(279 days)
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:
| Acceptance Criteria Category | Reported Device Performance (or Study Type) |
|---|---|
| Mechanical Performance | New ASTM F2077 static and dynamic compression tests were performed. |
| Structural Integrity | An FEA (Finite Element Analysis) was created. |
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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.