Search Results

Non-Sterile Zirconia Block (Model name: ARENA Star, MontBlanc) are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

Non-Sterile Zirconia Block (Model name: ARENA Star. MontBlanc), used to produce dental restoration to support designing computer for dental use and to process cutting as a manufacture unit, on which CAD/CAM system is applied for processing and sintering.

This document is a 510(k) Premarket Notification from the FDA regarding a dental device, specifically "Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)". It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific acceptance criteria through clinical or even extensive non-clinical performance data against set thresholds.

Therefore, many of the requested details about acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment (typical for AI/software as a medical device submissions) are not present in this document. This submission primarily relies on showing similarity in material properties and intended use to an already cleared device.

Here's an attempt to answer your questions based solely on the provided text:

Device: Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)

1. Table of acceptance criteria and the reported device performance

The document does not present a table of acceptance criteria with specific quantitative thresholds that the device was tested against in a performance study, nor does it report detailed device performance metrics beyond stating that tests "passed the evaluation criteria and met the requirement."

Instead, it relies on comparison to a predicate device and adherence to a recognized standard (ISO 6872:2015). The "acceptance criteria" are implied by meeting the requirements of this standard and demonstrating equivalence to the predicate.

Note: The document explicitly states "No clinical study is included in this submission." The reported performance is based on non-clinical, in-vitro testing.

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

The document does not specify the sample sizes (e.g., number of blocks, number of samples tested for biocompatibility, etc.) used for the non-clinical tests.

The data provenance is from non-clinical tests conducted by ARUMDENTISTRY Co., Ltd. (Republic of Korea, based on the submitter's address). The tests are in-vitro studies, not clinical data from patients. The document does not specify if the data is retrospective or prospective, but given it's non-clinical testing, it would generally be considered prospective for the purpose of this submission.

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

This question is not applicable to this submission. The "ground truth" for material properties is established through standardized laboratory testing methods (e.g., measuring flexural strength, chemical composition, biocompatibility assays), not through expert consensus or interpretation of medical images. No human readers or experts are mentioned in the context of "ground truth" for the performance tests conducted.

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

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation (e.g., radiology reads) to establish a consensus ground truth. The tests performed are objective, laboratory measurements of material properties, not subjective assessments requiring 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

This question is not applicable. This device is a dental material (zirconia block) used for manufacturing dental prosthetics, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and assessment of AI assistance for human readers are not relevant. The document explicitly states, "No clinical study is included in this submission."

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

This question is not applicable. This device is a physical dental material, not an algorithm or software. Therefore, "standalone algorithm-only performance" is not a concept that applies here.

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

The "ground truth" for the non-clinical tests is based on objective, quantitative measurements of material properties according to recognized international standards (e.g., ISO 6872:2015 for mechanical properties, ISO 10993 series for biocompatibility). For instance, flexural strength is measured directly, rather than being determined by expert consensus or pathology.

8. The sample size for the training set

This question is not applicable. This is a physical device submission demonstrating substantial equivalence to a predicate, not a machine learning or AI device that requires a 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 submission.

Ask a specific question about this device

The mont blanc system is 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/iliac spine.

This mont blanc system is intended for posterior noncervical pedicle fixation and non-pedicle fixation (from T1 to S1) for the following indications in skeletally mature patients:

· 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;
• · deformities (i.e., scoliosis, kyphosis, and/or lordosis);
• · spinal tumor,
• · pseudoarthrosis; and
• · failed previous fusion.

The mont blanc system is intended to be used with autograft and/or allograft.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Mont Blanc and Mont Blanc MIS Spinal Systems metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Mont Blanc and Mont Blanc MIS Spinal Systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The mont blanc MIS system is 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.

This mont blanc MIS system is intended for posterior noncervical pedicle fixation and non-pedicle fixation (from T1 to S1) utilizing a percutaneous minimally approach for the following indications in skeletally mature patients:

· 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;
• · deformities (i.e., scoliosis, kyphosis, and/or lordosis);
• · spinal tumor,
• · pseudoarthrosis; and
• · failed previous fusion.

The mont blanc MIS system is intended to be used with autograft and/or allograft.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Mont Blanc MIS Spinal Systems metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The Mont Blanc and Mont Blanc MIS Spinal Systems are intended to be used with autograft and/or allograff. Pediatric pedicle screw fixation is limited to a posterior approach.

The Spineway mont blanc & mont blanc MIS Spinal Systems are implant device systems comprised of a titanium alloy Ti 6Al-4V ELI per ISO 5832-3 and Cobalt-Chrome per ISO 5832-12. The fenestrated screws are polyaxial screws in diameters from 5.0 – 8.0 mm and in lengths from 30 – 55 mm. 6 fenestration holes are present in screws of length 35 mm or longer, 3 fenestration holes are present in screws of length 30 mm.

Dual connectors and domino connectors are available to connect 2 parallel rods together, lliac lateral connectors are available to create an Iliac fixation, and Axial connectors are available to connect 2 coaxial rods together.

Associated instrumentation to complete the procedure is provided reusable and non-sterile.

The provided FDA 510(k) summary (K191726) for the mont blanc & mont blanc MIS Spinal Systems does not contain information typically associated with acceptance criteria and study designs for AI-powered medical devices. Instead, it focuses on demonstrating substantial equivalence for a traditional implantable medical device (spinal fixation system) through mechanical testing.

Therefore, many of the requested categories (such as AI performance metrics, sample size for test/training sets, expert qualifications, adjudication methods, or MRMC studies) are not applicable to this document. The study described is a performance testing study for physical implants, not an AI efficacy study.

Here's a breakdown of the information that is available or not applicable/provided based on the document:

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in terms of numerical quantity but refers to "worst-case constructs comprised of Screws, Rods, Locking Screws, & Connectors." This implies a set of physical prototypes or manufactured units selected to represent the most challenging mechanical scenarios.
• Data Provenance: Not applicable in the context of clinical data. This refers to in-vitro mechanical testing conducted by the manufacturer.

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

• Not applicable. Ground truth for mechanical testing is established by engineering specifications and objective measurements against ASTM standards, not by expert interpretation of clinical data.

4. Adjudication Method for the Test Set

• Not applicable. This relates to clinical expert review, which is not part of mechanical performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study is for evaluating the impact of AI assistance on human reader performance, which is not relevant for a spinal implant device.

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.

7. The Type of Ground Truth Used

• Not explicitly stated as "ground truth" but based on: Objective measurements from mechanical testing (Static Compression Bending, Static Torsion, Torque to Failure, Dynamic Compression Bending) against established engineering standards (ASTM F1717-15) and comparison to predicate device performance.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical implant, not a machine learning model.

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

• Not applicable. No training set for an AI model is described.

Ask a specific question about this device

The Mont Blanc and Mont Blanc MIS Spinal Systems 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 and sacral/iliac screw fixation.

The Mont Blanc and Mont Blanc MIS Spinal Systems are intended for noncervical pedicle fixation and nonpedicle fixation 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 failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the Mont Blanc MIS System is intended for noncervical pedicle fixation and nonpedicle fixation 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 failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Mont Blanc MIS Spinal Systems metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Mont Blanc and Mont Blanc MIS Spinal Systems are intended to be used with autograft. Pediatric pediale screw fixation is limited to a posterior approach.

The Spineway Mont Blanc and Mont Blanc MIS Spinal Systems are composed of implant device made from a titanium alloy Ti6Al4V-ELI per ISO 5832-3 and Cobalt-Chrome per ISO 5832-12. All implant components are provided sterile. It is to be implanted from the posterior approach. The screws are available as monobloc and monobloc reduction (traction) screws and polyaxial reduction (traction) screws in diameters from 4.0-8.0 mm and in lengths from 25-55 mm and polyaxial iliac screws of 7 and 8mm diameters with lengths from 55mm to 110mm. Rods are available in 5.5mm diameter in lengths from 40-500 mm. Hooks are available in various sizes to attach to the thoracic and lumbar spine. Transverse connectors are available in various sizes to attach to the two parallel rods. Associated instrumentation to complete the procedure is provided.

Screws for MIS applications are available as polyaxial cannulated screws in diameter from 4.5-8mm and in lengths from 25-60mm. Rods for MIS applications are available as 5.5mm pre-bent rods from 50-140mm and straight rods from 50-500mm.

This document is a 510(k) Pre-Market Notification from the FDA regarding the Spineway Mont Blanc and Mont Blanc MIS Spinal Systems. It focuses on establishing substantial equivalence to previously cleared predicate devices, primarily through mechanical performance testing.

Here's an analysis of the provided text in relation to your request about acceptance criteria and studies that prove the device meets them:

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

The document does not explicitly state numerical acceptance criteria in a table format, nor does it provide specific reported device performance values in a table. Instead, it relies on comparison to predicate devices and established ASTM standards. The "Conclusion" states that the device is substantially equivalent to predicate devices in terms of "mechanical test results." This implies that the device's performance in the listed tests was comparable to or better than the predicate devices, thereby meeting an implicit acceptance criterion tied to the predicate's performance and the ASTM standards.

The performance standards listed are the tests performed, not the numerical acceptance criteria or the specific device performance outcomes.

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

The document does not specify the sample sizes used for the mechanical tests (e.g., number of implants tested). It refers to "pre-clinical testing performed per ASTM F1717-14" and "pre-clinical testing performed per ASTM F1798-98 (2003)." These ASTM standards typically outline the methodologies and requirements for testing, which would include sample size recommendations, but the specific sample sizes used in this particular study are not detailed in the provided text.

The data provenance is implied to be from Spineway S.A., a company located in Ecully, France. The testing is pre-clinical bench testing, not human clinical trial data, so the terms retrospective or prospective don't directly apply in the same way.

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 to the provided document. The document describes pre-clinical mechanical testing of a spinal implant system. "Ground truth" in this context would refer to the physical properties and performance of the device under specific test conditions, which are measured directly by engineering methods, not established by expert consensus or interpretations in the way medical images or diagnostic outcomes are.

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 typically used in clinical studies for resolving discrepancies in expert interpretations (e.g., of medical images). The studies described here are mechanical bench tests, where measurements are objective and do not require expert adjudication in this manner.

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. The device described is a spinal implant system (pedicle screws, rods). It is not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.

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

This question is not applicable. The device is a physical spinal implant system, not a software algorithm.

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

As mentioned in point 3, the concept of "ground truth" for a mechanical device largely pertains to its physical and mechanical properties. The "ground truth" for the test set would be the objective measurements obtained from the mechanical tests (e.g., force at failure, stiffness) as defined by the ASTM standards. There is no expert consensus, pathology, or outcomes data used to establish "ground truth" for these pre-clinical tests. The acceptable "truth" is whether the device meets or exceeds the mechanical properties of the predicate device and the standard requirements.

8. The sample size for the training set

This question is not applicable. There is no machine learning or AI component to this device that would require a "training set." The testing described is traditional mechanical engineering testing.

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.

In summary, the provided document focuses on demonstrating substantial equivalence for a physical spinal implant system through pre-clinical mechanical testing, rather than studies involving AI, human readers, or clinical outcomes data.

Ask a specific question about this device

The Mout Blanc Spinal System is intended for noncervical pedicle fixation from the T1 to S1 vertebrae and sacral/iliac screw fixation in skeletally mature patients as an adjunct to fission for the following indications: degenerative disc disease (defined as back pain of discogence 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 failed previous fusion.

The Spineway Mont Blanc Spinal System is an implant device made from a titanium alloy TI 6Al 4V-ELI. It is to be implanted from the posterior approach. The screws are available as monobloc and monobloc reduction (traction) screws and polyaxial reduction (traction) screws in diameters from 4.0-8.0 mm and in lengths from 25-55 mm and polyaxial iliac screws of 7 and 8mm diameters with lengths from 55mm to 110mm. Rods are available in 5.5mm diameter in lengths from 40-500 mm. Hooks are available in various sizes to attach to the thoracic and lumbar spine. Transverse connectors are available in various sizes to attach to the two parallel rods. Associated instrumentation to complete the procedure is provided.

This document is a 510(k) premarket notification for a medical device and, as such, does not contain the detailed study information typically found in a scientific publication or clinical trial report. The provided text outlines the regulatory submission for the Mont Blanc Spinal System but does not describe a study that proves the device meets specific acceptance criteria in terms of a clinical or AI-based performance evaluation.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device based on pre-clinical mechanical testing and similarities in design, materials, and intended use.

Here's an breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

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

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 for Test Set: Not applicable in the context of this regulatory submission. The "test set" here refers to the actual physical devices undergoing mechanical testing, not a data set for an AI model. The number of samples for mechanical testing is not specified.
• Data Provenance: The device is manufactured by Spineway S.A. in Ecully, France. The pre-clinical testing was performed according to ASTM F1717-10, an international standard for spinal implant fatigue testing.

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 document describes mechanical component testing, not a clinical study involving expert interpretation or ground truth establishment in a medical imaging or diagnostic context.

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

• Not applicable. This pertains to clinical data interpretation, not 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 about a spinal implant system, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness is discussed.

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

• Not applicable. This device is a physical spinal implant, not an algorithm.

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

• The "ground truth" for the mechanical testing is based on established engineering principles and the specifications within the ASTM F1717-10 standard. The "truth" is whether the device meets the mechanical performance requirements defined by this standard for similar predicate devices.

8. The sample size for the training set

• Not applicable. This document does not describe an AI/machine learning model, so there is no training set.

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

• Not applicable. As above, no AI/machine learning model is described.

In summary: The provided FDA 510(k) submission describes a spinal implant system and its regulatory clearance based on substantial equivalence to a predicate device. The "study" referenced is a set of pre-clinical mechanical tests (static compression bend, static torsion, dynamic compression bend) performed according to the ASTM F1717-10 standard. The document does not provide quantitative performance results for these tests, but concludes that they were sufficient to demonstrate equivalence. It does not involve a clinical study, human readers, AI, or any methodologies related to establishing ground truth from expert consensus or patient outcomes.

Ask a specific question about this device

The Mont Blanc Pedicle Screw System is intended for noncervical pedicle fixation from the T1 to S1 vertebrae in skeletally mature patients 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, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

The Mont Blanc Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws and rods. The rods are provided straight and intended to interface with the screws, which are traditional saddle design. This device is intended to be used with bone graft to provide immobilization and stabilization of a spinal segment as an adjunct to fusion. The Mont Blanc Pedicle Screw System is fabricated from wrought Ti-6Al-4V (ISO 5832-3).

The provided text is a 510(k) summary for a medical device called the "Mont Blanc Pedicle Screw System." It describes the device, its intended use, and the basis for its substantial equivalence to previously cleared devices.

However, the questions you've asked are about "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of device performance, sample sizes for test and training sets, expert review, and ground truth establishment.

Based on the provided document, the device described is a pedicle screw system, which is an orthopedic implant. For this type of device, "performance testing" typically refers to mechanical testing to ensure the device's structural integrity and durability, rather than a clinical study evaluating diagnostic accuracy or algorithmic performance as would be the case for an AI/ML device.

Therefore, the information you are requesting about

1. Acceptance criteria and reported device performance (in terms of sensitivity, specificity, etc.)
2. Sample sizes for test set and data provenance
3. Number of experts and qualifications for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study
6. Standalone algorithm performance
7. Type of ground truth (pathology, outcomes data, etc.)
8. Sample size for training set
9. How training set ground truth was established

is not present in the provided 510(k) summary.

The document states:

• Performance Testing: "Testing performed indicates the Mont Blanc Pedicle Screw System is substantially equivalent to predicate devices. Testing included mechanical testing per ASTM F1717, including static and dynamic compression bending and static torsion." This refers to laboratory-based mechanical tests, not clinical studies.
• Acceptance Criteria: These would be defined by the ASTM F1717 standard for pedicle screw systems (e.g., minimum loads for static and dynamic failure, or deformation limits) but are not explicitly detailed in the summary.
• Device Performance: The documented performance is that it met the requirements of ASTM F1717, showing it is "substantially equivalent" to predicate devices. Specific numerical results from these tests (e.g., actual breaking strength values) are not provided in this summary.

In summary, this document does not contain the type of information you are asking for, which is typically found in submissions for AI/ML-driven diagnostic devices or devices that rely on complex data analysis and expert interpretation. It describes a traditional, passive mechanical implant.

Ask a specific question about this device