Search Results
Found 3 results
510(k) Data Aggregation
(40 days)
Threshold V2 Pedicular Fixation System, Threshold Pedicular Fixation System, Fortress Pedicular Fixation
System, Palisade Pedicular Fixation System
Spineology Pedicular Fixation Systems are intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients 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); turnor; pseudoarthrosis; and/ or failed previous fusion.
Spineology Fortress™, Threshold™ V2, and Palisade™ Pedicular Fixation Systems consist of screws (titanium alloy), curved and straight rods (see table below for diameters and material), and ConneX™ Connector (see table below for configurations and materials) devices to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. All screws are available with or without a hydroxyapatite coating. These systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The screws can be placed in the pedicles in a variety of trajectories ranging from the standard anatomic transpedicular path projected medially toward the ventral vertebral body, to a caudocephalad path sagittally and a laterally directed path in the transverse plane.
Spineology Connex Cross Connector devices are transversely-placed titanium alloy implants that are intended to connect the rod on one side of a spinal construct to the rod on the other side. These devices are manufactured from titanium alloy and are adjustable to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Connextor devices are intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
Spineology ConneX Rod Connector devices are titanium alloy implants that are intended to connect two rods in a spinal construct. These devices are manufactured from titanium alloy and the components allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Connex Rod Connector devices are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
The Spineology Power Adapter is an instrument accessory intended to facilitate the preparation and placement of pedicle screws using powered instrumentation as an optional alternative to the existing manual technique. The Power Adapter is intended for exclusive use with Spineology Fortress, Threshold, Threshold V2, and Palisade System surgical instruments. The Power Adapter serves as a mechanical interface between the power driver and surgical instruments. When the Power Adapter is attached, the power driver provides appropriate power to rotate the surgical instrument for preparation and placement of pedicle screws.
The provided text describes modifications to existing pedicular fixation systems and a new power adapter for surgical instrumentation, rather than a standalone AI device with specific acceptance criteria and a study to prove its performance in the typical sense of AI/ML evaluation (e.g., sensitivity, specificity, AUC, etc.).
Therefore, the requested information elements related to AI/ML device evaluation metrics, expert ground truth development, MRMC studies, or training sets are not applicable or derivable from this submission, as the submission pertains to a conventional medical device and not an AI/ML-driven diagnostic or prognostic tool.
However, I can extract the non-clinical testing performed to establish substantial equivalence for the modifications and the new Power Adapter, which functionally serve as "acceptance criteria" and the "study" demonstrating they meet those criteria within the context of a 510(k) submission for a non-AI device.
1. Table of Acceptance Criteria and Reported Device Performance
| Component/Modification | Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|---|
| 4.75mm and 5.5mm Rods | Confirmatory ASTM F1798 Grip Testing | Deemed acceptable (implied as no issues reported) |
| Drawing verification | Deemed acceptable (implied as no issues reported) | |
| Sterilization adoption | Deemed acceptable (implied as no issues reported) | |
| Risk Assessment | Deemed acceptable (implied as no issues reported) | |
| Confirmatory ASTM F1717 (dynamic compression bending) | Deemed acceptable (implied as no issues reported) | |
| Packaging adoption | Deemed acceptable (implied as no issues reported) | |
| Shelf Life adoption | Deemed acceptable (implied as no issues reported) | |
| 4.5mm Pedicle and Reduction Screws | Review, risk assessment, and comparison to cleared equivalent devices (primary design characteristics, materials, manufacturing processes, existing mechanical performance testing, product experience) | Substantially equivalent to predicate devices, no new risks identified |
| 7.5mm Pedicle and Reduction Screws (Additional Lengths) | Review, risk assessment, and comparison to cleared equivalent devices (primary design characteristics, materials, manufacturing processes, existing mechanical performance testing, product experience) | Substantially equivalent to predicate devices, no new risks identified |
| Power Adapter | Strength assessment testing of instrumentation and implantable devices under simulated clinical use conditions | Deemed acceptable (implied as no issues reported) |
| Screw loading and screw insertion during normal use without loss of function | Deemed acceptable (implied as no issues reported) | |
| Compatibility with existing surgical instruments | Deemed acceptable (implied as no issues reported) | |
| Evaluation of quality and accuracy of screw placement in simulated use environment | Deemed acceptable (implied as no issues reported) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated in terms of number of devices tested for each test. The tests are described by type (e.g., ASTM F1798, ASTM F1717, simulated clinical use for the Power Adapter). For screw modifications, "a thorough review, risk assessment, and comparison" was performed.
- Data Provenance: Not specified. Standard mechanical and performance tests (e.g., ASTM standards) are typically conducted in a laboratory setting. The "simulated use environment" for the Power Adapter implies lab-based testing rather than clinical data. No country of origin for data is mentioned. The studies appear to be laboratory-based and prospective in the sense that they were conducted for this specific submission, but not prospective clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is a conventional medical device submission, not an AI/ML device relying on expert-annotated "ground truth" for performance evaluation. The "ground truth" is typically defined by engineering specifications, material properties, and adherence to performance standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not an AI/ML device requiring human adjudication of results from a diagnostic or prognostic algorithm.
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 not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device and an instrument accessory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the rods: Engineering specifications, material properties, and established mechanical testing standards (ASTM F1798, ASTM F1717).
- For the pedicle screws: Comparison to the primary design characteristics, materials, manufacturing processes, existing mechanical performance testing, and product experience of already cleared equivalent devices.
- For the Power Adapter: Functional performance in simulated use conditions, adherence to mechanical and functional specifications (e.g., screw loading, screw insertion, compatibility).
8. The sample size for the training set
- Not applicable. There is no AI/ML component, and therefore no "training set."
9. How the ground truth for the training set was established
- Not applicable. Since there is no training set, there is no ground truth established for it.
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(77 days)
Fortress Pedicular Fixation System
The Spineology Fortress™ Pedicular Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients 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; pseudoarthrosis; and/ or failed previous fusion.
The Spineology Fortress Pedicular Fixation System consists of screws (titanium alloy), curved and straight rods (cobalt chrome), adjustable ConneX Cross Connector (titanium alloy), and fixed ConneX Rod Connector (titanium alloy) devices to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Fortress System screws are available with or without a hydroxyapatite coating. The system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The screws can be placed in the pedicles in a variety of trajectories ranging from the standard anatomic transpedicular path projected medially toward the ventral vertebral body, to a caudocephalad path sagittally and a laterally directed path in the transverse plane.
Spineology Connex Cross Connector devices are transversely-placed implants that are intended to connect the rod on one side of the spinal construct to the rod on the other side. These devices are manufactured from titanium alloy and are adjustable to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. ConneX Cross Connector devices are intended to be used with Spineology's Fortress™, Threshold V2™, and Palisade™ Pedicular Fixation Systems which are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
Spineology Connex Rod Connector devices are implants that are intended to connect two rods in a spinal construct. These devices are manufactured from titanium alloy and the components allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Connex Rod Connector devices are intended to be used with Spineology's Fortress™, Threshold™, Threshold V2™, and Palisade™ Pedicular Fixation Systems which are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
The provided document is a 510(k) clearance letter for a medical device called the "Fortress™ Pedicular Fixation System." This type of document is for device clearance, not a study proving the device meets acceptance criteria.
The 510(k) process in the US FDA framework establishes "substantial equivalence" to a legally marketed predicate device, rather than requiring new clinical studies to prove effectiveness or safety from scratch, especially for Class II devices like this one.
Therefore, many of the requested details about acceptance criteria, efficacy studies, sample sizes, ground truth, and expert involvement are not applicable to this document or the 510(k) clearance process described. This document focuses on demonstrating that new components added to an existing system are "substantially equivalent" to already-cleared devices, primarily through non-clinical (mechanical) testing.
Here's how to address your questions based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document does not explicitly state "acceptance criteria" in terms of specific performance thresholds for clinical outcomes. Instead, the "acceptance criteria" for the 510(k) clearance are implicitly demonstrating substantial equivalence to predicate devices through mechanical testing. The core "acceptance" is that the device behaves mechanically similarly to other cleared spinal fixation systems.
- Reported Device Performance: The document doesn't provide specific numerical performance results from the mechanical tests (e.g., specific bending strength values). It only lists the tests performed and states that the devices "have been shown to be substantially equivalent."
Since specific numerical acceptance criteria and performance data are not detailed in this regulatory document, a table cannot be constructed with these specifics. The document simply confirms that mechanical testing (ASTM F1717, ASTM F1798, ASTM F2193, and Bacterial Endotoxin Testing) was conducted according to FDA guidance and applicable standards, and the conclusion was that the devices are "substantially equivalent."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for the mechanical tests. Mechanical testing typically uses a certain number of representative samples for each test condition, but the exact count is not given in this summary document.
- Data Provenance: The testing appears to be non-clinical (mechanical and endotoxin) rather than human subject data. Therefore, "country of origin of the data" and "retrospective or prospective" are not applicable. The tests were conducted according to US FDA Guidance and ASTM standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable. The "test set" here refers to mechanical testing of physical device components, not diagnostic or clinical data requiring expert interpretation or "ground truth" establishment in a biological sense. The "ground truth" for mechanical testing is derived from engineering principles and standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or expert review panels for clinical data, not for mechanical laboratory testing of device components.
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 question is not applicable. This document is about a spinal fixation system (physical implant for surgery), not an AI/imaging diagnostic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable. This document is about a spinal fixation system (physical implant), not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical testing comprises the established mechanical properties and safety profiles (e.g., sterilization/biocompatibility) required for spinal implant components, as defined by FDA guidance and
ASTM standards (e.g., F1717, F1798, F2193, ANSI/AAMI ST-72). There isn't "expert consensus" or "pathology" in the typical sense for this type of device clearance.
8. The sample size for the training set
- This question is not applicable. This is not a machine learning or AI device, so there is no "training set."
9. How the ground truth for the training set was established
- This question is not applicable. As there is no training set for this type of device, there is no ground truth to establish for one.
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(30 days)
Fortress Pedicular Fixation System
The Spineology Fortress™ Pedicular Fixation System 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 and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.
The Spineology Fortress™ Pedicular Fixation System consists of screws (titanium) and rods (cobalt chrome) to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Fortress System screws are available with or without hydroxyapatite coating. The system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The devices are provided sterile. The associated instruments are provided non-sterile.
The provided text describes a 510(k) premarket notification for a medical device called the "Fortress™ Pedicular Fixation System." This document is a regulatory approval, and as such, it focuses on demonstrating "substantial equivalence" to predicate devices rather than proving performance against specific acceptance criteria in the manner one might expect for a new AI/software device.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software device is not directly applicable or available in the provided text.
Here's why and what information is available:
- Type of Device: The Fortress™ Pedicular Fixation System is a physical medical implant (pedicle screws and rods) used in spinal fusion surgery. It's not an AI or software device that processes data or makes diagnostic/predictive outputs.
- Regulatory Pathway: The 510(k) pathway is for devices that are "substantially equivalent" to legally marketed predicate devices. This means the primary goal is to show that the new device has the same intended use, technological characteristics, and safety and effectiveness as a previously cleared device. It does not typically involve the kind of performance studies with acceptance criteria, test sets, ground truth, and expert adjudication that would be performed for AI/software.
- "Study" in this Context: The "study" mentioned for this device is the "Coating characterization/analyses" and a "risk analysis." These are focused on the physical properties and safety of the hydroxyapatite coating, not on algorithmic performance.
However, I can extract information relevant to the comparison made in the 510(k) process, which functions as the nearest equivalent to "acceptance criteria" and "proof" in this regulatory context:
1. Table of Acceptance Criteria and Reported Device Performance (as interpreted for a 510(k) submission):
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance (Demonstrated Equivalence) |
|---|---|
| Intended Use: Same as predicate device(s). | The Fortress™ Pedicular Fixation System is for posterior, non-cervical fixation as an adjunct to fusion for indications like degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and/or failed previous fusion. This matches the intended use of the primary predicate device, Spineology Fortress Pedicle Screw System [K140010]. |
| Technological Characteristics: Same or similar to predicate device(s), with any differences not raising new questions of safety or effectiveness. | The subject screws have a hydroxyapatite coating on the screw threads. The base material, thread form, and screw sizes are the same as the predicate devices. The technological characteristics are stated to remain the same as the predicate devices with respect to intended use, indications for use, design, fundamental technology, and operational principles, except for the addition of the HA coating. (The coating characterization/analyses were provided to support the safety and effectiveness of this specific technological difference). |
| Performance (Safety & Effectiveness): Demonstrated through physical/material testing and risk analysis, showing equivalence to predicate(s). | "Coating characterization/analyses were provided." "The results of a risk analysis support a determination that the device is substantially equivalent to the identified predicate devices." This implies that the testing performed demonstrated that the HA coating did not compromise the safety or effectiveness, and likely met relevant mechanical or biocompatibility standards comparable to the predicate. |
Regarding the specific questions about an AI/software device:
- Sample size for the test set and data provenance: Not applicable. This is not an AI/software device. The "test set" would be the samples of the physical device or its components used for mechanical, material, or biocompatibility testing. The document does not specify sample sizes for these tests. Data provenance would refer to the materials/components themselves.
- Number of experts used to establish ground truth & qualifications: Not applicable. No "ground truth" (in the AI/clinical data sense) was established by experts for this device. The evaluation is based on engineering specifications, material science, and regulatory comparison.
- Adjudication method: Not applicable. There is no clinical data or expert interpretation requiring adjudication mentioned.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic or imaging device.
- Standalone (algorithm-only) performance: Not applicable. This is a physical implant, not an algorithm.
- Type of ground truth used: Not applicable in the AI sense. Ground truth in this context would implicitly be established engineering standards, material properties, and biocompatibility requirements for spinal implants.
- Sample size for the training set: Not applicable. This is not a machine learning model.
- How ground truth for the training set was established: Not applicable.
In summary, the provided document details the regulatory clearance of a physical medical device (spinal implant) via the 510(k) pathway, which focuses on demonstrating substantial equivalence to predicate devices, not on the performance criteria and studies typical for AI/software devices.
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