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510(k) Data Aggregation
(83 days)
The Illico MIS Posterior Fixation System is intended for posterior, non-cervical, spinal fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. It is intended to provide stabilization during the development of fusion utilizing autograft or allograft bone graft. It is intended that this device, in any system configuration, be removed after development of solid fusion mass.
The Illico MIS Posterior Fixation System is a Noncervical Pedicle Screw and Rod System intended to facilitate the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The Illico MIS Posterior Fixation System provides implants and instruments for percutaneous and "mini-open" access and includes:
- Non-cannulated titanium polyaxial pedicle screws assemblies .
- Cannulated titanium polyaxial pedicle screws assemblies .
- Titanium set screws .
- Titanium and Cobalt Chrome rods ●
- Instrumentation unique to the Illico MIS Systems .
The provided text describes the Illico MIS Posterior Fixation System, a pedicle screw system, seeking 510(k) clearance. The document focuses on establishing substantial equivalence to previously cleared devices through non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method (Acceptance Criteria) | Reported Device Performance |
|---|---|
| ASTM F-1717 (Dynamic Compression) | Met acceptance criteria |
| ASTM F-1717 (Static Compression) | Met acceptance criteria |
| ASTM F-1717 (Static Torsion) | Met acceptance criteria |
| Overall Comparison to Predicate | Comparable to predicate device |
2. Sample size used for the test set and the data provenance:
The document states "Construct testing was conducted in accordance with ASTM F-1717". While it indicates the type of testing performed, it does not specify the sample size used for these tests. Data provenance is not explicitly mentioned, but as the tests were conducted for a US 510(k) submission, it is implied that the testing was carried out in a controlled laboratory setting (likely in the US) and is prospective in nature for the purpose of demonstrating device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this submission. The "ground truth" for the non-clinical performance testing is established by the specifications and pass/fail criteria defined within the ASTM F-1717 standard itself, not by expert consensus on clinical data.
4. Adjudication method for the test set:
This information is not applicable. As these are non-clinical engineering tests, the results are objectively measured against pre-defined engineering criteria, rather than requiring adjudication by experts.
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:
This is not applicable. The submission is for a medical device (pedicle screw system), not an AI-powered diagnostic or interpretive tool. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable. The device is a surgical implant, not an algorithm.
7. The type of ground truth used:
The "ground truth" for the non-clinical performance testing is the established engineering specifications and performance criteria defined by the ASTM F-1717 standard for spinal implant constructs.
8. The sample size for the training set:
This information is not applicable. There is no "training set" in the context of this type of non-clinical, mechanical performance evaluation for a pedicle screw system.
9. How the ground truth for the training set was established:
This information is not applicable. As there is no training set, there is no ground truth for it to be established.
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(63 days)
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthritis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.
With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.
The CD HORIZON SPIRE™ Plate is a posterior, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (as previously defined); spondylolisthesis, trauma; and/or tumor.
In order to achieve additional levels of fixation as an adjunct to fusion, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.
The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
Certain implant components from other Medtronic spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washer, GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors: LIBERTY®rods and screws: DYNALOK® PLUS and DYNALOK CLASSIC® bolts along with rod/bolt connectors: and Medtronic Multi-Axial rods and screws. Please note that certain components are specifically designed to connect to 03.5mm, 04.5mm, 05.5mm rods or 06.35mm rods, while other components can connect to both Ø5.5mm rods and Ø6.35mm rods. Care should be taken so that the correct components are used in the spinal construct.
CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and associated screws are intended for anterior use only. However, for patients of smaller stature, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.
The CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, medical grade cobaltchromium-molybdenum alloy, or medical grade PEEK OPTIMA-LT1. Certain CD HORIZON® Spinal System components may be coated with hydroxyapatite.
Never use stainless steel and titanium implant components in the same construct.
Medical grade titanium, titanium alloy and/or medical grade cobalt-chromiummolybdenum alloy may be used together. Never use titanium, titanium alloy and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct.
The provided document is a 510(k) summary for the
CD HORIZON® Spinal System. This type of regulatory submission is for a medical device and is not a study that proves a device meets acceptance criteria in the typical sense of a clinical trial or algorithm performance study.
Instead, the document focuses on demonstrating substantial equivalence to previously approved predicate devices, which is the primary requirement for 510(k) clearance. Substantial equivalence means the new device is as safe and effective as a legally marketed device (predicate device).
Therefore, the requested information categories related to acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training sets are not directly applicable to this type of document because it is not a clinical study or an AI/algorithm performance study.
However, I can extract information related to the demonstration of substantial equivalence, which serves a similar purpose in the regulatory context of this device.
Here's a breakdown of the available information in the context of your request:
I. Acceptance Criteria and Device Performance
The "acceptance criteria" in this context are not quantitative performance metrics as in a clinical trial. Instead, the acceptance criterion for a 510(k) submission is to demonstrate substantial equivalence to predicate devices. This is achieved by showing that the new device has "similar technological characteristics" and is "as safe and effective" as the predicate.
The "reported device performance" is not given as numerical results from a clinical study, but rather implied through mechanical testing and risk analysis compared to predicate devices.
| Acceptance Criterion (Regulatory) | Reported "Device Performance" (Demonstration of Substantial Equivalence) |
|---|---|
| Demonstration of Substantial Equivalence (Safety and Effectiveness) to Predicate Devices | "Documentation, including mechanical test results and a risk analysis, was provided which demonstrated that the subject CD HORIZON® Spinal System devices are substantially equivalent to predicate CD HORIZON® Spinal System rods and associated connecting and fixation components (K042025 SE 08/25/04, K030840 SE 05/15/03, K031655 SE 06/27/03. K032265 SE 08/11/03. K033322 SE 12/15/03. K042167 SE 09/08/04. K043488 SE 03/22/05, K050439 SE 03/24/05, K050809 SE 06/14/05, K053474 SE01/09/05. K061579 SE 08/11/06. K061591 SE 09/08/06. K082236 SE 10/10/08. K090390 SE 05/15/09, K091442 SE 07/15/09) and TSRH® Spinal System screws (K052054 SE 08/19/05)." The new components (4.75mm diameter rods and associated connecting and fixation components) are fabricated from "medical grade titanium, titanium alloy and/or grade cobalt-chromium-molybdenum alloy," which are materials used in predicate devices. The indications for use are also largely consistent with those of the predicate devices. |
II. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. This document refers to mechanical testing and risk analysis, not a clinical "test set" of patients or data in the way an AI algorithm study would. The focus is on the new components themselves.
- Data Provenance: The document does not specify country of origin for the mechanical test data. It is a regulatory submission to the US FDA. The "study" is a collection of engineering tests and a risk analysis, not a clinical data study. It is retrospective in the sense that it evaluates new components against established predicate devices and materials.
III. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. This is not a study requiring expert clinical review to establish ground truth. Substantial equivalence is determined by regulatory bodies (FDA) based on submitted engineering data and comparison to predicates.
- Qualifications of Experts: N/A.
IV. Adjudication method for the test set
- Adjudication Method: Not applicable. No clinical test set or subjective interpretations requiring adjudication are mentioned.
V. 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 Study: Not applicable. This is a spinal implant system, not an AI diagnostic tool.
VI. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device (spinal implant), not an algorithm.
VII. The type of ground truth used
- Ground Truth Type: Not applicable in the traditional sense of a clinical study. For a medical device 510(k), the "ground truth" for demonstrating safety and effectiveness relies on established engineering principles, material science, biomechanical testing standards, and the history of safe and effective use of the predicate devices.
VIII. The sample size for the training set
- Training Set Sample Size: Not applicable. No training set is relevant for this type of device submission.
IX. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
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