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510(k) Data Aggregation
(16 days)
ZygoFix Ltd.
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 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.
The purpose of this 510(k) was to add a new screw size to the previously cleared zLOCK Lumbar Facet Fixation System (K240085) and to modify the length of the spacer component.
The provided text describes a 510(k) premarket notification for a medical device called the zLOCK Lumbar Facet Fixation System. However, it does not contain the information required to answer your specific questions regarding acceptance criteria and the study that proves the device meets those criteria.
This document focuses on regulatory approval, particularly demonstrating substantial equivalence to a previously cleared device (K240085). It mentions "Performance Testing" including "Axial Pullout per ASTM F543" and "Driving Torque per ASTM F543," but it does not provide the acceptance criteria or reported performance data for these tests. It also does not involve any AI or software components, meaning there would be no ground truth, expert review, or MRMC studies involved.
Therefore, I cannot populate the table or provide details for the study as requested. The information is simply not present in the provided text.
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(98 days)
ZygoFix Ltd.
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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