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510(k) Data Aggregation
(371 days)
Idys ALIF 3DTi
The Idys® ALIF 3DTi (Anterior Lumbar Integrated Fusion) 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 level. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys® ALIF System should be used with the integrated fixation screws provided.
The Idys® ALIF 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 3DTi 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 3DTi 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 autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion process between the endplates.
The device has to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone graft.
The Idys® ALIF 3DTi cage is manufactured from medical grade Ti-6Al-4V ELI Titanium alloy compliant with ASTM F3001 and ASTM F136 and is used with bone graft. The insert for fixation of the plate is made of ASTM F2026 compliant polyetheretherketone (PEEK). The screws and plates are made from Ti-6Al-4V ELI per ASTM F136 and are anodized in different colors, according to their length. Idys® ALIF 3DTi cages are positioned using a set of surgical 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.
The provided text is a 510(k) summary for the Idys® ALIF 3DTi device, which is an intervertebral body fusion device. The document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove acceptance criteria for device performance in terms of clinical outcomes or diagnostic accuracy.
Therefore, the following information cannot be fully extracted from the provided text:
- A table of acceptance criteria and the reported device performance (in a clinical context for diagnostic/prognostic devices)
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study existence or effect size
- Standalone algorithm performance
- Type of ground truth used (for clinical outcomes)
- Sample size for the training set (for an AI/ML device)
- How ground truth for the training set was established
The document primarily describes bench mechanical testing and biocompatibility to demonstrate that the new device (Idys® ALIF 3DTi) is as safe and effective as its predicate devices, despite changes in material and manufacturing processes. It does not refer to a clinical study establishing performance against specific acceptance criteria in the manner typically seen for diagnostic AI/ML devices.
Here's an attempt to structure the available information relevant to the prompt, highlighting what is present and what is not:
Acceptance Criteria and Study for Idys® ALIF 3DTi Device
This 510(k) summary for the Idys® ALIF 3DTi focuses on demonstrating substantial equivalence to predicate devices (Idys® ALIF (K172083) and Idys® ALIF ZP 3DTi (K192168)) through performance data derived primarily from bench mechanical testing and biocompatibility assessments. The goal is to show that material and manufacturing changes do not raise new safety or effectiveness concerns compared to the already cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied / Demonstrated Equivalence) | Reported Device Performance (Idys® ALIF 3DTi) |
|---|---|---|
| Mechanical Performance | Demonstrated substantial equivalence to predicate devices (Idys® ALIF (K172083) and Idys® ALIF ZP 3DTi (K192168)) per ASTM F2077 and ASTM F2267 standards. | Successfully completed static and dynamic axial compression testing, static and dynamic compression shear testing, subsidence testing, expulsion testing, static torsion testing, and wear testing (titanium particles). All tests demonstrated substantial equivalence to legally marketed predicate devices. |
| Biocompatibility | Demonstrated to be biocompatible in accordance with ISO 10993-1 Part 1. | Demonstrated to be biocompatible. (Specific findings are not detailed in the summary, but the conclusion is positive). |
| Sterility & Cleaning | Sterilization validation per ISO 11737 and ISO 11137. Acceptable limits of residues after cleaning validation. | Repeated sterilization validation successfully completed. Cleaning validation showed acceptable limits of residues. (Specific limits and results are not detailed). |
| Clinical Performance | Safety and effectiveness profile similar to the predicate device, as documented in a pivotal clinical study (mentioned in predicate documentation, implied for this device). | "Based on the clinical performance as documented in the pivotal clinical study, the Idys® ALIF 3DTi has a safety and effectiveness profile that is similar to the predicate device." (This statement refers to prior clinical data on the predicate device, extrapolating to the subject device due to demonstrated equivalence in mechanical and biological properties, rather than presenting a new clinical study for the subject device). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable for a clinical test set from this document. For mechanical testing, the sample sizes would be defined by the ASTM standards (F2077, F2267) but are not explicitly stated in this summary.
- Data Provenance: The mechanical and biocompatibility testing was performed by CLARIANCE, the manufacturer. The document does not specify a country of origin for a clinical test set, as no new clinical test set appears to have been generated for this 510(k). The clinical performance reference points to a "pivotal clinical study" previously conducted for the predicate device. The information is retrospective to the predicate's clearance regarding clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable as the summary does not detail a clinical study with human readers to establish ground truth for a diagnostic or prognostic device. Ground truth for mechanical testing would be the measured physical properties against established standard requirements.
4. Adjudication Method for the Test Set
- Not applicable as no clinical images or diagnostic assessments requiring adjudication are part of this 510(k) summary for the Idys® ALIF 3DTi.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Improvement with AI vs. Without AI Assistance
- Not applicable. This is not an AI/ML device, and no MRMC study is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
- Mechanical Testing: Ground truth is based on the requirements and pass/fail criteria defined by the relevant ASTM standards (F2077, F2267) for various mechanical properties.
- Biocompatibility: Ground truth is based on the risk assessments and testing requirements of ISO 10993-1.
- Clinical Performance (reference to predicate): The "pivotal clinical study" for the predicate device would have established clinical outcomes data relevant to fusion, pain relief, and adverse events. The specific type of ground truth for that original study (e.g., radiographic fusion assessment, patient-reported outcomes) is not detailed here.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not an AI/ML device that requires a training set.
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