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The Altiva Classic ACP System is intended for anterior screw fixation to the cervical spine (C2 to C7). The system is intended for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

• degenerative disc disease (as defined by neck pain of discogenic . origin with degeneration of the disc confirmed by patient history and radiographic studies),
• spondylolisthesis, ●
• trauma (i.e. fractures or dislocations), .
• tumors, .
• deformity (defined by kyphosis, lordosis, or scoliosis), .
• pseudoarthrosis, and .
• failed previous fusion. .

The Altiva Classic ACP System is an anterior screw fixation system for the cervical spine. It includes titanium alloy plates and screws which are provided clean and non-sterile. Various sizes of the implants are provided.

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

The provided document (K070891) is a 510(k) Premarket Notification for the Altiva® Classic ACP System, a spinal intervertebral fixation orthosis. However, it is primarily a regulatory submission for substantial equivalence and does not contain detailed performance study data, acceptance criteria, or ground truth information in the way typically found for AI/software-as-a-medical-device (SaMD) clearances.

The document states: "Performance data were submitted to characterize the Altiva Classic ACP System." However, the details of these performance data, including specific acceptance criteria, study methodologies, sample sizes, and how ground truth was established, are not present within this summary document. 510(k) summaries often only state that performance data were submitted without detailing the results or methodology.

Therefore, I cannot fulfill all parts of your request based solely on the provided text, as much of the requested information (especially points 1-9 regarding a device's performance against detailed acceptance criteria and a study to prove it) is not included in this type of regulatory summary.

Here's what I can provide based on the given text, and where I must state that information is not available:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided 510(k) summary. This document focuses on the regulatory clearance for a physical orthopedic implant system, not a software-based diagnostic device with measurable performance metrics like sensitivity or specificity against a ground truth. The "performance data" mentioned would typically relate to mechanical testing (e.g., fatigue, static strength, torsion) to ensure the device's structural integrity and biocompatibility, not diagnostic accuracy in the way you've outlined.

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

Not available in the provided 510(k) summary. Given this is a physical implant, typical "test sets" would involve mechanical testing, not patient data in the context of diagnostic performance.

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

Not applicable/available. Ground truth as typically understood for diagnostic device performance (e.g., expert reads, pathology) is not relevant for the regulatory clearance of a physical orthopedic implant.

4. Adjudication method for the test set

Not applicable/available.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/SaMD product.

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

Not applicable. This is not an AI/SaMD product.

7. The type of ground truth used

Not applicable. For a physical implant, "ground truth" would relate to engineering specifications for material properties and mechanical performance. The document states "Performance data were submitted to characterize the Altiva Classic ACP System," indicating engineering tests were conducted, but the specifics of these tests (e.g., fatigue strength, pull-out force, torsion) and their acceptance criteria are not detailed in this summary.

8. The sample size for the training set

Not applicable. This is not an AI/SaMD product.

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

Not applicable. This is not an AI/SaMD product.

Summary of What Is Available in the Document:

• Device Type: Spinal Intervertebral Fixation Orthosis (physical implant, screws and plates).
• Intended Use: Anterior screw fixation to the cervical spine (C2 to C7) for temporary stabilization during developing fusion for various conditions (degenerative disc disease, spondylolisthesis, trauma, tumors, deformity, pseudoarthrosis, failed previous fusion).
• Regulatory Clearance: 510(k) clearance based on substantial equivalence to a predicate device.
• Performance Data: The summary states "Performance data were submitted to characterize the Altiva Classic ACP System." This implies mechanical, material, and biocompatibility testing appropriate for an implant, but the details are not included in this public summary.

To obtain the detailed performance data, acceptance criteria, and specific testing methodologies for this device, one would typically need to review the full 510(k) submission, which is often not publicly available in its entirety. The provided document is a summary for public notification of regulatory clearance.

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The ALTES™ Buttress Plating System is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent interverbral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.

The ALTES™ Anterior Buttress Plating System consists of plates and screws. The plate is shaped to conform to the anatomy of the anterior spine. The system features two screws which engage the vertebral body and prevent rotation. A unique locking mechanism of the screw prevents the plate and screws from releasing. The plates are available in three sizes: 20mm, 25mm. and 30mm. The screws are available in two diameters: 4.5mm and 5.0mm, and two lengths: 15mm and 20mm. The components of the ALTES™ Anterior Buttress Plating System are manufactured from titanium alloy and have a smooth anodized color-coded finish.

The Altiva ALTES™ Buttress Plating System is a medical device designed for anterior intravertebral body screw fixation/attachment to the L1-S1 spine. The 510(k) submission (K061482) describes the device and its intended use, and indicates that performance data were submitted to characterize the system. However, the provided text does not include specific acceptance criteria or a detailed study description with performance metrics, sample sizes, or ground truth establishment.

The document is a 510(k) summary and the FDA's substantial equivalence letter, which confirms that the device is substantially equivalent to legally marketed predicate devices. This typically means that the device has similar technological characteristics and is as safe and effective as the predicate device(s). While performance data were submitted, the specifics of those data, including the acceptance criteria, study design, and results, are not contained within the provided excerpts.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.

Here's how I would present the information based on the provided text, highlighting what is missing:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary for the Altiva ALTES™ Buttress Plating System states that "Performance data were submitted to characterize the ALTES™ Anterior Buttress Plating System." However, the specific acceptance criteria for this performance data and the detailed results of the study are not included in the provided document. The document primarily focuses on the device description, intended use, and the FDA's determination of substantial equivalence.

Therefore, I am unable to populate the table of acceptance criteria and reported device performance or answer the detailed questions regarding the study.

Information not available in the provided text:

• Specific quantitative acceptance criteria (e.g., tensile strength, fatigue life, screw pull-out force thresholds).
• Reported device performance values against these criteria.
• Detailed study design (e.g., type of tests conducted, methodologies).
• Sample sizes for test sets (e.g., number of implants tested).
• Data provenance (e.g., in-vitro, in-vivo, country of origin).
• Any information regarding expert involvement in ground truth establishment or adjudication.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Standalone performance details.
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data), as applicable to a clinical study (which isn't detailed here).
• Sample size for any training set (if an AI/ML component were involved, which is not indicated).
• How ground truth for any training set was established.

General understanding from the document:

The 510(k) process relies on demonstrating "substantial equivalence" to a legally marketed predicate device. This typically involves showing that the new device is as safe and effective as the predicate, often through comparisons of design, materials, and performance data (e.g., mechanical testing, biocompatibility). The FDA's substantial equivalence letter confirms that Altiva Corporation provided sufficient information to meet this requirement for the ALTES™ Buttress Plating System. However, the specifics of that "performance data" are not elaborated in the public summary.

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The CONTOUR II™ Spinal System is intended for noncervical, pedicle fixation 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 the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

In addition, the CONTOUR II™ Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.

The CONTOUR II™ Spinal System (KWP) is also intended for use as a posterior noncervical, nonpedicle system indicated for degenerative disc disease which is defined as back pain of dicogenic origin with degeneration of the disc confirmed by history and radiographic studies. spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, tumor, pseudoarthosis, or revision of failed fusion attempts.

When used as an anterior fixation system, the CONTOUR II™ Spinal System (KWO) is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, tumor. pseudoarthosis, or revision of failed fusion attempts.

The CONTOUR II™ Spinal System is an anterior / posterior spinal fixation system consisting of pedicle screws, L and straight connecting rods as well as a variety of clamps and cross connectors. The CONTOUR II™ implant components are fabricated from Ti-6AI-4V ELI per ASTM F 136. Various sizes of these implants are available.

The provided document is a 510(k) summary for the CONTOUR II™ Spinal System, a medical device for spinal fixation. It details the device's indications for use, its classification, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML device.

The 510(k) process for a Class II medical device like the CONTOUR II™ Spinal System focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance metrics and acceptance criteria from a study in the way an AI/ML device would. The "safety information" section on page 4 describes user qualifications rather than device performance.

Therefore, I cannot fulfill the request as the necessary information (acceptance criteria, device performance table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies, training set details) is not present in the provided text.

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The ArcTecTM Semi-Rigid Plating System is intended for posterior, noncervical, pedicle fixation in order 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 the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the ArcTec™ Semi-Rigid Plating System is intended for skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.

The ArcTec™ Semi-Rigid Plating System includes plates, bolts, washers and locking nuts in addition to standard surgical instrumentation. The semi-rigid low profile plate has a low stiffness and is easy to contour. The patent pending washer design incorporates a unique polyaxial bandclamp feature that allows unlimited range of placement on the plate and screw angulation of up to 10 degrees in any plane. The system combines the simplicity of a plate with the adaptability of a polyaxial screw connection.

The provided text describes a 510(k) premarket notification for the ArcTec™ Semi-Rigid Plating System. This is a medical device for spinal fixation, not an AI/ML-based device. Therefore, many of the requested criteria related to AI/ML device performance and testing (such as effect size of human readers with AI, standalone algorithm performance, training set details, and ground truth establishment for AI models) are not applicable to this document.

However, I can extract information regarding the device's performance justification based on the mechanical testing described.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test set: Not applicable in the context of an AI/ML device. For this mechanical device, the "test set" refers to the physical devices subjected to mechanical testing. The document does not specify the number of samples used for ASTM F1717 testing.
• Data provenance: Not applicable. The testing is described as mechanical testing.

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

• Experts: Not applicable. This device is evaluated through mechanical testing, not by human experts establishing ground truth for diagnostic accuracy.

4. Adjudication method for the test set

• Adjudication method: Not applicable. This concept is relevant for reconciling expert disagreements in diagnostic studies, which is not the case here.

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

• MRMC study: No. This is a mechanical spinal implant, not an AI-assisted diagnostic tool for which MRMC studies would be conducted.
• Effect size: Not applicable.

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

• Standalone performance: Not applicable. This device does not have an "algorithm only" component.

7. The type of ground truth used

• Ground truth: For mechanical performance, the "ground truth" is defined by the standards and metrics outlined in ASTM F1717 for spinal implant testing. The document does not specify which particular aspects of ASTM F1717 were evaluated (e.g., static compression, fatigue, etc.), but it refers to the standard generally.

8. The sample size for the training set

• Training set sample size: Not applicable. This is not an AI/ML device that requires a training set.

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

• Ground truth for training set: Not applicable.

Summary of Device Performance Justification:

The ArcTec™ Semi-Rigid Plating System demonstrates its performance and safety through mechanical testing in accordance with ASTM F1717. This testing serves as the basis for establishing substantial equivalence to legally marketed predicate devices, considering its intended use, function, design, material, and overall mechanical performance. The FDA reviewed this information and found the device substantially equivalent.

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The HydraLok System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis)
In addition, when used as a pedicle screw fixation system, the HydraLok System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft only having the device attached to the lumbar and sacral spine (L3 and below), who are having the device removed after the development of a solid fusion.

The HydraLok System is a top-loading spinal fixation system including screws, rods, and connectors. The titanium alloy components are provided clean and non-sterile. Various sizes of the implants are provided.

This 510(k) premarket notification for the Altiva HydraLok™ System does not contain specific acceptance criteria or details of a comprehensive study proving the device meets acceptance criteria related to its performance characteristics (e.g., strength, durability, biomechanical stability).

The document states, "Performance data were submitted to characterize the HydraLok System." However, the actual performance data, acceptance criteria for that data, and the study design are not provided within this summary.

Based on the provided information, I cannot complete the requested tables and descriptions because the document primarily serves as a regulatory submission summary rather than a detailed performance study report.

Here's what can be inferred from the document regarding the type of data submitted, but not the specifics:

1. Table of Acceptance Criteria and Reported Device Performance

• Not available from the provided text. The document only states that "Performance data were submitted to characterize the HydraLok System." No specific criteria or reported performance values are given.

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

• Not available from the provided text.

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

• Not applicable. This specific type of "ground truth" establishment is typically relevant for AI/diagnostic devices, not for a spinal fixation system, unless the performance data involved human assessment of biomechanical outcomes, which is not indicated here.

4. Adjudication method

• Not applicable. See point 3.

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 device, not an AI or diagnostic tool where human reader performance would be enhanced by AI.

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

• Not applicable. This is a mechanical device.

7. The type of ground truth used

• Not applicable. For a mechanical device, performance is typically evaluated against engineering specifications, material properties, and biomechanical testing standards, rather than "ground truth" derived from expert consensus, pathology, or outcomes data in the way AI/diagnostic devices are.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an AI system that requires a "training set."

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

• Not applicable. See point 8.

Summary of available information:

The document is a 510(k) summary for a medical device called the "HydraLok™ System," a pedicle screw spinal fixation system. It outlines the company, contact, date, trade name, common name, classification, device description, intended use, and predicate device information. It explicitly states that "Performance data were submitted to characterize the HydraLok System," which is a mandatory part of a 510(k) submission to demonstrate substantial equivalence to a predicate device. However, the details of that performance data, including specific acceptance criteria, test results, study methodology, sample sizes, and how ground truth was established, are not contained within this summary document.

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