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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 (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.

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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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