Search Results
Found 2 results
510(k) Data Aggregation
(335 days)
The Athena Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. The system is intended for posterior, pedicle fixation as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (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; pseudoarthrosis; and failed previous fusion.
The Athena Pedicle Screw System is comprised of polyaxial pedicle screws in various diameters and lengths, spinal rods in various lengths, cross-connectors and set screws. The Athena Pedicle Screw System can be used for single or multiple level fixations. All implant components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static and dynamic axial compression bending testing per ASTM F1717 | Performed; results demonstrate substantial equivalence to predicate devices. |
| Static torsion testing per ASTM F1717 | Performed; results demonstrate substantial equivalence to predicate devices. |
| Use of titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 | Device manufactured from this material, consistent with predicates. |
| Same intended use as predicate devices | Confirmed. |
| Similar primary implant design as predicate devices | Confirmed. |
| Equivalent material of manufacture as predicate devices | Confirmed. |
| Overall substantial equivalence to predicate devices | Concluded based on non-clinical testing and shared characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes non-clinical mechanical testing of the device components. It does not refer to a "test set" in the context of patient data or clinical trials. Therefore, information regarding sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable to this type of study as described. The testing involves physical samples of the pedicle screw system components.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Given this is a non-clinical mechanical performance study rather than a clinical study evaluating diagnostic or treatment outcomes, there were no experts used to establish ground truth in the way one would for clinical data interpretation. The "ground truth" for this study is defined by the established standards of ASTM F1717 for mechanical testing. Compliance with these standards is objectively measured.
4. Adjudication Method
Since no experts were establishing ground truth for a clinical test set, an adjudication method is not applicable. The testing involves objective physical measurements against established engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This submission focuses on the mechanical substantial equivalence of a medical implant, not the effectiveness of a diagnostic or treatment method involving human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone "algorithm only" performance study was not done. This is a physical medical device, not a software algorithm. The "standalone performance" here refers to the mechanical integrity of the device components in isolation (i.e., without being implanted in a patient, but using standardized test fixtures). The study conducted was precisely that – standalone mechanical testing of the device components.
7. The Type of Ground Truth Used
The "ground truth" used for this study is based on established engineering standards (ASTM F1717) for mechanical performance and material specifications (ASTM F136). The performance of the Athena Pedicle Screw System was compared directly against these standards and to the mechanical performance of predicate devices that previously met these standards.
8. The Sample Size for the Training Set
Since this is a non-clinical mechanical study rather than a machine learning or clinical study, the concept of a "training set" is not applicable. The device's design is developed through engineering principles, not through training on a dataset.
9. How the Ground Truth for the Training Set Was Established
As the concept of a "training set" does not apply to this type of study, the question of how ground truth was established for a training set is not applicable. The design and manufacturing processes are validated against engineering specifications and industry standards.
Ask a specific question about this device
(90 days)
The Helena System is indicated for intervertebral body fusion of the lumbar spine, from L2 to Sl, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
The Helena System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of: Lumbar interbody fusion device(s), which may be implanted bi-laterally via a posterior (PLIF) approach; as a single device via a transforaminal (TLIF) approach - as a single device via an anterior (ALIF) approach; or The Helena System implant components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device. The Helena System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
The Helena System is an intervertebral body fusion device made of PEEK Optima LT1 with tantalum markers, designed for lumbar spine fusion from L2 to S1.
1. Acceptance Criteria and Device Performance
The acceptance criteria for the Helena System are based on non-clinical mechanical testing standards, demonstrating substantial equivalence to predicate devices. The device performance, as reported, met these criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static and Dynamic Compression Testing (per ASTM F2077-03) | Substantially equivalent results compared to predicate devices, indicating acceptable mechanical integrity under physiological loads. |
| Subsidence Testing (per ASTM F2267-04) | Substantially equivalent results compared to predicate devices, demonstrating acceptable resistance to subsidence into vertebral endplates. |
| Expulsion Testing (per ASTM Draft Standard F-04.25.02.02) | Substantially equivalent results compared to predicate devices, indicating acceptable resistance to unintentional expulsion from the intervertebral space. |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated in the provided documents. The testing was non-clinical, involving mechanical tests of the device itself rather than patient data.
- Data Provenance: The data is based on laboratory non-clinical testing of the Helena System implants, following specified ASTM standards. No human or animal data provenance (e.g., country of origin, retrospective/prospective) is applicable to this type of testing.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. The ground truth for the non-clinical mechanical tests is based on the performance standards defined by ASTM (American Society for Testing and Materials) specifications, not expert interpretation of medical images or patient data.
4. Adjudication Method for the Test Set
Not applicable. As the testing involved mechanical measurements against predefined standards, there was no need for expert adjudication. The results are quantitative and objective.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or mentioned. This type of study is relevant for imaging-based diagnostic or prognostic AI tools that involve human interpretation, not for mechanical orthopedic implants.
6. Standalone Performance Study
A standalone performance study was done in the sense that the device's mechanical properties were tested independently against established standards (ASTM F2077-03, ASTM F2267-04, and ASTM Draft Standard F-04.25.02.02). The "algorithm only" concept is not applicable here as it's a physical medical device. The tests evaluated the device's ability to withstand various forces encountered in the body.
7. Type of Ground Truth Used
The ground truth used was objective engineering standards and performance criteria as defined by the ASTM standards (ASTM F2077-03 for static and dynamic compression, ASTM F2267-04 for subsidence, and ASTM Draft Standard F-04.25.02.02 for expulsion).
8. Sample Size for the Training Set
Not applicable. There is no "training set" in the context of mechanical testing for a physical medical device like this. Machine learning algorithms require training sets, but this regulatory submission concerns a physical implant.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
Ask a specific question about this device
Page 1 of 1