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The TriALTIS™ Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The TriALTIS™ Spine System is intended for pedicle fixation of the thoracic, lumbar, and sacral spine (T1-S2) and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior pedicle screw fixation of the thoracic, lumbar, and sacral spine (T1-S2) and nonpedicle fixation in pediatric patients, the TriALTIS™ Spine System is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e, scoliosis, kyphosis, or lordosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the TriALTIS™ Spine System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The TriALTIS™ Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

When the TriALTIS™ Spine System fenestrated screws are used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the TriALTIS™ Spine System is intended to stabilize the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The TriALTIS™ fenestrated screws augmented with the CONFIDENCE™ High Viscosity Spinal Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.

The TriALTIS™ Spine System is a posterior spinal fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic lumbar and sacral spine (T1-S2). The system is composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system consists of bone anchors (such as screws) for connection by longitudinal components (such as rods) via an interconnection mechanism (e.g., set screws and connectors) to link the longitudinal components for additional stability. The TriALTIS™ Spine System implants are comprised of Titanium alloy conforming to ASTM F136 and Nitinol conforming to ASTM F2063. Implants of the TriALTIS™ Spine System may be provided either sterile or non-sterile and this will be clearly identified on the product labels.

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The TriALTIS™ System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The TriALTIS™ Spine System is intended for pedicle fixation of the thoracic, lumbar, and sacral spine (T1-S2) and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudarthrosis; and failed previous fusions in skeletally mature patients.

When used for posterior pedicle screw fixation of the thoracic, lumbar, and sacral spine (T1-S2) in pediatric patients, the TriALTIS™ Spine System is indicated as an adjunct to fusion to treat spinal deformities (i.e., scoliosis, or lordosis) including adolescent idiopathic scoliosis, and congenital scoliosis. Additionally, the TriALTIS™ System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The TriALTIS™ Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

When the TriALTIS™ Spine System fenestrated screws are used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the TriALTIS™ Spine System is intended to stabilize the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The TriALTIS™ fenestrated screws augmented with the CONFIDENCE™ High Viscosity Spinal Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.

The TriALTIS™ Spine System is a posterior spinal fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic lumbar and sacral spine (T1-S2). The system is composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system consists of bone anchors (such as screws) for connection by longitudinal components (such as rods) via an interconnection mechanism (e.g., set screws and connectors) to link the longitudinal components for additional stability. The subject TriALTIS™ System implants are comprised of Titanium alloy conforming to ASTM F136 and Nitinol conforming to ASTM F2063.

The provided FDA 510(k) clearance letter and summary for the TriALTIS™ Spine System do not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/algorithm-driven medical device.

The document describes a spinal fixation system, which is a physical implant, not a software or AI-driven diagnostic or treatment device. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section on page 5 explicitly states:

• "The TriALTIS® Spine System was evaluated against the predicate system, EXPEDIUM connectors on a component level using ASTM F1798 'Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants', specifically axial and torsional grip testing and flexion-extension testing."
• "Clinical testing is not applicable."

Therefore, the requested information regarding acceptance criteria, reported device performance (in terms of AI metrics), sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as typically found for AI/software devices, is not present in this document. This submission pertains to a traditional physical medical device.

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Navigation Enabled Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated and with the VELYS Spine System as well as with the Brainlab Navigation System and the Medtronic StealthStation® Navigation System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which:
· the use of EXPEDIUM™, VIPER™, SYMPHONY™ OCT and the TriALTIS™ Spine System is indicated,
· the use of stereotactic surgery may be appropriate, and
· reference to a rigid anatomical structure, such as the pelvis or a vertebra, can be identified relative to the aquired image (CT, MR, 2D fluoroscopic image or fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System.
The Navigation Enabled Instruments used in conjunction with the SYMPHONY OCT System are intended to support indicated cervical and thoracic polyaxial screw placement only.

Universal Navigation Adaptor Set (UNAS):
The Universal Navigation Adaptor Set (UNAS) is intended for use with the compatible DePuy Synthes Navigation Ready Instruments to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:
· the use of stereotactic surgery may be appropriate, and
· reference to a rigid anatomical structure, such as the pelvis or a vertebrac can be identified relative to the acquired image (CT. MR, 2D fluoroscopic image or fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.
These procedures include but are not limited to spinal fusion. The DePuy Synthes Navigation Ready Instruments, when used with UNAS, can be:
· pre-calibrated with the VELYS Spine System using VELYS Spine Instrument Arrays,
· pre-calibrated and/or manually calibrated with the Brainlab Navigation System,
where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.
Via the CROSSNAV Adaptor, the UNAS Navigation Arrays are also compatible with DePuy Synthes Navigation Enabled Instruments indicated for use with the Brainlab Navigation System.

Navigation Enabled Instruments (CROSSNAV™ Instruments) are reusable instruments used for the preparation and placement of DePuy Synthes EXPEDIUM™, VIPER™, SYMPHONY™ OCT and TriALTIS™ screws, in either open or percutaneous procedures. The Navigation Enabled Instruments include drills, taps and screwdrivers and can be operated manually or under power. These instruments are designed for navigated and non-navigated use. Navigation Enabled Instruments also include the CROSSNAV™ Adaptor to facilitate navigation of the Navigation Enabled Instruments with the VELYS Spine System as well as with the Brainlab Navigation System. Navigation of these instruments is achieved using the VELYS Spine System as well as Brainlab Navigation System and the Medtronic StealthStation Navigation System and their associated tracking arrays.

Universal Navigation Adaptor Set (UNAS)
The Universal Navigation Adaptor Set (UNAS) contains reusable spine surgical instruments used to aid in determining the correct location and trajectory of spinal instruments and implants. The UNAS has an interface between third-party navigation systems and the DePuy Synthes Navigation Ready Instruments as well as the Navigation Enabled Instruments. The UNAS can only be used with the VELYS Spine System as well as Brainlab and Medtronic StealthStation navigation systems. The UNAS includes:

• Brainlab compatible UNAS Navigation Arrays,
• VELYS Spine/Brainlab compatible Navigation Rings and
• Medtronic compatible Navigation Ring ST.
  The Navigation Rings and Navigation Ring ST mate with compatible DePuy Synthes Navigation Ready Instruments. These instruments include implant site preparation and implant insertion instruments as well as access and discectomy instruments.
  When the VELYS Spine/Brainlab compatible Navigation Ring is attached to the Navigation Ready Instrument:
• a VELYS Spine Instrument Array can be attached and the instrument can be used with the VELYS Spine System as a pre-calibrated instrument, or
• . a UNAS Navigation Array can be attached and the instrument can be used with the Brainlab Navigation System as either a manually calibrated and/or pre-calibrated instrument.
  Via the CROSSNAV Adaptor, the UNAS Navigation Arrays are also compatible with DePuy Synthes Navigation Enabled Instruments indicated for use with the Brainlab Navigation System.
  When the Navigation Ring ST is attached to the Navigation Ready Instrument, a Medtronic SureTrak" II Universal Tracker Fighter array (SureTrak II array) can be attached, and the instrument can be manually calibrated only with the Medtronic StealthStation Navigation System.

The provided text does not contain detailed acceptance criteria or a study that proves the device meets those criteria in the typical format seen for AI/ML-enabled devices, which often involve metrics like sensitivity, specificity, or AUC.

Instead, the document is a 510(k) summary for a medical device (CROSSNAV Navigation Enabled Instruments and Universal Navigation Adaptor Set (UNAS)) that primarily focuses on demonstrating substantial equivalence to predicate devices, particularly concerning its compatibility with additional navigation systems.

However, based on the Performance Data section, we can infer some aspects that align with typical acceptance criteria for this type of device, which revolve around accuracy and functional performance.

Here's an interpretation based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a "test set" in the context of a dataset for AI/ML evaluation. The performance data listed (Fulfillment of navigation systems instrument accuracy requirements, CAD Model Evaluation, Simulated Use Evaluation) suggests bench testing and internal evaluations rather than a clinical trial with a patient test set. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a test set is not available in this document.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document as it does not describe a study involving expert review for ground truth establishment. The evaluations mentioned (accuracy requirements, CAD model, simulated use) typically rely on engineering specifications, measurements, and functional testing.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where multiple human readers interpret data, and a consensus ground truth needs to be established. Since this document does not describe such a study or a test set requiring expert interpretation, an adjudication method is not applicable and not mentioned.

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

No, an MRMC comparative effectiveness study was not done or at least is not reported in this document. The device is a navigation instrument, not an AI/ML algorithm that assists human readers in interpreting medical images.

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

The device itself is an instrument used with navigation systems to assist surgeons, implying it is always used with a human in the loop. It is not an AI/ML algorithm that would have standalone performance in isolation. Therefore, a "standalone algorithm only" performance study is not applicable to this device.

7. The Type of Ground Truth Used

Based on the performance data mentioned, the "ground truth" for the evaluations likely involved:

• Engineering specifications and manufacturer requirements: For navigation systems instrument accuracy.
• Design specifications and measurements: For CAD Model Evaluations.
• Pre-defined procedural steps and outcomes: For Simulated Use Evaluations.

This is not clinical ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a physical instrument set, not an AI/ML model that undergoes a training phase with a "training set."

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

This information is not applicable and not provided for the same reason as above.

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The TriALTIS™ System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The TriALTIS™ Spine System is intended for pedicle fixation of the thoracic, lumbar, and sacral spine (T1-S2) and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior pedicle screw fixation of the thoracic, lumbar, and sacral spine (T1-S2) in pediatric patients, the TriALTIS™ Spine System is indicated as an adjunct to fusion to treat spinal deformities (i.e, scoliosis, or lordosis) including adolescent idiopathic scoliosis, and congenital scoliosis. Additionally, the TriALTIS™ System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The TriALTIS™ Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

When the TriALTIS™ Spine System fenestrated screws are used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the TriALTIS™ Spine System is intended to stabilize the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The TriALTIS™ fenestrated screws augmented with the CONFIDENCE™ High Viscosity Spinal Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.

The TriALTIST™ Spine System is a posterior spinal fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic lumbar and sacral spine (T1-S2). The system is components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system consists of bone anchors (such as screws) for connection by longitudinal components (such as rods) via an interconnection mechanism (e.g., set screws and connectors) to link the longitudinal components for addity. The subject TriALTIS™ Spine System implant components are comprised of Titanium alloy conforming to ASTM F136.

The provided document is a 510(k) premarket notification clearance letter for the TriALTIS™ Spine System. This document does not describe acceptance criteria or a study that proves the device meets acceptance criteria in the context of a software or AI/ML-enabled medical device.

The document pertains to a physical medical device (Thoracolumbosacral Pedicle Screw System) and its mechanical properties. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states:

• "The TriALTIS™ System was evaluated against the predicate system, EXPEDIUM connectors on a component level using ASTM F1798 'Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants', specifically axial and torsional grip testing."
• "Clinical testing is not applicable."

Therefore, the requested details about acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set information are not present in the provided text, as they are not relevant to the type of device and regulatory submission discussed.

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The TriALTIS™ Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine.

The TriALTIS™ Spine System is intended for pedicle fixation of the thoracic, lumbar, and sacral spine (T1-S2) and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior pedicle screw fixation of the thoracic, lumbar, and sacral spine (T1-S2) in pediatric patients, the TriALTIS™ Spine System is indicated as an adjunct to fusion to treat spinal deformities (i.e, scoliosis, or lordosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis. Additionally, the TriALTIS™ System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The TriALTIS™ Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

When the TriALTIS™ Spine System fenestrated screws are used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the TriALTIS™ Spine System is intended to stabilize the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The TriALTIS™ fenestrated screws augmented with the CONFIDENCE™ High Viscosity Spinal Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.

The TriALTIS™ Spine System is a posterior spinal fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic lumbar and sacral spine (T1-S2). The system is composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system consists of bone anchors (such as screws) for connection by longitudinal components (such as rods) via an interconnection mechanism (e.g., set screws) to link the longitudinal components for additional stability. The TriALTIS™ System implant components are comprised of Titanium alloy conforming to ASTM F136, and Cobalt-Chromium-Molybdenum alloy conforming to ASTM F1537.

The provided FDA 510(k) summary (K233684) for the TriALTIS™ Spine System does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics typically reported for AI/ML-enabled devices (e.g., sensitivity, specificity, AUC).

This document is a notification of intent to market a thoracolumbosacral pedicle screw system, which is a physical implant, not an AI/ML software device. The review focuses on substantial equivalence to a predicate device based on intended use, design, materials, and performance characteristics, typically established through non-clinical bench testing and engineering rationale.

Therefore, many of the requested details about acceptance criteria, study design for performance metrics (like sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this type of medical device submission.

The relevant information from the document is summarized below:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly defined in terms of specific performance metrics (e.g., sensitivity, specificity) as this is a physical implant, not an AI/ML diagnostic tool. The document implies meeting the safety and effectiveness profile of the predicate device through engineering rationale and non-clinical testing.
• Reported Device Performance:
  • Substantial Equivalence: The TriALTIS™ Spine System is substantially equivalent to the predicate (K231479).
  • Compatibility: The only changes are labeling updates to include compatibility with existing spine systems (SYMPHONY OCT, EXPEDIUM Spine System titanium alloy, EXPEDIUM VERSE, VIPER 2, VIPER PRIME).
  • Safety and Effectiveness: "Evaluation of the subject device performance data as compared to the predicate system has found that the TriALTIS™ System has a substantially equivalent safety and effectiveness profile compared to the predicate system identified above."

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

• Not Applicable. This submission is for a physical implant. Performance is evaluated through non-clinical testing and engineering rationale, not by analyzing a "test set" of data in the sense of AI/ML performance evaluation.

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

• Not Applicable. Ground truth in the context of diagnostic accuracy is not relevant for this device. Safety and effectiveness are established through engineering design, material properties, and mechanical testing, often against standards.

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

• Not Applicable.

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. This is not an AI/ML device, so MRMC studies are not relevant.

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

• No. This is not an algorithmic device.

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

• Not Applicable in the context of diagnostic accuracy. The "ground truth" for this device's safety and effectiveness focuses on mechanical properties, material biocompatibility, and structural integrity, typically evaluated through engineering tests and adherence to standards.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device.

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

• Not Applicable. This is not an AI/ML device.

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The SYMPHONY OCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3):

• · Traumatic spinal fractures and/or traumatic dislocations;
• Instability or deformity;
• · Failed previous fusions (e.g. pseudarthrosis);
• · Tumors involving the cervical/thoracic spine;

· Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and

· Degenerative disease of the facets with instability.

The SYMPHONY OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The SYMPHONY OCT System is compatible with occipital fusion components (plates, rods and clamps) from the SYNAPSE Occipital-Cervical-Thoracic (OCT) System and the MOUNTAINEER OCT Spinal System. Additionally, the SYMPHONY OCT System is compatible with SYNAPSE OCT System hooks and rods.

The SONGER Wire/Cable System may be used with the SYMPHONY OCT System to allow for wire/cable attachment to the posterior cervical spine.

The SYMPHONY OCT System may be connected to the EXPEDIUM® Spine System and VIPER® System using connectors and tapered rods. The SYMPHONY OCT System can also be linked to the USS Spinal System and MATRIX Spine System using connectors and tapered rods.

The SYMPHONY OCT System is a posterior system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the craniocervical junction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3). The system is composed of multiple components to allow the surgeon to build an implant s anatomical and physiological requirements. The system consists of bone anchors (such as screws) for connection by longitudinal components (such as rods) via an interconnection mechanism (e.g., set screws) with optional transverse connectors) to link the longitudinal components for additional stability.

This document describes a 510(k) premarket notification for the SYMPHONY OCT System, a posterior cervical screw system. The notification primarily focuses on a labeling change permitting reprocessing of previously sterile implants. There is no information provided in this document regarding AI/ML model performance, acceptance criteria, or studies proving device performance against such criteria.

The document states: "No additional testing was conducted to support this submission." This means there is no study included in this submission that evaluates new device performance, including anything related to AI/ML.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance, as the provided text pertains to a different type of medical device submission (a spinal implant system) and explicitly states that no additional testing was conducted.

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The GRYPHON™ Flex Knotless Anchor is indicated for use for reattachment of soft tissue to bone for the following procedures:
Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction, Superior Capsule Reconstruction (Glenoid Only)
Hip: Acetabular Labral Repair
Knee: MCL, LCL, Iliotibial Band Tenodesis
Foot/Ankle: Lateral Stabilization, Medial Stabilization

The proposed GRYPHON™ Flex Knotless PEEK and BIOCOMPOSITE Anchors is a line extension to the currently marketed GRYPHON Anchor family. The proposed product is a knotless anchor intended for fixation of soft tissue to bone in various soft tissue repair procedures. In its finished good configuration, the proposed device is a two-piece design; comprised of a permanent implant (anchor) component and a disposable (inserter) component. The 2.7mm anchor implant is preloaded on the inserter and a Nitinol distal tip retains the suture and the anchor while the device is malleted into the bone. The design offers surgeons maneuverability within the joint space. The disposable inserter will be offered in two design configurations, straight or curved to accommodate varying anatomies.
The proposed GRYPHON Flex Knotless PEEK and BIOCOMPOSITE Anchors will be available in a 2.7 mm size, molded from either Polyetheretherketone (PEEK) material or Absorbable Biocryl Biocomposite ((Polylactic Acid (PLA) and Tricalcium Phosphate (TCP)) material.
Both the GRYPHON Flex Knotless PEEK and BIOCOMPOSITE Anchors are provided sterile via Ethylene Oxide (EO) sterilization and are for single use only.

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "GRYPHON™ Flex Knotless PEEK Anchor" and "GRYPHON™ Flex Knotless Biocomposite Anchor."

This document does not describe a study that uses AI or machine learning. It describes the non-clinical verification activities performed for a physical medical device (suture anchor), focusing on its mechanical properties, sterilization, and biocompatibility. Therefore, it does not include the information requested regarding acceptance criteria and studies for AI/ML device performance, such as sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment, or training set details.

The acceptance criteria mentioned in the document relate to the physical and biological performance of the anchor, not to the performance of a diagnostic or predictive algorithm.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies that prove an AI/ML device meets those criteria based on the provided text, as the text describes a physical medical device, not an AI/ML system.

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The TriALTIS™ Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The TriALTIS™ Spine System is intended for pedicle fixation of the thoracic, lumbar, and sacral spine (T1-S2) and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies): spondvlolisthesis: trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior pedicle screw fixation of the thoracic, lumbar, and sacral spine (T1-S2) in pediatric patients, the TriALTIS™ Spine System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The TriALTIS™ Spine System is intended to be used with autograft and/or allograft. Pediatric screw fixation is limited to a posterior approach.

When used for posterior pedicle screw fixation of the thoracic, lumbar, and sacral spine (T1-S2) in pediatric patients, the TriALTIS™ Spine System is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the TriALTIS™ Spine System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The TriALTIS™ Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

When the TriALTIS™ Spine System fenestrated screws are used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the TriALTIS™ Spine System is intended to stabilize the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The TriALTIS™ fenestrated screws augmented with the CONFIDENCE™ High Viscosity Spinal Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.

The TriALTIS Spine System is a posterior system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic lumbar and sacral spine (T1-S2). The system is composed of multiple components to allow the surgeon to build an implant system to fit the patient s anatomical and physiological requirements. The system consists of bone anchors (such as screws) for connection by longitudinal components (such as rods) via an interconnection mechanism (e.g., set screws) to link the longitudinal components for addity. The TriALTS System implant components are comprised of Titanium alloy conforming to ASTM F136, and Cobalt-Chromium-Molybdenum alloy conforming to ASTM F1537.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the TriALTIS Spine System, which outlines the device's indications for use, its substantial equivalence to predicate devices, and the non-clinical testing performed.

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

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The MITEK TIGHT-N™ Tendon Docking Anchor is indicated for use for reattachment of soft tissue to bone for the following procedures:
• Shoulder: Biceps tenodesis
• Knee: Medial patellofemoral ligament repair/reconstruction (MPFL), posterior oblique ligament repair (POL), medial collateral ligament (MCL) repair, lateral collateral ligament (LCL) repair, anterolateral ligament (ALL) reconstruction, Iliotibial (IT) Band Tenodesis

The MITEK TIGHT-NTM Tendon Docking Anchor is designed to reattach soft tissue to bone when used in conjunction with suture (provided separately). The anchor is preloaded on a disposable inserter shaft with handle, held in place by a non-absorbable "stay suture". The proposed anchor will be offered in three sizes: 5.5 mm, 7.0 mm, and 8.5 mm and is molded from PEEK (Polyetheretherketone) material. The proposed anchor is provided sterile via Ethylene Oxide (EO) sterilization and is for single use only.

The provided text describes a medical device's 510(k) submission to the FDA, focusing on establishing substantial equivalence to a predicate device. It details the device's description, technological characteristics, indications for use, and a summary of non-clinical testing. However, it does not contain information about the acceptance criteria and the results of a study as typically outlined for AI/ML device performance.

Specifically, the document focuses on:

• Device Name: MITEK TIGHT-N™ Tendon Docking Anchor
• Regulatory Classification: Class II, Product Code MBI, regulated under 21 CFR 888.3040 (Fastener, Fixation, Nondegradable, Soft Tissue).
• Predicate Device: K201749 Arthrex Biocomposite 3.9mm SwiveLock Anchor.
• Technological Characteristics: The proposed anchor is a suspensory push-in anchor made of PEEK material, while the predicate is an interference thread-in anchor made of PEEK and PLLA/βTCP. Both secure soft tissue to bone.
• Non-clinical Testing:
  • Biocompatibility
  • Shelf-life
  • Pyrogenicity
  • Endotoxin testing
  • Performance testing (fixation strength and fatigue strength)
  • Ethylene Oxide Sterilization validation per ANSI/AAMI/ISO 11135:2014 to a SAL of 1 x 10^-6.
  • EO residuals testing per AAMI/ANSI/ISO 10993-7:2008.
  • Non-pyrogenic determination per ANSI/AAMI ST-72:2011, USP, and EP using Bacterial Endotoxin Testing (BET).
• Conclusion: "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use." And "Based on similarities in the intended use, technological characteristics, and performance in comparison to the predicate devices, the proposed MITEK TIGHT-NTM Tendon Docking Anchor has shown to be substantially equivalent to the predicate device under the Federal Food, Drug and Cosmetic Act."

Missing Information (relevant to AI/ML device studies):

The document does not provide the following information that would be expected for a detailed description of acceptance criteria and the study proving a digital or AI/ML device's performance:

1. A table of acceptance criteria and reported device performance: This would typically list metrics like sensitivity, specificity, accuracy, AUC, F1 score, etc., with pre-defined thresholds for acceptance and the observed performance.
2. Sample size used for the test set and data provenance: No test set sample size or details about data origin (e.g., country, retrospective/prospective) are mentioned.
3. Number of experts used to establish ground truth and their qualifications: Not applicable, as this is a physical medical device.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for this type of device.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: For this physical device, "performance testing" includes mechanical tests like fixation strength and fatigue strength, and biological tests like biocompatibility and sterilization efficacy. These are not "ground truth" in the AI/ML sense.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes the regulatory clearance for a physical medical device (tendon docking anchor) based on substantial equivalence and non-clinical performance testing. It does not contain the characteristics of an AI/ML device study, and therefore, the specific requested details regarding acceptance criteria and performance studies for such devices are not present.

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Discectomy Navigation Ready Instruments:
The Discectorny Navigation Ready Instruments when used with the compatible Universal Navigation Adaptor Set are intended to assist the surgeon in locating anatomical structures to facilitate disc space preparation, including discectorny or bony resection. These are indicated for use in surgical spinal procedures, in which:
· the use of stereotactic surgery may be appropriate, and
· reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT. MR. 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated navigation arrays.
These procedures include but are not limited to spinal fusion. The Discectomy Navigation Ready instruments can be precalibrated with the Brainlab Navigation System.

Universal Navigation Adaptor Set:
The Universal Navigation Adaptor Set (UNAS) is intended for use with the compatible DePuy Synthes Navigation Ready Instruments to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:
· the use of stereotactic surgery may be appropriate, and
· reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.
These procedures include but are not limited to spinal fusion. The DePuy Synthes Navigation Ready Instrument, when used with UNAS, can be pre-calibrated and/or manually calibrated with the Brainlab Navigation System, where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.

Discectomy Navigation Ready Instruments:
The Discectomy Navigation Ready Instruments are reusable instruments used for disc space preparation, including discectomy or bony resection. These instruments are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS) and associated navigation arrays. For further details on UNAS, refer to the UNAS labeling.
The Discectomy Navigation Ready Instruments are part of the DePuy Synthes Navigation Ready Instruments Portfolio. The instruments include Cobb Elevators, Curettes and a Bone Graft Delivery Device.

Universal Navigation Adaptor Set:
The Universal Navigation Adaptor Set (UNAS) contains reusable spine surgical instruments used to aid in determining the correct location and trajectory of spinal instruments and implants. The UNAS has an interface between third-party navigation systems and the DePuy Synthes Navigation Ready Instruments. The UNAS can only be used with Brainlab and Medtronic StealthStation® navigation systems. The UNAS includes:

• Brainlab compatible UNAS Navigation Arrays, ●
• Brainlab compatible Navigation Rings and ●
• Medtronic compatible Navigation Ring ST. ●
  The Navigation Rings and Navigation Ring ST mate with compatible DePuy Synthes Navigation Ready Instruments. These instruments include implant site preparation and implant insertion instruments as well as access and discectomy instruments.
  When the Brainlab compatible Navigation Ring is attached to the Navigation Ready Instrument, a UNAS Navigation Array can be attached and the instrument can be used only with the Brainlab Navigation System as either a manually calibrated and/or pre-calibrated instrument.
  When the Navigation Ring ST is attached to the Navigation Ready Instrument, a Medtronic SureTrak® II Universal Tracker Fighter array (SureTrak II array) can be attached, and the instrument can be manually calibrated only with the Medtronic StealthStation navigation system.

The provided text is a 510(k) summary for the Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set. It details the device description, indications for use, and performance data used to demonstrate substantial equivalence to predicate devices. However, the document does NOT contain information about acceptance criteria or a study proving that the device meets those criteria, specifically concerning AI/ML performance metrics, ground truth establishment, or human reader studies.

The performance data listed does not relate to an AI/ML algorithm. Instead, it focuses on the physical and functional aspects of the surgical instruments and their compatibility with navigation systems. Therefore, I cannot extract the information required by your prompt, as the provided document does not describe a study involving AI/ML.

Here's why the prompt's specific requirements cannot be met by the provided text:

• AI/ML Performance Metrics (e.g., Sensitivity, Specificity, AUC): Not present. The "Performance Data" section discusses "Accuracy Verification" but this refers to the accuracy of the navigation system's ability to track the physical instruments, not the accuracy of an AI algorithm in diagnosing or classifying medical images.
• Sample size for test set, data provenance: Not present, as there's no AI test set.
• Number of experts, qualifications, adjudication method: Not present, as there's no expert review for AI-generated output.
• Multi-Reader Multi-Case (MRMC) study: Not present, as there is no AI assistance for human readers mentioned.
• Standalone (algorithm-only) performance: Not present, as no AI algorithm is detailed.
• Type of ground truth (pathology, outcomes data, etc.): Not present, as there's no AI model producing diagnostic or prognostic output.
• Training set size and ground truth for training set: Not present, as there's no AI model that requires training data.

The document's "Performance Data" section outlines the following evaluations:

• Accuracy Verification:
  • Fulfillment of navigation systems instrument accuracy requirements
  • Instrument Length Comparison to Predicate Device
  • Array Characteristics Comparison to Predicate Device
• Navigation Connection Repeatability for Pre-Calibrated Instruments
• CAD Model Evaluation
• Simulated Use Evaluation

These are standard engineering and functional performance tests for medical devices, particularly surgical instruments used with navigation systems, and do not involve artificial intelligence or machine learning.

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