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510(k) Data Aggregation
(252 days)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the SOLSTICE OCT System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; fracture/dislocation: Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.
When used with occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.
The use of thoracic screws is limited to placement in T1-T3 for anchoring the construct only. They are not intended to be placed in the cervical spine.
The hooks and rods are also intended to provide stabilization following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The SOLSTICE OCT System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), multiple component system comprised of a variety of non-sterile, single use implantable components. The system consists of an assortment of occipital plates, occipital bone screws, polyaxial screws, hooks, rods, locking caps and breakaways.
This document is a 510(k) premarket notification for a medical device called the SOLSTICE OCT System. It is an FDA submission for substantial equivalence to legally marketed predicate devices, not a study describing acceptance criteria and device performance in the context of an AI/software as a medical device.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information is not available within this document. The document focuses on regulatory compliance for a physical spinal implant system.
The "Performance Data" section mentions "Mechanical Testing consisting of static and dynamic compression and torsion in accordance with ASTM 2706 as well interconnection testing was presented to show the substantial equivalence of the SOLSTICE OCT System." This refers to physical engineering tests, not clinical or algorithmic performance.
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(146 days)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput – T3), the SOLSTICE OCT System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; fracture/dislocation: Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.
When used with occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.
The use of thoracic screws is limited to placement in T1-T3 for anchoring the construct only. They are not intended to be placed in the cervical spine.
The hooks and rods are also intended to provide stabilization following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The SOLSTICE OCT System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), multiple component system comprised of a variety of non-sterile, single use implantable components. The system consists of an assortment of occipital plates, occipital bone screws, polyaxial screws, hooks, rods, locking caps and breakaways.
The provided text describes the SOLSTICE® OCT System, a spinal fixation system, and its substantial equivalence to predicate devices, but it does not contain a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.
Therefore, I cannot provide the requested information. The document focuses on a mechanical device and its regulatory clearance based on substantial equivalence to existing devices, not on the performance metrics of an AI system.
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(64 days)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the SOLSTICE OCT System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; fracture/dislocation: Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.
When used with occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.
The use of thoracic screws is limited to placement in T1-T3 for anchoring the construct only. They are not intended to be placed in the cervical spine.
The hooks and rods are also intended to provide stabilization following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The SOLSTICE OCT System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), multiple component system comprised of a variety of non-sterile, single use implantable components. The system consists of an assortment of occipital plates, occipital bone screws, polyaxial screws, hooks, connectors, rods, and locking caps.
This document is a 510(k) premarket notification for the SOLSTICE® OCT System, a spinal interlaminal fixation orthosis. The FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices.
Here's the breakdown of the acceptance criteria and study information provided (or lack thereof, as this is a 510(k) and not a clinical study report):
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from this document) | Reported Device Performance (from this document) |
|---|---|
| Mechanical Testing: Static and dynamic compression testing (No specific quantitative criteria provided). | The SOLSTICE OCT System successfully underwent static and dynamic compression testing. |
| Mechanical Testing: Benchtop rod lockup testing (No specific quantitative criteria provided). | The SOLSTICE OCT System successfully underwent benchtop rod lockup testing. |
| Material: Composed of titanium alloy (6AL-4V-ELI per ASTM F 136). | The SOLSTICE OCT System is 6AL-4V-ELI titanium manufactured according to ASTM F136. |
| Substantial Equivalence: Design, materials, indications for use, and sizing are substantially equivalent to predicate device. | The SOLSTICE OCT System is substantially equivalent to the predicate system in terms of design, materials, indications for use and sizing. |
Important Note: This 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting detailed clinical performance metrics against predefined acceptance criteria for a novel device. Therefore, the acceptance criteria are largely related to mechanical performance and material specifications that demonstrate equivalence to the predicate, rather than clinical efficacy endpoints. Specific quantitative thresholds for static/dynamic compression and rod lockup are not provided in this document.
2. Sample size used for the test set and the data provenance:
- This document describes mechanical testing of the device, not a clinical test set with patient data.
- The document does not specify the sample size for the mechanical tests (e.g., number of implant constructs tested).
- Data provenance is not applicable as it's mechanical benchtop testing, not human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This pertains to mechanical testing, not clinical evaluation requiring expert ground truth for patient diagnoses or outcomes.
4. Adjudication method for the test set:
- Not applicable. This pertains to mechanical testing.
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 document is for a spinal implant, which is a physical device, not an AI-powered diagnostic tool. Therefore, MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This document is for a spinal implant, not a standalone algorithm.
7. The type of ground truth used:
- For the mechanical testing, the "ground truth" would be the engineering specifications and standards (e.g., ASTM F136 for material, and potentially other industry standards for static/dynamic compression and rod lockup of spinal instrumentation). The device's performance is compared against these standards or the performance of the predicate device.
8. The sample size for the training set:
- Not applicable. This document describes mechanical testing of a physical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for a machine learning model is involved.
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(182 days)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the SOLSTICE OCT System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.
When used with occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.
The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The hooks, rods, and cross connectors are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The SOLSTICE OCT System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), multiple component system comprised of a variety of non-sterile, single use implantable components. When assembled, the components create a rigid structure providing stabilization and promote spinal fusion. The system consists of an assortment of occipital plates, occipital bone screws, polyaxial screws, hooks, rods, cross connectors and locking breakaways.
Here's a breakdown of the acceptance criteria and study information for the SOLSTICE OCT System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: Must demonstrate substantial equivalency to predicate devices in terms of mechanical stability and robustness for spinal fixation. Specific criteria were for dynamic testing in accordance with ASTM F1717. | Dynamic testing in accordance with ASTM F1717 was presented to demonstrate the substantial equivalency of the SOLSTICE OCT System. |
| Material Composition: Must be manufactured from medical grade titanium alloy (6AL-4V-ELI). | The SOLSTICE OCT System is manufactured from medical grade titanium alloy described by ASTM F136 (Ti 6Al-4V-ELI) implant grade titanium alloy. |
| Indications for Use: Must align with the intended use of predicate devices for promotion of spinal fusion in the cervical spine and occipito-cervico-thoracic junction. | The indication/intended use of the modified device as described in its labeling has not changed from predicate devices. The system is intended for degenerative disc disease, spondylolisthesis, spinal stenosis, fracture/dislocation, Atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The performance data refers to a dynamic testing study, which typically involves mechanical testing rigs rather than human or animal subjects that would generate "data" in the conventional sense of clinical trials.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study presented is a dynamic mechanical test (ASTM F1717) and not a study that requires human interpretation or expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as the study presented is a dynamic mechanical test (ASTM F1717) and does not involve subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The provided information focuses on mechanical performance testing and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
This is not applicable. The device is a physical spinal fixation system, not an algorithm or AI system.
7. Type of Ground Truth Used
The ground truth for this device's performance is established by technical specifications and standards, specifically:
- ASTM F1717: Standard mechanical test method for spinal implant constructs. The "ground truth" is that the device must meet or exceed the performance parameters defined by this standard, or demonstrate comparable performance to predicate devices tested under the same standard.
- ASTM F136: Standard specification for implantable titanium alloy. The "ground truth" is the material composition meeting this standard.
8. Sample Size for the Training Set
This is not applicable as the device is a physical spinal implant system and does not involve AI or machine learning that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8.
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(137 days)
The intended use of the Solstice is for the polymerization of light-cured materials by dental professionals.
The Solstice is a Light Emitting Diode (LED) visible light used for the polymerization of light-cured materials by dental professionals. The Solstice consists of an LED curing handpiece and a charging system. The plastic molded handpiece contains an LED light engine, battery, and printed circuit board containing the electronics. A digital circuit and microprocessor will be utilized to control two (2) different curing modes (10 and 20 seconds). Each mode specifies LED curing output and audible beep timing. The Solstice uses a single pushbutton trigger to activate the LED curing output and select the curing mode.
This document describes the Solstice LED Curing Light, identified by K102621, and its substantial equivalence to the predicate device, Kerr Corporation's Demi. The device is intended for the polymerization of light-cured materials by dental professionals.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria or a direct comparison table for performance metrics between the Solstice and the predicate device. However, it mentions specific performance aspects for which data was submitted to demonstrate substantial equivalence.
| Performance Metric | Acceptance Criteria (Implicit) | Solstice Performance | Study/Proof |
|---|---|---|---|
| Biocompatibility | Non-toxic, non-irritating | Representative resin (similar to handle material) passed biocompatibility tests. | Statement from component manufacturer. |
| Depth of Cure | Comparable to predicate device | Data included in submission demonstrating performance compared to predicate. | Non-Clinical Test Data |
| Irradiance | Appropriate light intensity and peak wavelength for curing dental materials | Data included showing light intensity and peak wavelength. | Non-Clinical Test Data |
| Software Validation | Software functions as intended | Successfully validated. | Non-Clinical Test Data |
| Thermal Management | Does not require a cooling fan (i.e., operates within acceptable temperature limits without external cooling) | Temperature data demonstrated no cooling fan needed. | Non-Clinical Test Data |
| Light Output Stability | Constant light output during curing (unlike predicate which has shifting output) | Emits a constant light output. | Device Description / Non-Clinical Test Data |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of machine learning or AI. Instead, it refers to non-clinical tests conducted on the device itself or representative materials.
- Biocompatibility: "samples from typical production lots of the resin" were tested. No specific number is given.
- Depth of Cure, Irradiance, Thermal Management: Data was generated from testing the Solstice device. The sample size (number of devices, number of measurements) is not provided.
- Data Provenance: All data appears to be prospective and generated by Sybron Dental Specialties Inc. or its component manufacturers in the United States (Orange, CA, where the submitter is located).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a medical instrument, not an AI/ML product where expert-established ground truth for a test set would be relevant. The performance evaluation is based on objective physical and chemical measurements.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this relates to expert review of data for AI/ML models, which is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement
Not applicable. This is a medical device, not an AI/ML diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a physical instrument, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests:
- Biocompatibility: The "ground truth" is established by standard biocompatibility testing protocols, with the definition of "passing" those tests serving as the benchmark.
- Depth of Cure, Irradiance, Thermal Management: The "ground truth" is derived from direct physical measurements of the device's output and behavior, and comparison against established scientific/engineering principles for effective light curing and safety, as well as comparison to the predicate device's known performance.
- Software Validation: The "ground truth" is defined by the software requirements and specifications, with successful validation meaning the software performs according to these predefined criteria.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. See #8.
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