(336 days)
The Paradigm Interspinous Fusion Plate is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1 - S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - with up to Grade 1 spondylolisthesis.
The Paradigm Interspinous Fusion Plate is a spinous process fixation device that stabilizes the spinous processes and spine to act as an adjunct to fusion. It consists of a single, U-shaped component, fabricated from medical grade titanium alloy (Ti6A14V). A set of two wings extends vertically from the superior long arm of the device, with a second set of wings extending below the inferior long arm. A screw and sleeve are inserted through a prepared hole and fixes the crimped wings to the superior and inferior spinous processes.
This 510(k) submission (K093438) describes the Paradigm Interspinous Fusion Plate, a spinal implant, and focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance metrics for acceptance criteria and a detailed study report for meeting those. Instead, it relies on preclinical and clinical data comparisons.
Here's an breakdown based on the provided text, addressing your questions where possible and noting limitations due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define quantified acceptance criteria in the format you've requested (e.g., "Accuracy > X%", "Sensitivity > Y%"). Instead, it states that "Performance testing demonstrated Paradigm Interspinous Fusion Plate is substantially equivalent to predicate devices."
The performance is described as:
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Performance | Demonstrated substantial equivalence to predicate devices in:Static tensionStatic compressionStatic torsionDynamic compressionDynamic compression-tensionScrew loosening and tightening |
| Clinical Performance | Demonstrated substantially equivalent performance to predicate devices through clinical data. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The submission mentions "clinical data was provided" but does not give the number of patients or cases in any comparative clinical study.
- Data Provenance: Not specified. It's unclear if the clinical data was retrospective or prospective, or the country of origin. Given the typical nature of 510(k) submissions, especially for an implant like this, the "clinical data" likely refers to evidence gathered on the predicate devices or general clinical performance related to the indication, rather than a dedicated new clinical trial for this specific device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the submission. For a device like an interspinous fusion plate, "ground truth" for the test set would typically relate to clinical outcomes (fusion rates, pain reduction, adverse events) as evaluated by clinicians (surgeons, radiologists) over time. However, the details of how this was established for this specific device's clinical data are not present.
4. Adjudication Method for the Test Set
This information is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done, as this device is a physical implant (spine plate), not an AI/imaging diagnostic tool that would typically involve human readers interpreting output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical implant and does not involve an algorithm with standalone performance.
7. The Type of Ground Truth Used
For the preclinical testing, the ground truth was based on engineering standards and measurements of mechanical properties (tension, compression, torsion, etc.).
For the clinical data, the "ground truth" implicitly relates to clinical outcomes (e.g., successful fusion, symptom resolution, absence of device failure or adverse events), typically assessed by surgeons, radiologists, and patient reports. However, the specific methodology for establishing this ground truth is not detailed for this particular device's submission.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical implant and does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above.
Summary of the Study that Proves Substantial Equivalence:
The submission leverages preclinical (bench) testing and clinical data comparison to demonstrate substantial equivalence.
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Preclinical Testing: This involved a series of mechanical tests—static tension, static compression, static torsion, dynamic compression, dynamic compression-tension, screw loosening, and tightening. The "study" here involved performing these tests on the Paradigm Interspinous Fusion Plate and comparing the results to those obtained for the predicate devices (Medtronic SPIRE (K032037), Lanx Spinous Process Plate (K071877), and NuVasive Spinous Process Plate System (K073278)). The implicit "acceptance criteria" for these tests were that the Paradigm plate's performance should be comparable to or better than the predicates, thus establishing substantial equivalence in mechanical properties.
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Clinical Data: The submission states that "clinical data was provided to demonstrate substantially equivalent performance of the subject device to predicate devices." This likely involved referencing existing clinical data or literature on the predicate devices and demonstrating that the Paradigm plate, with its similar design, function, and materials, would be expected to achieve similar clinical outcomes (e.g., fusion rates, complication profiles) as observed with the predicates. It is highly improbable that a new, dedicated clinical trial was conducted solely for this 510(k) submission for this type of device. The exact nature and scope of this clinical data are not detailed.
In essence, the "study" for this 510(k) approval was a comparison against established, cleared devices (predicates) across both mechanical performance and expected clinical outcomes, rather than a de novo investigation with its own distinct acceptance criteria and study endpoints.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.