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The Pantheon Pedicle Screw System is intended to provide immobilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (T1-S1). This system is intended for anterior/anteral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications: degenerative disc disease (DDD) (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, pseudoarthrosis, and failed previous fusion.

The Pantheon Iliac Bolt Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Pantheon Pedicle Screw Fixation System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, hooks, and cross links that are used for attachment to the non-cervical spine (the thoracic spine through the sacrum and in the ilium). Implant components are available in a variety of sizes so that constructs may be assembled to suit the individual pathology and anatomy of the patient. Rods span the distance between screws and achieve fixation by the mechanical joining of the rods with screws.

The Pantheon Iliac Bolt Fixation System has threaded screw implants with dual helix threads designed to be able to screw into pre-drilled bone in the sacrum. Implant components are available in a variety of sizes so that constructs may be assembled to suit the individual pathology and anatomy of the patient. Optional lag rings are also available.

Screws, rods, cross links, and other implant components are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3. Additionally, some rods may be manufactured from cobalt-chrome alloy (Co-Cr) conforming to ASTM F1537 or ISO 5832-12.

The provided text is a 510(k) summary for the Pantheon Pedicle Screw and Iliac Bolt Fixation System, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices based on mechanical performance testing, rather than an AI/ML device that requires performance metrics against specific acceptance criteria.

Therefore, the information requested in your prompt regarding acceptance criteria, study details (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), ground truth, and training set information is not applicable to this document.

The document explicitly states: "No clinical testing is being submitted with the 510(k)." and "Mechanical performance testing of the Pantheon Pedicle Screw and Iliac Bolt System was evaluated based on the Guidance for Industry and FDA Staff, Spinal System 510(k)s. The Pedicle Screw System was evaluated per ASTM F1717 and ASTM F1798. The Iliac Bolt Fixation System was evaluated per ASTM F2193 and ASTM F543."

This indicates that the acceptance criteria are based on meeting the requirements of specific ASTM standards for mechanical performance, and the "study" is the mechanical testing itself, not a clinical or AI-centric performance study.

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When used as an intervertebral fusion device, the Pantheon IBFD devices are intended for use as either one level or two contiguous levels in the lumbar spine from L2 to S1, for the treatment of treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who are skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the devices are intended for use with supplemental fixation cleared for use in the lumbar spine and with autograft to facilitate fusion.

The Pantheon IBFD is oval in shape with one or more openings through the structure. Pyramidal teeth are incorporated on the inferior surfaces of each device. Tantalum markers provide visual feedback with respect to the invivo implant position. An articulating hub provides adjustable angulation of the device with respect to the inserter shaft. The devices are available in a variety of sizes to accommodate differing anatomic requirements. The device is manufactured from medical grade PEEK in accordance with ASTM F2026 and Ti6Al4V titanium alloy with tantalum markers conforming to ASTM F136. The subject device introduces the 20 degree hyperlordotic sizes in a variety of lengths, widths and heights.

The provided text describes the 510(k) premarket notification for the Pantheon IBFD, an intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in a clinical or performance study involving human subjects or complex AI algorithms.

Therefore, many of the requested information points (like sample size for test sets, expert qualifications, MRMC studies, standalone AI performance, training set details) are not applicable or cannot be extracted from this type of regulatory document.

However, I can extract information related to the performance testing that was done to validate changes to the device:

1. Acceptance Criteria and Reported Device Performance:

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

• This information is not provided in the document. The performance testing mentioned (ASTM F2077 and FEA) are bench-top engineering tests, not clinical studies with human participants. Therefore, concepts like sample size for a "test set" in the context of clinical data or data provenance (country of origin, retrospective/prospective) are not applicable here.

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

• This information is not provided because the performance testing described are engineering tests, not studies requiring expert clinical assessment for ground truth establishment.

4. Adjudication Method:

• Not applicable as this was not a study requiring adjudication of clinical findings.

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

• No, a MRMC comparative effectiveness study was not done. The device is a physical intervertebral fusion device, not a diagnostic or prognostic system that would typically involve human readers.

6. Standalone (Algorithm Only) Performance:

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

7. Type of Ground Truth Used:

• For the ASTM F2077 tests, the ground truth would be established by the standardized methods and thresholds defined in the ASTM F2077 standard itself.
• For the FEA, the ground truth would be based on the principles of mechanical engineering and material science used to develop the model and interpret its results.

8. Sample Size for the Training Set:

• Not applicable. This is a physical medical device, not an AI system that requires a "training set."

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

• Not applicable for the reasons stated above.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria involved:

• New ASTM F2077 static and dynamic compression tests: These standard tests are used to evaluate the mechanical performance of intervertebral body fusion devices under various loading conditions. The purpose was to "validate changes to the device," implying that the device was tested against the established mechanical performance requirements and limits of the ASTM F2077 standard. The specific acceptance criteria (e.g., maximum deflection, fatigue cycles without failure) are inherent to the standard but not explicitly stated in this document.
• Finite Element Analysis (FEA): An FEA was created "to verify that a new worse case was not created with the new size additions." This computational analysis helps predict how the device will behave under different stresses and strains, especially with new geometric variations. The "acceptance criteria" here would be that the FEA results demonstrate the new sizes maintain sufficient structural integrity and do not introduce new failure modes or decrease safety margins below acceptable engineering limits.

The conclusion states: "Based on information contained in this submission, and the similarities of the subject and predicate devices, the subject IBFD Interbody Fusion System is substantially equivalent to the predicate devices." This substantial equivalence determination, supported by the performance testing, indicates that the device is considered safe and effective for its indicated uses, similar to the predicate device.

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The Pantheon Spinal Pontus Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. Pantheon Spinal Pontus Interiody Fusion Device is designed for use with autogenous bone graft to facilitate fusion. Pantheon Spinal Pontus Interbody Fusion Device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. Pantheon Spinal Pontus Interbody Fusion Device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and lateral.

The Pantheon Spinal Pontus Interbody Fusion Device is rectangular with one or more openings through the structure for placement of bone graft. The Epiphany device is hexahedral in geometry with two vertical openings. Pyramidal teeth are incorporated on the inferior and superior surfaces of each device. Tantalum markers provide visual feedback with respect to the invivo implant position. An articulating hub provides adjustable angulation of the device with respect to the inserter shaft. The devices are available in a variety of sizes offered in widths 18-24mm (2mm increments), in lengths 40-60mm (5mm increments), heights 8-16mm (2 mm increments), in 0. 7 and 12 degree lordosis to accommodate differing anatomic requirements.

The provided text is a 510(k) summary for the Pantheon Spinal Pontus Interbody Fusion Device. It describes the device, its intended use, materials, and a comparison to predicate devices, focusing on technological characteristics and performance data through biomechanical testing.

However, the document does not contain the detailed information required to answer all parts of your request regarding acceptance criteria and a study proving device performance, especially in the context of an AI/algorithm-driven device. The information provided pertains to a physical interbody fusion device, and the "performance data" refers to biomechanical testing, not a clinical study involving human readers or algorithmic performance.

Therefore, I can only provide limited information based on the text.

Here's what can be extracted and what cannot:

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

Note: The document states that the "Pantheon Spinal Interbody Fusion System possesses the same technological characteristics as the predicate devices including basic design... materials, mechanical safety and performances, and intended use." The conclusion states that the device is "similar to the predicate systems with respect to technical characteristics, performance and intended use" and supports "substantial equivalence." This implies that the acceptance criteria are met by demonstrating equivalence in these biomechanical tests to the already cleared predicate devices. Specific quantitative acceptance values are not provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not available in the provided text, as the "test set" refers to biomechanical testing of the device itself, not a dataset for an AI algorithm.

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 available as the device is a physical implant, not an AI diagnostic tool.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not available as the device is a physical implant, not an AI diagnostic tool.

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 available as the device is a physical implant, and there is no mention of an AI component or a study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not available as the device is a physical implant and not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the biomechanical testing, the "ground truth" would be the established success criteria and performance characteristics defined by the ASTM standards (F2077 and F2267) for intervertebral body fusion devices, and the comparative performance of legally marketed predicate devices.

8. The sample size for the training set:
This information is not available as the device is a physical implant and does not involve a training set for an AI algorithm.

9. How the ground truth for the training set was established:
This information is not available as the device is a physical implant and does not involve a training set for an AI algorithm.

In summary, the provided document is a 510(k) summary for a physical medical device (interbody fusion device) and not for an AI/software as a medical device. Therefore, most of the requested information, which pertains to AI performance evaluation, is not present. The "study" mentioned is biomechanical testing to demonstrate mechanical safety and equivalence to predicate devices.

Ask a specific question about this device

Ask a specific question about this device