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The Apollo Medial Suture Anchor, Medial with Needles, XT Suture Anchor, Knotless Anchor Delivery Systems 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. Implants are fabricated from Solvay Zeniva ZA-500, ZA-600, or ZA-600 CF30 PEEK (ASTM F2026).

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Apollo Suture Anchor System. This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance acceptance criteria through a clinical study involving human readers or AI.

Therefore, many of the requested elements regarding acceptance criteria, study design, ground truth, and human-in-the-loop performance are not applicable to this type of regulatory submission and are not found in the provided text.

Here's what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "table of acceptance criteria" with numerical targets for clinical performance metrics (like sensitivity, specificity, AUC for AI, or improvement in human reader performance). Instead, it relies on demonstrating equivalence through various engineering and material tests.

Acceptance Criterion (Implicit)	Reported Device Performance
Biocompatibility (ISO 10993-1)	"Biocompatibility was established according to ISO 10993-1."
Bacterial Endotoxins (for implantable components)	"Bacterial Endotoxin testing meets pyrogen limit specifications." (Determined using LAL testing).
Mechanical Performance (Axial Pull-Out)	"Axial Pull-Out per ASTM F543-17 testing was conducted to confirm the material additive did not introduce any new risk." (The implicit acceptance criterion is that the performance is comparable to or better than the predicate, or at least not worse, suggesting the material additive does not negatively impact the established mechanical properties.) The document doesn't state specific numerical pull-out strength values, but implies acceptable performance.
Material Equivalence (Solvay Zeniva PEEK)	The materials (Solvay Zeniva ZA-500, ZA-600, or ZA-600 CF30 PEEK) "share a MAF" (Master Access File, indicating they are known and acceptable materials). The additional configurations of Solvay Zeniva PEEK (ZA-600 and ZA-600 CF) are considered substantially equivalent to the predicate.
Suture Equivalence (UHMWPE)	An additional UHMWPE suture manufacturer is proposed, and its sutures "have been demonstrated to be substantially equivalent to those used in the predicate device."
Sterilization and Shelf-Life	"The subject and predicate devices are offered sterile (EtO), and have a shelf-life of 2 years." (Implicitly, the device successfully maintains sterility and functionality for this duration).
Intended Use & Indications for Use Equivalence	The device is intended for the "same indications" and "same fundamental technology" as the predicate. The Indications for Use are explicitly listed for various anatomical regions and repairs (Shoulder, Foot/Ankle, Knee, Elbow, Hip, Wrist/Hand). The acceptance is that the device can safely and effectively be used for these stated indications, similar to the predicate.
Overall Substantial Equivalence	"Based on the intended use, indications for use, technological characteristics, and comparison to the predicate device, the Subject device has been shown to be substantially equivalent to the legally marketed predicate device and is safe and effective for the intended use."

2. Sample size used for the test set and the data provenance:

This document describes a 510(k) submission based on bench testing (e.g., mechanical, biocompatibility) and comparison to a predicate device, not a clinical test set with patient data for an AI/device performance study. Therefore, there's no "test set" in the context of a dataset of patient cases. The "samples" would refer to the physical devices or materials used for the specified laboratory tests. The provenance is internal testing by Valeris Medical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. As this is not an AI or diagnostic device that requires expert review of clinical images/data for ground truth.

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

Not applicable. No clinical case adjudication process described.

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 not an AI-assisted device.

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

Not applicable. This is not an algorithmic device.

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

The "ground truth" for this type of device lies in:

Material properties and standards: e.g., ASTM F2026 for PEEK, ISO 10993-1 for biocompatibility, ASTM F543-17 for mechanical testing.
Predicate device's established performance: The predicate's prior clearance serves as a benchmark for safety and effectiveness.
Laboratory test results: Measuring physical properties like pull-out strength and endotoxin levels against pre-defined specifications.

8. The sample size for the training set:

Not applicable. This is not an machine learning/AI device requiring a training set.

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

Not applicable.

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K Number

K142230

Device Name

Apollo Suture Anchor System and Titan Screws

Manufacturer

Valeris Medical

Date Cleared

2014-09-10

(28 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K133036

Intended Use

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).

Device Description

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.

AI/ML Overview

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).

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K Number

K133036

Device Name

APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS

Manufacturer

AMENDIA INC.

Date Cleared

2014-03-06

(161 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K083635,K120449,K071569,K060693,K041356

Intended Use

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: Shoulder (Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, AcormieClavicular Separation Repair, Deltoid Repair, Capisular Shift or Capsulolabral Reconstruction), Foot/Ankle (Lateral Stabilization, Medial Stabilizatio, Achilles Tendon Repair), Knee (Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis), Elbow (Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction), Hip (Capsular Repair, Acetabular Labral Repair).
Indications - Apollo Lateral Anchor: Shoulder (Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, AcormieClavicular Separation Repair, Deltoid Repair, Capisular Shift or Capsulolabral Reconstruction), Wrist/Hand (Scapholunate Ligament Reconstruction, Ulnar/Radial Collateral Ligament Reconstruction), Foot/Ankle (Lateral Stabilization, Medial Stabilizatio, Achilles Tendon Repair/Reconstruction, Hallux Valgus Reconstruction, Midland Forefoot Reconstruction), Elbow (Biceps Tendon Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repai(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 - Apollo Labral Suture Tac Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromioclavicular Separation Repair, Deltoid Repair, Capisular 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 – 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, Extracapsular 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, Rotor 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/reconstruions, 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, Tendo transfers).
Indications – Tenodesis Screws: The Titan Tenodesis Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. The Tenodesis 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, Iliotibial 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, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, Tendon transfer irthe hand/wrist, Lateral Epicondylitis repair).

Device Description

The Apollo Medial Suture Anchor, Lateral Anchor, and Suture Tac Delivery Systems 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.
The Titan Interference and Tenodesis 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 (6Al4V) per ASTM F136, or PEEK (Zeniva ZA-500) per ASTM F2026 from Solvay Advanced Polymers.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for Amendia's Apollo Suture Anchor and Titan Screws:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not contain explicit, quantitative acceptance criteria in the typical sense (e.g., "device must achieve X % accuracy," or "strength must exceed Y N"). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through performance testing. The reported device performance is that it met this standard.

Acceptance Criteria Type	Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Performance	Substantial equivalence in axial pullout, axial push out, insertion torque, and torque to failure as per ASTM F543-07 to predicate devices.	"Side-by-side testing to predicate devices was completed with test results demonstrating that the Apollo Suture Anchor System and Titan Screws are substantially equivalent to the predicate devices" in axial pullout, axial push out, insertion torque, and torque to failure tests per ASTM F543-07.
Indications for Use	Substantial equivalence of intended use/indications compared to predicate devices.	"The Apollo Suture Anchor System and Titan Screws are substantially equivalent to the predicate devices in regards to... Indications for Use." The specific indications are listed extensively in the document.
Materials	Substantial equivalence of materials used compared to predicate devices.	"The Apollo Suture Anchor System and Titan Screws are substantially equivalent to the predicate devices in regards to... Materials." (Implied to be titanium alloy (6Al4V) per ASTM F136, or PEEK (Zeniva ZA-500) per ASTM F2026, as described for the device).
Mechanism of Action	Substantial equivalence of mechanism of action compared to predicate devices.	"The Apollo Suture Anchor System and Titan Screws are substantially equivalent to the predicate devices in regards to... Mechanism of action."
Dimensions	Substantial equivalence of dimensions compared to predicate devices.	"The Apollo Suture Anchor System and Titan Screws are substantially equivalent to the predicate devices in regards to... Dimensions."
Safety and Efficacy	No new types of safety or efficacy issues compared to predicate devices.	"There are no significant differences in technological characteristics compared to the predicate device that would raise any new types of safety or efficacy issues."

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

Sample Size for Test Set: The document simply states "side-by-side testing to predicate devices was completed." It does not specify the sample size for the test set for any of the performance tests (axial pullout, axial push out, insertion torque, and torque to failure).
Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. Since it's mechanical testing of physical implants, "provenance" in the context of patient data (country, retrospective/prospective) isn't directly applicable here. The data would be generated from laboratory testing.

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

This information is not applicable and not provided in the document. The "ground truth" for this device's performance testing is based on standardized mechanical engineering tests (ASTM F543-07) comparing the device to predicate devices, not on expert clinical interpretation of patient data.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or subjective assessments, not for objective mechanical performance tests.

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

This information is not applicable and not provided. This device is a surgical implant (suture anchor and screws) and not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and not provided. This device is a physical surgical implant and does not involve any algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this submission is:

Standardized Mechanical Test Results: Specifically, compliance with ASTM F543-07 for axial pullout, axial push out, insertion torque, and torque to failure.
Comparison to Predicate Device Performance: The primary ground truth is the performance data generated for the predicate devices, against which the new device's performance is compared to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is a physical implant and does not involve machine learning or AI, so there is no training set in the computational sense.

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

This information is not applicable and not provided, for the same reasons as #8.

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