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Megaloop Button System - Megaloop Button with Megaloop Adjustable Loop
The device is intended to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction.

Megaloop Button System - Megaloop AD Device
The device is intended to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction.

Megaloop Button System - Megaloop FLB Device, Megaloop FLW Device, Megaloop XL Button
Megaloop FLB Device and Megaloop FLW Device are used for fixation of soft tissue to bone in orthopedic procedures such as ACL repair.

When used in conjunction with the Megaloop FLB Device or Megaloop FLW Device, the Megaloop XL Button is intended for fixation of soft tissue to bone in orthopedic procedures such as ACL repairs.

Megaloop Button System - Megaloop DB Device, Megaloop AC Button with Megaloop Adjustable Loop
The Megaloop DB Device and Megaloop AC Button are intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically:

• The Megaloop DB Device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.

• The Megaloop AC Button is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

The Megaloop Button System is a family of titanium buttons for the fixation of bone to bone or soft tissue to bone. The system includes a variety of buttons made of Ti-6AI-4V ELI titanium alloy, with or without pre-assembled nonabsorbable loops, sutures and needles. The loops and sutures are offered in non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) material. The long straight needles are offered in XM-16 stainless steel material. The sutures and needles are not implantable and are discarded after assisting with button placement.

The Megaloop Button System is provided sterile, non-absorbable, for single use only.

The provided text describes a 510(k) premarket notification for the "Megaloop Button System," which is a family of titanium buttons used for fixation of bone or soft tissue to bone. The submission asserts that the device is substantially equivalent to several predicate devices.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are primarily based on comparing the subject device's characteristics and performance to legally marketed predicate devices. The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., minimum pullout strength in Newtons, minimum cycles for fatigue life). Instead, it relies on demonstrating that the subject device's non-clinical test results are comparable to or perform as well as the predicate devices.

Therefore, the table below outlines the general performance aspects evaluated and the reported outcomes:

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

The document explicitly states: "Non-clinical bench tests were conducted in support of the substantial equivalence determination."

• Sample Size: The document does not specify the sample size used for the pullout or fatigue tests, or any other non-clinical bench tests.
• Data Provenance: The nature of "non-clinical bench tests" implies that the data was generated in a controlled laboratory environment, likely by the manufacturer (Suzhou Endophix Co., Ltd.) or a contracted testing facility. There is no information regarding the country of origin of the data beyond the manufacturer's location (China), nor any mention of retrospective or prospective human data. This entire submission relies on bench testing, not human or clinical data.

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

This information is not applicable to this submission. The "ground truth" for the non-clinical bench tests would be the measured physical properties of the materials and devices under specific testing conditions, as determined by laboratory instruments and protocols. There is no mention of human experts establishing a "ground truth" for the test set, as these are mechanical and material property tests.

4. Adjudication Method for the Test Set

This is not applicable. Since the evaluation is based on non-clinical bench tests measuring objective physical properties, there is no need for an adjudication method by human reviewers. The test results are quantitative measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic medical devices where expert readers evaluate cases. The Megaloop Button System is a surgical implantable device, and its evaluation is based on non-clinical bench testing.

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

This question is not applicable. The Megaloop Button System is a physical surgical implant, not a software algorithm or an AI-powered device. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical bench tests consists of:

• Material Specifications: Compliance with established international standards (ISO, ASTM) for the chemical composition and mechanical properties of the materials (titanium alloy, UHMWPE).
• Biocompatibility Standards: Compliance with ISO 10993-1.
• Mechanical Test Results: Measured load-to-failure (pullout) and cycles-to-failure (fatigue) data, which are compared against general performance expectations for such devices and, implicitly, against the predicate device's performance. The "ground truth" here is the objectively measured physical behavior of the device under stress.
• Sterilization Validation: Demonstrated SAL of 10^-8.
• Shelf-life Data: Results from accelerated aging tests.

No pathology, expert consensus, or outcomes data were used for establishing ground truth in this non-clinical submission.

8. The Sample Size for the Training Set

This is not applicable. The Megaloop Button System is a physical medical device, not an AI or machine learning model. Therefore, there is no "training set" in the context of algorithm development. The design and manufacturing process would involve internal testing and iteration, but not "training data" in the AI sense.

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

This is not applicable for the same reason as point 8.

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The Javelot Ti and Javelot Ti-D Suture Anchor are intended for connection and fixation of soft tissue to bone in the knee, hip, shoulder, elbow, ankle, foot, wrist and hand for the following indications: Shoulder: - · Bankart lesion repair - · SLAP lesion repair - · Acromio-clavicular separation repair - · Rotator cuff tear repair - · Capsular shift or capsulolabral reconstruction - · Biceps tenodesis - · Deltoid repair Foot and Ankle: - Hallux valgus repair - · Medial or lateral instability repair/reconstruction - · Achilles tendon repair/reconstruction - · Midfoot reconstruction - · Metatarsal ligament/tendon repair/reconstruction Elbow, Wrist and Hand: - Ulnar or radial collateral ligament reconstruction - · Lateral epicondylitis repair - · Biceps tendon reattachment - · Scapholunate ligament reconstrontion (not for 4.5-6.5mm pro anchors) Knee: - · Extra-capsular repair - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament - · Iliotibial band tenodesis - · Patellar realignment and tendon repair - Vastus medialis obliquus advancement Hip: (2.8-6.5mm anchors only) - · Capsular repair - · Acetabular labral repair

Javelot titanium anchors and sutures are preassembled onto an inserter, which enables insertion of the anchor into bone. After the anchor is fully seated, the inserter is removed from the implant site, leaving the anchor in the bone and the suture looped through the anchor. Javelot titanium suture anchors come in various configurations, including: with attached non-absorbable needle(s). In certain configurations, the Javelot titanium suture anchors are packaged with a drill, a drill guide and a drill guide handle. The anchors are offered in titanium material. The sutures are offered in non-absorbable USP braid Ultra High Molecular Weight Polyethylene (UHMWPE) material. The preassembled inserter consists of an insertion rod and an insertion handle, the insertion rods are offered in stainless steel material, the insertion handles are offered in polycarbonate (PC) material. The needles are offered in 302 stainless steel material, the drills are offered in 630 stainless steel material, the drill guides are offered in 304 stainless steel material, and the drill guide handles are offered in polyphenylsulfone (PPSU) material. Javelot titanium suture anchors are provided sterile, non-absorbable, for single use only.

The provided document is a 510(k) summary for a medical device (Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor), not a study report. Therefore, it primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data from a specific study designed to meet those criteria for an AI/software device.

The requested information regarding acceptance criteria and a study proving the device meets them, particularly points 2-9 which are specific to the evaluation of AI/software performance, are not applicable to this submission. This document describes a physical medical device (suture anchors) and its performance is evaluated through bench testing (mechanical, biocompatibility, sterilization, shelf-life, and MRI safety), not through AI/software performance metrics like sensitivity, specificity, or reader studies.

Here's a breakdown of what can be extracted from the provided text, recognizing that it doesn't align with the detailed AI/software performance study request:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical device, the "acceptance criteria" are implied by the standards and types of tests performed to demonstrate safety and effectiveness. The "reported device performance" refers to the successful completion of these tests in comparison to predicate devices, without specific numerical thresholds stated in this summary.

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

This information is not provided in the 510(k) summary. These details would typically be found in the full test reports, which are not included here. The tests are bench tests, not clinical studies on patient data.

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 is a physical device, not an AI/software requiring expert adjudication for ground truth.

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

Not applicable, as this refers to expert review processes for AI/software data.

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 physical device, not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable. This does not involve an algorithm.

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

For mechanical tests, the "ground truth" would be the measured physical properties of the device under test conditions, evaluated against engineering specifications. For biocompatibility, it's compliance with established biological safety assessments. For sterilization, it's achieving a specified sterility assurance level. For MRI safety, it's adherence to defined safety limits for MR interaction. These are not types of ground truth relevant to AI performance.

8. The sample size for the training set

Not applicable. This is a physical device, no training data set is involved.

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

Not applicable. As there is no training set for a physical device.

In summary: The provided FDA 510(k) summary is for a physical medical device (suture anchors) and outlines the non-clinical bench testing conducted to demonstrate its substantial equivalence to predicate devices. The majority of the requested information pertains to the evaluation of AI/software performance, which is not relevant to this type of device submission.

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The Javelot PK-S suture anchor is intended for the reattachment of soft tissue to bone for the following indications: Shoulder: -Bankart lesion repair -SLAP lesion repair -Acromioclavicular separation repair -Rotator cuff tear repair -Capsular shift or capsulolabral reconstruction -Biceps tenodesis -Deltoid repair Foot/Ankle: -Hallux Valgus repair -Medial or lateral instability repair/reconstruction -Achilles tendon repair/reconstruction -Midfoot reconstruction -Metatarsal ligament/tendon repair/reconstruction Elbow: -Ulnar or radial collateral ligament reconstruction -Lateral epicondylitis repair -Biceps tendon reattachment Knee: -Extra-capsular repair Medial collateral ligament Lateral collateral ligament Posterior oblique ligament -Iliotibial band tenodesis -Patellar realignment and tendon repair Vastus medialis obliquus advancement

The Javelot PK-S suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications: Shoulder: -Bankart repair - -SLAP lesion repair - -Acromioclavicular separation repair - -Rotator cuff repair - -Capsular shift or capsulolabral reconstruction - -Biceps tenodesis - -Deltoid repair Foot/Ankle: - -Hallux Valgus reconstruction - -Medial stabilization - -Lateral stabilization - -Achilles tendon repair - -Mid-foot reconstruction - -Metatarsal ligament/ tendon repair - -Bunionectorny Elbow: - -Ulnar/ radial collateral ligament reconstruction -Biceps tendon reattachment - -Lateral epicondylitis repair Hand/Wrist: - -Scapholunate ligament reconstruction - -Ulnar/Radial collateral ligament reconstruction Knee: - -Medial collateral ligament repair - -Lateral collateral ligament repair - -Posterior oblique ligament repair - -Iliotibial band tenodesis - -Patellar tendon repairs - -Anterior cruciate ligament repair (4.75-5.5mm anchors only) - -Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5mm anchors only) -Quadriceps tendon repair (4.75 mm anchors only) -Meniscal root repair (4.75 mm anchors only) Hip: -Capsular Repair -Acetabular labral repair - -Proximal hamstring repair (4.75-5.5mm anchors only) - -Gluteus Medius Repair (4.75-5.5mm anchors only)

The Javelot PK-P suture anchor is intended for the reattachment of soft tissue to bone for the following indications: Shoulder: - -Rotator cuff repair -Bankart repair -SLAP lesion repair -Biceps tenodesis -Acromioclavicular separation repair -Deltoid repair -Capsular shift or capsulolabral reconstruction Foot/Ankle: - -Lateral stabilization -Medial stabilization -Achilles tendon repair -Metatarsal ligament repair -Hallux valgus reconstruction -Digital tendon transfers -Mid-foot reconstruction Knee: -Medial collateral ligament repair -Lateral collateral ligament repair -Patellar tendon repair -Posterior oblique ligament repair -Iliotibial band tenodesis Hand/Wrist: -Scapholunate ligament reconstruction -Carpal ligament reconstruction -Repair/Reconstruction of collateral ligaments -Repair of flexor and extensor tendons at the PIP, DIP, and MCP joints for all digits -Digital tendon transfers Elbow: -Biceps tendon reattachment -Ulnar or radial collateral ligament reconstruction Hip: -Capsular repair -Acetabular labral repair

The Javelot PK-P suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications: - Shoulder: -Bankart repair - -SLAP lesion repair - -Acromioclavicular separation repair - -Rotator cuff repair - -Capsular shift or capsulolabral reconstruction - -Biceps tenodesis - -Deltoid repair - Foot/ Ankle: -Hallux Valgus reconstruction -Medial stabilization -Lateral stabilization -Achilles Tendon Repair -Mid-foot reconstruction -Metatarsal ligament repair/ tendon repair -Digital tendon transfers (2.5mm anchor only) -Bunionectomy (2.9-4.5mm anchors only) Elbow: -Ulnar or radial collateral ligament reconstructions -Biceps tendon reattachment - -Lateral epicondylitis repair (2.9-4.5mm anchors only) Hand/ Wrist: -Scapholunate ligament reconstruction -Ulnar collateral ligament reconstruction (2.9-4.5mm anchors only) -Radial collateral ligament reconstruction (2.9-4.5mm anchors only) -Carpal ligament reconstruction (2.5mm anchors only) -Repair/Reconstruction of collateral ligaments (2.5mm anchors only) -Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits (2.5mm anchors only) -Digital tendon transfers (2.5mm anchors only) Knee: -Medial collateral ligament repair -Lateral collateral ligament repair -Posterior oblique ligament repair -Iliotibial band tenodesis -Patellar tendon repairs Hip: (2.9-4.5mm anchors only) -Acetabular labral repair -Capsular repair

The Javelot PK-L suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications: - Shoulder: - -Bankart lesion repair - -SLAP lesion repair - -Acromioclavicular separation repair - -Rotator cuff tear repair - -Capsular shift or capsulolabral reconstruction - -Biceps tenodesis - -Deltoid repair - -Anterior shoulder instability (3.7mm anchors only) Foot/ Ankle: - -Hallux Valgus repair - -Medial or lateral instability repair - -Midfoot reconstruction - -Metatarsal ligament/tendon repair/reconstruction - -Achilles tendon repair/reconstruction - -Bunionectomy (3.7mm anchors only) Elbow: - -Ulnar or radial collateral ligament reconstruction -Biceps tendon reattachment -Lateral epicondylitis repair (3.7mm anchors only) - Hand/Wrist: - -Scapholunate ligament reconstruction - -Ulnar collateral ligament reconstruction - -Radial collateral ligament reconstruction Knee: - -Medial collateral ligament repair -Lateral collateral ligament repair -Posterior oblique ligament repair - -Iliotibial band tenodesis - -Patellar tendon repair Hip: (3.7mm anchors only) -Hip capsule repair Acetabular labrum reattachment/ reconstruction

All Javelot PEEK suture anchors are preassembled onto an inserter, which enables insertion of the anchor into bone after creation of a pilot hole. The anchors are offered in a polyetheretherketone (PEEK) material with a screw-in, push-in (with or without lock-in) design. The sutures are offered in non-absorbable USP braid ultrahigh molecular weight polyethylene (UHMWPE) material. The preassembled inserter consists of an insertion rod and an insertion handle, the insertion rod is offered in stainless steel material, the insertion handle is offered in acrylonitrile butadiene Styrene copolymers (ABS) material. Javelot PEEK suture anchors come in various configurations, including: with attached nonabsorbable suture(s). Javelot PEEK suture anchors are non-absorbable, provided sterile, for single use only.

This is a 510(k) premarket notification for multiple suture anchors. The document focuses on establishing substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing. It does not describe a clinical study of the device or an AI/human-in-the-loop study.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with reported device performance in the format usually seen for clinical studies or AI product validations. Instead, it states that "Non-clinical bench tests were conducted in support of the substantial equivalence determination" and that the "testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device."

The types of mechanical tests performed are listed, with the implication that the new devices met the performance characteristics expected for substantial equivalence:

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

The document describes non-clinical bench tests. It does not specify sample sizes for these tests, nor does it refer to "test sets" in the context of human data or AI validation. Therefore, provenance information like country of origin or retrospective/prospective is not applicable.

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)

This information is not applicable as the document describes non-clinical bench testing, not a clinical study requiring expert-established ground truth.

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

This information is not applicable as the document describes non-clinical bench testing, not a clinical study requiring 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

No such study was conducted or described in this document. This is a medical device (suture anchor) and not an AI-powered diagnostic or assistive technology.

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

This is not applicable since the device is a physical medical implant, not an algorithm.

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

For the non-clinical bench tests, "ground truth" would be established by standardized testing methods and measurement against predefined performance metrics (e.g., pullout strength, fatigue limits) according to relevant ASTM and ISO standards. This is not comparable to ground truth in a clinical or AI study.

8. The sample size for the training set

This is not applicable as the document describes a physical medical device, not an AI system.

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

This is not applicable as the document describes a physical medical device, not an AI system.

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The Syntheface PEEK Interference Screw is 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 9mm or less are also indicated for use in the following procedures: Knee -ACL Repair -PCL Repair -Extra-capsular repair Medial collateral ligament Lateral collateral ligament Posterior oblique ligament -Patellar realignment and tendon repair Vastus medialis obliquus advancement -Iliotibial band tenodesis Shoulder -Capsular stabilization Bankart repair Anterior shoulder instability SLAP lesion repair Capsular shift or capsulolabral reconstruction -Acromioclavicular separation repair -Deltoid repair -Rotator cuff tear repair -Biceps tenodesis Foot and Ankle -Hallux valgus repair -Medial or lateral instability repair/reconstruction -Achilles tendon repair/reconstruction -Midfoot reconstruction -Metatarsal ligament/tendon repairs/reconstruction -Bunionectomy -Flexor Hullucis Longus (FLH) -Tendon Transfer Elbow, Wrist, and Hand -Biceps tendon reattachment -Ulnar or radial collateral ligament reconstruction -Lateral epicondylitis repair -Scapholunate ligament reconstruction -Tendon Transfer -Tendon Transfer -Carpometacarpal Joint Arthroplasty -Carpal Ligament Reconstruction

The Syntheface PEEK Screw Sheath is indicated for use in combination with Syntheface PEEK Interference Screw for fixation of soft tissue to bone during cruciate ligament reconstruction.

All Syntheface PEEK Interference Screws are non-absorbable. All interference screws are offered in a polyetheretherketone (PEEK) material. Syntheface PEEK Interference Screws are provided sterile, for single use only. The Syntheface PEEK Interference Screws are composed of 6 different configurations ranging from 6mm to 11mm in diameter and 25mm in length. The Syntheface PEEK Interference Screw can be used alone or be used in conjunction with the Syntheface PEEK Screw Sheath. The Syntheface PEEK Screw Sheath shall be used in conjunction with the Syntheface PEEK Interference Screw. All Syntheface PEEK Screw Sheaths are non-absorbable, and are intra-tunnel devices used to secure soft tissue grafts to bone during cruciate ligament reconstruction procedures. The Syntheface PEEK Screw Sheath is a polyetheretherketone (PEEK) material implant for use with Syntheface PEEK Interference Screw. Syntheface PEEK Screw Sheaths are provided sterile, for single use only.

The provided document is an FDA 510(k) Premarket Notification for the "Syntheface PEEK Interference Screw" and "Syntheface PEEK Screw Sheath." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than establishing de novo performance criteria against a specific clinical condition or a human reader. Therefore, the information regarding acceptance criteria, study design for proving device performance, sample sizes for test sets, expert involvement, and ground truth establishment (as typically requested for AI/diagnostic device studies) is not directly applicable or available in this document in the manner you specified.

Instead, the document details non-clinical bench tests performed to demonstrate that the subject device performs as well as the predicate device. The acceptance criteria for these tests would generally be based on comparison to the predicate device's performance or established engineering standards for similar medical devices.

Here's an attempt to extract and present the relevant information within the framework you provided, acknowledging the limitations for an equivalence submission:

Acceptance Criteria and Device Performance Study (Based on 510(k) Equivalence)

This 510(k) submission establishes substantial equivalence to legally marketed predicate devices, not de novo clinical effectiveness. Therefore, the "acceptance criteria" and "study" are primarily focused on demonstrating that the new device is as safe and effective as the predicate through non-clinical bench testing and material compliance.

1. Table of Acceptance Criteria and Reported Device Performance

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

For non-clinical bench testing, the "test set" typically refers to the number of devices or material samples subjected to the tests. The document states that "Non-clinical bench tests were conducted in support of the substantial equivalence determination," but it does not specify the sample sizes used for each mechanical test (screw-in, pullout, fatigue) or for the biocompatibility, endotoxin, sterilization, or shelf-life tests.

Data Provenance: All data appears to be retrospective from internal lab testing performed by the manufacturer, Suzhou Endophix Co., Ltd., based in China.

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

This question is not applicable to this type of 510(k) submission. "Ground truth" established by experts is relevant for diagnostic devices or AI algorithms that interpret medical images or data. For an orthopedic implant seeking substantial equivalence, the "ground truth" is typically defined by engineering specifications, material standards, and benchmark performance of the predicate device, rather than expert consensus on clinical cases. The tests are designed to meet these engineering and material "truths."

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for clinical studies involving multiple readers evaluating patient cases, often to establish a consensus "ground truth" for ambiguous findings. Since this submission relies on non-clinical bench testing, no such adjudication method was employed.

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. An MRMC study is relevant for diagnostic devices, particularly AI-powered ones, to assess their impact on human reader performance. The Syntheface PEEK Interference Screw and Screw Sheath are orthopedic implants, not diagnostic tools, and do not involve human readers or AI assistance in their function.

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

Not applicable. This question pertains to the performance of an AI algorithm in isolation. The devices in this submission are physical orthopedic implants, not algorithms.

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

As mentioned in point 3, the concept of "ground truth" as typically defined for diagnostic or AI studies (e.g., expert consensus, pathology, outcomes data) does not directly apply here. Instead, for this orthopedic implant, the "ground truth" for its performance is established through:

• Material Standards: Adherence to established ASTM and ISO standards for PEEK and biocompatibility.
• Engineering Specifications: Meeting predefined dimensional tolerances and mechanical property requirements.
• Predicate Device Performance: Demonstrating comparable mechanical performance (screw-in, pullout, fatigue) to the legally marketed predicate devices through bench testing.

8. The sample size for the training set

Not applicable. The concept of a "training set" belongs to machine learning and AI algorithms. These devices are physical implants, and their development did not involve a training set.

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

Not applicable, as there is no "training set" for these physical orthopedic implants.

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