(56 days)
The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
MectaLIF Transforaminal lumbar intervertebral body fusion device is characterized by different sizes of PEEK-OPTIMA LT1 (Polyetheretherketone) implants that can be applied with a TLIF procedure (Transforaminal Lumbar Intervertebral Fusion). Mectal IF Transforaminal is used to replace a degenerative disc in order to restore the height of the spinal column structure. They are made of PEEK-OPTIMA LT1 and contain Tantalum Markers as well as a titanium gear which enables the surgeon to alter the angle of the MectaLIF Transforaminal in situ in 15° increments and to reposition during surgery without switching instrumentation. MectaLIF Transforaminal is intended to be used in combination with posterior fixation (e.g. Pedicle Screw System) as well as an autogenous bone graft. The dimensions of MectaLIF Transforaminal are within the following range: Length 30-34mm; Height 8-15mm; Width 12-14mm; Lordosis 5°. The materials of the components of MectaLIF Transforaminal are as follows: Implant: PEEK-OPTIMA LT1: Implant Grade Polyetheretherketone (ASTM F 2026), Gear: Titanium: Ti6Al4V ELI (ISO 5832-3/ASTM F 136), and Marker: Tantalum (ISO 13782 / ASTM F 560).
This document describes the premarket notification (510(k)) for the MectaLIF Transforaminal intervertebral body fusion device.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the MectaLIF Transforaminal device are implicitly based on comparison to legally marketed predicate devices, demonstrating substantial equivalence in terms of performance characteristics. The document states that the device has "similar performance testing as the predicates." While specific quantitative acceptance criteria or pass/fail thresholds are not explicitly stated for each test, the successful completion of these tests and the determination of substantial equivalence indicates that the device met the necessary performance benchmarks.
| Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance |
|---|---|
| Mechanical Performance (ASTM F2077, F2267 standards): | MectaLIF Transforaminal has similar performance testing as the predicates for: |
| * Static Axial Compression | * Static Axial Compression - Performed according to ASTM F2077. The document implies the device met performance comparable to predicates. |
| * Dynamic Axial Compression | * Dynamic Axial Compression - Performed according to ASTM F2077. The document implies the device met performance comparable to predicates. |
| * Static Compression/Shear | * Static Compression/Shear - Performed according to ASTM F2077. The document implies the device met performance comparable to predicates. |
| * Dynamic Compression/Shear | * Dynamic Compression/Shear - Performed according to ASTM F2077. The document implies the device met performance comparable to predicates. |
| * Subsidence Resistance | * Subsidence Resistance - Performed according to ASTM F2267. The document implies the device met performance comparable to predicates. |
| Indications for Use Equivalence: | MectalIF Transforaminal is substantially equivalent in terms of indications for use to predicate devices for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 requiring interbody fusion, with autogenous bone graft and supplemental fixation, after 6 months of non-operative treatment, in skeletally mature patients. |
| Material Equivalence: | MectalIF Transforaminal is substantially equivalent in terms of material to predicate devices, utilizing PEEK-OPTIMA LT1, Ti6Al4V ELI, and Tantalum. |
| Design Equivalence: | MectalIF Transforaminal is substantially equivalent in terms of design to predicate devices, characterized by different sizes of PEEK-OPTIMA LT1 implants with Tantalum Markers and a titanium gear for angle adjustment. |
2. Sample Size and Data Provenance:
The provided document describes the mechanical testing conducted for the MectaLIF Transforaminal device. For this type of device, "sample size" typically refers to the number of devices tested in the mechanical studies. However, the document does not specify the exact sample sizes used for each of the performance tests (Static Axial Compression, Dynamic Axial Compression, Static Compression/Shear, Dynamic Compression/Shear, Subsidence Resistance).
The data provenance for these mechanical tests would be from laboratory testing performed on the physical devices. The document does not specify the country of origin where the testing was physically conducted, but the applicant, Medacta International SA, is based in Switzerland, and Medacta USA (contact person) is in the USA. The testing is assumed to be prospective laboratory testing for regulatory submission rather than retrospective or prospective clinical data.
3. Number of Experts and Qualifications for Ground Truth:
This submission is for a medical device (intervertebral body fusion device) primarily supported by mechanical testing and substantial equivalence to predicate devices, not an AI/ML software device. Therefore, the concept of "ground truth" derived from expert consensus, typically used for assessing diagnostic or prognostic AI/ML algorithms, does not apply in this context. The "ground truth" for the performance of this device is established by its physical and mechanical properties as measured by the specified ASTM standards.
4. Adjudication Method:
Since no human "experts" were used to establish a diagnostic or prognostic ground truth for a test set (as this is not an AI/ML device), there was no adjudication method used in the sense of reconciling expert opinions. The performance is based on objective laboratory measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this type of medical device submission. MRMC studies are typically used to evaluate the impact of AI on human reader performance in diagnostic imaging. This submission focuses on the mechanical and material equivalence of an implantable device. The submission does not refer to human readers or AI assistance.
6. Standalone Performance (Algorithm Only):
This section is not applicable as the MectaLIF Transforaminal is a physical medical device, not an algorithm or software. Its performance is inherent to its physical properties and design, not an algorithm's output.
7. Type of Ground Truth Used:
The ground truth used for proving the device meets acceptance criteria is based on objective mechanical and material property testing performed according to recognized industry standards (ASTM F2077, ASTM F2267). This is a form of engineering or laboratory "ground truth" rather than clinical or expert consensus ground truth. The comparison to predicates also establishes substantial equivalence based on previously cleared devices meeting these same standards.
8. Sample Size for the Training Set:
The concept of a "training set" is not applicable to this type of device submission. Training sets are used in the development of AI/ML algorithms. This submission pertains to a physical medical implant.
9. How Ground Truth for the Training Set Was Established:
As there is no "training set" for this physical device, this question is not applicable.
§ 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.