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510(k) Data Aggregation
(98 days)
The zLOCK Lumbar Facet Fixation System is an integrated construct comprised of a modular spacer and a single facet screw. The system is intended for temporary stabilization of the spine as an adjunct to fusion through bilateral immobilization of the facet joints in skeletally mature patients.
The zLOCK Lumbar Facet Fixation System is intended for use as an adjunct to a 1-level interbody lumbar fusion from L3 to L5 with autogenous and/or allogenic bone graft and must be accompanied by an FDA cleared intervertebral body fusion device implanted at the same spinal level. The zLOCK Lumbar Facet Fixation System is indicated for the treatment of patients with lumbar degenerative disc disease at a single level from L3 to L5 in skeletally mature patients who have failed conservative care.
The zLOCK Lumbar Facet Fixation System is composed of a modular spacer and facet screws as an integrated construct to achieve posterior lumbar facet fixation as an adjunct to fusion. All implants are supplied sterile for single use only. The modular spacers are available in one footprint with a variety of heights to accommodate varying anatomical conditions of the patient, contain a screw hole, and are bendable with toothed surfaces to firmly anchor into the joint space and contain bone graft. The facet screw is cannulated, self-tapping, with a preassembled polyaxial washer; it is provided in one size. The modular spacer and facet screw are manufactured from Titanium Grade 1 and Titanium 6Al 4V alloy, respectively.
The system is supplied with a set of non-sterile, reusable instruments to access the site, prepare it for implantation, and perform device implantation.
This document describes the zLOCK Lumbar Facet Fixation System, a medical device, and its acceptance criteria as demonstrated through non-clinical and clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text details the non-clinical and clinical studies conducted but does not explicitly state numerical acceptance criteria with corresponding device performance metrics in a readily extractable table format. Instead, it describes the types of tests performed and concludes that the device "supports substantial equivalence to predicate devices" and that clinical data "supports there are no increased safety or effectiveness concerns compared to predicates."
To present this in a structured table, we'll infer the acceptance criteria from the nature of the tests and the general goal of demonstrating substantial equivalence. The reported performance is qualitative, indicating the device met the implied benchmarks for substantial equivalence.
| Acceptance Criteria Type | Implied Acceptance Standard | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance Testing | ||
| Screw Testing per ASTM F543: | Device performance (static axial pullout, torsional strength, insertion/removal) should be comparable to or better than predicate devices and meet relevant standards for spinal implants. | Non-clinical testing "supports substantial equivalence to predicate devices." |
| - Static axial pullout test | ||
| - Torsional strength test | ||
| - Insertion and removal tests | ||
| Modular Spacer Testing per ASTM F2077: | Device performance (static/dynamic axial compression, static/dynamic compression-shear) should be comparable to or better than predicate devices and meet relevant standards for intervertebral body fusion devices. | Non-clinical testing "supports substantial equivalence to predicate devices." |
| - Static and dynamic axial compression | ||
| - Static and dynamic compression-shear | ||
| Biomechanical study in cadaveric specimens | Biomechanical stability and performance in a cadaveric model should be comparable to or better than predicate devices and demonstrate appropriate stabilization. | Non-clinical testing "supports substantial equivalence to predicate devices." |
| Finite Element Analysis (FEA) | FEA should confirm that shear forces on the device are within acceptable limits for the intended use and comparable to predicate devices, demonstrating structural integrity and safety. | Non-clinical testing "supports substantial equivalence to predicate devices." |
| Clinical Performance Data | ||
| Radiographic and CT evaluations | Radiographic fusion and stability should be demonstrated, comparable to outcomes of predicate devices or established clinical success for lumbar fusion, with no increased safety concerns. | Clinical data "supports there are no increased safety or effectiveness concerns compared to predicates when used for lumbar facet fixation." |
| Safety data | Incidence of adverse events should be acceptable and comparable to predicate devices or established safety profiles for similar procedures, with no increased safety concerns. | Clinical data "supports there are no increased safety or effectiveness concerns compared to predicates when used for lumbar facet fixation." |
| Patient Reported Outcomes (PROs) | Improvement in Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) for back and leg pain should be observed, consistent with clinically meaningful improvement seen with predicate devices or standard of care for lumbar fusion, with no increased effectiveness concerns. | Clinical data "supports there are no increased safety or effectiveness concerns compared to predicates when used for lumbar facet fixation." (implies effectiveness is comparable) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the specific number of patients included in the clinical study. It refers to a "prospective, multi-center single arm interventional study."
- Data Provenance: The clinical study was conducted "outside the United States." It was a "prospective" study, meaning data was collected forward in time specifically for this research.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not provide information on the number or qualifications of experts used to establish a ground truth for the clinical test set. It mentions "radiographic and CT evaluations" were used, but not who interpreted them or how consensus was reached.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1) used for the clinical test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The clinical study was described as a "single arm interventional study," meaning there was no direct comparison between AI assistance and unassisted human readers, or between human readers with and without the device's specific outputs. The device itself is a surgical implant, not an AI or imaging diagnostic tool that would typically involve a MRMC study for assessing reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The zLOCK Lumbar Facet Fixation System is a physical implant, not a software algorithm or diagnostic tool. Therefore, a "standalone algorithm-only" performance study is not relevant to this device.
7. Type of Ground Truth Used
For the non-clinical tests, the "ground truth" would be the engineering specifications, material properties, and biomechanical parameters established by the ASTM standards and finite element analysis models.
For the clinical data, the ground truth for safety and effectiveness was established through:
- Radiographic and CT evaluations: These provided objective imaging evidence of fusion and device placement/stability.
- Safety data: Collection of adverse events.
- Patient Reported Outcomes (PROs): Subjective measures like Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) for back and leg pain.
These measures collectively served as the basis for evaluating the device's performance against the implicit "ground truth" of no increased safety or effectiveness concerns compared to predicate devices.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not a machine learning or AI algorithm that requires a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of medical device.
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(267 days)
PMT Facet Fixation System, Lumbar (PMT FFS-LX) is an integrated construct comprised of a CAVUX Cage and an ALLY Bone Screw. PMT FFS-LX is placed bilaterally through a posterior surgical approach and spans the facet interspace with points of fixation at each end of the construct. PMT FFS-LX is intended to provide temporary stabilization as an adjunct to a 1 or 2 level interbody lumbar fusion with autogenous and/or allogenic bone graft and must be accompanied with an FDA cleared intervertebral body fusion device implanted at the same spinal level (s), and may be used with a pedicle screw and rod system implanted at the same spinal level(s). PMT FFS-LX is indicated for the treatment of patients with lumbar degenerative disc disease (DDD) from L4 to S1 in skeletally mature patients who have failed conservative care.
PMT Facet Fixation System, Lumbar (PMT FFS-LX) is composed of CAVUX® Cages and ALLY® Bone Screws, an integrated construct, manufactured from medical grade titanium alloy and supplied sterile for single use only with a pre-attached disposable delivery handle/inserter. PMT FFS-LX provides temporary stabilization by spanning the facet interspace with points of fixation at each end of the construct and provides fixation as an adjunct to fusion. An ALLY Bone Screw is intended to be utilized to provide additional anchoring. CAVUX Cages are offered in a variety of sizes to accommodate various patient anatomies and pathology. The cage is designed to be filled with bone graft to permit formation of new bone through the device. ALLY Bone Screws are fully threaded. CORUS™ Spinal System is recommended to access the site and perform posterior fusion.
The provided text is a 510(k) Premarket Notification letter and summary for the PMT Facet Fixation System, Lumbar (PMT FFS-LX). This document details the device, its indications for use, comparison to predicate devices, and performance data.
However, the provided text DOES NOT describe an AI/machine learning medical device or its acceptance criteria and study findings. It refers to a physical medical device for spinal fusion (facet fixation system) and discusses mechanical and biomechanical testing, along with clinical and radiographic evaluations.
Therefore, I cannot extract the information required to answer your prompt, as it specifically asks for details related to:
- AI/Machine Learning device performance criteria.
- Sample sizes for test sets (in the context of AI models).
- Data provenance for AI models.
- Number and qualifications of experts for AI ground truth.
- Adjudication methods for AI ground truth.
- Multi-reader multi-case (MRMC) comparative effectiveness studies for AI.
- Standalone AI performance.
- Ground truth types (pathology, outcomes data, typically for AI/imaging).
- Training set sample size and ground truth establishment for AI.
The document mentions "Clinical data were provided on the subject device, comparing to other lumbar fusion techniques, utilizing radiographic and CT evaluations, peri-operative findings, patient reported outcomes, and assessments of safety and effectiveness." and "Clinical and radiographic data provided satisfactory clinical outcomes to support use of the subject device". This refers to the clinical evidence for the physical device, not an AI algorithm.
In summary, the provided document does not contain the information requested in your prompt because the device in question is a physical surgical implant, not an AI/ML-based diagnostic or assistive software.
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