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C-VBR is a vertebral body replacement device indicated for use in the cervical spine (spanning C2-T1 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The C- VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.

These implants are intended for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The C-VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

C-VBR is a vertebral body replacement device manufactured from titanium alloy (Ti-6AI-4V), and is available in a variety of sizes to suit the individual anatomic and clinical circumstances of each patient. C-VBR is a single-piece device manufactured using electrical discharge machining. having a trapezoidal cross section with a hollow interior to accommodate the placement of autograft or allograft bone. Intended for placement via an anterior approach. C-VBR is to be used in combination with supplemental fixation indicated for use in the cervical spine. C-VBR is provided with superior and inferior endplates that are either parallel (no lordosis) or angled to provide intrinsic lordosis (9.6° or 11.5°), and with various heights from 16 mm to 72 mm.

This document describes the regulatory approval of the C-VBR vertebral body replacement device. The approval is based on a demonstration of substantial equivalence to previously marketed predicate devices, rather than a separate clinical study with predefined acceptance criteria for the C-VBR device itself. Therefore, many of the requested details about acceptance criteria, specific study design for the C-VBR, and AI-related aspects are not directly applicable or available in this document.

However, I can extract the relevant information regarding the performance testing and clinical data review that were used to support the substantial equivalence.

Here's a breakdown of the available information:

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

Since this is a substantial equivalence submission relying on predicate devices and specific performance tests, there aren't explicit acceptance criteria for the C-VBR in the format of "minimum sensitivity X, specificity Y." Instead, the acceptance is based on demonstrating mechanical performance equivalent to or better than the predicate devices and a review of clinical outcomes from actual device use.

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

• Sample Size (Clinical Data Review): 97 patients treated with a total of 103 C-VBR devices.
• Data Provenance: The document does not specify the country of origin. It is a "review of the results of a series of 97 patients." This implies retrospective data collection, reviewing existing patient records or a previous study. It does not appear to be a newly conducted prospective clinical trial for this specific 510(k) submission.

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. The clinical data presented is a review of outcomes from actual patient treatments, likely relying on the assessments of the treating physicians and radiologists involved in those cases, rather than a separate "ground truth" expert panel specifically for this 510(k) submission. No information is provided about the number or qualifications of experts involved in the original patient care or the subsequent review mentioned in this document.

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

Not applicable. This was a review of existing clinical outcomes, not a study involving independent readers or adjudication for a diagnostic accuracy assessment.

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 surgical implant (vertebral body replacement) and the submission does not involve Artificial Intelligence (AI) or an MRMC study.

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

Not applicable. This device is a surgical implant and does not involve an algorithm.

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

The clinical performance was assessed based on outcomes data including:

• Nurick Classification scores (mobility restriction assessment)
• Cobb angle measurements (cervical sagittal alignment)
• Radiographic evidence (absence of significant subsidence, evidence of fusion)
• Absence of device-related complications or revision surgeries.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. The design and validation relied on engineering principles and comparison to predicate devices, not a training set in the context of AI.

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

Not applicable.

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STGC-Lordotic is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). STGC-Lordotic is intended to be used with autograft in combination with supplemental fixation indicated for use in the thoracolumbar spine.

STGC-Lordotic is a vertebral body replacement device manufactured from titanium allov (Ti-6Al-4V), and is available in a variety of sizes to suit the individual anatomic and clinical circumstances of each patient. STGC-Lordotic is a single-piece device manufactured using electrical discharge machining, having a trapezoidal cross section with a hollow interior to accommodate the placement of autograft or allograft bone. Intended for placement via an anterior approach, STGC-Lordotic is to be used in combination with supplemental fixation indicated for use in the thoracolumbar spine. STGC-Lordotic is provided with 8.2° to 11.5° of endplate angulation (lordosis). STGC-Lordotic is provided non-sterile to the end user.

This document describes a 510(k) premarket notification for the STGC-Lordotic device, a vertebral body replacement. The focus is on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in a clinical setting. Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not directly available from this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit acceptance criteria or detailed performance metrics against those criteria. Instead, it states that "performance testing to demonstrate substantial equivalence included methods described in the standards ASTM F2077 Test Methods for Intervertebral Body Fusion Devices (static compression, dynamic compression, static torsion, dynamic torsion) and ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression (subsidence). Static expulsion testing also was performed."

The conclusion is that "The performance data included in this submission demonstrate substantial equivalence to the predicate device K121176 and K003043." This implies that the device performed comparably to, or within acceptable ranges of, the predicate devices for these mechanical tests. Specific numerical performance values or defined acceptance thresholds are not presented in this document.

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

This document describes non-clinical performance testing (mechanical testing), not a clinical study involving human patients or data. Therefore:

• Sample size for test set: Not applicable in the context of human data. For mechanical testing, the sample size would refer to the number of device units tested, which is not specified in this summary.
• Data provenance: Not applicable in the context of human data. The data originates from laboratory mechanical testing.

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

This information is not applicable as no clinical study involving human assessment of ground truth is described. The "ground truth" here is the physical performance of the device against established mechanical standards.

4. Adjudication Method

This is not applicable as no clinical study with human readers/assessors or their adjudication is described.

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

A MRMC comparative effectiveness study was not done or reported in this document. The device is a physical implant, not an AI-assisted diagnostic tool.

6. Standalone Performance Study

Yes, a form of standalone performance was done in the sense of non-clinical bench testing of the device's mechanical properties (static compression, dynamic compression, torsion, subsidence, expulsion). This testing was against recognized ASTM standards. However, this is "algorithm only" performance, given the device is mechanical.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical performance evaluation was the established mechanical testing standards (ASTM F2077 and ASTM F2267) and the performance of the predicate devices. The device's performance was compared against these standards and the known performance of the predicate devices to establish substantial equivalence.

8. Sample Size for the Training Set

This is not applicable. The device is a physical implant assessed through mechanical testing; there is no "training set" in the context of an algorithm or AI.

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

This is not applicable for the reasons stated above.

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The STGC is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The STGC is intended to be used with autograft or allograft in combination with supplemental fixation indicated for use in the thoracolumbar spine.

The STGC is a vertebral body replacement device manufactured from titanium alloy (Ti-6Al-4V), and is available in a variety of sizes to suit the individual anatomic and clinical circumstances of each patient. The STGC is a single-piece device manufactured using electrical discharge machining, having a trapezoidal cross section with a hollow interior to accommodate the placement of autograft or allografi bone. Intended for placement via an anterior approach, the STGC is to be used in combination with supplemental fixation indicated for use in the thoracolumbar spine.

The provided text describes the 510(k) summary for the STGC vertebral body replacement device, which focuses on demonstrating substantial equivalence to predicate devices based on design and performance testing. It does not describe a study involving algorithms, human readers, or AI. Therefore, I cannot generate the requested information regarding acceptance criteria and a study that proves a device meets those criteria in the context of AI or algorithm performance.

The document is a submission for a medical device (a spinal implant), not an AI or diagnostic device that would typically have the kind of performance metrics requested (e.g., sensitivity, specificity, F1-score, or an MRMC study).

The "Performance testing" mentioned refers to mechanical tests conducted to demonstrate the structural integrity and equivalence of the STGC device to existing predicate devices, using ASTM standards. This is a very different type of "performance" than what is typically assessed for an AI or diagnostic device.

Therefore, most of the specific points you asked for, such as sample size for the test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable or present in this document.

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The STCC is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an anterior approach and used with autogenous bone graft and supplemental fixation, such as an anterior plating system.

STCC is an implantable intervertebral body fusion device manufactured from titanium alloy (Ti-6Al-4V) and is available in a variety of different sizes to suit the individual anatomic and clinical circumstances of each patient. Intended for placement via an anterior approach, the device has a trapezoidal cross section with a hollow interior designed to accommodate the placement of autologous bone graft.

The Cardinal Spine, LLC STCC is an intervertebral body fusion device. The acceptance criteria for this device are based on passing a series of biomechanical tests as outlined in relevant ASTM standards.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided text explicitly states that the device was "demonstrated to meet or exceed the biomechanical requirements of the intended use" for all listed tests. The specific quantitative acceptance criteria or thresholds for these tests are not detailed in the provided 510(k) summary, but are instead referenced to the respective ASTM standards.

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

• Sample Size: The document does not specify the sample size (number of devices) used for each biomechanical test.
• Data Provenance: The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that these are laboratory biomechanical tests, it's implied that the testing was conducted under controlled laboratory conditions, likely in the US where the manufacturer and consultant are located.

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

This is not applicable for this device. The "ground truth" for the performance of this intervertebral body fusion device is established through an objective assessment against pre-defined biomechanical standards (ASTM protocols), rather than through expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

This is not applicable for this device. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of data (like medical images) where human expert consensus is required to establish ground truth. For biomechanical testing, the "adjudication" is inherent in whether the device meets the quantitative pass/fail criteria of the specified ASTM standards.

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 diagnostic or interpretive AI/software devices where human readers are involved. The STCC is an implantable medical device, and its performance is evaluated through engineering and biomechanical testing.

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

This is not applicable as the STCC is a physical implantable device, not an algorithm or software. Its performance is inherently "standalone" in a biomechanical sense, meaning its physical properties are tested without human interaction for its functionality, but it is ultimately implanted with human surgical intervention and used in conjunction with human healthcare.

7. The Type of Ground Truth Used

The "ground truth" for the STCC's performance is established by biomechanical engineering standards and test protocols (specifically ASTM F2077, ASTM F2267, and ASTM Draft Standard F-04.25.02.02). The device's ability to withstand specified loads and forces, as defined by these standards, serves as the objective measure of its performance and suitability for its intended use.

8. The Sample Size for the Training Set

This is not applicable for this device. The STCC is a manufactured medical device, not an AI or machine learning algorithm that requires a training set.

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

This is not applicable for this device as it does not involve AI or machine learning and thus does not have a "training set" or "ground truth for a training set."

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