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The Mecta-C intervertebral body fusion device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with supplemental spinal fixation.

The Mecta-C device is intended for use at one level in the cervical spine, from C2-T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment prior to treatment with the device.

The purpose of this submission is to add the Mecta-C with titanium markers and the Mecta-C TiPEEK with titanium markers to Medacta's Mecta-C product offering. The Mecta-C with titanium markers and the Mecta-C TiPEEK with titanium markers are intervertebral body fusion devices intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the cervical spine. The Mecta-C and the Mecta-C TiPEEK intervertebral body fusion devices are indicated for the treatment of degenerative diseases of the cervical disc and can be used for cervical fusion from C2-T1.

The Mecta-C with titanium markers are intervertebral body fusion devices manufactured with an implant grade polyetheretherketone (PEEK) body and titanium markers. The Mecta-C TiPEEK with titanium markers are intervertebral body fusion devices manufactured with a PEEK body, commercially pure titanium (CPTi) coating, and titanium markers' material is changing from tantalum to titanium to reduce artefact during imaging scans.

The titanium marker's spikes are also being modified to reduce the conical edge from 90° to 50°. The purpose of the conical edge change is to create a sharper tip design which allows for better penetration of the titanium pin and a more uniform contact between the PEEK cage and vertebral body.

The markers are placed in the implant on each end of the TiPEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent TiPEEK cages.

The cages are offered in various widths, heights, footprint geometries, and lordosis which can be inserted between two cervical vertebra bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

This document describes the 510(k) submission for the Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers intervertebral body fusion devices. This submission aims to extend the existing Mecta-C product offering by changing the marker material from tantalum to titanium and modifying the conical edge of the marker spikes.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the performance testing of the predicate devices and states that engineering rationales determined that the proposed implants (with titanium markers) did not represent a new worst-case for mechanical testing. This implies that the acceptance criteria for the new devices are met if their performance is equivalent to or better than the predicate devices, especially considering the minor changes. Explicit quantitative acceptance criteria are not detailed for the new device variant within this summary; instead, reliance is placed on the existing predicate device testing.

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

The document does not explicitly state specific sample sizes for the performance tests conducted on the predicate devices. It refers to "verification activities, as identified through risk analysis, were previously conducted on the worst-case implants to written protocols with pre-defined acceptance criteria."

The data provenance is retrospective, as the performance data cited was generated for the predicate devices (K112862 and K142744) in previous submissions. The country of origin for the data is not specified, but Medacta International SA is based in Switzerland.

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

This information is not applicable to this submission. The device is a physical intervertebral body fusion device, not an AI/software device requiring ground truth established by medical experts for diagnostic or prognostic purposes. The "ground truth" here relies on established engineering and material science standards and mechanical testing results.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable as this is not an AI/software device.

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

This information is not applicable as this is not an AI/software device.

7. The Type of Ground Truth Used:

For this type of medical device, the "ground truth" is established through:

• Engineering Standards: Adherence to recognized national and international standards (e.g., ASTM F2026-16, ISO 5832-3:1996, ASTM F1580-12) for materials.
• Mechanical Testing Results: Quantitative measurements obtained from shear, tension, fatigue, and subsidence tests showing mechanical integrity and performance under simulated physiological conditions.
• Biocompatibility Standards: Compliance with established biocompatibility requirements for implantable devices.

8. The Sample Size for the Training Set:

This information is not applicable as this is not an AI/software device and thus does not have a "training set."

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

This information is not applicable as this is not an AI/software device.

In summary: This 510(k) submission relies on demonstrating substantial equivalence to its predicate devices by providing an engineering rationale that minor changes (marker material and conical edge) do not negatively impact device performance, combined with existing performance data from the predicate devices. The "study" proving the device meets acceptance criteria refers to the previous performance tests conducted on the predicate devices, the adherence to material standards, and the engineering justification for the minor modifications.

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The Mecta-C intervertebral body fusion device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with supplemental spinal fixation.

The Mecta-C device is intended for use at one level in the cervical spine, from C2-T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment prior to treatment with the device.

The Mecta-C TiPEEK Intervertebral Body Fusion Devices are fusion devices intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the cervical spine. The Mecta-C TiPEEK intervertebral body fusion device is indicated for the treatment of degenerative diseases of the cervical disc and can be used for cervical fusion from C2-T1. The Mecta-C TiPEEK intervertebral body fusion device consists of a PEEK Implant Grade Polyetheretherketone (ASTM F 2026) body with a commercially pure titanium (CPTi, ASTM F 1580) coating and tantalum markers (ISO 13782 / ASTM F 560). The markers are placed in the implant on each end of the TiPEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent TiPEEK cages. The cages are offered in various widths, heights, footprint geometries and lordosis which can be inserted between two cervical vertebra bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

The provided document is a 510(k) summary for a medical device called Mecta-C TiPEEK, an intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than describing a study to prove the device meets specific acceptance criteria based on clinical outcomes or standalone AI algorithm performance.

Therefore, the requested information elements related to AI/algorithm performance, ground truth establishment, expert adjudication, multi-reader multi-case studies, and training set details are not applicable or cannot be extracted from this document, as it concerns a physical implantable device, not an AI/software.

However, I can provide information regarding the performance testing conducted to demonstrate substantial equivalence for the physical device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are derived from relevant ASTM standards and FDA guidance documents for intervertebral body fusion devices and metallic plasma-sprayed coatings on orthopedic implants. The document states that the device "passed all requirements" of the testing performed, implying meeting the pass/fail criteria within those standards. However, specific numerical acceptance criteria (e.g., minimum load to failure, wear rates) and the exact reported performance values are not detailed in this summary. Instead, it makes a general statement of compliance and substantial equivalence to predicate devices.

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

The document describes performance testing on physical devices, not a clinical study with human subjects.

• Sample size: Not explicitly stated for each test, but standard engineering tests typically involve a relevant number of samples (e.g., n=5 or more) to achieve statistical significance according to the ASTM standards.
• Data provenance: Not applicable in the context of clinical data provenance. The testing was conducted in accordance with international and US standards (ASTM, FDA Guidance).

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)

This question is not applicable. The "ground truth" here is objective physical performance data obtained through standardized mechanical and wear testing, not expert interpretation of medical images or clinical outcomes.

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

Not applicable, as this refers to a human-involved process for establishing ground truth in clinical or imaging studies. The tests are objective per ASTM standards.

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 intervertebral body fusion device, not an AI-assisted diagnostic tool or imaging software.

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

Not applicable. This is a physical intervertebral body fusion device, not an AI algorithm.

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

The "ground truth" in this context is the objective mechanical and material properties and performance of the device as measured against established engineering standards (e.g., ASTM F2077, ASTM F1877, ASTM F1580, ASTM F2267) and FDA guidance documents.

8. The sample size for the training set

Not applicable. There is no AI model or "training set" for this physical device.

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

Not applicable. There is no AI model or "training set" for this physical device.

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