(77 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.
The MectaLIF family is characterized by different sizes of PEEK (Polyetheretherketone) implants that can be applied with common surqical techniques such as PLIF (Posterior Lumbar Intervertebral Fusion) and TLIF (Transforaminal Lumbar Intervertebral Fusion). The MectaLIF family consists of the PEEK Oblique Interbody Fusion Device (33 sizes) and PEEK Posterior Interbody Fusion Device (28 sizes).
The PEEK Oblique and Posterior Interbody Fusion Devices are used to replace a degenerative disc in order to restore the height of the spinal column structure. They are made of PEEK and contain Tantalum Markers. The devices are intended to be used in combination with posterior fixation (e.g. Pedicle Screw System) as well as an autogenous bone graft.
This 510(k) summary describes the MectaLIF intervertebral body fusion device and its substantial equivalence to predicate devices. It focuses on mechanical testing for performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria (Similar to Predicate) | Reported Device Performance (MectaLIF) |
|---|---|---|
| Static Compression Strength (ASTM F 2077) | Similar to Lumbar I/F Cage and Boomerang | Similar to the Lumbar I/F Cage and Boomerang |
| Dynamic Compression Strength (ASTM F 2077) | Similar to OPAL and Boomerang | Similar to the OPAL and Boomerang |
| Dynamic Compression/Shear Strength (ASTM F 2077) | Similar to OPAL | Similar to the OPAL |
| Subsidence Resistance (ASTM F 2267) | Similar to Devex | Similar to the Devex |
| Size Range | Similar to Medtronic Clydesdale Spinal System (max length 40mm) | Similar size range (Oblique) to Medtronic Clydesdale Spinal System (max length 40mm) |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes used for each of the performance tests (e.g., number of devices tested for static compression). However, it refers to industry standard ASTM test methods (ASTM F 2077 and ASTM F 2267). These standards typically specify the number of samples required for robust testing.
The data provenance is from mechanical testing performed by the manufacturer, Medacta International SA, for the purpose of demonstrating substantial equivalence to predicate devices. This is a prospective set of tests carried out specifically for the 510(k) submission. The country of origin of the device manufacturer is Switzerland, and the regulatory submission is for the US market.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission relies on objective mechanical performance testing according to established ASTM standards rather than expert consensus on clinical data. The "ground truth" for these tests is defined by the physical properties of the materials and the mechanical behavior of the device under specific load conditions.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "test set" involves objective mechanical performance measurements, not human-interpreted data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for an intervertebral body fusion device and focuses on demonstrating substantial equivalence through mechanical testing and comparison of device features and indications for use to existing predicate devices. MRMC studies are typically used for diagnostic or screening devices where human interpretation of medical images or data is a key component.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a physical implant, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance tested is the device's inherent mechanical properties.
7. The Type of Ground Truth Used
The "ground truth" used for this submission is based on objective mechanical and material properties as determined by industry standard test methods (ASTM F 2077 for various compression strengths and ASTM F 2267 for subsidence resistance) and comparison of physical and material characteristics to legally marketed predicate devices. It also relies on the established "indications for use" of the predicate devices for clinical equivalence.
8. The Sample Size for the Training Set
Not applicable. As this is not a machine learning or AI-driven device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this 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.