(28 days)
The Apollo Suture Anchors and Titan Screws are indicated for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The screws are intended for use in the following procedures:
Indications - Apollo Medial Suture Anchor and Apollo XT Suture Anchors: Shoulder (Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction), Foot/Ankle (Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair), Knee (Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis), Elbow (Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction), Hip (Capsular Repair, Acetabular Labral Repair).
Indications - Apollo Labral Suture Anchor: Shoulder (Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction), Wrist (Scapholunate Ligament Reconstruction), Elbow (Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction), Hip (Capsular Repair, Acetabular Labral Repair), Knee (Extracapsular Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Joint Capsule Closure, Iliotibial Band Tenodesis Reconstruction, Patellar Ligament/Tendon Repair, Vastus Medialis Obliquus Muscle Advancement).
Indications - Apollo Lateral Anchor: Shoulder (Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction), Wrist/Hand (Scapholunate Ligament Reconstruction, Ulnar/Radial Collateral Ligament Reconstruction), Foot/Ankle (Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair/Reconstruction, Hallux Valgus Reconstruction, Mid and Forefoot Reconstruction), Elbow (Biceps Tendon Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair (PEEK Anchor Only)), Knee (Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Joint Capsule Closure, Iliotibial Band Tenodesis, Patellar Ligament/Tendon Repair).
Indications –Interference Screws: The Titan Interference Screws are 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 9 mm or less and a length of 23 mm or less are also intended for the use in the following procedures: Knee (ACL repairs, PCL repairs, Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis oliquous advancement), Iliotibial band tenodesis), Shoulder (Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift of capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis), Foot and Ankle (Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy, Flexor Hullucis Longus, Tendon transfers), Elbow, Wrist, and Hand (Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Scapholunate ligament reconstruction, Tendon transfers).
Indications –Titan Mini-Interference Screws: The Titan Mini-Interference Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. The Mini-Interference Screws are intended to provide soft tissue reattachment (i.e. fixation of ligament and tendon graft tissue). See below for specific indications. Shoulder (Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift of capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis), Foot and Ankle (Hallux valgus reconstruction, Medial stabilization, Lateral stabilization, Achilles Tendon Repair, Midfoot reconstructions, Metatarsal ligament repair, Bunionectomy, Flexor Hullucis Longus for Achilles Tendon reconstruction, Tendon transfers in the foot and ankle), Knee (Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, Posterior Cruciate Ligament Repair), Elbow (Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction), Wrist and Hand (Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometalcarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, Tendon transfer in the hand/wrist, Lateral Epicondylitis repair).
Apollo Family: The Apollo Medial Suture Anchor, XT Suture Anchor, Lateral Anchor, and Labral Suture Anchor are delivery systems for anchors for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. These anchors consist of cannulated anchors with integrated suture attachment or separate suture punch eyelet. The Anchors are provided loaded on individual inserters with and without integrated sutures, sterile, for single use only.
Titan Family: The Titan Interference and Mini-Interference Screws are interference screws for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The screws are provided sterile, for single use only.
Screw and anchor implants are made from either a titanium alloy (6AI4V) per ASTM F136, or PEEK (Zeniva ZA-500) per ASTM F2026 from Solvay Advanced Polymers.
Here's a breakdown of the requested information based on the provided text.
This document is a 510(k) premarket notification for a medical device called the "Apollo Suture Anchor System and Titan Screws." It's primarily concerned with demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a standalone study of its performance in a clinical setting against a gold standard.
Therefore, the typical acceptance criteria and study data associated with AI/software devices (e.g., sensitivity, specificity, clinical outcome measures) are not directly applicable or present in this type of regulatory submission. This submission focuses on demonstrating the device is as safe and effective as a previously cleared device.
However, I can extract the relevant information regarding performance testing that was done to support the safety and effectiveness for this type of device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Performance) | Reported Device Performance (Reference Standard/Predicate) |
|---|---|
| Axial Pull-Out (comparison to predicate) | Confirmed that modifications did not introduce new risks when compared to the predicate device. |
| Insertion Torque (comparison to predicate) | Confirmed that modifications did not introduce new risks when compared to the predicate device. |
Explanation: The "acceptance criteria" here are not numerical thresholds for clinical performance or diagnostic accuracy. Instead, the acceptance criterion for this 510(k) submission is that the modified device performs comparably to the predicate device and that the modifications (adding a 3rd suture portal) do not introduce new risks. The reported device performance is that this comparison was confirmed through mechanical testing.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of devices or cases. The testing conducted was "Axial Pull-Out and Insertion Torque per ASTM F543-7 testing." ASTM F543-7 is a standard test method, but the specific number of samples tested by Valeris Medical is not provided in this summary.
- Data Provenance: Not applicable in the context of clinical data provenance (country of origin, retrospective/prospective). This refers to mechanical testing data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a surgical implant (suture anchor and screws). The "ground truth" for its performance is assessed via engineering and mechanical testing standards (ASTM F543-7) rather than expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes. The testing here is mechanical.
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
Not applicable. This document does not describe an AI/software device or a clinical study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation in this context is established by validated mechanical testing standards (ASTM F543-7). This standard provides methods for determining the axial pull-out and insertion torque of metallic bone screws. The goal was to show that the modified device's performance aligned with these established standards and did not significantly differ from the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device that requires a training set.
Summary of the Study Discussed in the Document:
The study described is a performance testing study.
- Purpose: To confirm that a modification (addition of a 3rd suture portal) to the Apollo Suture Anchor System and Titan Screws did not introduce new risks compared to the predicate device.
- Methodology: Axial Pull-Out and Insertion Torque testing was conducted according to ASTM F543-7.
- Conclusion: The testing confirmed that the modification did not introduce any new risks, supporting the substantial equivalence of the subject device to the predicate device (K133036).
§ 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.