Search Results

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:

"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.

Ask a specific question about this device

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 an implant and associated instruments for installation of the implant that is designed for specific indications in arthroscopic and orthopedic procedures.

This 510(k) summary (K100457) describes the ArthroCare Corporation Opus SpeedScrew System, which is a bone anchor (Class II per 21 CFR 888.3040, Product code: HWC). The submission is for "additional ancillary instrumentation" to be used with an existing bone anchor, the Opus SpeedScrew Knotless Fixation Device (cleared under K081893). This is crucial because this document does not present any new acceptance criteria or new studies to demonstrate device performance beyond what was established for the predicate device (K081893).

The document explicitly states: "The SpeedScrew System design and technology is substantially equivalent to the existing SpeedScrew System cleared by the Food and Drug Administration (K081893). The differences between the SpeedScrew System and the predicate system do not raise questions regarding the safety and effectiveness of the implant. The proposed system, as designed, is as safe and effective as the predicate system."

Therefore, the sections of your request related to acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable to the provided K100457 document. This submission relies on the substantial equivalence to its predicate device rather than presenting new performance data.

If information on acceptance criteria and a study proving device performance is needed, it would be found in the 510(k) submission for the predicate device, K081893.

Ask a specific question about this device