(105 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 TiPEEK is characterized by different sizes of PEEK-OPTIMA LT1 (Polyetheretherketone) implants with a Titanium coating and Tantalum Markers. MectaLIF TiPEEK consists of the Oblique Interbody Fusion Device and Posterior Interbody Fusion Device. The Oblique and Posterior Interbody Fusion Devices are used to replace a degenerative disc in order to restore the height of the spinal column structure. MectaLIF TIPEEK can be applied with common surgical techniques such as PLIF (Posterior Lumbar Intervertebral Fusion) and TLIF (Transforaminal Lumbar Intervertebral Fusion). The devices are intended to be used in combination with posterior fixation (e.g. Pedicle Screw System) as well as an autogenous bone graft. The materials of MectaLIF TiPEEK are as follows: Implant: PEEK-OPTIMA LT1: Implant Grade Polyetheretherketone (ASTM F 2026) with commercially pure titanium (CPTi, ASTM F 1580) coating and Marker: Tantalum (ISO 13782 / ASTM F 560).
Here's a breakdown of the acceptance criteria and study information for the MectaLIF TiPEEK device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the MectaLIF TiPEEK "passed all requirements" for the performance tests. The specific quantitative acceptance criteria or threshold values are not provided in the text. However, the tests performed indicate the areas where the device's performance was evaluated against industry standards.
| Test Category | Specific Test (ASTM Standard) | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance |
|---|---|---|---|
| Mechanical Strength | Static axial compression | (Implied by standard conformance) | Passed all requirements |
| Dynamic axial compression | (Implied by standard conformance) | Passed all requirements | |
| Static shear compression | (Implied by standard conformance) | Passed all requirements | |
| Dynamic shear compression | (Implied by standard conformance) | Passed all requirements | |
| Static Tensile strength | (Implied by standard conformance) | Passed all requirements | |
| Static Shear strength | (Implied by standard conformance) | Passed all requirements | |
| Shear fatigue strength | (Implied by standard conformance) | Passed all requirements | |
| Stability | Subsidence | (Implied by standard conformance) | Passed all requirements |
| Coating Performance | Abrasion resistance | (Implied by standard conformance) | Passed all requirements |
| Material Analysis | Micrographical Analysis | (Implied by standard conformance) | Passed all requirements |
| Wear | Wear Analysis | (Implied by standard conformance, explicitly mentioned) | Passed all requirements |
| Wear analysis for particulates | (Implied by standard conformance, explicitly mentioned) | Passed all requirements |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "MectaLIF TiPEEK was tested using the worst-case device for each of the following tests".
- Sample Size: For each specified mechanical and material test, the sample size was "the worst-case device." This implies a very limited sample size, likely one or a few devices representing the highest stresses or risks, common in medical device mechanical testing for substantial equivalence.
- Data Provenance: The study was conducted as part of Medacta International's premarket notification (510(k)) to the FDA. The testing was performed in accordance with FDA Guidance documents. The location of the testing facility is not explicitly stated, but it's likely a laboratory, either internal or third-party, that adheres to relevant international standards (e.g., ISO, ASTM). This is a prospective study in the sense that the testing was performed before market clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of performance testing. The "ground truth" for mechanical and material performance is established by the specified ASTM standards and FDA guidance, which define the test methods, conditions, and expected outcomes (e.g., fracture loads, wear rates, material properties). Expert consensus is typically used for clinical endpoints or diagnostic accuracy, not mechanical device performance.
4. Adjudication Method for the Test Set
This is not applicable. As this is mechanical and material performance testing, there is no "adjudication" in the traditional sense of human interpretation of results. The results are quantitative measurements against predefined criteria within the ASTM standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not conducted or mentioned. This type of study is relevant for evaluating the clinical effectiveness or diagnostic accuracy of a device when interpreted by humans, typically in imaging or diagnostic applications. MectaLIF TiPEEK is an implantable intervertebral fusion device, and its performance is assessed through mechanical and material testing, not human interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
No, a standalone performance study in the context of an algorithm or AI without human-in-the-loop was not conducted or mentioned. The device itself is a physical implant, not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" for this performance testing is based on established industry standards and regulatory guidance. Specifically:
- ASTM Standards: F2077, F2267, F1877, F1978, F1147, F1044, F1160, F1854. These standards define the scientific methods and expected results for evaluating intervertebral body fusion devices and metallic coatings.
- FDA Guidance Documents: "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" and "Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements." These guidances provide regulatory expectations and testing protocols.
8. Sample Size for the Training Set
This is not applicable. The MectaLIF TiPEEK is a physical medical device. It does not involve a "training set" in the context of machine learning or artificial intelligence. Its design and manufacturing processes are informed by engineering principles, material science, and previous predicate device designs, but not a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no "training set" for this device. The design and validation are based on engineering principles and compliance with established standards, not a data-driven training process.
§ 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.