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When intended to promote fusion of the occipito-cervico-thoracic region of the spine (occiput-T3) in skeletally mature patients, the Lanx Posterior Cervicothoracic Spinal Fixation System is indicated for the following:

• Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
• . Spondylolisthesis
• Spinal Stenosis ♥
• . Trauma/Fracture/Dislocation
• Atlanto-Axial Fracture with Instability .
• Occipito-Cervical Dislocation .
• . Failed Previous Fusion
• . Tumor

The use of occipital bone screws is limited to placement in the occiput only.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-73) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The Lanx Posterior Cervicothoracic Spinal Fixation System consists of various screws, hooks, plates, rods, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, with the anchors and connectors rigidly locked to the rod, allowing the surgeon to tailor the construct to the particular needs of the patient.

The Lanx Posterior Cervicothoracic Spinal Fixation System implants are fabricated from medical grade titanium alloy per ASTM F136 and cobalt chrome alloy per ASTM F1537. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.

The Lanx Posterior Cervicothoracic Spinal Fixation System is a medical device for spinal fixation.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. The study was non-clinical (mechanical testing), so concepts like "test set" in the context of patient data or "data provenance" (country of origin, retrospective/prospective) are not applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the study was non-clinical (mechanical testing). Ground truth in this context would refer to established engineering standards (ASTM F1717), not expert clinical consensus.

4. Adjudication Method for the Test Set

This information is not applicable as the study was non-clinical mechanical testing, not a clinical study involving human assessment or adjudication.

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

No, an MRMC comparative effectiveness study was not performed. The study was non-clinical mechanical testing comparing the modified device to a predicate device.

6. Standalone Performance Study

Yes, a standalone performance study was done in the sense of a laboratory-based mechanical test of the device itself. The "algorithm only" aspect of the question is not relevant here as this is a physical medical device. The study characterized the modified Lanx Posterior Cervicothoracic Spinal Fixation System's mechanical performance.

7. Type of Ground Truth Used

The "ground truth" for this non-clinical study was the established mechanical testing standard, ASTM F1717. The performance of the modified device was compared against the performance of the predicate device under these standardized conditions to demonstrate substantial equivalence.

8. Sample Size for the Training Set

This information is not applicable as there was no "training set" in the context of an algorithm or machine learning. The study involved mechanical testing of the physical device.

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

This information is not applicable for the reasons stated above.

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When intended to promote fusion of the occipito-cervico-thoracic region of the spine (occiput-T3) in skeletally mature patients, the Lanx Posterior Cervicothoracic Spinal Fixation System is indicated for the following:

• Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis .
• Spinal Stenosis .
• Trauma/Fracture/Dislocation .
• Atlanto-Axial Fracture with Instability .
• Occipito-Cervical Dislocation .
• Failed Previous Fusion .
• Tumor .
  The use of occipital bone screws is limited to placement in the occiput only.
  The use of polyaxial screws is limited to placement in the upper thoracic spine (TI-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The purpose of this Special 510(k) is to add a modified screw configuration in multiple sizes. The modified system has the same intended use and fundamental scientific technology as the previously-cleared system.
The Lanx Posterior Cervicothoracic Spinal Fixation System consists of various screws, hooks, rods, plates, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient.
The Lanx Posterior Cervicothoracic Spinal Fixation System implants are fabricated from medical grade titanium alloy and/or cobalt chrome alloy per ASTM F136 and ASTM F1537. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.

This document describes the Lanx Posterior Cervicothoracic Spinal Fixation System, which is a spinal fixation system that provides supplemental stabilization of spinal segments to support fusion. This submission is a Special 510(k) to add a modified screw configuration in multiple sizes. The device is substantially equivalent to a predicate device and is intended for use in the occipito-cervico-thoracic region of the spine in skeletally mature patients for various conditions.

Here's the information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device." This implies that the acceptance criteria for the modified device were to perform comparably to the previously-cleared predicate device in the specified mechanical tests. The specific quantitative thresholds for "substantial equivalence" or "functioned as intended" are not provided in this summary.

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

• Sample Size: Not explicitly stated. The document mentions "Performance testing was conducted to characterize the modified components of the system. Tests were performed on the modified and predicate systems..." This implies a comparative test, but the number of units tested is not specified.
• Data Provenance: Not applicable in the context of device performance testing. The tests are experimental/laboratory-based, not based on patient data.

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

Not applicable. This is mechanical performance testing of a physical device, not an AI/software device that requires expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable. This is mechanical performance testing of a physical device.

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

No. This document describes the mechanical performance testing of a spinal fixation system, not a study involving human readers or AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This document is about a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the mechanical performance testing, the "ground truth" is established by the standardized test methods outlined in ASTM F1717 and ASTM F1798. The performance of the predicate device serves as the benchmark against which the modified device's performance is compared to establish substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model.

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

Not applicable. This is a physical medical device, not a machine learning model.

Ask a specific question about this device

When intended to promote fusion of the occipito-cervico-thoracic region of the spine (occiput-T3) in skeletally mature patients, the Lanx Posterior Cervicothoracic Spinal Fixation System is indicated for the following:

• Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• . Spondylolisthesis
• . Spinal Stenosis
• . Trauma/Fracture/Dislocation
• Atlanto-Axial Fracture with Instability .
• . Occipito-Cervical Dislocation
• Failed Previous Fusion .
• . Tumor

The use of occipital bone screws is limited to placement in the occiput only.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The purpose of this 510(k) submission is to add a head-to-head cross connector and additional longitudinal rods and polyaxial pedicle screws. The modified system has the same intended use and fundamental scientific technology as the previously-cleared system.

Both the modified and predicate Lanx Posterior Cervicothoracic Spinal Fixation System consist of various screws, hooks, plates, rods, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, with the anchors and connectors rigidly locked to the rod, allowing the surgeon to tailor the construct to the particular needs of the patient,

Both the modified and predicate Lanx Posterior Cervicothoracic Spinal Fixation System implants are fabricated from medical grade titanium alloy per ASTM F136. The modified Lanx Posterior Cervicothoracic Spinal Fixation System implants are manufactured using the same manufacturing processes, and are passivated and anodized in the same manner as the implants in the predicate Lanx Posterior Cervicothoracic Spinal Fixation System.

The provided text describes a 510(k) premarket notification for a medical device (Lanx Posterior Cervicothoracic Spinal Fixation System) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study proving a device meets specific clinical acceptance criteria.

Therefore, many of the requested categories are not applicable to this type of regulatory submission, as it deals with mechanical performance and equivalence, not clinical efficacy or diagnostic accuracy.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance for Lanx Posterior Cervicothoracic Spinal Fixation System (K100888)

This submission is a 510(k) for adding a head-to-head cross connector, additional longitudinal rods, and polyaxial pedicle screws to an existing spinal fixation system. The primary goal is to demonstrate substantial equivalence to the predicate device (K092656), not to prove the device meets new, independent clinical performance acceptance criteria. The "acceptance criteria" here are implicitly related to the mechanical performance of the modified system being comparable to the predicate device, as tested by specific ASTM standards.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study was a series of mechanical performance tests conducted to characterize the modified Lanx Posterior Cervicothoracic Spinal Fixation System and compare it to the predicate device.

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

• Sample Size: Not explicitly stated as numerical values for each test. The text mentions "the modified and predicate systems" were tested, implying a sufficient number of samples for each configuration to satisfy the ASTM standards.
• Data Provenance: Not specified. This would typically be internal laboratory data generated by the manufacturer or a contracted testing facility. Given the regulatory context, it would be considered prospective for the purposes of this submission (i.e., tests specifically performed to support this submission). Country of origin is not mentioned.

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

• Not Applicable. This is a mechanical testing study, not a study involving human interpretation or ground truth established by experts in a clinical context. The "ground truth" is defined by the physical properties and performance metrics specified by the ASTM standards.

4. Adjudication Method for the Test Set:

• Not Applicable. Mechanical testing results are objective measurements from instruments; they do not involve human adjudication in the sense of reconciling subjective opinions.

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

• No. This is a mechanical performance study, not a clinical or comparative effectiveness study involving human readers or cases.

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

• Not Applicable. This is a physical medical device (spinal fixation system), not an algorithm or AI software.

7. The Type of Ground Truth Used:

• For the mechanical tests, the "ground truth" is defined by the metrics and pass/fail criteria established by the referenced ASTM standards (F1717 and F1798). The performance of the predicate device also serves as a comparative "truth" against which the modified device is evaluated for substantial equivalence.

8. The Sample Size for the Training Set:

• Not Applicable. This is a physical device where "training sets" are not relevant in the way they are for AI/machine learning algorithms. Instead, the design and manufacturing processes are likely informed by prior engineering principles and data from similar devices.

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

• Not Applicable. As above, the concept of a "training set" with established ground truth does not apply to this type of mechanical device submission. The design and testing methodologies are based on established engineering principles and industry standards (ASTM).

Ask a specific question about this device

When intended to promote fusion of the occipito-cervico-thoracic region of the spine (occiput-T3) in skeletally mature patients, the Lanx Posterior Cervicothoracic Spinal Fixation System is indicated for the following:

• Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis .
• ◆ Spinal Stenosis
• Trauma/Fracture/Dislocation .
• Atlanto-Axial Fracture with Instability .
• Occipito-Cervical Dislocation .
• Failed Previous Fusion .
• Tumor .

The use of occipital bone screws is limited to placement in the occiput only.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The purpose of this 510(k) submission is to add modified rods, screws and hooks to the Lanx Posterior Cervicothoracic Spinal Fixation System. The modified system has the same intended use and fundamental scientific technology as the previously-cleared system.

Both the modified and predicate Lanx Posterior Cervicothoracic Spinal Fixation System consists of various screws, hooks, plates, rods, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, with the anchors and connectors rigidly locked to the rod, allowing the surgeon to tailor the construct to the particular needs of the patient.

The predicate Lanx Posterior Cervicothoracic Spinal Fixation System is fabricated from medical grade titanium alloy per ASTM F136. The modified system includes components fabricated from medical grade cobalt chrome alloy per ASTM F1537 in addition to the titanium components. As documented within this premarket notification, the addition of cobalt chrome alloy components does not raise new issues of safety or effectiveness. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.

The provided text describes a 510(k) submission for a medical device, the Lanx Posterior Cervicothoracic Spinal Fixation System, seeking clearance to add modified components and demonstrate substantial equivalence to a predicate device. The information provided focuses on the mechanical testing conducted and does not contain details about acceptance criteria, clinical study design, or performance metrics typically associated with AI/software-as-a-medical-device (SaMD) evaluations.

Therefore, many of the requested categories (2-9) are not applicable or cannot be answered from the provided text.

Here's an analysis of what can be extracted:

Acceptance Criteria and Device Performance

Specific Test Requirements (Implied):

• Static axial compression bending per ASTM F1717
• Dynamic axial compression bending per ASTM F1717
• Static torsion tests per ASTM F1717 | Performance: The modified device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device in static axial compression bending, dynamic axial compression bending, and static torsion tests in accordance with ASTM F1717. |

Study that Proves Device Meets Acceptance Criteria:

A non-clinical performance study was conducted to characterize the modified Lanx Posterior Cervicothoracic Spinal Fixation System.

• Type of Study: Non-clinical (mechanical) performance testing.
• Tests Performed: Static and dynamic axial compression bending and static torsion tests in accordance with ASTM F1717.
• Comparison: The results of the modified system were compared to those of the predicate systems (Lanx PCFS K092656 and Solanas K052201).
• Conclusion: The study found that the modified device functioned as intended and the observed test results demonstrated substantial equivalence to the predicate device. This conclusion serves as the proof that the device meets the acceptance criteria of mechanical equivalence.

Information Not Applicable or Not Provided:

The following information is not present in the provided 510(k) summary, as it is primarily a mechanical device submission and not related to AI/SaMD or clinical trial performance in the way the questions are framed:

2. Sample size used for the test set and the data provenance: Not applicable for a mechanical performance study. The test "set" would refer to the number of components or constructs tested, but this detail is not provided, nor is data provenance in the context of 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. Ground truth for mechanical testing is based on objective measurements from standardized tests.
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: No MRMC study was conducted, as this is not an AI-enabled device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical implant device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" is derived from the physical properties and performance against ASTM standards.
8. The sample size for the training set: Not applicable as this is not a learning algorithm.
9. How the ground truth for the training set was established: Not applicable as this is not a learning algorithm.

Ask a specific question about this device

When intended to promote fusion of the occipito-cervico-thoracic region of the spine (occiput-T3) in skeletally mature patients, the Lanx Posterior Cervicothoracic Spinal Fixation System is indicated for the following:

• o Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis .
• . Spinal Stenosis
• Trauma/Fracture/Dislocation
• Atlanto-Axial Fracture with Instability .
• . Occipito-Cervical Dislocation
• Failed Previous Fusion .
• . Tumor

The use of occipital bone screws is limited to placement in the occiput only.

The use of polyaxial screws is limited to placement in the upper thoracic spine (TI-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The Lanx Posterior Cervicothoracic Spinal Fixation System consists of various titanium alloy screws, hooks, plates, rods, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient.

The provided text describes a 510(k) premarket notification for the "Lanx Posterior Cervicothoracic Spinal Fixation System," a Class II medical device. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing specific acceptance criteria and proving performance through detailed clinical or standalone studies with statistical endpoints as might be required for a PMA or novel device.

Therefore, the information requested regarding acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment, is largely not present in this 510(k) summary. The provided document emphasizes mechanical testing to show comparable properties to predicate devices.

Here's an attempt to answer based on the given text, noting when information is unavailable:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the "acceptance criteria" are implicitly based on demonstrating substantial equivalence to predicate devices, primarily through engineering analysis and performance testing showing comparable mechanical properties. Specific quantified acceptance criteria (e.g., "sensitivity > X%", "accuracy > Y%") for diagnostic performance are not applicable to this type of device and submission.

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

The document mentions "Performance testing and engineering analysis was conducted." This typically refers to benchtop mechanical tests. The specific "sample size" (i.e., number of devices or components tested) is not specified. The "data provenance" (country of origin, retrospective/prospective) is not applicable as there is no human subject data or clinical data described here. The testing is laboratory-based.

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 device is a spinal fixation system, not a diagnostic AI device requiring expert-established ground truth for its performance evaluation in this context. The "ground truth" for mechanical testing would be established by engineering standards and measurements.

4. Adjudication method for the test set

This information is not applicable as there is no diagnostic test set or human interpretation being adjudicated.

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

An MRMC study is not applicable here. This is a spinal fixation system, not an AI-powered diagnostic tool for human readers.

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

This is not applicable as the device is a spinal fixation system, not an algorithm. Performance of the device is assessed through mechanical testing.

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

For the performance testing mentioned, the "ground truth" would be based on engineering specifications and measurements from mechanical testing (e.g., material strength tests, fatigue tests, torsional tests), benchmarked against established standards and predicate device performance. It is important to note that specific ground truth metrics (e.g., specific load at failure) are not detailed in this summary.

8. The sample size for the training set

This information is not applicable as the device is a hardware spinal fixation system, not an AI/machine learning model that uses a "training set."

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

This information is not applicable for the same reason as above; there is no training set for a hardware device.

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