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The FORTICO Anterior Cervical Fixation System (Fortico Plate and Screws) is intended for anterior screw fixation to the cervical spine (C2-T1) in skeletally mature patients for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (such as fracture or dislocation), spinal stenosis, deformities or curvatures (such as scoliosis, or lordosis), tumor, pseudarthrosis, and failed previous fusion.

The FORTICO Anterior Cervical Fixation System is a cervical plating system that consists of a cervical plate that includes bone screw holes and blocking mechanisms to prevent screw back-out.

This document is a 510(k) submission summary for a medical device, the FORTICO Anterior Cervical Fixation System. It describes the device and its intended use, and argues for substantial equivalence to existing devices.

The document does not describe a study that uses acceptance criteria in the context of device performance related to a specific metric, such as sensitivity, specificity, or accuracy, which would typically be included in a software algorithm or diagnostic device submission. This submission focuses on the mechanical and physical performance of an orthopedic implant.

Therefore, the requested details regarding acceptance criteria for device performance based on metrics like sensitivity, specificity, sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information are not applicable to this type of device submission.

Here's a breakdown of what the document does provide in relation to performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table with specific numerical acceptance criteria for mechanical performance in the format of a typical diagnostic device. Instead, it states that testing was performed per ASTM F1717 and that the device is "as mechanically sound as similar devices which are legally marketed for sale in the United States."

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

• Sample Size: Not explicitly stated for each test, but standard ASTM F1717 testing involves a defined number of samples per test type.
• Data Provenance: The testing was performed by Camber Spine (the manufacturer) or a contracted lab. This is internal testing to support the 510(k) submission. It's prospective in the sense that the tests were conducted specifically for this submission.

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

• Not applicable. Mechanical testing does not involve establishing ground truth through expert consensus in the way a diagnostic algorithm would. The "ground truth" is established by the specified parameters and methodologies of the ASTM standard.

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

• Not applicable. Adjudication methods are for clinical interpretations, not mechanical testing.

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 mechanical implant, not an AI or diagnostic device.

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

• Not applicable. This is a mechanical implant, not an algorithm.

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

• For mechanical testing, the "ground truth" is adherence to the specified test methodology and performance metrics outlined in the ASTM F1717 standard. It's based on engineering specifications rather than clinical interpretations or pathological findings.

8. The sample size for the training set:

• Not applicable. There is no "training set" for this type of mechanical device submission.

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

• Not applicable for the same reason as above.

In summary, this document is a regulatory submission for an orthopedic implant. The "acceptance criteria" and "study" described relate to engineering and mechanical performance against recognized industry standards (ASTM F1717) to demonstrate substantial equivalence to predicate devices, rather than clinical performance metrics of a diagnostic or AI-driven device.

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The ORTHROS™ MIS Posterior Stabilization System, when used in a posterior percutaneous approach is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1-S1/Ilium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis). In addition, ORTHROS™ MIS Posterior Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L-3sacrum/ilium.

The ORTHROS™ Posterior Stabilization System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1-S1/Ilium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). In addition, the ORTHROS™ Posterior Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

The ORTHROS™ Posterior Stabilization System is a multiple component, posterior stabilization system which consists of a variety of shapes and sizes of rods, monoaxial screws, polyaxial screws, cannulated polyaxial screws, reduction screws, cannulated reduction screws, locking caps, locking set screws, cross links, and associated manual surgical instruments. The ORTHROS™ Posterior Stabilization System is designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion in skeletally mature patients. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws are intended for posterior and anterior use. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking Caps and Locking Set Screws are used to connect the screws to the rods. All implants are composed of Titanium Alloy (TAV), as specified in ASTM F136.

The ORTHROS™ MIS Posterior Stabilization System is a multiple component, minimally invasive posterior stabilization system which consists of a variety of shapes and sizes of rods, cannulated percutaneous/MIS polyaxial screws, locking set screws, and associated manual surgical instruments. The ORTHROS™ MIS Posterior Stabilization System is designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion in skeletally mature patients. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. The MIS polyaxial screws are intended for posterior use. Locking Set Screws are used to connect the screws to the rods. All implants are composed of Titanium Alloy (TAV), as specified in ASTM F136. The ORTHROS™ MIS System also utilizes select instrumentation from the ORTHROS™ Posterior Stabilization System.

The provided text describes a 510(k) submission for the ORTHROS™ Posterior Stabilization System and the ORTHROS™ MIS Posterior Stabilization System. This document focuses on demonstrating substantial equivalence to predicate devices for a spinal implant system and does not contain information related to an AI/ML device.

Therefore, I cannot extract the requested information about acceptance criteria and study details for an AI device, as these are not relevant to the content provided. The "Performance Data" section specifically refers to mechanical testing of the spinal implant, not performance of a software algorithm.

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The Camber Spine Technologies SPIRA Open Matrix LLIF is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine Technologies SPIRA Open Matrix LLIF is intended to be used with additional FDA-cleared supplementary fixation systems. The Camber Spine Technologies SPIRA Open Matrix LLIF system must be used with autogenous bone graft material.

The Camber Spine Technologies SPIRA Open Matrix LLIF is an Interbody Fusion Device that has spiral support arches to allow for a hollow chamber to permit packing with autogenous bone to facilitate fusion. The superior and inferior surfaces of the device have a roughened surface to help prevent movement of the device while fusion takes place.

The provided text describes a 510(k) premarket notification for a medical device called the "SPIRA Open Matrix LLIF," an intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than a study proving the device meets specific performance criteria for an AI/algorithm-driven device.

Therefore, the prompt's request for information related to AI/algorithm performance, such as sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, cannot be answered based on the provided text. These elements are typically part of the regulatory review for diagnostic or AI-powered devices, not for an implantable device like the SPIRA Open Matrix LLIF, where the focus is on mechanical and material performance.

However, I can extract the information related to the device's mechanical performance testing as described in the document.

Here's an analysis based on the provided text, focusing on the mechanical acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance & Study Design:

The document states: "Testing performed indicate that the SPIRA Open Matrix LLIF is as mechanically sound as predicate devices. Testing included static compression, static compression-shear, dynamic compression, dynamic compression-shear, expulsion, and subsidence per ASTM F2077-14 and F2267-04. The results demonstrate that the acceptance criteria defined by predicate device performance were met."

While a table with exact numerical acceptance criteria is not explicitly provided, the criteria are implicitly defined by the performance of the predicate devices according to the specified ASTM standards. The study design involves testing the SPIRA Open Matrix LLIF against these standards to demonstrate equivalent mechanical performance to the predicates.

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

The document does not specify the sample size (e.g., number of devices tested) for the mechanical performance testing.
The data provenance is not explicitly mentioned as "country of origin," but given it's an FDA submission, the testing would typically be conducted in a laboratory accredited for such tests, likely in the US or a country with comparable standards. The nature of these tests (mechanical performance of an implant) makes them more akin to laboratory experiments than clinical data from patients (retrospective/prospective).

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

This question is not applicable to the type of safety and performance testing described. The "ground truth" for mechanical testing is established by the specified ASTM standards (F2077-14 and F2267-04) and the measured performance of predicate devices, not by human experts adjudicating medical images or clinical outcomes.

4. Adjudication Method for the Test Set:

This question is not applicable. Mechanical tests are objective measurements, not human interpretations requiring adjudication.

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

This question is not applicable. An MRMC study is relevant for evaluating diagnostic accuracy or reader performance with AI assistance, not for the mechanical performance of an implantable device.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

This question is not applicable. The device is a physical intervertebral body fusion device, not an algorithm or AI-powered system.

7. The Type of Ground Truth Used:

The "ground truth" for the mechanical performance study is defined by:

• Established ASTM Standards: Specifically, ASTM F2077-14 ("Standard Test Methods for Intervertebral Body Fusion Devices") and ASTM F2267-04 ("Standard Test Method for Determining the Rate of Resorption of Porous Bioceramics for Surgical Implants and Bone Graft Substitutes").
• Performance of Predicate Devices: The new device's performance is compared against known characteristics and performance data of the identified predicate devices (SPIRA Open Matrix ALIF, 4WEB Medical LATERAL Spinal Truss System, Alphatec Spine Novel) to establish substantial equivalence.

8. The Sample Size for the Training Set:

This question is not applicable. There is no "training set" in the context of mechanical performance testing for an implantable medical device. This term is used for machine learning models.

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

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

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