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The Magnes-C™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumors, pseudarthrosis or failed previous fusion.

The Magnes-C™ Anterior Cervical Plate System components are intended for anterior screw fixation and stabilization of the cervical spine during the development of cervical interbody spinal fusion. The Magnes-C™ Anterior Cervical Plate System consists of one through three-level plates and fixed and variable screws, in a variety of sizes to accommodate individual patient anatomy. The Magnes-C components are provided nonsterile. Instruments to facilitate unilateral anterior fixation are included.

The provided text describes a medical device, the Magnes-C Anterior Cervical Plate System, and its clearance by the FDA. However, it does not include information about acceptance criteria for an AI/ML powered device, nor a study proving meeting such criteria. Instead, it details the indications for use, device description, materials, and mechanical testing results to demonstrate substantial equivalence to predicate devices for a spinal implant.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study for an AI-powered device based on the given text.

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The SpineNet SSP System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumors, pseudarthrosis or failed previous fusion.

The SpineNet SSP System is an anterior cervical plate and screw system which includes fixed and variable self-tapping screws and one- through four level plates. The implants are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.

The provided document is a 510(k) Premarket Notification from the FDA regarding the SpineNet SSP System. It confirms the device's clearance and substantial equivalence to predicate devices. However, the document does not contain any information about acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies for an AI/ML powered device.

The document primarily focuses on the mechanical testing of the implant device itself (spinal intervertebral body fixation orthosis), confirming its mechanical performance is substantially equivalent to predicate devices.

Therefore, it is not possible to complete the requested table or answer the questions related to AI/ML device performance and validation based on the provided text. The document refers to "Performance Data" which states: "Mechanical testing of the worst case SpineNet SSP System construct was performed according to ASTM F1717 and included static and dynamic compression and static torsion. The mechanical test results demonstrate that the SpineNet SSP System device performance is substantially equivalent to the predicate devices." This clearly indicates a physical device, not a software or AI/ML product that would require the type of performance evaluation outlined in your request.

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The DeGen Medical Hyper-C Anterior Cervical Plate system is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Hyper-C Anterior Cervical Plate system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2 to T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with following indications:
• Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Spinal Stenosis
• Trauma (i.e. fracture or dislocation)
• Deformity or curvatures (including scoliosis, kyphosis, or lordosis)
• Spinal Tumors
• Pseudoarthrosis or failed previous fusion
• Spondylolisthesis
• Decompression of the spine following total or partial cervical vertebrectomy

The DeGen Medical Hyper-C Anterior Cervical Plate Systems consists of cervical plates and bone screws. All implants are intended to provide stabilization of the cervical vertebrae. The HACP provides anterior fixation from either fixed or variable angle construct in self-tapping or self-drilling bone screw options.

The system is provided in both sterile and non-sterile versions. The system is constructed from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The provided text describes a 510(k) premarket notification for a medical device called the "Hyper-C Anterior Cervical Plate System." This document is a regulatory approval letter and a summary of the device, not a study report demonstrating the device meets specific acceptance criteria through clinical or AI performance metrics.

Therefore, I cannot extract the information required to answer your questions as they pertain to the evaluation of an AI/ML-driven device or a medical imaging study. The document explicitly states:

• Non-Clinical Performance Testing Conclusion: "Non-clinical testing was performed to demonstrate the DeGen Medical Hyper-C Anterior Cervical Plate System (HACP) is substantially equivalent to other predicate devices in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. The following tests were performed: Static and dynamic compression testing per ASTM F1717, Static torsion testing per ASTM F1717, Screw strength via ASTM F543, Push-out testing for Locking Screws."

This indicates that the device's performance was evaluated through mechanical and material testing (non-clinical), not studies involving image analysis, AI algorithms, human readers, or clinical outcomes that would generate the kind of data you're asking for.

The questions you've posed (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) are highly relevant for the assessment of AI/ML-enabled medical devices, especially those involved in diagnostic imaging or similar analytical tasks. However, the Hyper-C Anterior Cervical Plate System is a physical orthopedic implant, and its approval is based on demonstrating substantial equivalence to existing devices primarily through mechanical integrity and biocompatibility, as outlined in the non-clinical testing section.

In summary, the provided document does not contain the information needed to answer your questions because it describes the regulatory clearance of a physical medical implant, not an AI/ML diagnostic or image analysis system.

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The uNion™ Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to T1). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

uNion™ is an anterior cervical plate and screw system used to provide mechanical support across implanted level(s) in the cervical spine until fusion is achieved. The components include Ø4.0mm and Ø4.5mm fixed and variable screws having self-tapping, self-drilling or self-drilling/self-tapping tips, one- through four-level standard plates having lengths from 10mm to 84mm and one- and two-level midline plates having lengths from 10mm to 46mm. Both the standard and the midline plates incorporate a pivoting insert which functions as an anti-back out mechanism. The devices are sold non-sterile.

The provided text describes a 510(k) Pre-market Notification for the uNion™ Cervical Plate System, focusing on its substantial equivalence to predicate devices based on mechanical testing. It does not contain information about an AI/ML device or its performance study against acceptance criteria in the way described in the prompt. Therefore, I cannot extract the requested information.

The document discusses:

• Device: uNion™ Cervical Plate System (a medical implant for spinal fixation).
• Regulatory Category: Class II, Spinal intervertebral body fixation orthosis.
• Purpose of filing: 510(k) Pre-market notification to demonstrate substantial equivalence to legally marketed predicate devices.
• Performance Data: Mechanical testing of worst-case uNion™ constructs (static and dynamic compression bending, static torsion) according to ASTM F1717.
• Conclusion: The mechanical test results showed that the uNion™ performance is substantially equivalent to the predicate devices.

None of the requested information regarding acceptance criteria, AI/ML performance study, sample sizes for test/training sets, ground truth establishment, or expert adjudication is present in the provided text, as it pertains to a traditional medical device, not an AI/ML system.

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The Genesys Spine Anterior Cervical Plate II System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion 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, or scoliosis), pseudoarthrosis, failed previous fusion, and/or spinal stenosis.

The Genesys Spine Anterior Cervical Plate II System will be offered in various device configurations based on surgical approach and patient anatomy, and will consist of a Genesys Spine cervical plate and screws that are inserted into the anterior surface of adjacent cervical vertebrae.

The Genesys Spine Anterior Cervical Plate II System is comprised of multiple sizes of plates and screws that are inserted into the anterior surface of adjacent cervical vertebrae. The device is applied after discectomy and insertion of autograft or allograft in the interbody space, and acts to stabilize the spine during fusion.

The plate components are manufactured from medical grade Ti-6Al-4V ELI titanium alloy per ASTM F-136. Additionally, cervical plates contain a securement tab component comprised of Nickel-Titanium (Nitinol) per ASTM F2063-00 to ensure that the screw is locked in place. The bone screws are manufactured from medical grade Ti-6Al-4V ELI titanium alloy per ASTM F-136.

This document describes a medical device, the Genesys Spine Anterior Cervical Plate II System, and its substantial equivalence to previously cleared devices, rather than a study proving the device meets specific acceptance criteria in a clinical or diagnostic context.

Therefore, many of the requested categories related to diagnostic device performance, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details, are not applicable to this 510(k) summary for a spinal implant.

However, I can extract the information pertinent to the performance data presented, which focuses on mechanical testing.

Here's the relevant information:

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

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

This document discusses mechanical testing of the device itself, not a clinical study on human subjects. Therefore, the concept of "sample size for the test set" in a clinical context or "data provenance" (country of origin, retrospective/prospective) is not applicable. The "samples" would refer to the physical devices or components tested in a laboratory setting. No specific number of devices tested is provided in this summary, but it would have been sufficient to meet the requirements of the ASTM standards.

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 section is not applicable as the evaluation is based on mechanical performance standards (ASTM) and comparison to predicate devices, not on expert clinical ground truth.

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

This section is not applicable as the evaluation is based on mechanical performance standards and comparison to predicate devices, not on expert clinical 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 section is not applicable. This document describes a spinal implant, not an AI-powered diagnostic device.

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

This section is not applicable. This document describes a spinal implant, not an algorithm.

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

The "ground truth" for this device's performance is established by engineering standards and comparison to legally marketed predicate devices. Specifically, the mechanical performance was assessed against ASTM F1717 and ASTM F2129, and the results were found to be equivalent to or superior to the predicate devices.

8. The sample size for the training set

This section is not applicable. This document describes a spinal implant, not a machine learning model.

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

This section is not applicable. This document describes a spinal implant, not a machine learning model.

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The Zavation Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

The Zavation Cervical Plate System consists of self-tapping/self-drilling screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.

This document describes the Zavation Cervical Plate System, a medical device. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical performance. It does not contain information typically found in a study for an AI/ML diagnostic device, such as acceptance criteria based on metrics like sensitivity/specificity, nor does it discuss ground truth establishment, expert adjudication, or reader studies.

Therefore, many of the requested categories related to AI/ML device studies are not applicable to this submission.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified. The submission refers to "a worst-case, cervical plate construct" being tested, implying a limited number of constructs rather than a large clinical test set.
• Data provenance: Mechanical testing was performed according to ASTM F1717. This is laboratory-based testing, not human data.

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 performance is established by standardized testing protocols (ASTM F1717) and engineering measurements, not by expert medical review.

4. Adjudication method for the test set

Not applicable. See point 3.

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 spinal implant device, not an AI/ML diagnostic device requiring a reader study.

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

Not applicable. This is a spinal implant device, not an AI/ML diagnostic device.

7. The type of ground truth used

"Ground truth" was established through standardized mechanical testing (ASTM F1717) on physical device constructs, measuring parameters like bending strength, torsion stability, and fatigue resistance.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/ML system that requires a training set. Development and validation rely on engineering design principles and physical testing.

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

Not applicable. See point 8.

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The Reliance Anterior Cervical Plate System is indicated for stabilization of the anterior cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include:

• instability caused by trauma or fracture; .
• instability associated with correction of cervical lordosis and kyphosis deformity; ●
• . instability associated with pseudoarthosis as a result of previously failed cervical spine surgery;
• instability associated with major reconstructive surgery for primary tumors or metastatic . malignant tumors of the cervical spine;
• instability associated with single or multiple level corpectomy in advanced degenerative . · disk disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal canal stenosis and cervical myelopathy.

This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Reliance Anterior Cervical Plate System device is intended to be used as an anterior cervical plate device. The Reliance Anterior Cervical Plate System is comprised of implant and instrument components. The Reliance Anterior Cervical Plate implant device is manufactured from Titanium alloy as specified by ASTM F-136. The Reliance Anterior Cervical Plate is a combination of the plate, cover plate, set screw, and bone screw components. The cover plate is attached to the plate by means of the set screw.

1. Acceptance Criteria and Reported Device Performance:

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

The provided document describes mechanical and other non-clinical performance testing. It does not mention a "test set" in the context of clinical data, human subjects, or data provenance from specific regions. The testing was conducted on samples of the Reliance Anterior Cervical Plate System itself.

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 was a non-clinical performance study involving mechanical testing and assessments of material properties, not a study requiring expert clinical review to establish ground truth.

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

Not applicable. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish ground truth. This document describes non-clinical performance 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 device is a spinal implant, not an AI-assisted diagnostic or imaging device, so an MRMC study is not relevant.

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.):

The "ground truth" for this performance study was established through standardized mechanical testing protocols (ASTM F-1717) and assessments of material properties (sterilization, biocompatibility). The comparison was made against the performance of legally marketed predicate devices.

8. The sample size for the training set:

Not applicable. This document describes non-clinical performance testing of a physical device, not a machine learning model that requires a training set.

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

Not applicable, as no training set for a machine learning model was used.

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The King Cobra™ Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

The King Cobra™ Cervical Plate System consists of self-tapping screws and plates. Screws are available in a variety of diameter- length combinations. Plates are available in a variety of lengths.

The provided text describes the "King Cobra™ Cervical Plate System" and its substantial equivalence to a predicate device, rather than an AI/ML device. Therefore, the questions related to AI/ML specific aspects like acceptance criteria for algorithmic performance, expert adjudication, MRMC studies, standalone algorithm performance, and training/test set details are not applicable here.

However, I can extract the information related to the device's technical characteristics and the study performed to support its substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices, "acceptance criteria" often refer to performance standards met through specific tests. In this case, the device is a spinal plate system, and its performance is evaluated against mechanical testing standards. The acceptance criterion is that the device performs "as well as or better than the predicate device."

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

• Sample Size: The document does not specify a "sample size" in the context of human data or test sets. The performance data is based on mechanical testing of the "worst case King Cobra™ construct." The specific number of constructs tested is not detailed.
• Data Provenance: Not applicable as this is mechanical testing of a medical device, not a study involving human data.

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

• Not applicable as this is mechanical testing of a medical device, not a study establishing ground truth with expert review.

4. Adjudication Method

• Not applicable.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done as this is a mechanical medical device, not an AI/ML system or diagnostic tool typically evaluated with such studies.

6. Standalone Performance Study (Algorithm Only)

• Not applicable as this is a mechanical medical device.

7. Type of Ground Truth Used

• The "ground truth" for the mechanical performance was established by ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model), which is an industry standard for mechanical testing of spinal implants. The comparison was against the performance of a predicate device.

8. Sample Size for the Training Set

• Not applicable as this is a mechanical medical device, not an AI/ML model that requires training data.

9. How Ground Truth for the Training Set Was Established

• Not applicable.

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The IST Anterior Cervical Plate is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion 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)
• Spondvlolisthesis .
• Trauma (i.e., fractures or dislocations) .
• Tumors .
• Deformity (defined as kyphosis, lordosis, or scollosis) .
• Pseudoarthrosis .
• Failed previous fusions .

The IST Anterior Cervical Plate is made of titanium alloy. The plate is offered in various lengths to meet individual patient anatomy. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The provided text describes a medical device, the IST Anterior Cervical Plate System, and its 510(k) submission (K072650) to the FDA. The submission focuses on substantial equivalence to predicate devices rather than a standalone clinical study proving specific performance metrics against an acceptance criterion.

Therefore, the information traditionally found in a comprehensive acceptance criteria study (like those for AI/Software as a Medical Device - SaMD) is not present in this document. This submission relies on performance data based on mechanical testing.

Based on the provided text, the direct answers to your questions are as follows:

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

Explanation: In this 510(k) submission, the "acceptance criteria" for the device's performance are implicitly tied to demonstrating substantial equivalence through mechanical testing according to a recognized standard (ASTM F1717). There are no specific numerical clinical performance metrics (e.g., sensitivity, specificity, accuracy) defined in this document that the device had to meet. The performance reported is that it met the ASTM F1717 standard, indicating mechanical equivalence.

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

Not applicable. This submission primarily relies on mechanical testing, not a clinical test set with patient data. Therefore, there is no "test set" in the context of patient data, sample size for such a set, or data provenance. The "testing" refers to mechanical properties in a lab setting.

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. As there is no clinical test set with patient data, there was no need for experts to establish ground truth for such a set.

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

Not applicable. Without a clinical test set requiring expert interpretation or labeling, there is no adjudication method.

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 physical implant (Anterior Cervical Plate System), not an AI/software device designed to assist human readers. Therefore, an MRMC study is irrelevant to this submission.

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

Not applicable. This is a physical medical device, not an algorithm or AI system.

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

Not applicable. For mechanical testing, the "ground truth" is defined by the physical standards and measurement methodologies outlined in ASTM F1717, which determine material properties and performance under stress. It does not involve clinical ground truth types like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model, so there is no "training set."

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

Not applicable. As there is no training set, this question is not relevant.

Summary of this particular 510(k) submission: This 510(k) for the IST Anterior Cervical Plate System is a traditional submission for a physical medical implant. It primarily relies on mechanical testing (ASTM F1717) to demonstrate substantial equivalence to existing predicate devices. It does not involve clinical trials with patient data, AI algorithms, or human-in-the-loop performance studies. Therefore, many of the questions related to clinical performance, ground truth, and AI-specific evaluations are not applicable to the information provided in this document.

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The Synthes TiLPS is intended for anterior intravertebral body screw fixation/attachment to the LI-S1 spine over one vertebral body extending onto the adjacent intervetebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease. DDD is defined as follows: back pain of a discogenic origin with degeneration of the disc confirmed by history and radiographic studies

The system consists of a two hole locking plate, 4.35 mm expansion screws with 1.8 mm locking screws. The two hole plate is available in various lengths and is manufactured from commercially pure titanium.

The provided document is a 510(k) premarket notification for the Synthes Titanium Locking Plate System (TiLPS). This document establishes substantial equivalence to previously marketed devices and outlines the intended use and limitations. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically expected for a diagnostic or AI-based device.

The concept of "acceptance criteria" and "device performance" in this context refers to the device being substantially equivalent to existing predicate devices, primarily in terms of materials, design principles, and intended use. The "study" proving this is the 510(k) submission itself, where the manufacturer provides a comparison to legally marketed predicate devices.

Here's an attempt to answer your questions based only on the provided information, interpreting "acceptance criteria" and "device performance" in the context of a 510(k) submission for a spinal implant:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not describe a "test set" in the context of clinical studies for performance metrics. The "test set" here refers metaphorically to the comparison set of predicate devices.

• Sample Size: Three predicate devices (Synthes Anterior Cervical Vertebrae Plate System (K926453 and K945700) and Synthes Anterior Spinal Plate System (K925351)).
• Data Provenance: Not applicable in the typical sense. The information comes from the design specifications, materials, and intended uses of the predicate devices already cleared by the FDA, and a comparison of the new device to these. This is analogous to a retrospective review of existing product data.

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 refers to the established safety, effectiveness, and regulatory status of the predicate devices. The "experts" are the FDA reviewers who previously cleared the predicate devices and who are reviewing this 510(k) submission. The document doesn't specify the number or qualifications of the FDA reviewers, but they are regulatory experts within the Office of Device Evaluation.

4. Adjudication Method for the Test Set

Not applicable. There's no "adjudication method" described for a test set. Substantial equivalence is determined by the FDA based on the provided comparison to predicate devices, material specifications, and design.

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

No. This document does not describe an MRMC study. These studies are typically for diagnostic AI devices assessing human reader performance.

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

No. This document describes a physical medical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" is the established regulatory clearance and perceived safety/effectiveness of the predicate devices based on their prior 510(k) submissions. The "truth" is that these predicate devices are legally marketed, and the new device is sufficiently similar to them.

8. The Sample Size for the Training Set

No "training set" is mentioned as this is not an AI/machine learning device.

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

Not applicable. There is no training set mentioned.

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