Search Results

Solstice CCI is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The Solstice CCI is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, The Solstice CCI may be connected to the titanium Life Spine NAUTILUS Spine System using the 3.5mm/5.5mm titanium parallel connectors.

The Solstice CCI 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, hooks, connectors, rods, and locking caps.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Solstice CCI components with components from any other system or manufacturer. The components should never be reused under any circumstances.

The provided FDA 510(k) clearance letter and summary for the Solstice CCI device primarily focus on mechanical and material equivalency to predicate devices, rather than an AI/ML-driven diagnostic or assistive technology. Therefore, the typical acceptance criteria and study designs associated with AI performance (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by expert consensus) are not applicable to this device submission.

The "Performance Data" section explicitly states:

"The Solstice CCI was tested according to ASTM F2706 which included Static & Dynamic Axial Compression Bending and Torsion."

This indicates that the performance evaluation was primarily mechanical testing to ensure the device's structural integrity and ability to function as intended, rather than its diagnostic accuracy or impact on human reading performance.

Given this, I cannot extract the information requested in your prompt regarding acceptance criteria and study design for an AI/ML medical device.

If this were an AI/ML device submission, the requested information would typically look like this (illustrative example based on common AI/ML diagnostic device submissions):

Hypothetical Example for an AI/ML Device (NOT based on the provided document)

Let's imagine, for the sake of demonstrating the requested output, that the Solstice CCI was an AI-driven system designed to detect spinal fractures from medical images.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: 1500 medical images (e.g., CT scans of the spine).
• Data Provenance: Retrospective data collected from multiple institutions across the United States (e.g., university hospitals, large medical centers). Data diversity included varying scanner types, patient demographics, and image acquisition protocols.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: 3 board-certified radiologists.
• Qualifications: Each radiologist had at least 10 years of experience specializing in musculoskeletal or neuroradiology and had previously participated in consensus reading studies.

4. Adjudication method for the test set

• Adjudication Method: 2+1; All cases were independently reviewed by two primary radiologists. In cases of disagreement between the two primary readers, a third, senior radiologist acted as an arbiter to establish the final ground truth.

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

• MRMC Study: Yes, an observer performance study was conducted.
• Effect Size: Human readers demonstrated a statistically significant improvement in fracture detection accuracy (measured by AUROC) when assisted by the AI algorithm compared to reading without AI assistance. The average AUROC for human readers increased from 0.85 (without AI) to 0.91 (with AI assistance), representing an improvement of 0.06 AUROC points (p < 0.001). This translated to a 15% reduction in missed fractures and a 10% reduction in false positives.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Yes, the standalone performance of the AI algorithm was evaluated independently against the established ground truth on the test set. (See table in section 1 for metrics).

7. The type of ground truth used

• Type of Ground Truth: Expert Consensus (Radiologist Consensus). In some challenging cases, correlation with pathology reports (e.g., for surgical samples from confirmed fractures) or follow-up clinical outcomes (e.g., imaging at later time points) was used to support consensus.

8. The sample size for the training set

• Training Set Sample Size: 50,000 medical images (CT scans).

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Ground truth for the training set was primarily established through a combination of radiological reports and labels provided by a team of experienced radiologists (different from the test set readers). A subset of these images (e.g., 5-10%) underwent a more rigorous internal consensus review process (e.g., by 2-3 radiologists) to ensure high-quality labeling for critical cases or ambiguous findings. Automated methods, where clinically robust (e.g., based on structured reports or PACS annotations), might also be used to augment initial labeling.

Ask a specific question about this device

1. Solstice™ SRS Immobilization System (when used with customizable cushion):

The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the head, brain, and neck, including Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Surface Guided Radiation Therapy (SGRT) and electron, photon treatments. The device is also used during image acquisition. including Computed Tomography (CT), to support treatment planning.

2. Solstice™ SRS Immobilization System (when used with headrest):

The device is indicated to position and/or immobilize adult and pediatic patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT), to support treatment planning.

3. Solstat™ Immobilization System & Solstice™ Thermoplastic Mask:

The device is indicated to position and/or immobilize adult and pediatic patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT) Magnetic Resonance (MR) Imaging, to support treatment planning.

The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and the locking level allows the bowl to be tilted up to 10º in relation to the baseplate at infinite intervals. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can immobilize the patient to under 1 millimeters. The provider can correct the patient position for simulation and treatments by tilting the device.

The Static Head Fixation (Solstat) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and cannot be tilted. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can reproduce the patient position to under 3 millimeters within a treatment cycle.

The Open-Face Thermoplastic mask is comprised of a thermoplastic mask bonded with a frame. The frame has five swivel clamps that allow secure attachment onto either the Solstice or Solstat device. When heated, the thermoplastic mask can be formed around the patient anatomy and allows the Region of Interest (ROI) to be capture by camera systems, allowing Surface Guided Radiation Therapy to occur via camera systems. The same mask will be used throughout the course of the treatment. The Open-Face style mask is ideal for Surface Guided Radiation Therapy (SGRT) via camera systems.

The Solstice Immobilization device and Solstat Immobilization device are reusable devices that are provided non-sterile. Solstat and Solstice thermoplastic are single-patient reusable and is provided non-sterile and manufactured of non-magnetic materials. The devices are used in a healthcare facility/hospital. All devices are intended to be used on adult and pediatric patients.

The provided text describes premarket notification K182079 for the Solstice™ SRS Immobilization System/Solstat™ Immobilization System/Solstice™ Thermoplastic Mask. It does not contain information about a study proving the device meets acceptance criteria in the manner requested, particularly regarding clinical effectiveness studies involving human readers or expert consensus on ground truth.

However, it does provide acceptance criteria related to device performance in terms of patient immobilization accuracy, which is substantiated by non-clinical testing.

Here's an attempt to extract and frame the available information in the requested format, clearly stating where information is "Not Applicable" or "Not Provided" based on the document:

Device: Solstice™ SRS Immobilization System / Solstat™ Immobilization System / Solstice™ Thermoplastic Mask

Purpose of Testing (Non-Clinical): To substantiate the immobilization performance for Stereotactic Radiosurgery (SRS) and Stereotactic Radiotherapy (SRT), and suitability for Surface Guided Radiation Therapy (SGRT) and MRI compatibility.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated for the non-clinical tests. The data points presented for the Solstice device are statistical confidence intervals (99.73% and 95.45%), but the raw number of measurements or repetitions for these tests is not provided.
• Data Provenance: Non-clinical testing data; likely internal laboratory testing (MEDTEC Inc. dba CIVCO MEDICAL SOLUTIONS). The country of origin and whether it was retrospective or prospective is not specified, but non-clinical tests are generally prospective.

3. Number of Experts Used to Establish the Ground Truth and Qualifications

• Not Applicable / Not Provided. The "ground truth" for these performance claims appears to be derived from physical measurements using camera systems (e.g., VisionRT's AlignRT system) and standard test methods (e.g., ASTM F2119-07 for MR safety), rather than human expert interpretation of medical images.

4. Adjudication Method for the Test Set

• Not Applicable / Not Provided. This concept (2+1, 3+1, none) typically applies to human reader studies where expert disagreement on ground truth needs resolution. Here, it's about physical performance measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study was not conducted as this is a device for patient immobilization and positioning, not an AI image analysis device requiring human-in-the-loop performance evaluation.

6. Standalone (Algorithm Only) Performance

• Not Applicable. The device itself is a physical immobilization system. The "performance" relates to its mechanical stability and ability to maintain patient position, measured non-clinically. It does not employ an algorithm in the sense of AI for diagnostic or clinical decision support.

7. Type of Ground Truth Used

• Physical Measurements and Standard Test Methods.
  • For Solstice: Intrafraction movement measured by camera systems (e.g., VisionRT's AlignRT system).
  • For Solstat MRI safety: Compliance with ASTM F2119-07.

8. Sample Size for the Training Set

• Not Applicable / Not Provided. There is no "training set" in the context of this physical device's non-clinical performance evaluation. This concept is relevant for machine learning models.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable / Not Provided. See point 8.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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:

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.

Ask a specific question about this device

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

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.

Ask a specific question about this device

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.

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.

Ask a specific question about this device