(28 days)
The SpeedScrew 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 attachment
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 SpeedScrew Knotless Fixation Device is an implant that facilitates the attachment of tissue to bone. The SpeedScrew implant is a knotless fixation device, in other words surgical knots are not necessary for fixation of suture to tissue. The Opus SpeedScrew System consists of a 5.5 mm implant and a 6.5 mm implant, and associated instruments for installation of the implant that is designed for specific indications in arthroscopic and orthopedic procedures.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Opus SpeedScrew System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed reported device performance values. Instead, it refers to "side by side bench testing" against predicate devices and a general claim that the device is "as safe and effective as the predicate system."
However, we can infer the implied acceptance criteria based on the type of testing mentioned:
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Static Testing Performance: Must perform comparably or better than the predicate devices (K081893 and K100457) in static pull-out strength/fixation. | "The in vitro testing conducted involved insertion of the anchors in a simulated human bone substrate followed by both static and cyclic fatigue testing." |
"The Opus SpeedScrew System design and technology is substantially equivalent to the existing Opus SpeedScrew System cleared by the Food and Drug Administration (K081893 and K100457)."
No specific numerical data is provided in this document. |
| Cyclic Fatigue Testing Performance: Must perform comparably or better than the predicate devices (K081893 and K100457) in resisting fatigue failure over repeated stress cycles. | "The in vitro testing conducted involved insertion of the anchors in a simulated human bone substrate followed by both static and cyclic fatigue testing."
"The Opus SpeedScrew System design and technology is substantially equivalent to the existing Opus SpeedScrew System cleared by the Food and Drug Administration (K081893 and K100457)."
No specific numerical data is provided in this document. |
| Material Biocompatibility: Materials must be well-characterized and have a history of safe use in similar predicate devices. | "Furthermore, the materials are well characterized and have been used in predicate devices with similar indications." |
| Safety and Effectiveness: Differences from the predicate device must not raise new questions of safety and effectiveness. | "The differences between the Opus SpeedScrew System and the predicate system do not raise questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The proposed system, as designed, is as safe and effective as the predicate system." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document. The document only mentions "side by side bench testing" and "in vitro testing."
- Data Provenance: The testing was "in vitro testing" using "a simulated human bone substrate." The country of origin for the data is not specified, but given the submitter's address is in Sunnyvale, California, USA, and the FDA submission, it's likely U.S.-based. The testing is prospective as it was conducted for the purpose of this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/not provided for this type of device submission. Bench testing of medical implants like bone anchors does not typically involve expert review for "ground truth" in the way clinical studies or diagnostic imaging might. The "ground truth" for mechanical performance is established by the standardized test methods themselves and the physical measurements obtained.
4. Adjudication Method for the Test Set
This is not applicable/not provided. Adjudication methods are relevant for clinical trials or studies where subjective assessments (e.g., by experts) need to be reconciled. For bench testing, the results are typically quantitative measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not performed as this is a mechanical implant device, not a diagnostic or imaging device requiring human reader interpretation. Therefore, there's no "effect size of how much human readers improve with AI vs without AI assistance."
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Not applicable. This is a mechanical implant device; there is no "algorithm" in the sense of AI or software processing data that would have a standalone performance. The "device" itself is the implant.
7. Type of Ground Truth Used
The ground truth for the bench testing was established by physical measurements and mechanical properties derived from standardized in vitro tests (static and cyclic fatigue testing) on a simulated human bone substrate. The ground truth is the measured mechanical performance of the device and its predicate devices under controlled conditions.
8. Sample Size for the Training Set
There is no concept of a "training set" in this context. This is a medical device clearance based on substantial equivalence established through bench testing, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for a machine learning model, this question is not applicable.
§ 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.