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The NeoSpan® Compression Implant System is a nitinol implant intended to provide fixation of fractures, fusions, or osteotomies of the hand and foot.

In2Bones NeoSpan® Compression Implant System (CIS) is a product expansion of the existing NeoSpan Compression Staple Implant w/ Instruments (K161426). The NeoSpan® Compression Implant System consists of implants offered in various configurations from 2 and 3 legs with no hole or 1-to-3 holes intended for bone screw assembly for additional fixation. The fixed-leg implants are comprised of Nitinol per ASTM F2063. The devices are sterile implants intended to provide fixation of fractures, fusions, or osteotomies of the hand and foot.

Bone screw options for the NeoSpan® Compression Implant System are previously cleared 3.0mm and 3.5mm locking and non-locking screws in lengths 10-30mm made from titanium alloy.

The provided text is a 510(k) summary for the NeoSpan® Compression Implant System, describing a medical device used for bone fixation. It does NOT contain any information about a study proving the device meets acceptance criteria for an AI/software-based medical device.

The document primarily focuses on demonstrating substantial equivalence of the physical implant system to previously cleared predicate devices through performance testing related to mechanical properties (e.g., static bending, fatigue bending, pull-out, corrosion) and biological/sterilization properties, not performance of an AI algorithm.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device or a study proving an AI device meets those criteria, as the input document is about an implantable hardware device.

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The In2Bones IBS-B MIS Beveled Screw System is indicated for the fixation of arthrodesis, osteotomies of long or short bones of the upper and lower limbs appropriate for the size of the device.

The In2Bones IBS-B MIS Beveled Screw System includes screws and surgical instruments intended for fixation of arthrodesis, osteotomies of the long or short bones of the upper and lower limbs. The screws will be offered in neutralization version (fully threaded) and compression version (partially threaded) in 3.3mm, 4.0mm and 6.5mm diameters. The screws are offered sterile single-use and are made from titanium alloy (ASTM F136).

The provided text is a 510(k) summary for the In2Bones IBS-B MIS Beveled Screw System, which is a medical device for bone fixation. It does not contain information about the acceptance criteria or a study proving that the device meets those criteria, particularly in the context of an AI/algorithm-based device as implied by the detailed questions (e.g., number of experts, MRMC study, training set ground truth).

The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, which is a different regulatory pathway than proving performance against specific acceptance criteria for a novel or AI-driven device.

Here's why the requested information cannot be extracted from the provided text:

• Type of Device: The IBS-B MIS Beveled Screw System is a physical implant (screws for bone fixation) made of titanium alloy. It's not an AI or algorithm-based device that would typically have performance metrics like sensitivity, specificity, or require ground truth established by experts or MRMC studies.
• Performance Testing: The document states that "Engineering analysis was utilized to compare the IBS-B MIS Beveled Screw System to the predicate devices to support substantial equivalence with regard to mechanical performance." It also mentions validation "per ISO 11137-2 for gamma sterilization." This refers to mechanical integrity and sterility, not diagnostic or AI-driven performance.
• Substantial Equivalence: The entire submission hinges on showing that the new device is "substantially equivalent" to existing, legally marketed devices in terms of indications, materials, and geometry. This approach generally does not require extensive clinical trials or performance studies with acceptance criteria as would be needed for a de novo or new AI/ML device.

Therefore, I cannot provide the requested table and study details because the provided document does not pertain to an AI/algorithm-based device and focuses on substantial equivalence for a physical medical implant.

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The CoLink® PCR Plating System is indication and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle.

The In2Bones CoLink® PCR Plating System includes plates and screws and surgical instruments intended for treating fusions and fractures of the extremities. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink® PCR Plating System. The CoLink® PCR Plating System consists of the MTP Narrow NX and Universal style plates available in Carbon Fiber Reinforced PEEK-OPTIMA™ with Barium Sulfate. The plates are used with previously cleared 3.0mm and 3.5mm titanium alloy locking and non-locking screws.

The provided document ({0} - {4}) is a 510(k) Summary for the CoLink® PCR Plating System, a medical device for bone fixation. It describes the device, its indications for use, and how it demonstrates substantial equivalence to previously cleared predicate devices.

However, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving a digital health or AI/ML device meets those criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance for a digital health/AI device. The document focuses on performance testing for mechanical properties (static and dynamic four-point bending per ASTM F382) and biocompatibility, sterilization, and packaging standards for a physical bone plating system.
• Sample size and data provenance for a test set (clinical data for AI/ML).
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for a training set (for AI/ML models).
• How ground truth for a training set was established.

The document details the substantial equivalence of a physical medical device (bone plates and screws) by comparing its materials, geometry, and mechanical performance to legally marketed predicate devices. It is not an AI/ML or digital health device, and therefore the type of information requested in the prompt (related to AI model validation, clinical test sets, human-in-the-loop studies, etc.) is not present in this document.

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The Hercules® Syndesmosis Implant System 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 and as an adjunct in external and intramedullary fixation systems. The Hercules® Syndesmosis Implant System is also intended to provide fixation during healing process after joint reconstruction in the midfoot and forefoot including correction of hallux valgus deformity.

The In2Bones Hercules® Syndesmosis Implant System is a sterile, single-use, device intended to stabilize syndesmotic trauma of the ankle. The subject system consists of UHMWPE suture tensioned between two low profile titanium alloy buttons, designed to complement plate fixation or to allow use as a stand-alone device. This device is also packaged with various ancillary instruments to aid in insertion.

The provided text describes a 510(k) premarket notification for the "Hercules® Syndesmosis Implant System." This document is a regulatory submission to the FDA demonstrating substantial equivalence to a predicate device, rather than a study proving the device meets clinical acceptance criteria.

Therefore, the information required to answer the prompt regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies, is not present in the provided text.

The document primarily focuses on:

• Regulatory Clearance: Announcing the FDA's determination of substantial equivalence for the Hercules® Syndesmosis Implant System (K220260) to previously cleared predicate devices.
• Device Description: A sterile, single-use system composed of UHMWPE suture and titanium alloy buttons, intended to stabilize syndesmotic trauma of the ankle.
• Indications for Use: Providing fixation during healing after syndesmotic trauma (e.g., Weber B and C ankle fractures) and as an adjunct in other fixation systems, as well as for fixation after joint reconstruction in the midfoot and forefoot.
• Basis for Substantial Equivalence: Similarities in indications, materials, and geometry to predicate devices (e.g., Arthrex Tightrope, Wright Medical Gravity Syndesmosis LP, Arthrosurface KISSLoc Suture System).
• Performance Testing (Bench Testing): Mentions "Cyclic displacement and load to failure bench testing (mechanical testing)" was performed and "The Hercules® Syndesmosis Implant System was validated per ISO 10993-1 for biocompatibility, ISO 11137-2 for gamma sterilization, ISO 11135 for ETO sterilization and ISO 11607-1 for packaging. Endotoxin testing was completed per ANSI/AAMI ST72." This refers to engineering/mechanical/biocompatibility testing, not clinical performance data or studies involving human subjects/readers.

In summary, there is no information in this document about studies that prove the device meets acceptance criteria in a clinical or AI-assisted context, as the questions imply. The document pertains to the regulatory clearance process for a medical implant based on substantial equivalence, relying on mechanical and material testing, not diagnostic performance or human reader studies.

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The Avenger Radial Head System is intended for replacement of the proximal end of the radius:
• Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at radial-humeral and/or proximal radio-ulnar joint with:

• a. Joint destruction and/or subluxation visible on x-ray; and/or
• b. Resistance to conservative treatment.
• · Primary replacement after fracture of the radial head.
• · Symptomatic sequelae after radial head resection.
• Revision following failed radial head arthroplasty.
  The components are intended for uncemented use.

The Avenger Radial Head System is a two-piece modular system comprised of cobalt chrome (ASTM F 1537) head and stem components. The system consists of a range of lengths and diameters for the stem as well as heads in a range of diameters and heights to accommodate the patient anatomy. The subject of this 510(k) is to clear a new range of stem implants (+4mm offset stems) that can be used to extend the current range of the Avenger Radial Headle modular system. The implant allows for replacement of the radial head.

The provided document describes the clearance of the "Avenger Radial Head System" by the FDA. However, it does not include detailed information regarding acceptance criteria, device performance results, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document primarily focuses on the regulatory clearance process, stating that the device is substantially equivalent to previously cleared predicate devices. It mentions "Performance Testing: Head disassembly (ASTM F2009) was performed for the Avenger Radial Head System, +4mm offset stems comparing to the previously cleared K192754 devices. Fatigue testing, sterilization and endotoxin testing were able to adopt into the previously cleared devices." This indicates that some performance testing was done, but the specific acceptance criteria and the quantitative results are not provided in this document.

Therefore, I cannot populate the table or answer most of your specific questions based on the input text.

Information NOT available in the provided document:

• A table of acceptance criteria and the reported device performance: While performance testing related to head disassembly, fatigue, sterilization, and endotoxin is mentioned, the specific acceptance criteria (e.g., maximum force for disassembly, number of cycles for fatigue) and the actual reported device performance values are not detailed.
• Sample sized used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical medical device (radial head prosthesis) and not an AI/diagnostic software.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable, as this is a physical medical device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For a physical device, "ground truth" typically refers to established engineering standards or physical measurements, which are implied by the mention of ASTM F2009 and other testing, but not explicitly detailed as "ground truth."
• The sample size for the training set: Not applicable for a physical device.
• How the ground truth for the training set was established: Not applicable for a physical device.

What is available (though limited in detail):

• Study that proves the device meets the acceptance criteria: Performance Testing, including "Head disassembly (ASTM F2009)," "Fatigue testing," "sterilization," and "endotoxin testing." The document states these tests were performed and were "able to adopt into the previously cleared devices," suggesting the results were consistent with or met the requirements established for the predicate devices.
• Type of device: Physical medical device (radial head prosthesis).
• Indications for Use: Replacement of the proximal end of the radius for various conditions, including degenerative/post-traumatic disabilities, primary replacement after fracture, symptomatic sequelae after radial head resection, and revision after failed arthroplasty. Intended for uncemented use.

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The CoLink® NeoFuse Plating System is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus.

The addition of a compression screw through the tibiotalar joint (example CoLag 6.7mm screw) is required.

The In2Bones CoLink® NeoFuse Plating System includes sterile fusion plates and screws for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus. The addition of a medial-lateral compression screw through the tibiotalar joint is required. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink NeoFuse Plating System.

This is not an AI/ML device, so elements of the typical AI/ML acceptance criteria and study information are not applicable. The provided text describes a traditional medical device (metallic bone fixation system) and its regulatory clearance process, which focuses on demonstrating substantial equivalence to previously cleared predicate devices through performance testing and material comparisons.

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) for this type of device:

Device Name: CoLink® NeoFuse Plating System
510(k) Number: K213069

1. Table of Acceptance Criteria and Reported Device Performance

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: The document does not specify the exact number of plates or screws tested. It refers to "testing conducted per a modified ASTM F382 set up" for plates. For biocompatibility, sterilization, packaging, and endotoxin tests, these are typically conducted on representative samples of the device and its components, but specific sample numbers are not provided.
• Data Provenance: Not explicitly stated, but typically, these types of performance tests are conducted in a laboratory setting (e.g., by the manufacturer or a contract testing facility) in support of regulatory submissions. This is not clinical data, so terms like "retrospective" or "prospective" do not apply.

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)

• N/A. This is a hardware device review, not an AI/ML diagnostic or prognostic device that relies on ground truth established by experts interpreting clinical data. Ground truth in this context refers to the validated performance of the physical device under various engineering tests. Expert involvement would be in the design, testing methodology, and interpretation of engineering data, rather than clinical interpretation.

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

• N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple experts evaluate ambiguous cases or results for AI/ML performance evaluation. This device's evaluation is based on objective engineering tests and material comparisons.

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

• N/A. No MRMC comparative effectiveness study was performed as this is not an AI/ML device designed to assist human readers.

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

• N/A. This is not an AI/ML algorithm. Its "performance" is assessed through physical and material testing, not through algorithmic output.

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

• Engineering Standards and Predicate Device Performance: The "ground truth" for this device's acceptance is based on its ability to meet established engineering standards (e.g., ASTM F382, ISO 10993-1, ISO 11137-2, ISO 11607-1, ANSI/AAMI ST72) and demonstrate "substantial equivalence" in mechanical properties, biocompatibility, sterilization, and function to previously cleared predicate devices. The performance of predicate devices against these standards serves as a benchmark.

8. The sample size for the training set

• N/A. This is not an AI/ML device, so there is no "training set."

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

• N/A. As there is no training set for an AI/ML algorithm, this question is not applicable.

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The In2Bones USA, CoLink Vallux Plating System is indicated for fixational osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

The In2Bones CoLink Vallux Plating System includes a plate and screws and surgical instruments used to treat Hallux Valgus and reconstruction of bone for bunion corrections. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink Vallux Plating System.

I am sorry, but the provided text does not contain information about the acceptance criteria and study proving a device meets them. The document is an FDA 510(k) clearance letter for the "CoLink Vallux Plating System," which is a metallic bone fixation device.

The document discusses:

• The FDA's determination of substantial equivalence to previously cleared predicate devices.
• The intended use of the device (fixation of osteotomies and corrective procedures of the hallux and associated disorders like hallux valgus).
• The materials used (Titanium Alloy).
• The fact that no additional mechanical testing was required because the screws are identical to previously cleared screws and no new worst-case plates or screws were added. A rationale was conducted to show substantial equivalence based on existing CoLink Plating System data.
• Adoption into previously provided sterilization, packaging, and endotoxin validations.

There is no mention of any study involving AI, human readers, ground truth establishment, training sets, or test sets. The entire document is focused on demonstrating substantial equivalence for a medical device (bone plates and screws), not a software or AI-based diagnostic tool.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the provided text does not contain this information.

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The In2Bones USA CoLink® Sfx Implant System is a system of implantable K-wires and caps indicated for temporary fixation and stabilization of bone fractures and reconstructions. In addition, the K-wires can be used as guide pins for insertion of other implants. The caps are indicated for use in the protection of protruding ends of wires.

The CoLink® Sfx Implant system is a system of implantable k-wires with tip protectors (caps) used to provide temporary fixation and stabilization of fractured bones of the extremities. The k-wire is made from stainless steel (ASTM F138) and the tip protectors are made from polyethylene. The tip protectors are not implantable and are for protection for protruding ends of wires. These subject devices are part of the overarching CoLink® Plating System.

The provided text is a 510(k) summary for the D CoLink® Sfx Implant System, a medical device used for temporary fixation and stabilization of bone fractures. It describes "performance testing" but explicitly states that no additional mechanical testing was required. This means the FDA cleared the device based on an "engineering analysis comparing the subject implants to legally marketed predicates" and not on specific acceptance criteria for performance met by a study of the device itself.

Therefore, many of the requested details cannot be extracted from this document, as they pertain to a performance study that was not conducted for this specific device.

Here's what can be extracted and what cannot:

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

This information is not available in the provided document. The submission states: "No additional mechanical testing was required for the CoLink® Sfx Implant System as the subject wires are not considered a worst case based on engineering analysis comparing the subject implants to legally marketed predicates." This implies that the acceptance criteria for performance were met by the predicate devices, and the subject device was deemed substantially equivalent without direct performance testing against specific criteria.

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

This information is not available. No mechanical performance study was conducted for this device. The assessment was based on an engineering analysis comparing it to predicate devices.

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

This information is not available. No performance study requiring expert ground truth was conducted.

4. Adjudication method for the test set

This information is not available. No performance study requiring adjudication was conducted.

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. This device is a bone fixation implant system, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI performance metrics are irrelevant.

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

This information is not applicable. This device is a bone fixation implant system, not an algorithm.

7. The type of ground truth used

This information is not available. No performance study requiring ground truth was conducted. The clearance was based on substantial equivalence to predicate devices, supported by an engineering analysis and non-mechanical validations.

8. The sample size for the training set

This information is not applicable. This device is a physical implant, not an AI model requiring a training set.

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

This information is not applicable. This device is a physical implant, not an AI model requiring a training set.

Summary of what was reported regarding "Performance Testing":

The "Performance Testing" section primarily discusses non-mechanical validations and refers to an "engineering analysis" instead of direct performance testing for the subject device's mechanical properties.

• Validations and risk assessments were conducted for:
  • Sterilization (ISO 11137-2)
  • Biocompatibility (ISO 10993-1)
  • Packaging and shelf life (ISO 111607-1)
  • Pyrogenicity (ANSI-AAMI ST72)
• Bacterial endotoxin testing (LAL) is performed on each lot.

It's important to note that these are essential validations for medical devices but do not represent performance testing in the sense of functional mechanical performance criteria typically seen for AI/diagnostic devices or even some other classes of implants where specific performance benchmarks must be met by the device itself in a study. In this case, the decision was made on substantial equivalence, relying on the performance of the predicate devices and an engineering comparison.

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The CoLink® Mfx Plating System is intended for stabilization of fractures, revision procedures, joint fusion, osteotomies and reconstruction in the midfoot bones of the foot, including repair of Lis Franc injuries, in both pediativ and adult patients.

The CoLink® Mfx Plating System is a line extension to the current CoLink® plating system offerings. The CoLink® Mfx Plating System has eight plate styles: 1st TMT Plates, 1st/2nd Lisfranc Plates, 2nd/3rd Lisfranc Plates, an NC Plate, a Medial Column TNC Plate, a Medial Column NCM Plate, and a Medial Column Bridge Plate. The plates and associated screws are manufactured from Titanium Alloy (ASTM F136).

The provided text describes a 510(k) premarket notification for a medical device called the CoLink Mfx Implant System. It does not contain information about acceptance criteria or a study proving the device meets them in the context of an AI/ML-driven medical device.

Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices through engineering analysis and performance testing of a physical implant system. The "performance testing" mentioned is mechanical testing (four-point bend testing per ASTM F382) to compare the subject plates to predicate plates, and also references previous validations for sterilization, biocompatibility, shelf life, and pyrogenicity for the broader CoLink® Afx System.

Therefore, I cannot provide the requested information for acceptance criteria, device performance, sample sizes, ground truth establishment, or studies related to AI/ML performance because the provided text is for a physical orthopedic implant and not an AI/ML-based device.

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The In2Bones Hercules™ Suture Anchors are intended for use in the following applications:

1. Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.

2. Foot/Ankle: Lateral and Medial stabilization. Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction.

3. Knee: Medial collateral and Lateral ligament repair, Patellar tendon and Posterior oblique ligament repair.

4. Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.

5. Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.

The In2Bones Hercules™ Suture Anchor System is a bone implant device intended for the fixation of soft tissue to bone. This system consists of two anchor styles manufactured from ASTM F 2026 Poly Ether Ether Ketone (PEEK) - Fully threaded anchor and Knotless anchor - that are available in five sizes ranging from 2.0mm to 5.5mm and 4 sizes ranging from 2.5mm to 5.5mm respectively, for use in a range of fixation applications.

This document is a 510(k) summary for the Hercules™ Suture Anchor System. It details the device's indications for use, comparison to predicate devices, and performance testing conducted to demonstrate substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for the mechanical performance tests in an easily digestible table format with reported performance. Instead, it states that "mechanical testing was done in accordance with ASTM F543-07 to evaluate the anchors and establish substantial equivalence." This implies that the acceptance criteria are met if the device's performance is comparable to or better than previously cleared predicate devices, as assessed against the standards of ASTM F543-07.

To extract acceptance criteria and reported performance, we infer from what is mentioned:

Note: The document focuses on demonstrating substantial equivalence rather than defining specific acceptance criteria for a new, novel product. Therefore, the "reported device performance" is often a statement that the relevant standard was met, implying that the performance was acceptable relative to the predicate devices.

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

• Sample Size for Test Set: The document does not specify the exact sample size (number of anchors) used for each mechanical test (Anchor Insertion Torque, Torque to Failure, Tensile Pullout, Cyclic Load, Post-Fatigue Pullout). It only mentions that "mechanical testing was done."
• Data Provenance: The studies were bench tests (non-clinical performance mechanical testing). This means the data is not from human subjects. The location where the tests were performed is not specified, but it would have been in a laboratory or testing facility. The data is prospective in the sense that these tests were conducted specifically for this submission, although they are based on established standards.

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

This section is not applicable as the studies are mechanical bench tests, not involving human interpretation or expert evaluation of data to establish a ground truth. The "ground truth" for these tests is defined by the physical properties and performance characteristics measured against industry standards (ASTM, ISO).

4. Adjudication Method for the Test Set

This section is not applicable as the studies are mechanical bench tests. Adjudication methods (like 2+1, 3+1) are typically used for studies involving multiple human readers assessing medical images or patient data where disagreements may arise.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves human readers, and the provided information pertains to the mechanical performance of a medical device (suture anchors), not an AI algorithm for diagnostic purposes.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

Not applicable. The device is a physical medical implant (suture anchor system), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

The "ground truth" for the mechanical performance tests is based on established engineering standards and specifications (e.g., ASTM F543-07, ANSI/AAMI ST72, ISO 11135, ISO 11137-2, ISO 10993-1, ISO 11607-1). The device's performance is compared against these objective, quantifiable standards and against the performance of predicate devices as measured under these standards.

8. Sample Size for the Training Set

Not applicable. This submission is for 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 stated above, there is no training set for a physical medical device.

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