(140 days)
The Expandable PEEK VBR Implant is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Expandable PEEK VBR Implant is also indicated for treating fractures of the thoracic and lumbar spine. The Expandable PEEK VBR Implant is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
The Expandable PEEK VBR Implant is an expandable device constructed of Polyetheretherketone, medical grade (PEEK OPTIMA™ LTI) as described by ASTM F-2026. The tantalum markers used for this product are made to the voluntary standard ASTM F-560. The Expandable PEEK VBR Implant is inserted between vertebral bodies in the posterior thoracolumbar spine from T1 to LS. Following insertion into the surgical site, the implant may be left undistracted or may be expanded via a ratcheting mechanism. When expanded, a reinforcement clip is inserted into the implant to aid in maintaining height. The radiolucent PEEK material allows visualization of the defect site on radiograph to assess bone growth.
This document is a 510(k) Summary for the Expandable PEEK VBR Implant, submitted to the FDA in 2004. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a study proving that the device meets specific performance criteria through clinical data.
Therefore, much of the requested information regarding acceptance criteria, performance metrics, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML medical devices, is not present in this type of submission for a traditional implantable medical device.
However, I can extract the information that is available and indicate where the requested details are not provided.
Here's an analysis of the provided text in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission does not provide a table of acceptance criteria with corresponding device performance metrics in the way you'd expect for an AI/ML device (e.g., sensitivity, specificity, accuracy thresholds). For implantable devices like the Expandable PEEK VBR, "acceptance criteria" are generally met through:
- Substantial Equivalence to Predicate Devices: The primary "acceptance criterion" for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is done by comparing:
- Indications for Use: Must be the same.
- Technological Characteristics: Must be the same or substantially similar. If different, the differences must not raise new questions of safety and effectiveness.
- Performance Data: Often includes bench testing (biomechanical), material testing, and sometimes animal studies, but rarely human clinical trials for a 510(k) orthopedic device unless significant new questions of safety/effectiveness arise.
The text states: "Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the Expandable PEEK VBR Implant is considered substantially equivalent to the legally marketed predicate devices."
Therefore, the tacit acceptance criteria are that the device performs equivalently to its predicates in terms of:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Material Composition (Safety/Biocompatibility) | Constructed of Polyetheretherketone (PEEK OPTIMA™ LTI) as described by ASTM F-2026. Tantalum markers used are made to ASTM F-560. (Implicitly, these materials are known to be safe and biocompatible, meeting predicate device standards). |
| Biomechanical Integrity/Performance (Effectiveness) | "Equivalent biomechanical performance" to predicate devices. (Specific quantitative results are not provided in this summary, but would have been presented in bench testing data within the full 510(k) submission). "Designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column." |
| Indications for Use (Scope of treatment) | Same indications for use as predicate devices: replacing diseased vertebral bodies for tumor treatment, restoring height, and treating thoracic/lumbar spine fractures. |
| Device Functionality (Expansion, maintenance of height) | "Expandable device... expanded via a ratcheting mechanism. When expanded, a reinforcement clip is inserted into the implant to aid in maintaining height." (Implicitly functions acceptably compared to predicate). |
| Radiolucency (Visualization) (Post-op assessment) | "The radiolucent PEEK material allows visualization of the defect site on radiograph to assess bone growth." (Implicitly, this is an acceptable or advantageous characteristic compared to predicate). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable/not provided for a traditional biomechanical equivalence study. The "test set" would typically refer to the samples used in bench testing. The 510(k) summary only states "equivalent biomechanical performance," which implies testing was done, but does not provide details on sample sizes of implanted devices/materials, nor "data provenance" (country of origin, retrospective/prospective) as these are not clinical trial results.
- Data Provenance: Not applicable/not provided. Biomechanical testing is usually performed in a lab setting, not using patient data in the sense of AI/ML device validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. For an implantable device's biomechanical testing, "ground truth" is established through engineering principles, material science, and established ASTM standards, not typically by expert consensus of clinical cases.
- Qualifications of Experts: If any experts were involved in test design or review, they would typically be biomechanical engineers, material scientists, or orthopedic surgeons, but their number and specific qualifications are not detailed in this summary.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. This concept is relevant for reconciling discrepancies in human expert labeling/diagnosis in AI/ML studies. For a medical implant, "adjudication" would refer to reviewing and interpreting test results against predetermined engineering specifications, not expert consensus on medical cases.
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
- MRMC Comparative Effectiveness Study: No, this type of study was not done. MRMC studies are specific to evaluating diagnostic imaging devices or AI-assisted diagnostic tools and measuring their impact on human reader performance. The Expandable PEEK VBR Implant is an orthopedic implant, not a diagnostic or AI device.
- Effect Size of AI Improvement: Not applicable, as no AI component is involved.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: No, this refers to algorithm-only performance for AI/ML devices. The Expandable PEEK VBR is an implantable medical device and does not have an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "ground truth" for demonstrating substantial equivalence for this device primarily relies on:
- Material Standards: Adherence to ASTM F-2026 (for PEEK) and ASTM F-560 (for tantalum).
- Biomechanical Test Standards/Engineering Principles: Testing according to relevant standards (though not specified in the summary) to demonstrate "equivalent biomechanical performance" to predicate devices.
- Established Clinical Practice: The indications for use are established treatments for spinal conditions.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device does not use machine learning, so there is no "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of medical device.
In summary, this 510(k) submission is for a traditional, non-digital, implantable medical device. Its "acceptance criteria" and "study" for marketing clearance are centered around demonstrating substantial equivalence to an existing predicate device through comparisons of indications for use, technological characteristics, material compliance, and biomechanical performance (typically verified through bench testing). The concepts of test sets, training sets, ground truth by experts, MRMC studies, and standalone algorithm performance are not relevant to this type of device and submission.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.