(552 days)
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:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Static Axial Compression (ASTM F2077) | Biomechanical test results demonstrated equivalence to predicate devices. |
| Dynamic Axial Compression (ASTM F2077) | Biomechanical test results demonstrated equivalence to predicate devices. |
| Static Compression Shear (ASTM F2077) | Biomechanical test results demonstrated equivalence to predicate devices. |
| Dynamic Compression Shear (ASTM F2077) | Biomechanical test results demonstrated equivalence to predicate devices. |
| Load Induced Subsidence under Static Axial Compression (ASTM F2267) | Biomechanical test results demonstrated equivalence to predicate devices. |
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.
§ 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.