(24 days)
The SpeedLock Knotless Fixation Device is indicated for use in fixation of soft tissue to bone.
Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair
Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon reattachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
The SpeedLock Knotless Fixation System is an implantable bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The SpeedLock is a knotless fixation device, meaning that manually tying surgical knots is not necessary for the fixation of suture to tissue.
The SpeedLock Knotless Fixation System consists of two primary parts: an implantable bone anchor and an anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool.
The entire product is packaged in a tray with a Tyvek® Iid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.
Here's an analysis of the provided information regarding the SpeedLock Knotless Fixation System's acceptance criteria and studies:
Context: The provided document is a 510(k) premarket notification from the FDA, along with the applicant's 510(k) Summary. This means the device is seeking clearance based on substantial equivalence to a legally marketed predicate device, rather than requiring a full demonstration of safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) device. Therefore, the "acceptance criteria" and "studies" will primarily revolve around demonstrating this substantial equivalence through non-clinical (bench) testing.
Description of Acceptance Criteria and the Study that Proves the Device Meets Them:
The SpeedLock Knotless Fixation System is a Class II medical device, and its clearance is based on demonstrating substantial equivalence to a previously cleared predicate device (SpeedLock Knotless Fixation System, K130196). The acceptance criteria for this type of submission are primarily met through performance testing that shows the new device functions similarly and meets safety specifications comparable to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit from Submission) | Reported Device Performance and Study Findings |
|---|---|
| Mechanical Performance: | |
| Comparable static and cyclic fatigue strength to predicate device when anchored in simulated bone. (Based on FDA Guidance Document, Testing Bone Anchors, April 1996) | Bench Testing: |
| Performed on both the proposed and predicate devices. | |
| Involved insertion of anchors into a simulated human bone substrate. | |
| Followed by both static and cyclic fatigue testing. | |
| The test results demonstrate that the proposed SpeedLock meets its design, performance, and safety specifications and that its mechanical properties are substantially equivalent to the predicate device. | |
| Biocompatibility: | |
| Materials chosen for the implantable component must be biocompatible. (Implied by use of PEEK Optima LT3, a commonly accepted biomaterial for such applications) | Material Comparison: |
| Predicate device uses Invibio PEEK Optima® LT1. | |
| Proposed device uses Invibio PEEK Optima® LT3. | |
| (Both are forms of PEEK, suggesting a material family known for biocompatibility. No specific biocompatibility study is detailed beyond the material change). | |
| Sterility: | |
| Device must be supplied sterile. | Sterilization Method: |
| Sterilized by ethylene oxide (EtO), matching the predicate device. | |
| (Implies validation of the sterilization process was performed, though not detailed). | |
| Design Verification: | |
| Design outputs meet design inputs. | Design Verification Testing: |
| Performed to verify design outputs met design inputs. | |
| The summary states the tests demonstrate the device meets design specifications. | |
| Simulated Use Performance: | |
| Safety and effectiveness affirmed during simulated use for the device and accessory devices. | Simulated Use Testing: |
| Performed on the device and accessory devices promoted for use with the SpeedLock system. | |
| Affirmed safety and effectiveness. | |
| Intended Use / Indications: | |
| Must be comparable to the predicate device. | Comparison: |
| The intended use and indications for use are identical to the predicate device. | |
| Technological Characteristics: | |
| Comparable operating principle, design technology, delivery method, and other characteristics to the predicate device. | Comparison Chart: |
| Numerous characteristics (e.g., delivery method, suture material, anchor material, design technology, suture locking mechanism, anchor diameter, depth of barb, deployed length, insertion method) were found to be either "Same" or very similar (e.g., PEEK LT1 vs LT3) to the predicate device. | |
| The summary explicitly states "minor differences between the proposed SpeedLock and predicate device do not raise any new questions of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the provided text for the bench testing. The document mentions "bench testing was performed on both the proposed and predicate devices" and "this in vitro testing involved insertion of the anchors into a simulated human bone substrate followed by both static and cyclic fatigue testing." While not a specific number, it indicates comparative testing was done.
- Data Provenance: The testing was retrospective in the sense that it was conducted after the device design was finalized to demonstrate its performance against the set criteria. The tests were performed as part of the regulatory submission process by ArthroCare Corporation. There is no mention of country of origin for the "data" as it's mechanical test data, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This question is not applicable (N/A) in this context. The "test set" here refers to the mechanical bench testing of the device itself, not a diagnostic or AI-driven system requiring expert ground truthing of patient data. The "ground truth" for mechanical testing is established by engineering specifications, relevant ASTM/ISO standards, and the performance of the predicate device. The experts involved would be engineers and quality control personnel, ensuring the tests are conducted correctly and the results interpreted against the established performance criteria.
4. Adjudication Method for the Test Set:
- This question is not applicable (N/A) for mechanical bench testing. Adjudication methods like "2+1" or "3+1" are used for clinical studies involving multiple human readers assessing data (e.g., images), where an ultimate decision on a case (ground truth) needs to be reached by consensus or a tie-breaker. For mechanical testing, the "results" are quantitative measurements (e.g., force, displacement, cycles to failure) directly obtained from instruments. The "adjudication" is against pre-defined performance thresholds or comparison to the predicate device's performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- No MRMC study was done, nor were any clinical studies. The submission explicitly states "No clinical or animal data are included in this submission." This device is a surgical fixation system, not a diagnostic or interpretative AI tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No standalone (algorithm-only) performance study was done. This device is a physical surgical implant, not a software algorithm.
7. The Type of Ground Truth Used:
- The "ground truth" for the device's performance in this context is established through a combination of:
- Engineering Specifications: Internal design requirements for the device's mechanical strength, fatigue life, and other performance characteristics.
- Predicate Device Performance: The established performance of the legally marketed predicate device (K130196) serves as a benchmark for substantial equivalence.
- FDA Guidance Document: The "FDA Guidance Document, Testing Bone Anchors, April 1996" provides recommendations for the types of tests (static and cyclic fatigue) and methodologies considered appropriate for evaluating such devices.
- Simulated Use Conditions: Performance during simulated surgical procedures.
8. The Sample Size for the Training Set:
- This question is not applicable (N/A). There is no "training set" as this is a physical medical device submission, not an AI/machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established:
- This question is not applicable (N/A), as there is no training set for this type of 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.