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The Calvary Spine Pedicle Screw 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 spine (T1 to S1/ilium); degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical (T1 to S1/ilum), pedicte screw fixation in pediatric patients, the Calvary Spine Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Calvary Spine Pedicle Screw System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.

This system is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Calvary Spine Pedicle Screw System includes screws and connecting components in a wide variety of sizes and shapes, which can be locked in various configurations, each assembly being tailor-made. Calvary pedicular screws must be used with Ø 5.5mm straight and curved rods.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Calvary Spine Pedicle Screw System:

Based on the provided FDA 510(k) summary (K201568), there is no information about acceptance criteria or a study proving the device meets specific performance criteria in terms of an AI/algorithm-based medical device.

The document describes a traditional medical device, specifically a pedicle screw system, which is a hardware implant used in spinal fusion surgery. The "acceptance criteria" discussed in this document refer to the regulatory requirements for establishing substantial equivalence to previously cleared predicate devices, primarily based on design, materials, and mechanical performance through non-clinical testing.

Therefore, I cannot populate most of the requested fields because they are specifically tailored for studies validating AI/algorithm performance.

However, I can extract the relevant information regarding the type of study and the basis for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a traditional medical device and not an AI/algorithm, there are no specific performance metrics like sensitivity, specificity, or AUC to list as acceptance criteria for automated diagnosis or analysis. The "acceptance criteria" for this device are broadly the demonstration of substantial equivalence to predicate devices based on:

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

• Not applicable (N/A) for an AI/algorithm test set.
• The "test set" in this context refers to the samples used in non-clinical mechanical testing, which are typically manufactured units of the device. No information on the specific number of units tested for each mechanical test is provided, but it would involve standard engineering sample sizes for material and mechanical property evaluations.
• Data Provenance: The data provenance for mechanical testing would be from internal laboratory testing of the manufactured devices. No country of origin for data in the AI sense is relevant here, nor is retrospective or prospective human data.

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

• N/A for an AI/algorithm test set.
• Ground truth for mechanical properties is established through standard engineering and materials testing protocols (e.g., ASTM standards), not by human experts adjudicating images or clinical data.

4. Adjudication Method for the Test Set

• N/A for an AI/algorithm test set.
• Mechanical test results are objective measurements against defined standards, not subject to human adjudication methods like 2+1 or 3+1.

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. An MRMC study was not done.
• This device is not an AI/algorithm, therefore, there is no human-in-the-loop performance improvement with AI assistance to measure.

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

• No. A standalone algorithm performance study was not done.
• This device is not an AI/algorithm.

7. The Type of Ground Truth Used

• Mechanical and Material Standards: The "ground truth" for this medical device's performance is compliance with established material specifications (e.g., ASTM F136, F67, F1582) and mechanical testing standards for spinal implants, demonstrating equivalent or superior strength to predicate devices.

8. The Sample Size for the Training Set

• N/A for an AI/algorithm training set.
• This device does not involve a training set as it's not an AI/algorithm.

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

• N/A for an AI/algorithm training set.
• Not applicable as there is no training set.

Summary of what was done (based on the provided text):

The Calvary Spine Pedicle Screw System underwent non-clinical testing to demonstrate that it is substantially equivalent to legally marketed predicate devices. This equivalence was established based on:

• Similar materials (Ti-6Al-4V ELI, CP Titanium, CoCrMo).
• Similar intended use.
• Similar design (shape, sizes, manufacturing process).
• Comparable or superior strength values, presumably measured through mechanical testing (though specific tests and methodology are not detailed in this summary).

The document explicitly states: "No clinical studies were performed." This is common for 510(k) clearances where substantial equivalence can be demonstrated through non-clinical data.

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The KHEIRON Spinal Fixation System is intended to provide immobilization 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 spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the KHEIRON System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the KHEIRON Spinal Fixation System is intended to treat pediatic patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.

This system is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The KHEIRON® Spinal Fixation System may be used for a variety of conditions that affect the thoracic and lumbar spine. In cases in which the posterior elements are fractured, the pedicle screw offers an excellent means of stabilizing a specific spinal segment. KHEIRON Spinal Fixation System includes screws and connecting components in a wide variety of sizes and shapes, which can be locked in various configurations, each assembly being tailor-made. KHEIRON pedicular screws must be used with Ø 5.5mm and Ø 6mm rods.

The KHEIRON® Spinal Fixation System is a medical device and the provided document is a 510(k) summary for its premarket notification to the FDA. This summary focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria through a standalone study of its capabilities in a clinical setting.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not directly available in the provided text. The document states "No clinical studies were performed."

However, the document does provide information on non-clinical testing to demonstrate the physical performance and safety of the device:

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

Since no specific numerical acceptance criteria (e.g., minimum strength values) are given, and only a comparative statement is made regarding performance against predicates, a direct table of acceptance criteria and the reported device performance as typically expected for an AI/diagnostic device is not applicable here.

Instead, the non-clinical test summary states:

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

• Test Set Sample Size: Not specified as clinical studies were not performed. For non-clinical tests (mechanical tests), the sample sizes for the devices tested were not provided.
• Data Provenance: Not applicable as no clinical data was used. Mechanical testing is typically done in a laboratory setting. No country of origin for the mechanical test data is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not applicable, as no clinical studies requiring expert consensus for ground truth were performed.

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

• Not applicable, as no clinical studies requiring ground truth adjudication were performed.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states, "No clinical studies were performed." This device is a mechanical spinal fixation system, not an AI or diagnostic tool that would typically involve human "readers."

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

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

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

• For the non-clinical mechanical tests, the "ground truth" would be the engineering standards (e.g., ASTM F1717 and ASTM F1798) and the performance characteristics of the predicate devices. The device's strength was directly measured against these established benchmarks.

8. The sample size for the training set:

• Not applicable, as this is a mechanical spinal fixation system and not an AI/machine learning device that requires a training set.

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

• Not applicable, as this is a mechanical spinal fixation system and not an AI/machine learning device.

Summary of Non-Clinical Testing:

The KHEIRON® Spinal Fixation System underwent the following non-clinical mechanical tests:

• Static and dynamic compression bending (according to ASTM F1717)
• Static torsion (according to ASTM F1717)
• Torsional and axial gripping capacity (according to ASTM F1798)

The results of these evaluations indicated that the KHEIRON Spinal Fixation System is "substantially equivalent to legally marketed predicate devices" and specifically noted that its "strength values" were "greater or equivalent" compared to other cleared devices for thoracolumbosacral spine use.

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The uNion™ Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to T1). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

uNion™ is an anterior cervical plate and screw system used to provide mechanical support across implanted level(s) in the cervical spine until fusion is achieved. The components include Ø4.0mm and Ø4.5mm fixed and variable screws having self-tapping, self-drilling or self-drilling/self-tapping tips, one- through four-level standard plates having lengths from 10mm to 84mm and one- and two-level midline plates having lengths from 10mm to 46mm. Both the standard and the midline plates incorporate a pivoting insert which functions as an anti-back out mechanism. The devices are sold non-sterile.

The provided text describes a 510(k) Pre-market Notification for the uNion™ Cervical Plate System, focusing on its substantial equivalence to predicate devices based on mechanical testing. It does not contain information about an AI/ML device or its performance study against acceptance criteria in the way described in the prompt. Therefore, I cannot extract the requested information.

The document discusses:

• Device: uNion™ Cervical Plate System (a medical implant for spinal fixation).
• Regulatory Category: Class II, Spinal intervertebral body fixation orthosis.
• Purpose of filing: 510(k) Pre-market notification to demonstrate substantial equivalence to legally marketed predicate devices.
• Performance Data: Mechanical testing of worst-case uNion™ constructs (static and dynamic compression bending, static torsion) according to ASTM F1717.
• Conclusion: The mechanical test results showed that the uNion™ performance is substantially equivalent to the predicate devices.

None of the requested information regarding acceptance criteria, AI/ML performance study, sample sizes for test/training sets, ground truth establishment, or expert adjudication is present in the provided text, as it pertains to a traditional medical device, not an AI/ML system.

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The DPZ Pedicular Fixation System is intended to provide immobilization 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 spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e., scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

The DPZ Pedicular Fixation System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e., fracture or dislocation); spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudarthrosis and failed previous fusion.

The DPZ Pedicular Fixation System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to more closely match the patient's anatomy.

The provided text describes the DPZ Pedicular Fixation System, its intended use, and the non-clinical tests conducted to demonstrate its equivalence to predicate devices. However, it explicitly states: "No clinical studies were performed."

Therefore, I cannot provide information on acceptance criteria based on human performance or studies involving human readers/experts, as no such clinical data is presented in this document.

Here's the information that can be extracted from the provided text regarding the device's acceptance criteria and the study that proves it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for the non-clinical tests. The document only mentions "The following analyses were conducted."
• Data Provenance: Not explicitly stated, but it refers to "non-clinical tests" which typically involve laboratory or bench testing of the device hardware.

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

• Not applicable. The "ground truth" for non-clinical mechanical testing is based on the specifications within the ASTM F1717 standard and the measured performance of the device compared to predicate devices. Human experts are not involved in establishing this ground truth for a mechanical test.

4. Adjudication method for the test set:

• Not applicable, as this refers to human reader review and consensus, which was not performed.

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 MRMC study was done, as "No clinical studies were performed."

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

• Not applicable. This is a medical device (pedicle fixation system), not an algorithm or AI. The standalone performance refers to the device's mechanical integrity under specified ASTM standards.

7. The type of ground truth used:

• The ground truth for the non-clinical tests was based on the performance requirements and methodologies outlined in the ASTM F1717 standard for spinal implant constructs. The device's performance was then compared to that of predicate devices to establish substantial equivalence.

8. The sample size for the training set:

• Not applicable. This is a non-AI/algorithm medical device. "Training set" refers to data used to train an AI model.

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

• Not applicable for the same reason as above.

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The APEX-DL Spine System with APEX Spine System Components is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudoarthrosis).

The APEX-DL Spine System with APEX Spine System Components is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained.

The APEX-DL Spine System with APEX Spine System Components is also a sacraliliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).

When used in a percutaneous posterior approach with AIM MIS instrumentation, the APEX-DL Spine System with APEX Spine System Components is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain 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, pseudoarthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.

When used for posterior non-cervical pediatic patients, the APEX-DL Spine System implants with APEX Spine System Components are indicated as an adjunct to treat adolescent idiopathic scoliosis. The APEX DL Spine System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The APEX-DL Spine System includes Monoaxial, Uniplanar, and Polyaxial Double Lead Thread Screws in the cannulated and non-cannulated versions and in regular and reduction (extended tab) versions. APEX-DL Spine System is a low profile thoracolumbar implant for use with wide range of patient statures. The APEX-DL Spine System Polyaxial screws feature a friction head, which is designed to provide precise reduction mechanism as a result of easier rod capturing. The APEX-DL Spine System also includes Lordosed Percutaneous Rods. The APEX-DL Spine System is compatible with the APEX Spine System 5.5mm and 6.0mm rods, hooks, side-by-side connectors, iliac connectors, cross connectors, and washers.

The APEX-DL Spine System is a spinal implant for immobilization and stabilization of spinal segments. The document indicates that no clinical studies were performed. The acceptance criteria and testing are based on non-clinical (mechanical) tests.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are implicitly defined as demonstrating mechanical properties that are "equal or higher" than the identified predicate devices, based on the testing standards.

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

• Sample Size: Not explicitly stated in the provided document. For each of the ASTM tests listed, a specific number of samples (implants/constructs) would have been used, but this detail is not provided.
• Data Provenance: The data is from non-clinical (mechanical) testing conducted presumably by SpineCraft, LLC or a contracted testing facility. It is not patient or human data; therefore, country of origin or retrospective/prospective does not apply in the typical sense.

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

Not applicable. This is a non-clinical, mechanical testing study, not a study requiring expert clinical assessment or ground truth establishment in a medical imaging or diagnostic context. The "ground truth" here is the objective measurement of mechanical properties according to established ASTM standards.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical, mechanical testing study. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical or imaging studies.

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

No. An MRMC study is a clinical study involving multiple human readers interpreting medical cases. The provided document explicitly states, "No clinical studies were performed."

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

Not applicable. This device is a physical spinal implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective mechanical measurements according to recognized industry standards (ASTM F1717 and ASTM F1798). The performance is then compared to "predicate systems" as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device undergoing mechanical testing, not a machine learning model that requires a training set.

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

Not applicable. As described in point 8, there is no "training set" for this type of device evaluation.

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The ASTRA System is intended to provide immobilization 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudo-arthrosis).

The ASTRA Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained.

The ASTRA System is also a sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).

When used in a percutaneous, posterior approach with AVANT Spine MIS instrumentation, the ASTRA Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain 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), tumor, pseudo-arthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.

The ASTRA Spine System is a top loading, multiple component, posterior spinal fixation system which consists of rods, cannulated and non-cannulated monoaxial, uniplanar and polyaxial screws, hooks, iliac connectors, rod connectors, and cross connectors. Most of the components are available in a variety of sizes to more closely match the patient's anatomy.

Materials:
Titanium alloy
CoCr alloy

Here's an analysis of the provided text regarding the ASTRA Spine System, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a medical device (Spine System), not an AI/ML device. Therefore, many of the requested fields related to AI/ML specific studies (like sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance) are not applicable to this type of medical device submission. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical (mechanical) testing.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" are implicitly defined by performance equivalence to predicate devices in standardized mechanical tests. The "reported device performance" is a statement of comparative equivalence.

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

This is a physical device, and the "test set" refers to the tested device components.

• Sample Size: Not explicitly stated in terms of number of components tested for each test, but standard engineering practices for medical device testing would involve a sufficient number (e.g., n=5 or n=10 per test) to ensure statistical significance, though the exact numbers are not provided in this summary.
• Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. There is no patient data provenance (e.g., country of origin, retrospective/prospective) since no human data was used for these mechanical tests.

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

• Not Applicable. For mechanical testing of a physical device, ground truth is established by standardized testing protocols (e.g., ASTM standards) and measured physical properties, not by expert consensus on clinical data. Engineers and lab technicians perform and analyze the tests according to these standards.

4. Adjudication Method for the Test Set

• Not Applicable. There is no adjudication in the sense of reconciling human expert opinions for clinical images or data. The results of mechanical tests are objective measurements against defined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• Not Applicable. This is a physical spinal implant, not an AI/ML diagnostic or assistive device. No MRMC studies were performed.

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

• Not Applicable. This is a physical spinal implant; there is no algorithm or standalone performance.

7. The Type of Ground Truth Used

• Mechanical Test Standards and Predicate Device Performance: The "ground truth" for the non-clinical tests is based on the established performance characteristics and safety profiles of legally marketed predicate devices, as defined by FDA regulations for substantial equivalence, and adherence to relevant ASTM standards (ASTM F1717 and ASTM F1798).

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device; there is no AI/ML model or "training set" in the context of machine learning. The device design and materials are based on engineering principles and knowledge of predicate devices.

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

• Not Applicable. As there is no training set for an AI/ML model, this question is not relevant. The "ground truth" for developing the physical device is based on established biomechanical and medical understanding of spinal fixation and the performance of existing, cleared devices.

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The VELOX Anterior Cervical Plate System is interior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fision of the cervical spine (C2 to C7). The system is indicated 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 discogenion of the disc confirmed by patient history and radiographic studies),

• · spondylolisthesis,
  · trauma (i.e. fractures or dislocations),

• tumors,

· deformity,

· pseudarthrosis.

· failed previous fusion,

· spinal stenosis.

The VELOX Anterior Cervical Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping bone screws using an anterior approach. The VELOX anterior cervical plate, screws and instruments were designed taking into consideration the whole procedure. Plates are available in a variety of lengths, addressing multiple levels of fixation. The VELOX plate incorporates vision ports that allow visualization of post-operative endplate/graft incorporation. Alignment notches on the cephalad and caudal ends of the plate facilitate precise midline placement and allow for Temporary Pin fixation of the plate. To accommodate normal cervical spine lordosis and, at the same time, minimize the need for additional plate contouring, the VELOX Anterior Cervical Plate comes with a pre-machined lordotic curve. Bone screws are available for fixed angle implantation in a variety of lengths.

The VELOX Anterior Cervical Plate is a medical device and is not subject to acceptance criteria in the same way an AI/ML diagnostic or prognostic device would be. Instead, its approval is based on demonstrating substantial equivalence to existing legally marketed predicate devices through non-clinical performance testing.

Here's an analysis of the provided information in the context of your request:

Acceptance Criteria and Device Performance (Derived from Substantial Equivalence Claim)

The "acceptance criteria" for a medical device like this are primarily demonstrating that its design, materials, and mechanical performance are equivalent or superior to predicate devices. The performance is reported in comparison to these predicates.

Explanation: In the context of a 510(k) submission for a traditional medical device, "acceptance criteria" are implied by the chosen predicate device's established safety and effectiveness. The manufacturer must demonstrate that the new device meets or exceeds the performance of these predicates.

Study Details (Non-Clinical)

1. Sample sizes used for the test set and data provenance:

   • Test Set Sample Size: Not explicitly stated in terms of the number of specific test articles. However, the study references "testing included Static Compression Bending Tests, Static Torsion Tests and Dynamic Compression Bending Tests" according to ASTM F1717-12. The ASTM standard itself would specify the number of samples required for each test.
   • Data Provenance: The testing was conducted by the manufacturer, SpineCraft, LLC, likely in a laboratory setting. The country of origin for the testing is implied to be within the USA, given the submitter's location in Westmont, IL, USA. This is a prospective non-clinical study designed for regulatory submission.

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

   • Not Applicable. This is a non-clinical mechanical performance study, not a clinical study involving human patients or expert interpretation of data. "Ground truth" in this context refers to the measured physical properties and performance characteristics determined by the mechanical tests, not expert consensus on medical conditions.

3. Adjudication method for the test set:

   • Not Applicable. As a non-clinical mechanical test, there is no expert adjudication process. The results are quantitative measurements against established engineering standards.

4. 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/ML algorithm. No human readers or AI assistance are involved in its primary function or testing for regulatory approval.

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

   • Not Applicable. This is a mechanical device, not an algorithm.

6. The type of ground truth used:

   • Mechanical Test Results against ASTM Standards. The "ground truth" for this device's performance is derived from the objective measurements obtained through standardized mechanical testing (ASTM F1717-12). These results are then compared to the known performance of predicate devices.

7. The sample size for the training set:

   • Not Applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set. The design of the device is based on engineering principles and potentially prior experience with similar devices, but not a data-driven training set in the AI sense.

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

   • Not Applicable. No training set was used.

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The Sintea Plustek Anterior Cervical Plate systems in indicated for use in the cervical spine (C3-C7) for the following conditions:

• Degenerative Disc Disease (defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
• . Spondylolisthesis
• . Trauma (fracture or dislocation)
• . Spinal stenosis
• Deformities or curvatures (scoliosis, kyphosis, lordosis) ●
• . Tumor
• . Pseudarthrosis
• . Failed previous fusion

The Sintea Plustek Anterior Cervical Plate system is made of medical grade titanium alloy Ti-6Al-4V according to ASTM-F136 and consists of plate and screws of various lengths to accommodate single or multilevel fusion and various patients' anatomy. All of the plates have 2.5mm thickness. One level plates are available from 18-38mm, two level plates from 34-56mm, three level plates from 68-112mm and 4 level plates from The screws are available in three configurations: 4mm diameter self 103-128mm. tapping screws in lengths of 10, 12, 14, 16 and 18mm. 4.5 diameter self tapping screws in lengths of 10, 12, 14, 16, and 18mm, 4mm diameter self drilling screws in lengths of 10, 12, 14, 16 and 18mm. The plates have an anti-backout feature based on an elastic ring The elastic ring is inserted into a (made titanium alloy Ti-6AI-4V as well). circumferential slot in the holes present on the plates. The ring can be deformed by the screw during the insertion in order to allow the screw to fit the hole of the plate. Once the screw it is completely inserted the ring return elastically to its original shape in order to prevent screw backout.

The provided text describes a medical device, the Sintea Plustek Anterior Cervical Plate System, and its 510(k) summary for FDA clearance. It focuses on the device's physical properties, indications for use, and a comparison to predicate devices, but does not describe an AI/ML-driven device or study parameters related to AI/ML performance.

Therefore, I cannot extract the information required to answer your prompt, as the prompt's questions pertain to acceptance criteria and studies for an AI/ML device, which are not present in the provided document.

The document only states:

1. Acceptance Criteria and Device Performance (Mechanical Testing):
The study for this device was a mechanical performance test to demonstrate substantial equivalence, not an AI/ML performance study.

2. Sample size and data provenance (for AI/ML test set): Not applicable, as this is a mechanical medical device, not an AI/ML device.

3. Number of experts and qualifications (for AI/ML ground truth): Not applicable.

4. Adjudication method (for AI/ML test set): Not applicable.

5. Multi-reader multi-case (MRMC) comparative effectiveness study (for AI/ML): Not applicable.

6. Standalone performance (for AI/ML algorithm): Not applicable.

7. Type of ground truth used (for AI/ML): Not applicable. The "ground truth" in this context refers to established mechanical testing standards (ASTM F1717-09) and performance of legally marketed predicate devices.

8. Sample size for the training set (for AI/ML): Not applicable.

9. How ground truth for the training set was established (for AI/ML): Not applicable.

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The ODALYS™ Pedicle Screw System is a pedicle screw system 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system ODALYS™ Pedicle Screw System is indicated for the 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 lumbar and sacral spine (13 to sacrum) with removal of the implants after the attainment of a solid fusion.

The ODALYS™ Pedicle Screw System has been developed with the objective of providing the surgeon with an adaptable fixation system in order to carry out dorsal stabilization of the spine simply, quickly and effectively.

The system consists of a variety of color coded top loading pedicle screws. The pedicle screws are available in various lengths and diameters. The screw is connected to the rod via a rod connector. Two sizes of connectors are available, short and long. The long is used in cases of spondylolisthesis where the short connector would not be able to engage the rod. The rods are available in multiple lengths.

Materials: The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136.

Function: The ODALYS™ Pedicle Screw System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments until fusion takes place.

The provided text describes the ODALYS™ Pedicle Screw System, a medical device, and its acceptance criteria as determined by the FDA's 510(k) clearance process.

Here's an analysis of the acceptance criteria and the "study" (non-clinical tests) used to prove the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a "test set" in the context of human data. The testing performed was non-clinical, involving mechanical tests of the device. The sample size for these mechanical tests (e.g., number of screws or constructs tested for each configuration) is not provided in the summary.
• Data Provenance: The data provenance is from non-clinical laboratory testing (mechanical testing per ASTM standards). There is no information regarding country of origin or whether it's retrospective or prospective, as it pertains to physical device testing, not human data.

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

This section is not applicable. The "ground truth" for this device, in the context of the 510(k) submission, is its mechanical performance and material properties. This is established by adherence to recognized ASTM standards for medical devices, rather than expert consensus on a dataset. The results are compared to predicate devices.

4. Adjudication Method for the Test Set

This section is not applicable. There was no human "test set" requiring adjudication. The assessment was based on objective mechanical testing results comparing the device to accepted standards and predicate device performance.

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, a Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic or AI-assisted devices that involve human interpretation of medical images or data. The ODALYS™ Pedicle Screw System is a physical implant, not an AI-based diagnostic tool.

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

No, a standalone algorithm performance study was not done. The device is a physical implant; there is no AI algorithm associated with it.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

• Compliance with recognized industry standards (ASTM F1717 and ASTM F136).
• Substantial equivalence to legally marketed predicate devices in terms of intended use, design, materials, and function, as demonstrated by meeting or exceeding the mechanical performance and material specifications of those predicates.

8. The Sample Size for the Training Set

This section is not applicable. The ODALYS™ Pedicle Screw System is a physical pedicle screw system, not an AI or machine learning device that requires a "training set."

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

This section is not applicable for the same reason as point 8. There is no training set for this device.

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The Pyrenees and K2M Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

The Pyrenees Cervical Plate System is a spinal fixation system which consists of cervical screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy. Materials: The devices are manufactured from Commercially Pure titanium alloy per ASTM and ISO standards. Function: The system functions as an adjunct to fusion to provide immobilization of cervical segments of the spine.

The Pyrenees Cervical Plate System, Translational Plate, is a spinal fixation system consisting of cervical screws and plates made from Commercially Pure titanium alloy. It's intended for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes mechanical testing and comparison to predicate devices rather than a clinical study with a test set of human subjects or data. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable in the context of this submission. The "test set" here refers to the physical devices subjected to mechanical loads.

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

This information is not applicable as the "ground truth" for mechanical testing is established by the specifications of ASTM F1717 and the performance of predicate devices, not expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable as the assessment is based on objective mechanical measurements against a standard (ASTM F1717) and direct comparison to predicate device performance. No human adjudication is mentioned or implied for this type of test.

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

There is no mention of an MRMC comparative effectiveness study, AI assistance, or human readers in the provided document. This submission focuses on the mechanical and functional equivalence of a spinal fixation device, not a diagnostic or interpretative AI-based system.

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

This is not applicable. The device is a physical spinal implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

• Established mechanical testing standards: Specifically, ASTM F1717.
• Performance of legally marketed predicate devices: The Pyrenees system's performance was compared directly to that of predicate devices in static torsion, dynamic compression, and static tension.
• Material and design specifications: Adherence to ASTM and ISO standards for materials, and equivalence in design features and sizing to predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. The device is an orthopedic implant, not a machine learning model that undergoes training on a dataset.

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

This is not applicable for the reasons stated in point 8.

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