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510(k) Data Aggregation
(29 days)
EXACTECH SARASOTA
When intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine.
The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. Polyaxial screws are not intended to be placed in the cervical spine.
This system can be used independently or in conjunction with Exactech 5.5mm or 6.0mm rod-based Thoraco-Lumbar Pedicle Screw Systems.
Gibralt Rod-to-Rod Cross Connectors represent a line extension to the Gibralt Spinal System. The Gibralt Spinal System is a top-loading spinal fixation system comprising a range of polyaxial screws, rods, hooks, and various connectors. Gibralt Spinal System devices are used by surgeons to immobilize and stabilize spinal segments as an adjunct to fusion of the cervical and/or upper thoracic spine.
As with other Gibralt System cross-connectors, Gibralt Rod-to-Rod Cross Connectors are designed to increase the rigidity of Gibralt Spinal System constructs. Gibralt Rod-to-Rod Cross Connectors can be used at any point along a Gibralt Spinal System rod, where previous cross connectors can only be used at connection points in a system construct. This line extension is proposed to provide surgeons with additional options for stabilizing and/or immobilizing spinal segments as an adjunct to spinal fusion.
Like all Gibralt Spinal System components, the proposed Gibralt Rod-to-Rod Cross Connectors are manufactured from titanium alloy per ASTM F136. All implantable Gibralt Spinal System components are provided non-sterile, and must be steam sterilized by the hospital prior to use.
This document describes a Special 510(k) submission for Exactech® Gibralt® Rod-to-Rod Cross Connectors, an extension to the Gibralt Spinal System. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device through mechanical bench testing.
Here's the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test) | Performance Outcome |
|---|---|
| Static compression bending (ASTM F1717-13) | Assessed; deemed substantially equivalent to predicate |
| Dynamic compression bend strength (ASTM F1717-13) | Assessed; deemed substantially equivalent to predicate |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for the bench testing. It indicates the tests were conducted per ASTM F1717-13, a standard for testing spinal fixation devices, which would implicitly define testing protocols and sample sizes. The data provenance is mechanical bench testing, not human or animal data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this device is based on mechanical properties and performance against established ASTM standards, not on expert clinical interpretation.
4. Adjudication method for the test set
Not applicable, as this was mechanical bench testing against a standard, not a clinical study requiring human adjudication.
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
Not applicable. This is a medical device (spinal implant components), not an AI-assisted diagnostic or predictive tool, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable as this is a medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" is defined by the performance requirements outlined in ASTM F1717-13 for static compression bending and dynamic compression bend strength, as well as comparison to the performance of the predicate device (Gibralt Spinal System).
8. The sample size for the training set
Not applicable. This is a medical device, not a machine learning model; therefore, there is no "training set."
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 submission.
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(48 days)
EXACTECH SARASOTA
The OPTETRAK Logic Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
In the USA, the OPTETRAK Logic Total Knee System is indicated for cemented use only.
The proposed Optetrak Logic PSC Tibial Insert devices represent modifications to existing Optetrak Logic Total Knee System components (K093360). Both proposed and predicate devices are made from the same materials using the same processes and are compatible with the same Optetrak Logic tibial trays and femoral components. The proposed Logic PSC devices combine the articulating geometry and locking features of predicate Optetrak Logic posterior stabilized inserts with a central spine that is slightly thicker in the medial/lateral dimensions, intended to provide surgeons with an option for treating patients with minor ligament laxity by introducing 2°-3° more varus/valgus constraint than the predicate.
The proposed and predicate devices have the same intended use and basic fundamental scientific technology and share the following similarities:
- . the same indications for use
- . similar design features
- . the same shelf life
- are packaged and sterilized using the same materials and processes. .
The provided content describes a medical device submission (Exactech® Optetrak® Logic™ PSC Tibial Insert Special 510(k)) and its path to clearance, not a study specifically designed to assess and report on acceptance criteria and device performance in the manner of AI/software or diagnostic devices.
Therefore, many of the requested points, such as sample sizes for test sets and training sets, the number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for training, are not applicable to this submission as it focuses on demonstrating substantial equivalence for a physical medical implant through engineering and cadaveric assessments rather than clinical performance metrics in the way a diagnostic AI would be evaluated.
However, I can extract the information that is present and explain the type of study conducted within the context of demonstrating substantial equivalence for a medical device (knee implant insert) based on design modifications.
1. Table of Acceptance Criteria and Reported Device Performance
- Note: The "acceptance criteria" here are implicitly related to the design and performance characteristics that ensure the modified device is substantially equivalent to the predicate device and safe/effective for its intended use. There are no explicit quantitative acceptance criteria defined as you might find for a diagnostic test. Instead, the "performance" is a demonstration of how the modified device maintains or improves upon the predicate's characteristics.
| Evaluation Area | Activities Performed & "Acceptance Criteria" (Implicit) | Reported Device Performance |
|---|---|---|
| Logic PSC tibial spine shear strength | Implicit: Demonstrating shear strength is maintained or enhanced compared to predicate. Activities: Review of predicate designs for clinical performance and resistance to shear forces; Engineering drawing comparison of Logic PSC spine dimensions to predicate designs with successful clinical performance. | The summary concludes that "Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Optetrak Logic PSC Tibial Insert devices are substantially equivalent to cleared predicate Optetrak Logic posterior stabilized tibial insert devices." This implies the shear strength was found to be acceptable relative to the predicate. |
| Logic PSC/mating femoral component compatibility | Implicit: Ensuring proper fit and articulation. Activities: Cadaver laboratory assessment; Review of predicate designs for clinical performance; Engineering drawing comparison of Logic PSC dimensions to predicate designs that successfully mate with the same components. | Substantially equivalent to predicate, implying successful compatibility. |
| Logic PSC varus/valgus constraint | Implicit: Achieve desired 2°-3° more varus/valgus constraint while maintaining safety. Activities: Cadaver laboratory assessment; Engineering drawing comparison of Logic PSC dimensions to predicate designs that successfully mate with the same components. | Substantially equivalent to predicate, confirming the intended increased constraint is achieved and is acceptable. |
| Logic PSC internal/external constraint | Implicit: Maintaining appropriate internal/external constraint. Activities: Cadaver laboratory assessment; Engineering drawing comparison of Logic PSC dimensions to predicate designs that successfully mate with the same components. | Substantially equivalent to predicate, indicating acceptable internal/external constraint. |
| Logic PSC tibial spine/mating femoral component clearance | Implicit: Ensuring no impingement or adverse interaction. Activities: Review of predicate designs for clinical performance; Engineering drawing comparison of Logic PSC spine dimensions to predicate designs with successful clinical performance. | Substantially equivalent to predicate, implying adequate clearance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of "cases" or "patients."
- For cadaver evaluations, the sample size would be the number of cadaveric knees used, which is not disclosed in this summary.
- For engineering drawing comparisons, it would involve the design specifications of the proposed device and relevant predicate devices.
- Data Provenance: The data comes from internal "engineering studies," "cadaver laboratory assessment," and a "review of predicate designs for clinical performance." This suggests a combination of prospective experimental testing (cadaver lab) and retrospective analysis (review of predicate clinical performance and engineering drawings). The country of origin of the data is not specified beyond being generated by Exactech® Inc. in Gainesville, Florida, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This type of detail is not applicable or provided for this submission. The "ground truth" here is established by engineering principles, biomechanical testing (cadaver lab), and comparison to a legally marketed predicate device's design and known clinical history. There were no "experts" in the sense of clinicians establishing diagnostic ground truth on a set of patient data as might be found in an AI/diagnostic device study.
4. Adjudication Method for the Test Set
- Not applicable. There was no "test set" in the sense of clinical cases requiring expert adjudication. The assessments were primarily engineering and biomechanical.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where multiple human readers evaluate cases with and without AI assistance. This submission is for a physical medical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. There is no algorithm or AI component in this medical device submission.
7. The Type of Ground Truth Used
- The "ground truth" is established through:
- Engineering specifications and measurements: Comparing dimensions and design features to ensure specific characteristics (e.g., spine thickness, clearances) and to assess compatibility.
- Biomechanical testing: Cadaver laboratory assessments to directly evaluate functionality such as varus/valgus constraint and compatibility.
- Predicate device's established safety and effectiveness: The underlying "ground truth" for demonstrating substantial equivalence is the prior legal marketing and presumably safe performance of the predicate device (Optetrak Logic Total Knee System K093360). The new device is shown to be similar in design and performance.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not a machine learning or AI device. The design (analogous to a "trained" entity) is based on existing engineering knowledge, predicate device designs, and biomechanical principles.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there's no training set, there's no ground truth process for it. The "ground truth" for the design process would be established through established biomechanical principles, materials science, and the clinical outcomes/performance of previously cleared devices.
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