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510(k) Data Aggregation
(54 days)
The Syntheface PEEK Interference Screw is indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9mm or less are also indicated for use in the following procedures: Knee -ACL Repair -PCL Repair -Extra-capsular repair Medial collateral ligament Lateral collateral ligament Posterior oblique ligament -Patellar realignment and tendon repair Vastus medialis obliquus advancement -Iliotibial band tenodesis Shoulder -Capsular stabilization Bankart repair Anterior shoulder instability SLAP lesion repair Capsular shift or capsulolabral reconstruction -Acromioclavicular separation repair -Deltoid repair -Rotator cuff tear repair -Biceps tenodesis Foot and Ankle -Hallux valgus repair -Medial or lateral instability repair/reconstruction -Achilles tendon repair/reconstruction -Midfoot reconstruction -Metatarsal ligament/tendon repairs/reconstruction -Bunionectomy -Flexor Hullucis Longus (FLH) -Tendon Transfer Elbow, Wrist, and Hand -Biceps tendon reattachment -Ulnar or radial collateral ligament reconstruction -Lateral epicondylitis repair -Scapholunate ligament reconstruction -Tendon Transfer -Tendon Transfer -Carpometacarpal Joint Arthroplasty -Carpal Ligament Reconstruction
The Syntheface PEEK Screw Sheath is indicated for use in combination with Syntheface PEEK Interference Screw for fixation of soft tissue to bone during cruciate ligament reconstruction.
All Syntheface PEEK Interference Screws are non-absorbable. All interference screws are offered in a polyetheretherketone (PEEK) material. Syntheface PEEK Interference Screws are provided sterile, for single use only. The Syntheface PEEK Interference Screws are composed of 6 different configurations ranging from 6mm to 11mm in diameter and 25mm in length. The Syntheface PEEK Interference Screw can be used alone or be used in conjunction with the Syntheface PEEK Screw Sheath. The Syntheface PEEK Screw Sheath shall be used in conjunction with the Syntheface PEEK Interference Screw. All Syntheface PEEK Screw Sheaths are non-absorbable, and are intra-tunnel devices used to secure soft tissue grafts to bone during cruciate ligament reconstruction procedures. The Syntheface PEEK Screw Sheath is a polyetheretherketone (PEEK) material implant for use with Syntheface PEEK Interference Screw. Syntheface PEEK Screw Sheaths are provided sterile, for single use only.
The provided document is an FDA 510(k) Premarket Notification for the "Syntheface PEEK Interference Screw" and "Syntheface PEEK Screw Sheath." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than establishing de novo performance criteria against a specific clinical condition or a human reader. Therefore, the information regarding acceptance criteria, study design for proving device performance, sample sizes for test sets, expert involvement, and ground truth establishment (as typically requested for AI/diagnostic device studies) is not directly applicable or available in this document in the manner you specified.
Instead, the document details non-clinical bench tests performed to demonstrate that the subject device performs as well as the predicate device. The acceptance criteria for these tests would generally be based on comparison to the predicate device's performance or established engineering standards for similar medical devices.
Here's an attempt to extract and present the relevant information within the framework you provided, acknowledging the limitations for an equivalence submission:
Acceptance Criteria and Device Performance Study (Based on 510(k) Equivalence)
This 510(k) submission establishes substantial equivalence to legally marketed predicate devices, not de novo clinical effectiveness. Therefore, the "acceptance criteria" and "study" are primarily focused on demonstrating that the new device is as safe and effective as the predicate through non-clinical bench testing and material compliance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implied from Equivalence) | Reported Device Performance |
|---|---|---|
| Material Standards Compliance | Compliance with relevant material standards for PEEK for surgical implant applications. | Complies with ASTM F2026-17: Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications. |
| Biocompatibility | Evaluation in accordance with ISO 10993-1:2018 for "Implant medical device - Tissue/bone" with a contact duration of "Long term (> 30 days)." | Evaluated in accordance with ISO 10993-1:2018 for the specified body contact category and duration. (Specific results not detailed, but states "evaluated in accordance with"). |
| Bacterial Endotoxin | Meet endotoxin limit specifications via LAL testing. | Determined using LAL testing to meet endotoxin limit specifications. |
| Mechanical Performance (Screw-in test) | Performance comparable to the predicate device. | Mechanical tests including screw-in test were performed. (Specific comparative results or quantitative acceptance criteria are not provided in this summary, but the intent is to show comparable performance to the predicate). |
| Mechanical Performance (Pullout test) | Performance comparable to the predicate device. | Mechanical tests including pullout test were performed. (Specific comparative results or quantitative acceptance criteria are not provided in this summary, but the intent is to show comparable performance to the predicate). |
| Mechanical Performance (Fatigue test) | Performance comparable to the predicate device. | Mechanical tests including fatigue test were performed. (Specific comparative results or quantitative acceptance criteria are not provided in this summary, but the intent is to show comparable performance to the predicate). |
| Sterilization | Validation according to ISO 11135:2014 to achieve a Sterility Assurance Level (SAL) of 10⁻⁶. | Sterilization method (EO sterilization) has been validated according to ISO 11135:2014 to a SAL of 10⁻⁶. (Note: The predicate used irradiation sterilization, but the subject's EO method was validated.) |
| Shelf-life | 5 years demonstrated by accelerated aging. | 5-year shelf-life of the device has been evaluated by accelerated ageing test. |
| MRI Safety | MR safe as a nonmetallic, nonconducting material without ferromagnetic materials or metallic markers, conforming to ASTM F2503 guidelines. | Labeled MR safe per ASTM F2503. The polyetheretherketone material is nonmetallic, nonconducting, and does not contain ferromagnetic materials or other metallic markers. No concerns with performance in an MRI environment. |
| Dimensional Verification (Interference Screw) | Diameter: 6-11mm; Length: 25mm, comparable to predicate. | Interference screw diameters: 6mm, 7mm, 8mm, 9mm, 10mm, 11mm. Length: 25mm. Substantially equivalent to predicate. |
| Dimensional Verification (Screw Sheath) | Width: 9mm, 10.5mm, 12.6mm, 14.6mm; Height: 10.5mm, 12.2mm, 14.7mm, 17.8mm; Length: 34mm, comparable to predicate, with performance bench tests to support substantial equivalence despite slight dimensional differences. | Screw Sheath width: 9mm, 10.5mm, 12.6mm, 14.6mm; Screw Sheath height: 10.5mm, 12.2mm, 14.7mm, 17.8mm; Screw Sheath length: 34mm. Declared substantially equivalent, and "performance bench tests had been conducted to support the substantial equivalence." |
2. Sample size used for the test set and the data provenance
For non-clinical bench testing, the "test set" typically refers to the number of devices or material samples subjected to the tests. The document states that "Non-clinical bench tests were conducted in support of the substantial equivalence determination," but it does not specify the sample sizes used for each mechanical test (screw-in, pullout, fatigue) or for the biocompatibility, endotoxin, sterilization, or shelf-life tests.
Data Provenance: All data appears to be retrospective from internal lab testing performed by the manufacturer, Suzhou Endophix Co., Ltd., based in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of 510(k) submission. "Ground truth" established by experts is relevant for diagnostic devices or AI algorithms that interpret medical images or data. For an orthopedic implant seeking substantial equivalence, the "ground truth" is typically defined by engineering specifications, material standards, and benchmark performance of the predicate device, rather than expert consensus on clinical cases. The tests are designed to meet these engineering and material "truths."
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1, 3+1) are used for clinical studies involving multiple readers evaluating patient cases, often to establish a consensus "ground truth" for ambiguous findings. Since this submission relies on non-clinical bench testing, no such adjudication method was employed.
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. An MRMC study is relevant for diagnostic devices, particularly AI-powered ones, to assess their impact on human reader performance. The Syntheface PEEK Interference Screw and Screw Sheath are orthopedic implants, not diagnostic tools, and do not involve human readers or AI assistance in their function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This question pertains to the performance of an AI algorithm in isolation. The devices in this submission are physical orthopedic implants, not algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned in point 3, the concept of "ground truth" as typically defined for diagnostic or AI studies (e.g., expert consensus, pathology, outcomes data) does not directly apply here. Instead, for this orthopedic implant, the "ground truth" for its performance is established through:
- Material Standards: Adherence to established ASTM and ISO standards for PEEK and biocompatibility.
- Engineering Specifications: Meeting predefined dimensional tolerances and mechanical property requirements.
- Predicate Device Performance: Demonstrating comparable mechanical performance (screw-in, pullout, fatigue) to the legally marketed predicate devices through bench testing.
8. The sample size for the training set
Not applicable. The concept of a "training set" belongs to machine learning and AI algorithms. These devices are physical implants, and their development did not involve a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for these physical orthopedic implants.
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