(53 days)
The Idys® ALIF ZP 3DTi devices (Anterior Lumbar Interbody Fusion) are intended for use in patients with degenerative disc disease (DDD) at one (1) or (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain in discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis 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 ZP 3DTi cages should be used with the integrated fixation screws provided.
The Idys® ALIF ZP 3DTi cages are intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion
The Idys® ALIF ZP 3DTi consists of interbody fusion devices intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the lumbar spine.
The Idys® ALIF ZP 3DTi cages, which have various widths and heights, are designed for use as lumbar intervertebral body fusion devices. The device has shape which restores the intervertebral height and lordosis. The device contains two slots to receive bone graft to promote the fusion process between the endplates. The device has to be used with bone graft.
The Idys® ALIF ZP 3DTi cage is manufactured from medical grade Ti-6Al-4V ELI Titanium alloy compliant with ASTM F3001 and ASTM F136. The screws are made from Ti-6AI-4V ELI per ASTM F136 and are anodized in different colors, according to their length, Idvs® ALIF ZP 3DTi cages are positioned using a set of surqical instruments common for anterior 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.
This document is a 510(k) summary for the Idys® ALIF ZP 3DTi intervertebral body fusion device. It details product information and demonstrates substantial equivalence to a predicate device, rather than describing a study with acceptance criteria for device performance in detecting or diagnosing a condition. Therefore, the requested information (acceptance criteria, study details, expert involvement, and ground truth characteristics) related to diagnostic performance cannot be extracted from this text.
The document focuses on the mechanical and biocompatibility performance of the device and its substantial equivalence to a previously cleared predicate device due to minor modifications (change in screw design and addition of cage sizes).
Here's what can be extracted regarding the performance data provided for the device itself:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Test/Area | Performance Reported |
|---|---|---|
| Biocompatibility | ISO 10993-5 (in vitro cytotoxicity) & -11 (systemic toxicity) | Successfully performed (confirmatory testing), no new testing required as no change in manufacturing methods or patient-contacting materials. |
| Sterility | ISO 11737 | Successfully completed (repeated sterilization validation). |
| Cleaning | Cleaning validation | Acceptable limits of residues shown. |
| Mechanical Performance | ASTM F2077 (for cages) | No new testing required for cages as additional cage sizes do not create new worst-case scenarios. |
| Mechanical Performance | ASTM F543 (for screws) | Tested to demonstrate and support substantial equivalence. |
2. Sample size used for the test set and the data provenance: Not applicable. These tests are laboratory-based mechanical and biocompatibility evaluations, not clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this refers to mechanical and biocompatibility testing, not expert-adjudicated clinical performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 document does not describe an AI medical device or a reader study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to the presented performance data, which are based on established ISO and ASTM standards for materials and mechanical testing.
8. The sample size for the training set: Not applicable. This is not a study involving machine learning or AI models with training data.
9. How the ground truth for the training set was established: Not applicable.
Summary of Device and Changes:
The document describes a Special 510(k) notice for the Idys® ALIF ZP 3DTi device.
- Original Device: Idys® ALIF ZP 3DTi (K192168)
- Modifications:
- Change in the screw's design.
- Addition of new cage sizes (with identical design and shape as previously cleared cages).
- Purpose of Testing: To demonstrate that these modifications do not raise new issues of safety or effectiveness and that the modified device remains substantially equivalent to the predicate 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.