(225 days)
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.
| Acceptance Criterion (Based on Standards) | Reported Device Performance |
|---|---|
| Mechanical Performance: | Demonstrated Substantial Equivalence and Compliance |
| Static Axial Compression (ASTM F2077) | Met requirements; comparable to predicate. |
| Dynamic Axial Compression (ASTM F2077) | Met requirements; comparable to predicate. |
| Static Compression/Shear (ASTM F2077) | Met requirements; comparable to predicate. |
| Dynamic Compression/Shear (ASTM F2077) | Met requirements; comparable to predicate. |
| Static Torsion (ASTM F2077) | Met requirements; comparable to predicate. |
| Dynamic Torsion (ASTM F2077) | Met requirements; comparable to predicate. |
| Subsidence (ASTM F2267) | Met requirements; comparable to predicate. |
| Wear Analysis: | Demonstrated Compliance |
| Wear Analysis using worst-case component size (ASTM F2077, ASTM F1877) | Passed all requirements. |
| Enzymatic digestion validation on titanium particulate testing (ASTM F1580) | Performed on predicate, results reviewed for Mecta-C TiPEEK. |
| Material Properties: | Compliant |
| PEEK Implant Grade (ASTM F2026) | Compliant material used. |
| Commercially pure titanium (CPTi, ASTM F1580) | Compliant material used for coating. |
| Tantalum markers (ISO 13782 / ASTM F560) | Compliant material used for markers. |
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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.