established standards or predicate device performance, not on expert adjudication of diagnostic findings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI systems where human readers interpret medical images or data. The Polymer Threaded Anchor / Suture Combination is a physical implantable device, and its effectiveness is determined by mechanical properties and clinical outcomes post-implantation, not by physician interpretation of its 'output' in a diagnostic sense.
6. Standalone Performance Study (Algorithm Only)
No, a standalone (algorithm only) performance study was not done. This is not an AI/software device. The performance refers to the biomechanical integrity of the physical device.
7. Type of Ground Truth Used
- For Pullout Strength: The ground truth is the force (in lbs or another force unit) at which the anchor is liberated from the foam model. This is a direct physical measurement. The "worst case" cancellous bone model (polyurethane foam with a density of 8 lbs/cft) serves as a standardized, uniform, and challenging environment for comparison.
- For Anchor/Suture Interface Strength: The ground truth is the force at which the suture breaks when tensioned through the anchor eyelet. This is a direct physical measurement. Comparison is made against USP listed Knot Break Strength, which serves as a recognized standard for suture performance.
8. Sample Size for Training Set
Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How Ground Truth for Training Set was Established
Not applicable for the reason stated above.
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