(100 days)
The Idys™ TLIF TiVac cages are indicated for use with autologous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplementation, which has been cleared by FDA for use in the lumbar spine.
The Idys™ TLIF 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™ TLIF TiVac cages, which have various widths and heights, are designed for use as lumbar intervertebral body fusion devices. 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 device has to be used with autograft.
The superior and inferior surfaces of the implant are designed with "teeth" to help prevent the device from migrating once it is positionally, the rough plasma-sprayed titanium surface interacts with the surface of the vertebral endblates and helps resist back out. The Idys™ TLIF TiVac cages are made of compliant ASTM F2026 polyetheretherketone (PEEK Optima®) with markers made of compliant ASTM F560 Tantalum and are coated with plasma-sprayed titanium compliant with ASTM F1580. Idys™ TLIF TiVac cages are positioned using a set of surgical instruments common for transforaminal lumbar approach. It is essential to insert implants with instrumentation specifically designed for this purpose. The cages are provided sterile and are for single use only.
The provided text is a 510(k) summary for the Idys™ TLIF TiVac intervertebral body fusion device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results of new device performance against acceptance criteria. Therefore, much of the requested information regarding detailed acceptance criteria, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and stand-alone algorithm performance is not typically part of a 510(k) submission for this type of device and is not present in the provided text.
However, based on the information available, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence of the Idys™ TLIF TiVac are primarily based on demonstrating comparable performance to the predicate devices through mechanical testing and biocompatibility assessments. The "reported device performance" is essentially the statement that the device met these comparability goals.
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1 Part 1 | Modified device demonstrated to be biocompatible in accordance with ISO 10993-1 Part 1. |
| Mechanical Performance | ASTM F2077 (Static & Dynamic Axial Compression) | Demonstrated substantial equivalence to the predicate device (K131178). |
| ASTM F2077 (Static & Dynamic Compression Shear) | Demonstrated substantial equivalence to the predicate device (K131178). | |
| ASTM F2077 (Subsidence Testing) | Demonstrated substantial equivalence to the predicate device (K131178). | |
| ASTM F2077 (Expulsion Testing) | Demonstrated substantial equivalence to the predicate device (K131178). | |
| ASTM F2077 (Static Torsion Testing) | Demonstrated substantial equivalence to the predicate device (K131178). | |
| ASTM F2077 (Wear Testing, PEEK and titanium particles) | Demonstrated substantial equivalence to the predicate device (K131178). | |
| Coating Performance | ASTM F1044 (Static Shear Strength) | Satisfactory results. |
| ASTM F1147 (Static Tensile Strength) | Satisfactory results. | |
| ASTM F1160 (Shear Fatigue Strength) | Satisfactory results. | |
| ASTM F1978-99 (Abrasion Resistance) | Satisfactory results. | |
| ASTM F1854 (Coating Porosity/Thickness) | Satisfactory results. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in terms of number of devices or clinical cases. The tests described are bench mechanical and biocompatibility tests, not clinical performance tests on human subjects.
- Data Provenance: The tests are described as "bench mechanical testing" and "biocompatibility testing," implying laboratory-based studies. The context suggests these were conducted by the manufacturer, Clariance SAS, a French company. Therefore, the data would be from non-clinical, prospective laboratory testing (meaning the tests were designed and conducted to evaluate the device as part of the submission process).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for mechanical and biocompatibility testing is defined by the standards (ASTM and ISO) and the physical properties of the materials and device under test, not by expert consensus on clinical cases.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically for clinical studies where human interpretation or classification is involved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is for evaluating diagnostic or screening devices involving human readers interpreting medical images. The Idys™ TLIF TiVac is an intervertebral body fusion device (implant), not an imaging diagnostic tool.
6. Standalone Performance (i.e. algorithm only without human-in-the-loop performance)
Not applicable. This device is an implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used for these tests is the quantitative and qualitative outcomes expected under the specified ASTM and ISO standards for mechanical stability, durability, and biocompatibility. For example, "satisfactory results" for coating tests imply meeting predefined thresholds or performance levels dictated by the standards.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not a machine learning or AI device. The submission is based on engineering testing and comparison to predicate devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as above.
§ 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.