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The Knotless Suture Fixation System is intended to secure soft tissue to bone of: The Shoulder, Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Rotator Cuff Repair Capsule Repair Biceps Tenodesis Deltoid Repair The Elbow: Ulnar or Radia! Collateral Ligament Reconstruction Bicep Tendon Reconstruction Tennis Elbow Repair The Hand and Wrist: Scapholunate Ligament Reconstruction Ulnar / Radial Collateral Ligament Reconstruction Ankle/Foot Indications: Lateral Stabilization Medial Stabilization Achilles Tendon Repair / Reconstruction Hallux Valgus Reconstruction Mid and Rear Foot Reconstruction

Knotless Suture Fixation System includes threaded anchors used to facilitate fixation of soft tissue to bone. This is a knotless suture anchor for surgical treatment of ligament, tendon and soft tissue pathologies of the shoulder and other joints. The implant is constructed of Polyetheretherketone (PEEK) which is widely used for products in the product code.

The provided text describes a 510(k) summary for the "Knotless Suture Fixation System" by Core Essence Orthopaedics, Inc. This document focuses on demonstrating substantial equivalence to predicate devices for market clearance, rather than presenting a detailed study proving the device meets specific acceptance criteria in a clinical or analytical setting with defined endpoints like accuracy, sensitivity, or specificity.

Here's a breakdown of the information based on your request, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "The following tests were performed to demonstrate that the Knotless Suture Fixation System is substantially equivalent to other predicate devices: Pullout force Suture retention".

• Sample Size for Test Set: Not specified. The document only states that tests were performed to demonstrate equivalence.
• Data Provenance: Not specified. It's implicitly laboratory testing, but details like country of origin or whether the data is retrospective/prospective are not relevant for these types of mechanical tests and are not provided.

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

Not applicable. The tests performed are mechanical (pullout force and suture retention), not diagnostic or clinical tests requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable. Mechanical tests do not typically involve adjudication methods for ground truth, as the measurements are objective.

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

No. The document explicitly states: "No clinical tests were performed." Therefore, no MRMC study was conducted.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This device is a physical medical device (suture fixation system), not an algorithm or AI system.

7. Type of Ground Truth Used

The ground truth for the "pullout force" and "suture retention" mechanical tests would be the measured physical properties themselves, determined by standardized testing protocols (e.g., ASTM standards). The document indicates that the tests showed the device "met the acceptance criteria," implying there were objectively measurable thresholds.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI or machine learning model that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

Summary of the Study and Acceptance Criteria:

The "study" described is a set of nonclinical mechanical tests (pullout force and suture retention) designed to demonstrate that the Knotless Suture Fixation System is substantially equivalent to existing predicate devices. The acceptance criteria for these tests were met, confirming the device's mechanical integrity for its intended use. However, the document does not provide the specific numerical values for these acceptance criteria nor the detailed results or sample sizes from these tests. It only states that the criteria were met. No clinical studies were conducted or presented as part of this 510(k) submission.

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The ArthroCare Spartan PEEK Suture Implant 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 ArthroCare Spartan PEEK (polyether-etherketone) Suture Implant is a fully-threaded, corkscrew shape anchor available in a 5.5mm diameter size. The suture anchor comes preconfigured with MagnumWire® sutures for traditional knot tying and is mounted on a disposable delivery driver. The device is supplied sterile. Associated Class I instruments for installation and removal of the implant are available separately. Together, the Spartan suture anchor and instrumentation will be known as the ArthroCare Spartan PEEK Suture Implant System.

The provided text describes a submission for a medical device (ArthroCare Spartan PEEK Suture Implant) seeking substantial equivalence to predicate devices, rather than a study proving performance against defined acceptance criteria (e.g., diagnostic accuracy metrics like sensitivity or specificity). Thus, many of the requested items (e.g., details on training/test sets, expert adjudication, MRMC studies) are not applicable to this type of submission.

However, the text does outline the type of assessment conducted and the criteria used to establish substantial equivalence.

Here's an attempt to answer the questions based on the provided document, noting where specific information is not present or applicable:

1. A table of acceptance criteria and the reported device performance

For a substantial equivalence claim for a bone fixation fastener, the "acceptance criteria" are generally that the new device performs comparably to the predicate device in relevant mechanical tests, demonstrating similar safety and effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in the document. The text mentions "bench performance testing" and "in vitro testing" involving "insertion of the anchors" in a "simulated human bone substrate," implying a laboratory-based study. The number of anchors tested, or repetitions performed, is not provided.
• Data Provenance: Not specified, but given it's "bench performance testing" and "in vitro testing," it's not applicable in terms of country of origin or retrospective/prospective human data. It is a laboratory study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a bone fixation fastener. The "ground truth" here is established through objective mechanical testing, not expert interpretation of diagnostic images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a mechanical engineering bench test, not a diagnostic study requiring expert adjudication.

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. This is a medical device (bone fixation fastener), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device (bone fixation fastener), not an algorithm. The testing described is "standalone" in the sense that it's the device itself being tested mechanically.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this type of device is established by objective physical measurements from controlled mechanical testing (ultimate strength, cyclic loading performance) against established standards or predicate device performance.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a "training set." The product development likely involved iterative design and testing, but not in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of an AI algorithm.

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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.

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