Search Results

This device (Polymer Threaded Anchor and Cinch Polymer Threaded Anchor) is intended for use only for the fixation of non-absorbable synthetic sutures.

The Polymer Threaded Series Anchor is intended for the fixation of surgical suture material for the following indications:

Shoulder:

• し、 Bankhart Repair
• SLAP Lesion Repair vi
• Acromio-clavicular separation 3.
• Rotator Cuff Repair 4.
• Capsule and Capsulolabral Reconstruction ર.
• 6. Biceps Tenodesis
• 7. Deltoid Repair

Hand, Wrist, Elbow:

• Scapholunate ligament reconstruction し、
• 2. Ulnar Collateral Ligament Reconstruction
• 3. Lateral Collateral Ligament Reconstruction
• 4. Biceps Tendon Reattachment
• Elbow Medial/Lateral Repair of Tendons in the Elbow న్.

Foot:

• 1. Hallux Valgus Reconstruction
• Mid and Forefoot Reconstruction 2.

Knee:

• medial collateral ligament l .
• lateral collateral ligament 2.
• posterior oblique ligament 3.
• 4. Joint capsule closure
• Illiotibial band tendonesis
• VMO Advancement 6.

The Cinch Polymer Threaded Anchor is intended only for the fixation of surgical material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

The proposed device, Polymer Threaded Anchor, is a pre-packaged, sterile polyacetal implant. The device is used to secure soft tissue to bone. The device is to be used with reusable insertion devices including a drill, tap, drill/tap combination, and inserter. Surgeons may loop suture of his/her choice through the eyelet of the anchor for the attachment of soft tissue. The device is single use. The device can be used for open and arthroscopic procedures. The anchor is packaged 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 constists 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 it's 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. Please see the drawings on page 9 for shape and dimensions of the device.

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 Polyacetal

Use

To implant the Anchor, the surgeon must first create an implantation site in bone. OBL supplies accessory drills, taps and drill/tap combinations to prepare these sites. The inserter is used to screw the anchor into the implantation site. After the anchor is fully seated, the inserter is removed from the implantation site, leaving the anchor in the bone and suture through the anchor. The suture can then be used to attach soft tissue.

The Polymer Threaded Anchor is a medical device designed to secure soft tissue to bone. The acceptance criteria and the study proving the device meets these criteria are detailed below:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• The document does not specify the exact sample size for either the pullout strength or anchor/suture interface tests. It refers to "All four of the proposed devices" for pullout strength (2.8 mm, 4.0 mm, 5.0 mm, and 6.5 mm anchors) and the "2.8 mm anchor" for interface testing, implying multiple units of each size were tested.
• Data Provenance: The tests were conducted using a "cancellous bone model made from polyurethane foam." This is an in vitro (laboratory) test, not originating from a country in terms of patient data. The study is prospective in nature, as it involves testing the device under controlled conditions to gather performance data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• This information is not applicable to this type of performance study. The "ground truth" here is the physical measurement of pullout strength and suture break strength, determined by mechanical testing, not by expert interpretation.

4. Adjudication Method for the Test Set:

• Not applicable. As the ground truth is established through objective mechanical testing, there is no need for expert adjudication. The results are quantitative measurements.

5. Multi-Reader-Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This is a performance study of a physical medical device (an anchor) measuring its mechanical properties. MRMC studies are typically used for diagnostic or imaging devices where human readers interpret results, and the effectiveness of AI assistance for these readers is being evaluated. This device's function does not involve human interpretation in a diagnostic context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, in essence. The performance tests described (pullout strength and anchor/suture interface) assess the inherent mechanical properties of the device itself, without any human interaction or algorithm involvement during the measurement of these properties. The device's "performance" is its intrinsic mechanical behavior.

7. Type of Ground Truth Used:

• Objective Mechanical Measurements: The ground truth for pullout strength was the force required to liberate the anchor from the foam model, and for the anchor/suture interface, it was the force at which the suture failed. These are direct, quantifiable physical measurements.

8. Sample Size for the Training Set:

• Not applicable. This study does not involve a "training set" in the context of machine learning or AI. The device's performance is evaluated based on its physical and mechanical properties, not on learned patterns from a dataset.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. No training set was used.

Ask a specific question about this device

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:

• 1. Bankart lesion repairs
• 2. 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:

• 1. 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.

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.

Ask a specific question about this device