(27 days)
The Idys™ ALIF (Anterior Lumbar Interbody Fusion) TiVac System is intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys™ ALIF TiVac System should be used with the integrated fixation screws provided. The Idys™ ALIF TiVac System is intended to be used with autograft.
The Idys™ ALIF TiVac consists of interbody fusion devices intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the lumbar spine.
The Idys™ ALIF TiVac System is designed for use as a lumbar intervertebral body fusion device. The device is manufactured from medical grade polyetheretherketone (INVIBIO PEEK OPTIMA LT1) coated with titanium on its superior and inferior surfaces and is to be used with autograft.
The device has a shape which restores the intervertebral height and lordosis. The device contains two slots to receive the autologous bone graft to promote the fusion process between the endplates. The superior and inferior surfaces of the implant coated with titanium are designed with teeth which interact with the surface of the vertebral endplates and helps in resisting back out. The Idys™ ALIF TiVac System is a standalone system intended to be used with plate and four bone screws, autogenous bone graft and requires no additional supplementary fixation. The Idys™ ALIF TiVac System cages are made of ASTM F2026 compliant polyetheretherketone (PEEK) coated with compliant ASTM F1580 titanium and, markers made of Tantalum according to ASTM F560, the plate and screws are made of ASTM F136 titanium alloy. It is essential to insert implants with instrumentation specifically designed for this purpose. The cages, plates and screws are provided sterile and are for single use only.
This document describes the marketing clearance for a medical device implant, specifically an intervertebral body fusion device, not an AI/Software as a Medical Device (SaMD). Therefore, the typical "acceptance criteria" and study designs related to diagnostic accuracy, sensitivity, specificity, or reader performance for AI/SaMD are not directly applicable.
The performance criteria for this device, a physical implant, are primarily based on biocompatibility and mechanical testing to demonstrate its safety and effectiveness compared to a previously cleared predicate device.
However, I can extract the relevant information from the provided text regarding the closest equivalent to "acceptance criteria" and "proof of meeting these criteria" for this specific type of medical device.
Key Information regarding Device Evaluation:
- Device Name: Idys™ ALIF TiVac
- Product Type: Intervertebral Body Fusion Device (Implantable)
- Regulatory Class: Class II
- Product Code: OVD
- Regulatory Mechanism: 510(k) Premarket Notification (demonstrates substantial equivalence to a legally marketed predicate device, rather than requiring de novo clinical trials for novel devices).
Based on the provided text, here's a breakdown of the information, adapting the requested categories to fit the context of an implantable medical device undergoing 510(k) clearance:
1. Acceptance Criteria and Reported Device Performance (Adapted for an Implantable Device)
For this type of device, "acceptance criteria" are not framed as diagnostic accuracy metrics but rather as meeting established performance standards for implants to demonstrate functional equivalence and safety to a predicate device.
| Acceptance Criteria Category (Equivalence to Predicate) | Specific Criteria / Performance Demonstrated |
|---|---|
| Material Biocompatibility | The modified device (with titanium coating) must be demonstrated to be biocompatible. |
| Mechanical Performance (Bench Testing) | The device must demonstrate equivalent mechanical integrity and performance to the predicate device under various simulated physiological loads. This includes: |
- Static and dynamic axial compression testing
- Static and dynamic compression shear testing
- Subsidence testing
- Expulsion testing
- Static torsion testing
- Wear testing (PEEK and titanium particles) |
| Coating Integrity & Performance | The added plasma-sprayed titanium coating must meet established standards for adhesion, strength, and durability. This includes: - Static tensile strength
- Static shear strength
- Shear fatigue strength
- Abrasion resistance
- Coating porosity/thickness |
| Clinical Equivalence (Indications for Use) | The device must have the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device, with any differences not raising new safety or effectiveness issues. |
Reported Device Performance:
- Biocompatibility: "The modified device has been demonstrated to be biocompatible in accordance with ISO 10993-1 Part 1."
- Mechanical Testing (Device Functionality): "The results of these studies were determined to be substantially equivalent to legally marketed devices." (Referring to functional tests such as axial compression, shear, subsidence, expulsion, torsion, and wear).
- Mechanical Testing (Coating Performance): Coating tests (static tensile, static shear, shear fatigue, abrasion resistance, porosity/thickness) were performed "with satisfactory results."
- Clinical Equivalence: "The Idys™ ALIF TiVac is as safe and effective as the Idys™ ALIF (K172083). The Idys™ has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Idys™ ALIF TiVac and its predicate device do not raise any new issues of safety or effectiveness. Performance data demonstrate that the Idys™ ALIF TiVac is as safe and effective as its predicate."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of human patient data for an AI test set. This device's performance was evaluated via bench testing of physical prototypes/samples. The specific number of mechanical test specimens used for each test (e.g., how many devices were subjected to axial compression) is not stated in this summary but would be detailed in the full premarket notification.
- Data Provenance: The data primarily originates from laboratory bench testing performed by the manufacturer, CLARIANCE SAS, in France ("Beaurains, France"). This is not retrospective or prospective human patient data.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
- Not Applicable. For a physical implantable device, "ground truth" is not established by human expert interpretation of medical images or clinical outcomes in the same way as for AI/SaMD. Instead, it's based on objective, quantifiable physical and mechanical properties measured in a lab setting against established ASTM/ISO standards.
- The "experts" involved would be engineers, material scientists, and quality assurance personnel conducting the mechanical and biocompatibility tests.
4. Adjudication Method for the Test Set
- None. Adjudication methods like "2+1" or "3+1" are specific to establishing ground truth from multiple human readers for diagnostic AI/SaMD. In this context, the "ground truth" for the device's performance relies on direct physical measurements and compliance with engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
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No. This type of study is specifically designed for AI systems that aid human readers in diagnostic tasks. It is not relevant for an implantable medical device.
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Effect Size of Human Readers Improvement: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No. This refers to the evaluation of AI algorithm performance. This product is a physical implant, not an algorithm.
7. Type of Ground Truth Used
- The "ground truth" for this device's performance is based on objective, quantifiable physical and mechanical properties measured through bench testing against established industry standards (e.g., ASTM, ISO) and comparison to the mechanical properties of the predicate device.
- Biocompatibility: In vitro and in vivo (animal, if applicable, though not specified here) testing against ISO 10993-1.
8. Sample Size for the Training Set
- Not Applicable. This is not an AI/machine learning device that requires a "training set." The device itself is the product, evaluated based on its physical properties.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no AI training set, there is no ground truth establishment for it.
§ 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.