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The Picasso II MIS Spinal 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. And the Picasso II MIS Spinal System can be used in an open approach and a percutaneous approach with MIS instrumentation. The Picasso II MIS Spinal System is intended for noncervical pedicle 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, kyphosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous approach with MIS Instrumentation, the Picasso II MIS Spinal System is intended for noncervical pedicle 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 for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

The Picasso II MIS Spinal System is comprised of percutaneous cannulated poly axial screws, a set screw and rods designed to allow for minimally invasive surgery. The screw diameters are 5.5mm, 6.5mm and 7.5mm. The screw length ranges from 30mm in 5mm increments.

The Picasso II system will utilize Ø6.0mm MIS rods. Straight and curved rods are provided with the subiect system. Straight rods are available in 35mm-600mm lengths, and curved rods are available in 35mm-150mm lengths.

The implant components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136. The device specific instrumentation intended for patient contact is manufactured from stainless steel materials that conform to ASTM F899.

The provided document is a 510(k) premarket notification for a medical device (Picasso II MIS Spinal System), not a study evaluating an AI device. This type of notification primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing, rather than a clinical study with detailed acceptance criteria and performance metrics typically associated with AI device evaluation.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies for an AI device is not applicable to this document.

However, I can extract information related to the device and the non-clinical testing performed to support its substantial equivalence.

Here's a breakdown of what can and cannot be provided from the given text:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: The document implies acceptance criteria by stating that the modified housing dimensions "do not create a worst case construct as compared to the predicate" and that "mechanical test results submitted in support of the predicate systems are considered applicable to the subject system." This suggests that the device must perform at least as well as, or not worse than, the predicate devices in specific mechanical tests. The specific numerical acceptance criteria (e.g., maximum deflection, ultimate load) are not explicitly stated in this document.
• Reported Device Performance: The document states, "Results of the engineering analysis provided in support of this premarket notification demonstrate that the modified housing dimensions for the proposed system do not create a worst case construct as compared to the predicate." It also indicates that non-clinical tests were conducted "to confirm the results of the engineering analysis." However, actual performance values (e.g., specific forces, deflections) are not reported. The conclusion is a qualitative statement of equivalence.

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

• This information is not applicable as this is not an AI device study requiring a "test set" in that context. The testing involved mechanical evaluations of the physical device. The sample size for the mechanical tests is not specified. Data provenance is also not applicable in the context of data for an AI algorithm.

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

• This is not applicable. This document describes the mechanical testing of a physical medical device, not an AI algorithm requiring expert-established ground truth.

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

• This is not applicable. This refers to expert adjudication in AI studies, which is not relevant here.

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 is not applicable. This type of study is for evaluating observer performance with AI in diagnostic or other decision-making tasks, which is not the subject of this 510(k) submission.

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

• This is not applicable. This document does not concern an AI algorithm.

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

• This is not applicable. For mechanical testing of a physical device, the "ground truth" would be the physical properties and performance characteristics defined by engineering standards (e.g., ASTM F1798-13). There is no "ground truth" in the clinical AI sense.

8. The sample size for the training set:

• This is not applicable. This document does not describe an AI device or a training set.

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

• This is not applicable. This document does not describe an AI device or a training set.

Summary of Relevant Information from the Document:

• Device: Picasso II MIS Spinal System (spinal pedicle fixation system)
• Purpose of Study/Submission: To demonstrate substantial equivalence to predicate devices (Picasso MIS Spinal System and Raphael System) to obtain clearance for market.
• Testing Performed: Non-clinical mechanical tests were conducted in accordance with ASTM F1798-13.
  • Static axial grip
  • Static torsional grip
  • Static cantilever bending
  • Static tulip head disassociation (nominal and extreme angle)
• Conclusion: The subject device is substantially equivalent to the predicate devices, with no impact on device performance due to minor differences. The modified housing dimensions do not create a worst-case construct compared to the predicate.

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The Cezanne II Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade l spondylolisthesis or retrolisthesis at the involved level(s). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Cezanne II Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy. The Cezanne II System consists of XLIF, TLIF and ALIF implants.

The System implant components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.

Note: The provided text describes a 510(k) premarket notification for a medical device, the "Accel Spine Cezanne II Interbody Fusion System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical testing (mechanical tests). It does not involve clinical studies or AI algorithm performance, which are the typical contexts for the acceptance criteria and study design questions you've posed.

Therefore, many of the requested fields are not applicable to the information provided in this 510(k) summary. I will answer based only on the information present in the document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. The study involved non-clinical mechanical testing of the device, not a test set of data such as images or patient records.
• Data Provenance: Not applicable. The "data" comes from engineering tests performed according to specific ASTM standards in a lab setting, not from patients or a specific country of origin. The tests were "non-clinical."

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 the context of expert review, is not relevant for this type of non-clinical mechanical testing. The "ground truth" for these tests is defined by the objective physical properties and performance measured according to the specified ASTM standards.

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

• Not applicable. Adjudication methods are used in studies involving expert review or subjective interpretation of data, which is not the case here.

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 a 510(k) submission for an interbody fusion system, not an AI-powered diagnostic device. No MRMC study was conducted.

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

• Not applicable. This is a physical medical device (interbody fusion system), not an algorithm or AI.

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

• The "ground truth" for the non-clinical testing is defined by the objective measurements and pass/fail criteria established by the specific ASTM standards (F2077-11, F2267-04, F-04.25.02.02, F2026, F560, F899). It is a form of empirical measurement against established engineering standards.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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The Degas Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include:

degenerative disc disease (DDD) (defined as neck 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 or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Degas Anterior Cervical Plate System consists of a variety of shapes and sizes of main plates. screws, sub-plates, rivets and associated instruments. The sub-plate is pre-assembled to the main plate and designed to prevent screws from backing out using the elastic behavior during the screw insertion.

The rivets are pre-assembled to the main plate, which firmly attach the sub-plate component to the main plate. Each component is color anodized to differentiate the screw type and diameter and to facilitate the surgical process.

The plates range in length to accommodate one, two, three, and four level procedures. Main plates are available from 20mm to 110mm. Screws are available in lengths from 10mm to 20mm in 2mm increments. The screws have either a 3.5mm or 4.0mm diameter. They are provided in fixed self-tapping, variable self-tapping, fixed self-drilling and variable self-drilling configurations.

The provided document K132366 is a 510(k) premarket notification for the Degas Anterior Cervical Plate System. This type of submission establishes substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through novel studies.

Therefore, the document explicitly states: "Non-clinical testing was not performed as part of this submission." This means that the information requested regarding acceptance criteria and performance studies for the Degas Anterior Cervical Plate System (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, ground truth type and establishment for test/training sets) is not available in this document.

The basis for clearance is that the subject device, the Degas Anterior Cervical Plate System, is identical to the previously cleared Rex System (K121862) in terms of:

• Indications for use
• Device dimensions
• Instrumentation
• Manufacturing process
• Cleaning/sterilization process
• Labeling

Therefore, the demonstration of safety and effectiveness relies on the prior clearance of the predicate device, not on new studies conducted for the Degas system.

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The Raphael Pedicle Screw System is a posterior pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S I vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the Raphael Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The Raphael Hook System is intended for use as a posterior, noncervical, nonpedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma(i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Raphael Hook System can be used in conjunction with Raphael Pedicle Screw System.

The Raphael Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system that consists of pedicle screws, rods, hooks, set screws, connectors, and a transverse (cross) linking mechanism. The Raphael Pedicle Screw System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion.

This document is a 510(k) premarket notification for the Raphael Pedicle Screw System. It seeks to demonstrate substantial equivalence to a predicate device, the Dio Medical Rexious Spinal Fixation System.

Based on the provided text, there is no study described that proves the device meets specific acceptance criteria in terms of performance derived from non-clinical or clinical testing.

Instead, the submission relies entirely on a claim of substantial equivalence to a previously cleared predicate device.

Here's an analysis based on the information provided and what is explicitly missing in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria are defined in the document for the Raphael Pedicle Screw System related to its performance.

The document states:
"Non-clinical testing was not performed as part of this submission."
"The subject device is identical to the predicate device in terms of indications for use, device dimensions, instrumentation, manufacturing process, cleaning/sterilization process and labeling..."

Therefore, a table of reported device performance for the Raphael Pedicle Screw System cannot be generated from this document, as no performance testing was conducted or reported for this specific submission. The acceptance criteria, by extension, are implicitly met if the device is indeed "identical" to the predicate, whose performance would have been established through prior clearance.

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

Not applicable. No test set was used for this submission because no new performance testing (non-clinical or clinical) was performed. The clearance is based on substantial equivalence to a predicate device.

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

Not applicable. No test set was used, and therefore no ground truth establishment by experts was required for this submission.

4. Adjudication Method for the Test Set

Not applicable. No test set was used.

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 device is a pedicle screw system, not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted.

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

Not applicable. This device is a pedicle screw system, not an algorithm or AI device. No standalone performance study was conducted.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

Not applicable. No new performance data requiring ground truth was generated for this submission. The "ground truth" for clearance in this case is the previously established performance and substantial equivalence of the predicate device.

8. The Sample Size for the Training Set

Not applicable. No training set was used as this is not an AI/ML device.

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

Not applicable. No training set was used.

In summary: The clearance for the Raphael Pedicle Screw System is based on a "Special 510(k)" pathway, where the manufacturer asserts that the device is identical to a previously cleared predicate device (Dio Medical Rexious Spinal Fixation System K113324, K111362, K100765) in terms of indications for use, device dimensions, instrumentation, manufacturing process, cleaning/sterilization process, and labeling. Therefore, no new performance testing or clinical studies were conducted or reported in this specific document.

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Cezanne Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bonegraft. Cezanne Lumbar Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Cezanne Lumbar Interbody Fusion Cage System is intended to help provide support in the intervertebral body space during fusion of vertebral bodies in the lumbar spine. This system is intended to be used with supplemental fixation. The Cezanne Lumbar Interbody Fusion Cage System consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The Implants are made of PEEK-OPTIMA CTI (ASTM F2026) body with the tantalum(ASTM F560) marker pins.

This document describes the regulatory submission for the "Cezanne Lumbar Interbody Fusion Cage System" and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study where a device's performance is measured against acceptance criteria in a clinical setting.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, how ground truth for training set was established) are not applicable or provided in this type of submission.

Here's an analysis of the provided text in relation to your request:

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

This document does not present acceptance criteria and reported device performance in the context of a clinical study or a study designed to measure the device's diagnostic/performance characteristics against specific numerical targets. Instead, it relies on non-clinical (bench) testing to ensure mechanical integrity and comparability to predicate devices. The acceptance criteria for these tests would typically be defined by the ASTM standards cited.

Explanation: The document states that the system "has been tested" according to these ASTM standards. In a 510(k) submission, the implicit understanding is that these tests demonstrated performance comparable to predicate devices or within acceptable limits defined by the standards, thus supporting the claim of substantial equivalence. The specific numerical results are not provided in this summary but would be available in detailed test reports.

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

This information is not applicable as this submission focuses on substantial equivalence based on mechanical testing and comparison to existing predicate devices, not on a clinical test set for performance evaluation in patients. The "test set" here refers to the physical devices subjected to bench 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)

This information is not applicable. Ground truth, in the context of clinical expert consensus, is not relevant for this type of mechanical testing and substantial equivalence claim. The "ground truth" for these tests would be the established scientific principles of mechanical engineering and material science, as embodied in the ASTM standards.

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

This information is not applicable. Adjudication methods are used in clinical studies, particularly for subjective assessments or when there's disagreement among experts. For mechanical bench testing, results are typically objective and quantifiable by standardized methods, not 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 information is not applicable. This is a submission for a physical intervertebral fusion cage, not an AI or imaging device that would involve human readers or AI assistance.

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

This information is not applicable. This is a physical medical device; there is no "algorithm only" performance to evaluate.

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

For the non-clinical testing, the "ground truth" is established by engineering principles and standardized testing methodologies (ASTM International standards). These standards define how the material properties and device performance under specified loads should be measured and what constitutes acceptable performance for intervertebral fusion devices.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of this 510(k) submission, as it relates to mechanical testing and substantial equivalence, not machine learning or AI.

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

This information is not applicable. As there is no training set, there is no ground truth for a training set to establish.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that "proves" the device meets acceptance criteria is a series of non-clinical bench tests conducted according to recognized ASTM International standards. These tests assess the mechanical properties and performance of the Cezanne Lumbar Interbody Fusion Cage System.

• Test Standards Utilized:

  • ASTM F2077: Standard Test Methods for Static and Dynamic Axial Compression, Compression-Shear, and Torsion Testing of Intervertebral Body Fusion Devices
  • ASTM F2267: Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

• Objective of Testing: To demonstrate that the mechanical performance (e.g., strength, stability, resistance to subsidence, expulsion, etc.) of the Cezanne device is comparable to that of legally marketed predicate devices and is suitable for its intended use within the lumbar spine.

• Conclusion: The submission concludes that the "Cezanne Lumbar Interbody Fusion Cage System has been tested [according to the listed standards]" and shares technological characteristics similar to predicate devices, implying that its performance is equivalent and therefore "safe and effective for its intended use." The FDA's substantial equivalence determination (K121567) indicates agreement with this conclusion based on the submitted data.

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The Dali Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use:

• degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies);
• spondylolisthesis;
• trauma (i.e. fracture or dislocation);
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
• tumor;
• stenosis, and;
• failed previous fusion (pseudoarthrosis)

This system is comprised of screws, set screws, rods, crosslink and connectors. The components of this system are manufactured of Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537). The screws are available from 4.0 to 8.5mm diameters with lengths ranging from 20-150mm.

The provided text describes the "Dali Spinal Fixation System," a Class III medical device for spinal fixation. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

• Static compression bending
• Static torsion
• Dynamic compression bending (in accordance with ASTM F1717-10)
• Gripping-push down (in accordance with ASTM F1798) |
  | Material Equivalence | The components of this system are manufactured of Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537), which are the same materials used in predicate devices. |
  | Design Equivalence (substantially similar) | The Dali Spinal Fixation System shares technological characteristics similar to the predicate devices, including similar design. |
  | Intended Use / Indications for Use | The device's intended use and indications for use as a non-cervical spinal fixation device (posterior pedicle fixation T1-S2/ilium, or anterolateral fixation T8-L5) for skeletally mature patients as an adjunct to fusion for conditions like degenerative disc disease, spondylolisthesis, trauma, deformities, tumor, stenosis, and failed previous fusion are deemed substantially equivalent to legally marketed predicate devices. |
  | Overall Safety and Effectiveness | The Dali Spinal Fixation System is substantially equivalent to the device referenced above and is therefore safe and effective for its intended use. |

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

The document explicitly states: "Clinical data and conclusions were not needed for this device." This means there was no clinical test set involving human subjects. The evaluation was based on non-clinical (bench) testing. Therefore, there is no sample size for an clinical test set or data provenance (country of origin, retrospective/prospective clinical data).

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

Not applicable. As no clinical data was required or used, there was no need for experts to establish ground truth for a clinical test set. The acceptance was based on engineering and material equivalence to predicate devices.

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

Not applicable. No clinical test set with human data requiring adjudication was performed.

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 device is a spinal fixation system (physical implant), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant and was not performed.

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

Not applicable. This device is a physical medical implant, not a software algorithm.

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

For the non-clinical performance evaluation, the "ground truth" was established by standardized mechanical testing protocols (e.g., ASTM F1717-10 for dynamic compression bending, and ASTM F1798 for gripping-push down) and material specifications (ASTM F136 for Titanium alloy, ASTM F1537 for CoCrMo alloy). The "truth" was that the device met or exceeded the performance of the predicate devices under these controlled, quantifiable conditions.

8. The sample size for the training set

Not applicable. This device is a physical implant evaluated through bench testing and comparison to predicate devices, not an AI or machine learning model that requires a training set.

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

Not applicable, as there was no training set.

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The VAN GOGH Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:

• degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
• spondylolisthesis,
• trauma (i.e. fractures or dislocations),
• tumors,
• deformity (defined as kyphosis, lordosis or scoliosis),
• pseudarthrosis,
• failed previous fusion,
• spinal stenosis.

The VAN GOGH Anterior Cervical Plate System is composed of plates and screws which are made from titanium alloy Ti-6AI-4V ELI (ASTM F136). These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates range in length to accommodate one, two, three, and four level procedures. The screws in the VAN GOGH Anterior Cervical Plate System are 3.5mm and 4.0mm diameter bone screws. They are fixed self-tapping, variable self-tapping, fixed self-drilling, variable self-drilling and are available in lengths ranging from 12 to 20mm.

The provided text describes a medical device, the VAN GOGH Anterior Cervical Plate System, and its clearance through the FDA's 510(k) process. This process focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing. It does not involve a study that evaluates device performance against specific acceptance criteria for AI/ML based devices, nor does it typically include details like human reader studies, training set data, or expert ground truth adjudication as would be relevant for such systems.

Therefore, many of the requested sections below cannot be populated from the provided text because the submission is for a physical medical device (an implantable plate system), not an AI/ML-based diagnostic or prognostic tool.

Here's an attempt to answer the questions based only on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on "substantial equivalence" to predicate devices, rather than meeting specific performance criteria. The acceptance criteria for the mechanical tests were implicitly met by performing "as well as the predicate device."

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

Not applicable. The "test set" in this context refers to mechanical testing of physical implants, not data for an AI/ML model. The study was non-clinical mechanical testing, not involving human data.

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

Not applicable. This was a non-clinical mechanical test, not dependent on expert interpretation of data or images.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical mechanical test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This type of study is relevant for diagnostic or interpretive AI systems, not a physical implantable device.

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

For the mechanical tests, the "ground truth" would be the direct physical measurements and compliance with ASTM F1717 standards, compared against the predicate device's performance. It is based on engineering standards and comparative mechanical properties.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set in the AI sense.

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

Not applicable. There is no AI/ML training set.

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The Picasso MIS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the Picasso MIS Spinal System can be used in an open approach and a percutaneous approach with MIS instrumentation.

The Picasso MIS Spinal System is intended for noncervical pedicle 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, kyphosis, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous approach with MIS Instrumentation, the Picasso MIS Spinal System is intended for noncervical pedicle 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, kyphosis, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

Picasso MIS Spinal System consists of cannulated polyaxial screw, straight and curved rod, Cross-link and set screw components that can be used via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants will be provided non-sterile.

Acceptance Criteria and Study for Picasso MIS Spinal System

The Picasso MIS Spinal System is a medical device, specifically a pedicle screw spinal system, designed to provide immobilization and stabilization of spinal segments. For such devices, acceptance criteria are typically based on mechanical performance to ensure the device can withstand the physiological loads it will experience in the human body. The provided document details a study demonstrating the device's compliance with these mechanical acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Performed as well as the predicate device." This implies that the Picasso MIS Spinal System met or exceeded the established mechanical performance benchmarks derived from the predicate device under these specific ASTM F1717 tests. The exact numerical values for these benchmarks and the device's performance are not provided in this summary.

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

The study described is a mechanical performance study, not a clinical study involving human or biological samples. Therefore, the concept of "sample size used for the test set" typically refers to the number of device constructs tested. The document specifies that the tests were performed "on a worst-case, screw construct." This suggests that at least one, and likely several, of the most challenging configurations of the device (e.g., specific screw diameter, length, and rod dimensions) were subjected to these mechanical tests.

Data Provenance: This is a pre-clinical, in-vitro study, meaning it was conducted in a laboratory setting using physical specimens of the device, not on humans. Therefore, there is no country of origin for clinical data, nor is it retrospective or prospective in the clinical sense. The data is generated directly from mechanical testing.

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

This being a mechanical performance study, the ground truth is established by the ASTM F1717 standard, which outlines the specific testing methodologies and criteria for pedicle screw systems. The "experts" in this context are the standardization bodies and engineers who developed and validated the ASTM F1717 standard itself. No additional external experts are typically used to establish a subjective "ground truth" for each specific test sample in such a study, as the test parameters are objective and defined by the standard.

4. Adjudication Method for the Test Set

Not applicable for a mechanical performance study. The outcome of each test (e.g., failure load, fatigue life) is a direct, measurable result, not subject to individual interpretation or adjudication by multiple parties in the same way clinical outcomes would be. The raw data from the testing equipment is the primary record.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the clinical performance or diagnostic accuracy of algorithms or imaging devices where human interpretation is involved. The Picasso MIS Spinal System is a physical implant, and its performance is assessed through mechanical testing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm only) performance study was not done. This term typically refers to the evaluation of AI algorithms. The Picasso MIS Spinal System is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used in this study is objective mechanical performance data as defined by the ASTM F1717 standard. This standard specifies how pedicle screw systems should be tested for static and dynamic strength and provides guidelines for their acceptance. The performance of the Picasso MIS Spinal System was compared against the performance of a predicate device under these standardized test conditions.

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is a mechanical engineering study, not an AI or machine learning study.

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

Not applicable. As there is no training set, there is no corresponding ground truth for it.

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The RENOIR Posterior Cervical Fixation System is indicated for the following:

• DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Spinal stenosis
• Fracture/dislocation
• Failed previous fusion
• Tumors

The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.

Hooks and rods 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 pedicle screws are limited to placement in T1 -T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

The RENOIR Posterior Cervical Fixation System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of polyaxial screws, semi-reduction poly screws, reduction poly screws, straight rods, curved rods, set screws, hooks and set screws.

The provided document describes the predicate device and the non-clinical testing performed on the RENOIR Posterior Cervical Fixation System. It does not contain information about a clinical study with human subjects, device performance in vivo, or an AI component. Therefore, many of your requested details cannot be extracted from this document.

Here's what can be extracted based on the provided text:

Acceptance Criteria and Study Details for RENOIR Posterior Cervical Fixation System

Summary of Non-Clinical Testing Performed:

• Tests Conducted: Static compression bending, tension, torsion, and dynamic compression bending.
• Standard Followed: ASTM F1717.
• Test Subject: "Worst-case, Screw construct" of the RENOIR Posterior Cervical Fixation System.
• Comparison: Performance was compared against a predicate device.
• Conclusion: The RENOIR Posterior Cervical Fixation System "performs as well as the predicate device."

Missing Information:

The document does not include any information regarding:

• Clinical studies involving human subjects.
• Performance metrics (e.g., sensitivity, specificity, accuracy) typically associated with AI/diagnostic devices.
• AI algorithms or human-in-the-loop performance.
• Specific numerical data from the mechanical tests, only the general conclusion of equivalency.

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Matisse Anterior Cervical Interbody Fusion Cage system is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Matisse Anterior Cervical Interbody Fusion Cage system is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. Matisse Anterior Cervical Interbody Fusion Cage system is to be used with supplemental fixation. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage.

Matisse Anterior Cervical Interbody Fusion Cage system intended for use as an . interbody fusion cage device and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of PEEK-OPTIMA®LTlwith marker pins made of Tantalum (ASTMF 560).

The provided document is a 510(k) summary for the Matisse Anterior Cervical Interbody Fusion Cage system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data in the format of a clinical trial for a novel AI or diagnostic device.

Therefore, many of the requested categories for AI/diagnostic device studies (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, etc.) are not applicable to this type of submission.

The "study" in this context refers to non-clinical (mechanical) testing used to demonstrate the device's physical properties are equivalent to devices already on the market.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics (e.g., accuracy, sensitivity, specificity) for a diagnostic AI. Instead, it demonstrates performance by showing the device meets established ASTM standards for interbody fusion cages.

• ASTM F 2077: Specifically, Static and Dynamic Axial Compression, Static and Dynamic Compression-Shear Testing, Static and Dynamic Torsion Testing, Expulsion Testing.
• ASTM F 2267: Specifically, Static Subsidence testing under Axial Compression.
  The document asserts that "the non-clinical testing conducted on the Lexus predicate [is] applicable to represent the Matisse Anterior Cervical Interbody Fusion Cage system." |
  | Design, materials, and intended use are identical or similar to legally marketed predicate devices. | The Matisse Anterior Cervical Interbody Fusion Cage system is stated to be "exactly identical" to the Lexus Cervical Intervertebral body Fusion Cage System (K120840) and "substantially equivalent" to several other predicate devices regarding design, sizes, manufacturing process, materials (PEEK-OPTIMA® LTi with Tantalum marker pins), and intended use. |

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

• Sample Size: Not applicable in the context of an AI/diagnostic device's test set. For mechanical testing, this refers to the number of physical devices or components tested. The document does not specify the exact number of units tested for each ASTM standard, but implies a sufficient number were tested to satisfy the standards.
• Data Provenance: Not applicable for an AI/diagnostic device's data provenance. The testing was conducted for the Lexus Cervical Intervertebral body Fusion Cage System (K120840) and considered applicable to the Matisse system due to their identical nature. The location of the testing laboratories is not specified.

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

Not applicable. This device is a physical implant, not an AI or diagnostic device requiring expert interpretation of outputs or ground truth establishment in this manner.

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

Not applicable. This is relevant for studies involving human interpretation or labeling, which is not the case for mechanical testing of an implantable device.

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 describes an MRMC study for AI/diagnostic devices, which is irrelevant to a spinal implant's 510(k) submission based on substantial equivalence and mechanical testing.

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

Not applicable. This concept applies to AI algorithms, not physical medical devices like the Matisse Anterior Cervical Interbody Fusion Cage system.

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

The "ground truth" for this device's performance is compliance with established ASTM mechanical testing standards (F 2077 and F 2267), which define acceptable physical and mechanical properties for intervertebral body fusion devices.

8. The sample size for the training set

Not applicable. This pertains to AI/machine learning models, not physical devices.

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

Not applicable. As above, this is for AI/ML models.

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