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PYRENEES and BLUE RIDGE Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

OZARK Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

The CAYMAN Buttress Plates are intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

The CAYMAN Thoracolumbar Plates are indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (L5-S1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograph or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities and deformities: a) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), b) pseudoarthrosis, c) spondylolysis, d) spondylolisthesis, e) fracture, f) neoplastic disease, g) unsuccessful previous fusion surgery, h) lordotic deformities of the spine, i) thoracolumbar or lumbar scoliosis, j) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.

The previously cleared K2M PYRENEES, BLUE RIDGE, OZARK and CAYMAN plate systems consist of a variety of plates and screws designed to provide support across implanted levels of the cervical, thoracolumbar and lumbosacral spine until fusion is achieved. The primary purpose of this submission is to establish an MR Conditional labeling claim for these implants. In addition, PYRENEES, BLUE RIDGE and CAYMAN components that were previously provided non-sterile are now being optionally offered as sterile packaged devices.

The provided text does not contain information about acceptance criteria and a study proving a medical AI device meets those criteria. Instead, it describes K2M Inc.'s PYRENEES, BLUE RIDGE, OZARK, and CAYMAN spinal plate systems, which are physical medical devices (spinal fixation systems).

The document discusses:

• Indications for Use for various spinal plate systems.
• The purpose of the submission as establishing an MR Conditional labeling claim for these implants and optionally offering previously non-sterile components as sterile.
• Performance Data related to:
  • MR Compatibility testing per ASTM F2503. The text states, "The test results demonstrate that the PYRENEES, BLUE RIDGE and OZARK Cervical Plate Systems and the CAYMAN Thoracolumbar and Buttress Plate Systems performance met the prescribed acceptance criteria."
  • Bacterial endotoxin testing (BET) performed in accordance with AAMI ST72:2011. The text states, "The test results demonstrate that the sterile devices met the specified testing limit."

Therefore, I cannot provide the requested table or information regarding acceptance criteria for an AI device. The details provided in the input pertain to the testing of spinal implants.

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PYRENEES and BLUE RIDGE Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondy lolisthesis, 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 consists of plates (1-5 levels) and screws (self-tapping and self-starting) made of titanium in accordance with ASTM F1472 and F136 and CP titanium per ASTM F67. The Pyrenees Cervical Plates are offered in both constrained and translational designs. The subject 510(k) adds additional Mono screws to the system. The Pyrenees system components are provided non-sterile.

Function: The system functions as a spinal fixation device to provide support and stabilization of the cervical vertebrae.

The provided text is a 510(k) summary for a medical device, the Pyrenees Cervical Plate System. It describes the device, its intended use, and its substantial equivalence to predicate devices based on technological comparison and non-clinical performance evaluation.

However, the document does not contain information related to a study that proves the device meets specific acceptance criteria based on clinical performance, human-in-the-loop studies (such as MRMC), or AI/algorithm performance. The assessment is based on non-clinical performance (mechanical testing) and demonstrates substantial equivalence to predicate devices, not on the kind of clinical or AI-driven performance metrics requested in the prompt.

Therefore, I cannot provide the detailed information requested in your prompt (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study results, standalone performance, ground truth details for AI/algorithm validation, etc.) because this information is not present in the provided text.

The document focuses on:

• Device Description: Plates and screws for cervical spine fixation.
• Materials: Titanium alloys.
• Intended Use: Anterior screw fixation to the cervical spine (C2-T1) for conditions like DDD, spondylolisthesis, trauma, stenosis, tumors, failed fusions, and deformity.
• Non-clinical Performance Evaluation: Static compression, static torsion, and dynamic compression testing in accordance with ASTM F1717 for the predicate plates, with engineering rationales for subject screws.
• Conclusion: Substantial equivalence to other marketed devices in design, function, material, and intended use.

This is typical for a 510(k) submission for a spinal implant, which primarily relies on mechanical testing and comparison to legally marketed predicate devices, rather than clinical efficacy studies or performance metrics derived from AI/algorithm evaluations.

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Pyrenees and Blue Ridge Cervical Plate Systems are intended for use in anterior screw fixation to the cervical spine (C2-T I ) for the following indications: degenerative 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 consists of plates (1-5 levels) and screws (self-tapping and self-starting) made of titanium in accordance with ASTM F1472 and F136 and CP titanium per ASTM F67. The Pyrenees Cervical Plates are offered in both constrained and translational designs. The subject 510(k) adds plates and screws to the system. The Pyrenees system components are provided non-sterile.

Function: The system functions as a spinal fixation device to provide support and stabilization of the cervical vertebrae.

The provided text describes the Pyrenees Cervical Plate System, a spinal implant, and its substantial equivalence to predicate devices, but it does not contain information related to a study proving the device meets acceptance criteria in the context of an AI/ML medical device, which is what your request implies by asking for details like "sample size used for the test set," "number of experts used to establish the ground truth," or "MRMC comparative effectiveness study."

The document is a K510(k) summary for a traditional medical device (spinal plate system) seeking premarket notification clearance, not an AI/ML device. Therefore, the "acceptance criteria" and "study" described here are related to the mechanical performance of the physical implant, not diagnostic or predictive performance of an algorithm.

Here's a breakdown of what is provided, and what is missing based on your prompt, assuming you are asking about an AI/ML context:

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

• Note: These are mechanical performance criteria for a physical device, not diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for an AI/ML system.

Missing Information (as per your AI/ML specific questions):

• 2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the physical devices subjected to mechanical testing, not a dataset for an AI/ML model.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model (e.g., disease presence) is not relevant for a mechanical test on a physical implant.
• 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: Not applicable. This device is not an AI algorithm assisting human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for mechanical testing is established by test standards and physical measurements.
• 8. The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
• 9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

The Pyrenees Cervical Plate System underwent mechanical testing to demonstrate its safety and effectiveness. The study involved comparing its mechanical performance (static compression, static torsion, dynamic compression) against predicate devices according to ASTM F1717. The conclusion was that the new system performed "equally to or better than" the predicate devices in these tests, thus meeting the criteria for substantial equivalence. The document does not describe studies or criteria relevant to AI/ML device performance.

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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) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), 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 consists of plates and screws made of titanium alloy (Ti-6Al-4V per ASTM F1472 and Ti-6Al-4V ELI per F136) and CP titanium per ASTM F67. The Pyrenees Cervical Plates are offered in both constrained and translational designs and the screws are fixed or variable. The subject 510(k) adds screws with a cobalt chrome component (per ASTM F1537) to the system. The Pyrenees system components are provided non-sterile.

Function: The system functions as a spinal fixation device to provide support and stabilization of the cervical vertebrae.

The provided document is a 510(k) premarket notification for a medical device called the "Pyrenees Cervical Plate System". It primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information about acceptance criteria and study details cannot be found in this document.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document in the format of acceptance criteria. The document states that the device was tested according to ASTM F1717 for static compression, static torsion, and dynamic compression. The conclusion is that the modifications to the screws did not represent a new worst-case, and there were no significant differences compared to predicate devices which would adversely affect the use of the product. No specific numerical acceptance criteria or performance metrics are listed.

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

The document describes non-clinical performance evaluation, which refers to mechanical testing of the implants rather than a clinical study with a patient test set. Therefore, information about a "test set" in the context of patient data (e.g., country of origin, retrospective/prospective) is not applicable or present.

• Sample size for non-clinical testing: Not explicitly stated, beyond stating that "the predicate and subject Pyrenees implants were tested."
• Data provenance: Not applicable as this refers to mechanical testing, not patient data.

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

This information is not applicable as the document describes mechanical testing of a medical device, not a study involving human experts to establish ground truth for a test set.

4. Adjudication method for the test set

This information is not applicable as the document describes mechanical testing of a medical device, not a study involving human readers or a test set requiring adjudication.

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 such study is mentioned or implied, as the document details the mechanical properties of a spinal plate system, not an AI-assisted diagnostic or interpretive device.

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

This concept is not relevant to this type of medical device (spinal plate system). The document describes mechanical testing of the physical device components.

7. The type of ground truth used

The "ground truth" in this context would be the physical properties and performance characteristics of the device under specific mechanical loads, as defined by engineering standards (ASTM F1717).

• Type of "ground truth": Mechanical test results and engineering analysis, based on ASTM F1717.

8. The sample size for the training set

This information is not applicable as the document describes mechanical testing of a medical device, not a machine learning model that would require a training set.

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

This information is not applicable.

Ask a specific question about this device

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) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), 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 consists of plates (1-5 level) and screws (self-tapping and self-starting) made of titanium alloy per ASTM F1472 and CP titanium per ASTM F67. The plates range in length from 18-110mm and the screws from 10-22mm. The Pyrenees Cervical Plates are offered in both constrained and translational designs. The subject 510(k) adds plates to the system. The Pyrenees system components are provided non-sterile.

The provided document describes the K2M Pyrenees Cervical Plate System, a spinal fixation device, and its substantial equivalence to predicate devices. It does not contain information about the acceptance criteria or a specific study that quantitatively proves the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy, which are typical for studies involving AI or diagnostic devices.

The document focuses on the regulatory clearance for a physical medical device (cervical plate system) based on material, design, function, and mechanical performance rather than a diagnostic algorithm or AI system. Therefore, most of the requested fields are not applicable to the information contained in this document.

Here's a breakdown of the available information and why other fields are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable. This is a mechanical device, not a diagnostic or AI system. The testing involved mechanical measurements on plate samples, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement equipment, not expert human assessment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for 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. No AI or human reader component is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the mechanical performance of the Pyrenees Cervical Plate System was established by adherence to ASTM F1717 standards for static and dynamic mechanical properties.

8. The sample size for the training set: Not applicable. There is no "training set" in the context of mechanical device testing as described. Product development iterations might involve prototypes, but it's not a "training set" as understood in AI/ML.

9. How the ground truth for the training set was established: Not applicable. No training set in the AI/ML sense exists.

Summary of available information from the document:

• Device Type: Pyrenees Cervical Plate System (spinal intervertebral body fixation orthosis).
• Purpose: Anterior screw fixation to the cervical spine (C2-C7).
• Indications for Use: Degenerative disc disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis, tumors, failed previous fusions (pseudarthrosis), and deformity.
• Materials: Titanium alloy per ASTM F1472 and CP titanium per ASTM F67.
• Testing Performed: Non-clinical mechanical performance evaluation.
• Standards Used: ASTM F1717 (for static compression, static torsion, and dynamic compression).
• Conclusion of Testing: The plates performed equally to or better than predicate devices in the specified mechanical tests.
• Regulatory Status: Substantially equivalent to legally marketed predicate devices.

Ask a specific question about this device

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) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), 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 consists of plates (1-5 level) and screws (self-tapping and self-starting) made of titanium alloy per ASTM F1472 and F136 and CP titanium per ASTM F67. The plates range in length from 18-110mm and the screws from 10-22mm. The Pyrenees Cervical Plates are offered in both constrained and translational designs. The subject 510(k) adds plates and screws to the system. The Pyrenees system components are provided non-sterile.

Function: The system functions as a spinal fixation device to provide support and stabilization of the cervical vertebrae.

This document is a 510(k) premarket notification for a medical device called the "Pyrenees Cervical Plate System". It's a submission to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

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

Analysis of Acceptance Criteria and Study Information

The document describes a medical device, the "Pyrenees Cervical Plate System," and its submission for FDA 510(k) clearance. A 510(k) submission primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than fulfilling specific acceptance criteria in the way a new drug trial or an AI algorithm validation might.

The "study" described here is a non-clinical performance evaluation focusing on mechanical testing, a common requirement for orthopedic implants.

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

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

For a mechanical device like this, "acceptance criteria" are typically related to meeting specific performance benchmarks established by recognized ASTM standards or demonstrating equivalence to predicate devices. The document states:

Note: The document doesn't explicitly state quantitative acceptance values (e.g., minimum load strength). Instead, the performance is reported relative to the predicate devices, which is typical for 510(k) mechanical testing. The ASTM F1717 standard itself establishes methodologies for such testing.

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

• Sample Size for Test Set: The document does not specify the exact number of plates or screws tested. It refers to "the Pyrenees plates" being "mechanically tested," implying a representative sample.
• Data Provenance: Not explicitly stated, but mechanical testing of medical devices is typically conducted in controlled laboratory settings, often by the manufacturer or a third-party testing facility. This is a non-clinical, prospective test in a laboratory environment. There is no patient data involved.

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)

• Experts: Not applicable. For mechanical testing of an orthopedic implant, "ground truth" is established through physical measurement and adherence to engineering standards (like ASTM F1717). No human experts are involved in "diagnosing" or "interpreting" the mechanical performance, beyond engineers conducting and analyzing the tests.

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

• Adjudication Method: Not applicable. This is mechanical testing, not a clinical trial involving human interpretation.

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 document is for a physical medical device (cervical plate system), not an AI/software as a medical device. Therefore, MRMC studies and concepts of human readers or AI assistance are not relevant.

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

• Standalone Performance: No. This is a physical implant, not an algorithm.

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

• Type of Ground Truth: The "ground truth" here is the physical mechanical properties of the device, measured quantitatively according to established engineering standards (ASTM F1717) and compared against the mechanical properties of predicate devices. There is no biological, clinical, or consensus-based ground truth in this context.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI device. There is no concept of a "training set" for a physical implant.

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

• Ground Truth for Training Set: Not applicable. As above, there is no training set.

Ask a specific question about this device

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) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radios ), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scollosis, kyphosis or lordosis).

The Pyrenees Cervical Plate System consists of plates (1-5 level) and screws (self-tapping and self-starting) made of titanium in accordance with ASTM F1472 and ASTM F67. The plates range in length from 18-110mm and the screws from 10-22mm. The Pyrenees Cervical Plates are offered in both constrained and translational designs. The subject 510(k) adds plates and screws to the system. The Pvrenees system components are provided non-sterile.

Function: The system functions as a spinal fixation device to provide support and stabilization of the cervical vertebrae.

The provided text describes the Pyrenees Cervical Plate System, a medical device for spinal fixation, and its substantial equivalence determination by the FDA. However, the document does not contain details about acceptance criteria, a study proving the device meets those criteria, or specific performance metrics in the way your request outlines (e.g., in terms of sensitivity, specificity, or AI-assisted improvements).

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against predefined acceptance criteria for a novel technology (like an AI device).

Therefore, I cannot provide the requested information from the given text. The text primarily addresses:

1. Device Description: The Pyrenees Cervical Plate System consists of titanium plates and screws for anterior cervical spine fixation (C2-C7).
2. Indications for Use: Degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, tumors, failed previous fusions, and deformity.
3. Predicate Devices: K2M Pyrenees Cervical Plate System (K063544, K092474, K111135), DePuy Uniplate (K042544), and Synthes CSLP (K003043).
4. Non-clinical Performance Evaluation: The subject Pyrenees plates did not create a new worst-case compared to predicate devices. Predicate plates performed equally to or better than these systems in static compression, static torsion, and dynamic compression in accordance with ASTM F1717. This section confirms mechanical performance, but not against AI-related acceptance criteria.
5. Conclusion: The device is substantially equivalent to other marketed devices in design, function, material, and intended use.

In summary, the provided document does not contain the information required to answer your specific questions related to acceptance criteria, study details for meeting those criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI device.

Ask a specific question about this device

The 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) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

The K2M 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 titanium alloy and nitinol, per ASTM and ISO standards. Function: The system functions as an adjunct to provide immobilization and stabilization of cervical segments of the spine.

The provided text describes a 510(k) premarket notification for a medical device, the K2M Cervical Plate System, Modifications. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing and comparison of design, materials, and intended use. It does not contain information related to software performance, AI algorithms, clinical study data, or human reader performance. Therefore, most of the requested information cannot be extracted from this document.

However, I can extract information relevant to the device's performance based on the provided text, specifically related to its physical properties and mechanical testing.

Here's a breakdown of the available information:

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

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

• Sample Size: Not specified in the provided text. The testing refers to "K2M implants" and "these systems" (predicate systems), but the number of devices tested is not mentioned.
• Data Provenance: Not specified. The testing was conducted by or for K2M, Inc. (based in Leesburg, VA, USA), but the location where the tests were performed is not mentioned. It is a engineering/mechanical test, not patient data.

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. This device is a mechanical implant, and the "ground truth" for its performance is established through standardized mechanical testing (ASTM F1717), not expert interpretation of clinical data.

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

Not applicable. This is a mechanical test, not an assessment requiring adjudication by human experts.

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 document describes a medical device (spinal plate system), not an AI or software-based diagnostic tool that would 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)

The "ground truth" for this device's performance is established by objective mechanical measurements against a recognized international standard (ASTM F1717) for static torsion and dynamic compression in comparison to predicate devices.

8. The sample size for the training set

Not applicable. This is a mechanical device, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable (as above).

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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.

Ask a specific question about this device

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.

This document is a 510(k) Summary for a medical device called the "Pyrenees Cervical Plate System, Semi-constrained Screw." It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document states "mechanically tested," implying physical testing, but does not provide details on the number of devices or components tested.
• Data Provenance: The study is described as "mechanical testing" and "comparison to predicate systems and other currently marketed systems." This is laboratory-based testing, not human patient data. Therefore, questions of country of origin or retrospective/prospective are not applicable in this context.

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

This type of study (mechanical testing for substantial equivalence of a spinal implant) does not typically involve human "experts" establishing a clinical ground truth in the way a diagnostic AI might. The "ground truth," in this case, is defined by the objective performance standards of ASTM F1717 and the characteristics of the predicate devices. The "experts" involved would be engineering and regulatory professionals performing and analyzing the mechanical tests and comparing specifications, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study requiring human adjudication for data interpretation. The "adjudication" is based on meeting the defined mechanical test standards and comparing physical and functional characteristics to predicate devices.

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

Not applicable. This document describes a 510(k) submission for a physical medical device (spinal implant), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or AI assistance is not relevant.

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

Not applicable, as this is not an algorithm or AI device.

7. The Type of Ground Truth Used

The ground truth used for this submission is:

• Mechanical Performance Standards: Specifically, ASTM F1717 for mechanical testing.
• Predicate Device Specifications: The documented design features, materials, and intended uses of previously cleared, legally marketed spinal plate systems.
• Regulatory Definitions: The FDA's criteria for substantial equivalence under 510(k).

8. The Sample Size for the Training Set

Not applicable. This is 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 there is no training set for this device.

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