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510(k) Data Aggregation
(181 days)
AccelFix Lumbar Expandable Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. AccelFix Lumbar Expandable Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The AccelFix Lumbar Expandable Cage System's implants are interbody fusion devices intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136). These hollow, rectangular implants are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies. The implants can be expanded in height after insertion in the unexpanded state using the system instrumentation. The implants have serrations on the superior and inferior surfaces designed for fixation.
The provided text, a 510(k) summary for the "AccelFix Lumbar Expandable Cage System," describes a medical device, specifically an intervertebral body fusion device.
The questions you've asked are typical for the validation of an Artificial Intelligence / Machine Learning (AI/ML) powered medical device, particularly those involved in diagnostic imaging or similar applications where performance metrics like sensitivity, specificity, and reader studies are crucial.
This document, however, does not describe an AI/ML device. It's a traditional medical device (an implantable cage) and its clearance is based on bench testing to demonstrate mechanical properties and substantial equivalence to existing predicate devices.
Therefore, many of the questions you've posed, such as those related to:
- Data provenance, sample sizes for training/test sets
- Number of experts for ground truth establishment, expert qualifications
- Adjudication methods
- MRMC studies, effect size of human reader improvement with AI
- Standalone algorithm performance
- Ground truth type (expert consensus, pathology, outcome data)
...are not applicable to the content provided in this 510(k) summary. The "study" proving the device meets acceptance criteria here refers to mechanical bench testing, not a clinical study involving human readers or AI.
Here's what can be extracted from the text relevant to the device validation:
Study Description: Bench Testing for Mechanical Properties
The study conducted to prove the device meets acceptance criteria was a series of bench tests evaluating the mechanical properties of the AccelFix Lumbar Expandable Cage System.
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the "AccelFix Lumbar Expandable Cage System met all pre-defined acceptance criteria." While the specific numerical acceptance criteria values are not explicitly listed, the types of tests performed and the general outcome are provided.
| Test Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Static Axial Compression Test (ASTM F 2077) | To demonstrate substantial equivalence to predicate devices (meeting or exceeding their performance/safety thresholds) | Showed a higher or similar mechanical value than predicate devices. |
| Static Compression-Shear Test (ASTM F 2077) | To demonstrate substantial equivalence to predicate devices | Showed a higher or similar mechanical value than predicate devices. |
| Static Torsion Test (ASTM F 2077) | To demonstrate substantial equivalence to predicate devices | Showed a higher or similar mechanical value than predicate devices. |
| Static Expulsion Test | To demonstrate substantial equivalence to predicate devices | Showed a higher or similar mechanical value than predicate devices. |
| Static Subsidence Test (ASTM F 2267/F 2077) | To demonstrate substantial equivalence to predicate devices | Showed a higher or similar mechanical value than predicate devices. |
| Dynamic Axial Compression Test (ASTM F 2077) | To demonstrate substantial equivalence to predicate devices (meeting or exceeding their performance/safety thresholds) | Showed a higher or similar mechanical value than predicate devices. |
| Dynamic Compression-Shear Test (ASTM F 2077) | To demonstrate substantial equivalence to predicate devices | Showed a higher or similar mechanical value than predicate devices. |
| Chemical and Physical Testing (general) | Demonstrates device is as safe and effective for its intended use as a predicate device and supports substantial equivalence | Yes, testing has shown this. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated in terms of number of devices tested. It refers to "battery of non-clinical testing" and details the types of mechanical tests. For mechanical testing of medical devices, sample size typically refers to the number of individual units or specimens tested for each specific test, which is not detailed here.
- Data Provenance: The tests are "non-clinical testing" and are laboratory-based bench tests performed by the manufacturer, L&K Biomed Co., Ltd., Republic of Korea. It is a retrospective summary of completed tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
- N/A. This information is for AI/ML validation or clinical studies. For mechanical bench testing, "ground truth" is established by the specified ASTM standards and the physics of the tests, with results measured by instrumentation. The experts are mechanical engineers or testing technicians performing the lab tests, not clinical experts establishing disease presence.
4. Adjudication Method for the Test Set:
- N/A. This is relevant for human reader studies or expert consensus. For mechanical testing, results are typically objective measurements against predefined pass/fail criteria from the ASTM standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is not an AI/ML device or a diagnostic device evaluated with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm.
7. The Type of Ground Truth Used:
- N/A (in the context of clinical "ground truth"). The "ground truth" for these tests are the established ASTM (American Society for Testing and Materials) standards (F 2077, F 2267) which define the methodologies and expected performance characteristics for intervertebral body fusion devices. The device's performance is measured against these standard requirements and compared to predicate devices, not against clinical outcomes or pathology.
8. The Sample Size for the Training Set:
- N/A. This device does not use a training set as it is not an AI/ML product.
9. How the Ground Truth for the Training Set was Established:
- N/A. No training set exists.
In summary, the provided document focuses on the mechanical and material verification of an implantable medical device, not the diagnostic performance of an AI/ML system.
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