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The Solitaire™ 2 Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IVt-PA) or fail IVt-PA therapy are candidates for treatment.

The Solitaire™ 2 device is designed to restore blood flow in subjects experiencing ischemic stroke due to large intracranial vessel occlusion within 8 hours of symptom onset. It is indicated for subjects who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy. The distal nitinol portion of the device facilitates clot retrieval and has Pt-Ir radiopaque markers on the proximal and distal ends.

This purpose of this application is to add one (1) new model number (SFR2-4-40) to the Solitaire™ 2 Revascularization Device family. The additional model will be identical to the currently cleared Solitaire™ 2 4x20 (SFR2-4-20) model, with the exception of a longer retriever length.

The provided document is a 510(k) summary for the Solitaire™ 2 Revascularization Device, specifically for the addition of a new 4x40mm model (SFR2-4-40). The application aims to demonstrate substantial equivalence to previously cleared Solitaire™ devices. As such, it relies on bench and animal testing rather than a new clinical study. The concept of "acceptance criteria" and "device performance" in the context of this document refers to the results of these non-clinical tests meeting specific thresholds, often in comparison to the predicate device.

Here's the breakdown of the information requested:

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

For this device, "acceptance criteria" are implied by the conclusions that "All devices met acceptance criteria" and that performance was "same as the predicate device" or that findings were "comparable." Specific numerical acceptance criteria are not explicitly detailed in this summary, but the successful conclusions for each test imply they were met.

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

• Bench Testing: The document does not specify the exact sample sizes for each bench test (e.g., number of devices tested for delivery force). It generally states "Samples were measured" or "Samples were evaluated."
• Animal Study Test Set:
  • Sample Size: 12 swine. (6 for acute study, 6 for chronic 30-day study).
  • Provenance: Not explicitly stated (e.g., country of origin for the animals), but it's an animal study conducted by the manufacturer/sponsor (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular) to support the device. It is a prospective study in the sense it was designed and executed for this submission.

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

• Bench Testing: Not applicable. Bench tests rely on direct measurement and established engineering principles, not expert interpretation of data as ground truth for a test set in the same way clinical data would.
• Animal Study: "Usability for the acute and chronic study were assessed by an interventionalist." The number of interventionalists is not specified, nor are their specific qualifications provided beyond the title "interventionalist."

4. Adjudication method for the test set

• Bench Testing: Not applicable. These are objective measurements against internal specifications or predicate device performance.
• Animal Study: No explicit adjudication method (e.g., 2+1, 3+1 consensus) is described for the animal study. The "interventionalist" assessed usability, and histological findings were compared.

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

• No MRMC study was done. This submission is for a medical device (thrombus retriever) that directly treats a condition, not an AI/imaging diagnostic tool that assists human readers.

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

• Not applicable. This device is a physical medical device (thrombus retriever), not an algorithm or AI system. Its performance is evaluated through its mechanical capabilities and biological interaction, not as a standalone algorithm.

7. The type of ground truth used

• Bench Testing: The "ground truth" for bench tests is the objective, physical measurement of device characteristics against pre-defined engineering specifications or direct comparison to the predicate device's measured performance.
• Animal Study: The "ground truth" was established through:
  • Angiographic images: Visual assessment of vessel status.
  • Histopathological evaluation: Microscopic examination of tissue for damage, hemorrhage, and thrombi.
  • Interventionalist assessment: Subjective (but expert-driven) assessment of usability attributes (delivery, positioning, deployment, etc.).

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this device's evaluation, as it is not an AI/machine learning device. The 510(k) process for this type of device relies on demonstrating equivalence through non-clinical (bench and animal) testing to a predicate device, not through training a model on data.

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

• Not applicable. As there is no training set for an AI/ML model, this question is not relevant to this device submission.

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The Solitaire™ 2 Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The Solitaire™ 2 device is designed to restore blood flow in subjects experiencing ischemic stroke due to large intracranial vessel occlusion within 8 hours of symptom onset. It is indicated for subjects who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy. The distal nitinol portion of the device facilitates clot retrieval and has Pt-Ir radiopaque markers on the proximal and distal ends.
The following modifications have been made to the device in support of this application:
• The attachment zone has been redesigned for greater tensile strength.
• The marker band has been redesigned to aid the crimping process.
• The pushwire now contains a fluorosafe marker.
• The Solitaire™ 2 Device uses one piece of PTFE tubing.

This K123378 submission for the Solitaire™ 2 Revascularization Device is a medical device submission for a thrombus retriever, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies for an AI/ML device (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable.

The submission focuses on demonstrating substantial equivalence to a predicate device (Solitaire™ FR Revascularization Device) based on modifications to the device design and subsequent non-clinical bench testing:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a non-clinical bench testing submission for a medical device modification, the "acceptance criteria" are implied by successful completion of the specified tests, demonstrating that the device modifications do not adversely affect its performance compared to the predicate. No specific numerical thresholds (e.g., sensitivity, specificity) for performance are provided as would be expected for an AI/ML diagnostic or prognostic tool.

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

• Test set sample size: Not applicable. These were non-clinical bench tests on the device itself, not clinical data sets. The "sample" would refer to the number of devices or components tested for each parameter. This information is not detailed in the summary provided.
• Data provenance: Not applicable in the context of clinical data. The tests were performed in a lab setting by the manufacturer (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular).

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

• Not applicable. Ground truth in this context typically refers to clinical diagnosis or outcome. For bench testing, the "ground truth" is defined by the engineering specifications and established test methods for device performance parameters.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. This is not a clinical study involving reader 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 not an AI/ML device. No MRMC study was performed.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For this device, the "ground truth" for non-clinical testing is defined by the engineering specifications and performance standards for medical devices of this type, which are assessed through a series of defined bench tests. There is no biological or clinical "ground truth" in the AI/ML sense in this submission.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

In summary, the K123378 submission demonstrates substantial equivalence for the Solitaire™ 2 Revascularization Device primarily through extensive non-clinical bench testing, focusing on the mechanical and physical performance characteristics of the modified device components. It does not involve any AI/ML components or clinical data analyses as would be relevant for the questions posed.

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The Solitaire -C Cervical Spacer System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Cervical degenerative disc disease is defined as intractable radior myclopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Solitaire -C Cervical Spacer is to be used with autograft and implanted via an anterior approach. The Solitaire-C spacer must be implanted with the Solitaire-C titanium screws that are part of the system. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The purpose of this submission is to gain market clearance for the Solitaire-C Cervical Spacer System. The Solitaire -C Cervical Spacer System consists of spacers and bone screws for stand-alone cervical intervertebral body fusion. The Solitaire -C spacer will be available in a variety of sizes, angles and footprints. This cervical spacer has a PEEK main body (PEEK-Optima LT1 per ASTM F-2026) with a titanium faccplate and band (Ti-6Al-4V ELI alloy per ASTM F-136), and tantalum markers (unalloyed tantalum per ASTM F-560). This device accepts titanium bone screws that are available in two diameters and multiple lengths.

The provided text describes a medical device, the Solitaire®-C Cervical Spacer System, and its clearance process. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML device performance.

The document K113796 is a 510(k) summary for a traditional medical device (cervical interbody fusion device), cleared in 2012. The "Performance Data" section details mechanical testing performed on the physical device to ensure its strength and suitability for its intended use, according to ASTM standards. This is standard for orthopedic implants, demonstrating the physical integrity and biocompatibility of the device itself.

There is no mention of an AI/ML component in this device, nor any discussion of diagnostic or prognostic performance metrics that would typically be associated with AI/ML devices (e.g., sensitivity, specificity, AUC). Therefore, the specific information requested about acceptance criteria, reported device performance (in terms of AI metrics), sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, ground truth types, and training set details are not applicable to the provided document.

To directly answer your request based on the absence of such information in the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document discusses mechanical testing to established ASTM standards but does not present acceptance criteria or performance in a table format relevant to AI/ML. Mechanical testing "shows that the mechanical strength of the subject device is sufficient for its intended use," implying it met internal or regulatory mechanical performance criteria, but these are not specified quantitatively.

2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical samples for mechanical testing, not a digital test set for AI/ML.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on physical measurements and compliance with engineering standards, not expert medical interpretation of images or patient data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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. No AI component is described.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No AI component is described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical testing, the "ground truth" is compliance with specified ASTM standards for static and dynamic compression, shear, torsion, subsidence, and expulsion, along with evaluation of screw back out, push through, and interconnection, and wear debris analysis.

8. The sample size for the training set: Not applicable. No AI component is described.

9. How the ground truth for the training set was established: Not applicable. No AI component is described.

In summary, the provided document describes the mechanical performance of a physical orthopedic implant and does not contain the type of information requested about AI/ML device performance and validation.

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The Solitaire™ FR Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The Solitaire™ FR Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The device is intended for use in the neurovasculature such as the internal carotid artery, M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The device is a nitinol self-expanding, fully retrievable, stent-based design that allows for clot retrieval when deployed in occluded target vessels after acute ischemic stroke. The distal nitinol portion of the device facilitates clot retrieval and has Pt-Ir radiopaque markers for visualization on the proximal and distal ends. The device is supplied sterile and is intended for single-use only by physicians trained in interventional neuroradiology and treatment of ischemic stroke.

Here's a summary of the acceptance criteria and study findings for the Solitaire™ FR Revascularization Device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the non-inferiority study design comparing the Solitaire FR device to the predicate Merci Retriever.

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The Solitaire™ and Solitaire™ PEEK Anterior Spinal System is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Additionally, the Solitaire™ Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Solitaire System is also indicated for treating fractures of the thoracic and lumbar spine. The Solitaire System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

The Solitaire™ Osseotite® Screws are used with the spacers in the Solitaire™ and Solitaire™ PEEK Anterior Spinal System. The screws are fabricated from Titanium alloy and are acid closed to create a roughened surface.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Solitaire™ and Solitaire™ PEEK Anterior Spinal System with Solitaire™ Osteotite® Screws:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting specific quantitative acceptance criteria or reporting detailed performance metrics against those criteria in a typical clinical study sense. The "acceptance criteria" here is met by showing that the device is "adequate for its intended use" and "substantially equivalent" to existing, legally marketed devices.

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

• Test Set Sample Size: Not explicitly stated for specific quantitative tests on human subjects. The primary "test" for this submission appears to be mechanical testing and animal studies, and comparability to predicate devices.
• Data Provenance:
  • Mechanical Testing: Performed on the device itself. No information on location or specifics of the labs.
  • Animal Testing: Conducted in a "healthy sheep model." No specific country of origin is mentioned beyond this. This is a pre-clinical/animal study, not a human clinical study. The document explicitly states: "Although animal data is not necessarily indicative of human clinical outcomes..."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• This information is not provided in the document. The study described is primarily mechanical and animal-based, not involving human expert consensus on diagnostic or prognostic performance.
• The FDA review process involves their own experts, but this refers to the study design itself.

4. Adjudication Method for the Test Set:

• Not applicable or not provided. As this is primarily mechanical and animal testing, there wouldn't be an adjudication method in the context of human reader disagreement.

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:

• No, an MRMC comparative effectiveness study was not done. This device is a spinal implant, not an AI-assisted diagnostic or treatment planning tool. Therefore, the concept of "human readers improving with AI assistance" is not relevant to this submission.

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

• No. This device is a physical spinal implant, not an algorithm or AI system. Standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used:

• Mechanical Testing: Engineering specifications and ASTM/ISO standards for material properties and device performance serve as the "ground truth" for mechanical integrity.
• Animal Testing: Biological outcomes (osseointegration, screw fixation strength) measured directly in the sheep model constitute the ground truth for that specific pre-clinical study.
• Substantial Equivalence: The ground truth for this aspect is the established safety and effectiveness of the predicate devices that are already legally marketed.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical medical device, not an AI/machine learning model that requires a training set. The "design" and "technological characteristics" are developed through engineering and manufacturing processes, not algorithmic training.

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

• Not applicable. As stated above, this is not an AI/ML device, so there is no training set or ground truth in that context.

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The Solitaire Anterior Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, the Solitaire Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Solitaire System is also indicated for treating fractures of the thoracic and lumbar spine. The Solitaire System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

As an intervertebral body fusion device designed for use with autograft, the Solitaire Anterior Spinal System is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The components of the Solitaire™ Anterior Spinal System are comprised of Titanium alloy and are inserted into the intervertebral body space of the lumbosacral spine with bone graft material. The system consists of a spacer with radiographic markers and three bone screws.

The provided text is a 510(k) summary for the Solitaire™ Anterior Spinal System, which is a medical device. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

It describes the device and its intended use, but it does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/CADe device.

Here's why and what information is available (or not available) based on your request:

• Device Type: This is a physical implantable device (intervertebral body fusion device), not an AI/CADe (Computer-Aided Detection/Diagnosis) software device. Therefore, the types of "acceptance criteria" and "studies" for this device are fundamentally different from what you would expect for an AI algorithm. Its "performance" is related to its mechanical and biological compatibility, not diagnostic accuracy or image interpretation.
• Safety and Effectiveness: For this type of device, "acceptance criteria" generally refer to demonstrating substantial equivalence to a predicate device in terms of material, design, sizing, indications for use, technological characteristics, and principles of operation, without introducing new issues of safety or effectiveness. The "study" proving this is often a comparison to the predicate device and possibly mechanical testing, but not typically a clinical trial in the sense of comparing diagnostic accuracy or clinical outcomes directly in a multi-reader, multi-case study as you described for AI devices.

Given this context, I will address each point of your request based on the limited applicability to this type of device and the information present in the document.

Here's the breakdown of the information based on your request:

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

   • Acceptance Criteria (Implicit for a 510(k) for a physical device): The primary acceptance criterion for a 510(k) submission like this is to demonstrate "substantial equivalence" to a legally marketed predicate device such that the new device does not raise new questions of safety or effectiveness. This is achieved by showing similar intended use, indications, technological characteristics (materials, design, sizing), and principles of operation.
   • Reported Device Performance: The document does not provide quantitative "performance" metrics in the way an AI algorithm's sensitivity/specificity would be reported. Instead, it states: "The Solitaire™ Anterior Spinal System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and principles of operation and do not present any new issues of safety or effectiveness."

   Acceptance Criteria (for 510(k) Substantial Equivalence)	Reported Device Performance (as stated in the 510(k) Summary)
   Intended Use is similar to predicate.	Substantially equivalent to predicate in intended use.
   Indications for Use are similar to predicate.	Substantially equivalent to predicate in indications.
   Technological characteristics (material, design, sizing) are similar to predicate.	Technological characteristics are the same as, or similar to, the predicate devices.
   Principles of operation are similar to predicate.	Substantially equivalent to predicate in principles of operation.
   Device does not raise new issues of safety or effectiveness.	Does not present any new issues of safety or effectiveness.
   Restore biomechanical integrity for a prolonged period (for vertebral body replacement).	Designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • This document does not describe a "test set" or "data provenance" in the context of an AI algorithm study. For a physical implant, "testing" typically involves mechanical tests, biocompatibility tests, and sometimes animal studies, but clinical data for 510(k)s often isn't required if substantial equivalence can be shown otherwise. No such clinical "test set" information is provided here.

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 information is not applicable to the provided document. There is no mention of a "test set" requiring ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • This information is not applicable to the provided document.

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

   • No MRMC study was done, as this is a physical implant, not an AI device aimed at assisting human readers.

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

   • Not applicable; this is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • Not applicable in the context of an AI study. For this device, "ground truth" would relate to successful implantation, fusion, biomechanical stability, and clinical outcomes for the patient, which are not detailed as specific "ground truths" in this 510(k) summary.

8. The sample size for the training set

   • Not applicable; this is not an AI algorithm.

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

   • Not applicable; this is not an AI algorithm.

In summary, the provided document is a 510(k) premarket notification for a physical medical device (spinal implant). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance metrics based on clinical trial data or AI algorithm validation studies.

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The Solitaire™ PEEK-Optima® Anterior Spinal System is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to SI in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.

The Solitaire™ Peek-Optima® Anterior Spinal System consists of a spacer with tantalum radiographic markers and bone screws for intervertebral body fusion. The spacer is PEEK with titanium inserts for the bone screw interface. The Solitaire™ Bone screws will be available in different versions of the the the the the the the types.

I am sorry, but the provided text is a 510(k) summary for a spinal system (Solitaire™ PEEK-Optima Anterior Spinal System). It describes the device, its intended use, and its substantial equivalence to predicate devices based on mechanical testing. This document does not contain information about acceptance criteria or a study that evaluates device performance in the way typically expected for an AI/ML medical device submission (e.g., diagnostic accuracy, sensitivity, specificity, or reader studies).

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and performance studies because the information is not present in the provided text. The document focuses on regulatory equivalence for a physical medical implant, not on the performance metrics of a diagnostic or AI-powered device.

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The Solitaire Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Solitaire Spine System is also indicated for treating fractures of the thoracic and lumbar spine. The Solitaire Spine System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

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The provided text describes a medical device, the Solitaire™ Anterior Spinal System, and its regulatory submission. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested by the prompt (i.e., performance metrics, sample sizes, expert involvement, etc.).

Instead, it's a 510(k) premarket notification for a spinal system, which is primarily focused on demonstrating "substantial equivalence" to predicate devices based on technological characteristics and mechanical performance. The "Performance Testing" section states that "Performance data comparatively evaluating the modified system to its predicate devices demonstrate that the proposed system adequately meets the requirements established in design specifications for its mechanical performance." It then adds, "The design requirements were established based on those of the previously cleared predicate devices."

This indicates that the study involved mechanical testing, but the details of that testing, including specific acceptance criteria, reported performance, sample sizes, or any human-in-the-loop aspects, are not present in this document.

Therefore, I cannot populate the table and answer the specific questions as requested, as the necessary information is not available in the provided text.

Summary of missing information:

• No specific acceptance criteria metrics are listed.
• No reported device performance values are given.
• No sample sizes for test sets or training sets are mentioned.
• No data provenance details are provided.
• No information on experts (number, qualifications, adjudication) is present, as this was a mechanical test, not an image-based or diagnostic study.
• No MRMC comparative effectiveness study or standalone algorithm performance is discussed, as this is a physical medical device, not an AI/software device.
• No details on ground truth establishment are available.

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Solitaire 2 is a light curing, fluoride releasing radio-opaque polyglass composite. This oonlant is designed for filling of the classes I, II, and V according to Black. It also can be pred for splinting of teeth which are traumatically loose, restoration of primary teeth and reconstruction of stumps. It is available in the shades A1, A2, A3, A3, A3, A4, B2, B3, B4, C3, and Incisal.

Solitaire 2 is a light curing, fluoride releasing radio-opaque polyglass composite. It is available in the shades A1, A2, A3, A3, A3, A4, B2, B3, B4, C3, and Incisal.

The provided text is a letter from the FDA regarding the "Solitaire® 2" dental restoration device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria. The letter primarily states that the device has been found substantially equivalent to devices marketed prior to May 28, 1976, allowing it to be marketed.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set and data provenance
• Number of experts and their qualifications for ground truth
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study details
• Standalone performance details
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

This document is a regulatory approval letter, not a scientific study report or performance evaluation.

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• Class I & II (Black) Cavities
• Class V Fillings (Black)
• Deciduous Tooth Reconstruction
• Stump Rebuilding

Solitaire is a light-curing, fluoride releasing radiopaque polyglas composite. Together with the Solid bond adhesive bonding system, it is composite. Together with the Still Come Can't

This document is a 510(k) clearance letter from the FDA for a dental composite device called "Solitaire." It does not contain information about acceptance criteria, device performance tables, study designs, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request based on the provided text.

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