(133 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 radios. These patients may have had a previous non-fusion spiral surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
The subject MectaLIF Posterior Extension implants are line extension to the MectaLIF Posterior PEEK implants (K110927 and K131671) and MectaLIF Posterior TiPEEK implants (K133192). The MectaLIF Posterior Interbody Fusion implants are used to to treat degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. The devices are not intended to be coupled with other implants but are intended to be used with a supplementary fixation as posterior fixation or with autogenous bone graft. The subject devices provide an enlarged MectaLIF Posterior implants product range through the introduction of implants with width 9mm, length 22 and 25mm, height from 7 to 15mm, lordosis 0°, 5°, and 10°. This range extension is carried out in order to better cover the patient population. The MectaLIF Posterior Extension implants have been designed with the same or similar shape, dimensions and materials as the previously cleared MectaLIF (K110927). Medacta MectaLIF Extension (K131671), Medacta MectaLIF TiPEEK (K133192), and Aesculap ProSpace88 Interbody System (K071983). The subject MectaLIF Posterior Extension implants are manufactured by the following materials: MectaLIF Posterior PEEK implants: PEEK Implant Grade Polyetheretherketone body (ASTM F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications) + Tantalum radiographic markers (ISO 13782:1996 Implants for surgery -Metallic materials - Unalloyed tantalum for surgical implant applications and ASTM F560-17 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications); and MectaLIF Posterior TiPEEK implants: PEEK Implant Grade Polyetheretherketone body (ASTM F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications) + Tantalum radiographic markers (ISO 13782:1996 Implants for surgery -Metallic materials - Unalloyed tantalum for surgical implant applications and ASTM F560-17 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications) + Titanium surface coating (CPTi (ASTM F1580-12 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants), Spondycoat-T 371A).
This document describes the MectaLIF Posterior Extension, an intervertebral body fusion device. While it mentions the performance data in the context of non-clinical studies and a comparison to predicate devices, it does not detail acceptance criteria or a study that rigorously "proves" the device meets specific performance thresholds in a clinical or AI-centric sense. The provided text is a 510(k) summary for a medical device, focusing on substantial equivalence to predicate devices rather than the kind of performance study you're asking about for a diagnostic or AI-driven tool.
Therefore, many of the requested fields cannot be directly extracted from the provided text as they pertain to a type of study not conducted or described here.
Here's an attempt to answer your questions based on the available information, with many points indicating that the information is "Not Applicable" or "Not Provided" in this specific document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from a clinical/AI perspective) | Reported Device Performance (from the provided text) |
|---|---|
| Not Applicable - No clinical acceptance criteria related to accuracy, sensitivity, specificity, or similar metrics for a diagnostic or AI device are mentioned. | The device underwent a series of non-clinical mechanical and material tests (listed below). The conclusion states that "Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics, as well as performance evaluations." |
| Mechanical Performance (Examples from referenced standards): | Mechanical Performance (Summary of tests conducted, specific results not detailed): |
| - Static and dynamic axial compression performance meets ASTM F2077-17 | Testing conducted to ASTM F2077-17 (static & dynamic axial compression, static & dynamic shear compression) |
| - Subsidence resistance meets ASTM F2267-04 (2018) | Testing conducted to ASTM F2267-04 (2018) for subsidence |
| - Abrasion resistance meets ASTM F1978-18 | Testing conducted to ASTM F1978-18 for abrasion resistance |
| - Static tensile strength meets ASTM F1147-2017 | Testing conducted to ASTM F1147-2017 for static tensile strength |
| - Static shear strength meets ASTM F1044-05 (2017) | Testing conducted to ASTM F1044-05 (2017) for static shear strength |
| - Fatigue shear strength meets ASTM F1160-14 (2017) | Testing conducted to ASTM F1160-14 (2017) for fatigue shear strength |
| - Micrographical analysis meets ASTM F1854-15 | Testing conducted to ASTM F1854-15 for micrographical analysis |
| - Wear analysis meets ASTM F2077-17, ASTM F1877-16, ISO 17853:2011 | Testing conducted to ASTM F2077-17, ASTM F1877-16, ISO 17853:2011 for wear analysis |
| - Pyrogenicity meets European Pharmacopoeia §2.6.14/USP chapter and USP chapter | Bacterial Endotoxin Test (LAL test) according to European Pharmacopoeia §2.6.14 / USP chapter and pyrogen test according to USP chapter for pyrogenicity determination. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not Applicable. The document describes non-clinical mechanical testing of the device itself (materials, design) rather than a test set of patient data for evaluating diagnostic performance.
- Data Provenance: Not Applicable. No patient data or clinical test set is mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. No clinical ground truth or experts for establishing ground truth are mentioned as this is not a diagnostic/AI device.
4. Adjudication Method for the Test Set
- Not Applicable. No clinical test set or adjudication method is mentioned.
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 or diagnostic tool that would involve human readers or AI assistance. No clinical studies were conducted, as explicitly stated: "No clinical studies were conducted."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable for clinical ground truth. The "ground truth" or reference for the mechanical testing would be the performance standards themselves (e.g., ASTM, ISO standards) and the material specifications.
8. The sample size for the training set
- Not Applicable. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. No training set or ground truth for one is mentioned.
§ 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.