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The Modified VERTEBRON SSP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical soins fue tempor patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic shudies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordnois, ar scoliosis), pseudoarthriosis, and/or failed previous fusions. The SSP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

The modified VERTEBRON SSP™ Cervical Plate System is comprised of non-sterile, single-use, titanium alloy components. The modified VERTEBRON SSP™ Cervical Plate System attaches to the vertebral body by means of self tapping and self drilling cervical screws. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. This submission adds a reduced stature cervical plate.

The provided text describes a medical device submission for the VERTEBRON SSP™ Cervical Plate System. However, it does not include information about acceptance criteria for a study, nor does it detail a study proving the device meets specific performance metrics.

The document primarily focuses on establishing "substantial equivalence" of a modified device to a previously cleared predicate device. This is a regulatory pathway that relies on demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness as a legally marketed device, rather than requiring a new, independent performance study with specific acceptance criteria.

Therefore, many of the requested sections regarding acceptance criteria and study details cannot be filled based on the provided text.

Here's what can be extracted and what cannot:

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

• Cannot be provided. The document does not describe specific acceptance criteria (e.g., minimum tensile strength, fatigue life) or quantitate device performance against such criteria. It states that "Testing in accordance with ASTM F1717 was performed and demonstrated that the modified VERTEBRON SSP™ Cervical Plate System is substantially equivalent" to the predicate device. This implies that the device met the requirements of ASTM F1717, but the specific acceptance criteria of that standard and the numerical performance results are not reported.

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

• Cannot be provided clearly. The document only mentions "Testing in accordance with ASTM F1717 was performed." It does not specify the sample size used for this testing or the provenance of any data (e.g., country of origin, retrospective/prospective). ASTM F1717 is a standard test method for spinal implant constructs, which would involve laboratory testing of physical samples, not clinical patient data.

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

• Not applicable. This question pertains to studies involving expert review for establishing ground truth, typically in imaging or diagnostic device studies. The described submission is for a physical orthopedic implant and its substantial equivalence, not a diagnostic or AI-driven device. Ground truth, in this context, would relate to the physical properties measured in laboratory tests, not expert consensus on clinical findings.

4. Adjudication method for the test set:

• Not applicable. Similar to point 3, adjudication methods (like 2+1, 3+1) are relevant for studies where expert disagreement needs to be resolved, typically in clinical interpretation or diagnostic accuracy studies. This is not described for the physical testing of an implant.

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 submission is for an orthopedic implant, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI assistance evaluation is mentioned or relevant.

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

• Not applicable. This submission is for an orthopedic implant, not an algorithm or AI-driven device.

7. The type of ground truth used:

• Cannot be explicitly stated with detail, but inferred. For the "Testing in accordance with ASTM F1717," the ground truth would be the physical measurements obtained from the mechanical tests (e.g., stiffness, strength, fatigue life) as defined by the ASTM standard. This is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not applicable. This submission is not about an AI/ML algorithm that requires a training set.

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

• Not applicable. This submission is not about an AI/ML algorithm that requires a training set.

In summary, the provided document details a 510(k) submission for a physical medical device (cervical plate system) seeking market clearance based on substantial equivalence to a predicate device, as demonstrated through testing in accordance with ASTM F1717. It does not contain the kind of performance data, acceptance criteria, or study design information typically associated with AI/ML device evaluations or detailed clinical performance studies, which your questions are geared towards.

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The VERTEBRON SCP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine 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), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthriosis, and/or failed previous fusions. The SCP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

The Reduced Stature VERTEBRON SCP™ Cervical Plate System is comprised of non-sterile, single-use, titanium alloy components. The VERTEBRON SCP™ Cervical Plate System attaches to the vertebral body by means of self tapping and self drilling cervical screws. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. This submission adds a reduced stature cervical plate.

The provided text describes a medical device, the VERTEBRON SCP™ Cervical Plate System, and its clearance process with the FDA. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics typically associated with AI/ML algorithms (e.g., sensitivity, specificity, accuracy).

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against quantitative acceptance criteria through a clinical study. The "study" mentioned refers to mechanical testing for equivalence, not a clinical performance study with human subjects, ground truth, or expert readers.

Therefore, most of the requested information cannot be extracted from this document, and the following answers reflect that absence.

Acceptance Criteria and Device Performance Study 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 applicable (No test set for clinical performance is described).
• Data Provenance: Not applicable (No clinical data provenance is described). The study mentioned is mechanical testing.

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

• Not applicable (No experts for establishing ground truth are mentioned as this is not a study assessing diagnostic or clinical performance against ground truth).

4. Adjudication method for the test set

• Not applicable (No adjudication method is mentioned).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. The device is a cervical plate system, not an AI-powered diagnostic or assistive tool for human readers.

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

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

7. The type of ground truth used

• Not applicable. The document describes mechanical testing for substantial equivalence, not a study requiring clinical or diagnostic ground truth. The "ground truth" for the mechanical testing would be the physical properties and performance of the device under specific loads, as compared to established standards (ASTM F1717) and predicate devices.

8. The sample size for the training set

• Not applicable (No training set is mentioned as this device is not an AI/ML product).

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

• Not applicable (No training set or associated ground truth establishment is mentioned).

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The VERTEBRON SCP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine 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), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthriosis, and/or failed previous fusions. The SCP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

The material used is medical grade titanium material that conforms to ASTM F136.

This is not an AI/ML device. It is a medical device for spinal fixation, not an AI diagnostic or prognostic tool. The provided text is a 510(k) summary and approval letter for a cervical plate system, not a study evaluating AI performance. Therefore, I cannot extract the requested information as it does not exist in the provided document.

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The Vertebron SCP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine 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), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthriosis, and/or failed previous fusions. The SCP Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.

The device consists of a system of implantable metal plates and screws intended the purpose of aiding in spinal fusion. The system also includes various hand tool used to assist in implantation of the system. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136-98. The device is supplied non-sterile and is intended for sterilization by hospital personnel.

The provided text is a 510(k) summary for the Vertebron SCP™ Cervical Plate System. It details the device's description, indications for use, and a general statement about testing. However, it does not contain the specific information required to answer all parts of your request regarding detailed acceptance criteria, sample sizes, ground truth establishment, or expert involvement in a study proving the device meets acceptance criteria.

The 510(k) summary states that the device was tested in accordance with ASTM F1717 and "found to perform comparably to other cervical plate systems." This indicates a reliance on a recognized standard for performance, but the detailed results or specific acceptance criteria are not provided in this document.

Here's what can be extracted and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: Not specified, but generally, device performance testing for 510(k) submissions relies on laboratory or bench testing, not clinical data from patients in a specific country. This would be a prospective test against a standard.

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

• This type of information (expert review for ground truth) is typically relevant for studies involving qualitative assessments, such as image analysis for diagnostic devices. For a mechanical implant like a cervical plate, the "ground truth" is typically defined by engineering standards and measurable physical properties. Therefore, this information is not applicable to the type of testing described (ASTM F1717).

4. Adjudication Method for the Test Set

• Not applicable for the reported mechanical testing against a standard.

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

• No. This type of study is relevant for diagnostic devices where human readers interpret data. The Vertebron SCP™ Cervical Plate System is a physical implant, and its performance is evaluated against mechanical and material standards, not through human reader interpretation of images/cases.

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

• Not applicable. This concept pertains to AI/software performance. The device is a mechanical implant.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the performance of this device would be the requirements and specifications outlined in the ASTM F1717 standard for spinal plating systems. The device's performance characteristics (e.g., strength, fatigue resistance, biocompatibility) are measured against these standardized benchmarks.

8. The Sample Size for the Training Set

• Not applicable. The concept of "training set" is relevant for machine learning algorithms. For a medical device like a cervical plate, there is no "training set" in this context. Performance is established through laboratory physical testing.

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

• Not applicable, as there is no "training set."

Summary of what the document does tell us about the study:

• Study Type: Bench testing.
• Standard Used: ASTM F1717.
• Outcome: The device was "found to perform comparably to other cervical plate systems" (predicate devices).
• Purpose: To demonstrate substantial equivalence to legally marketed predicate devices.

The provided document is a 510(k) summary, which is deliberately concise and focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed technical report of all testing. Detailed test reports would be part of the full 510(k) submission but are not typically included in the publicly available summary.

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