(113 days)
The Innovasis Px™ PEEK IBF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior (PLIF) or modified transforaminal (T-PLIF) approach.
This device is intended to be used in pairs and with internal supplemental spinal fixation systems such as the Innovasis Excella® Spinal System. The interior of the Px implant is intended to be packed with autograft.
The Innovasis Px™ PEEK IBF is designed for use in a posterior (PLIF) approach to the lumbar spine. Manufactured by Innovasis from implant grade polyetheretherketone (PEEK) conforming to ASTM F2026, the Px has excellent strength, stiffness and dimensional stability, with a modulus of elasticity similar to human vertebral bone. The device is radiolucent allowing straightforward assessment of the fusion process, while tantalum spheres are located around the periphery of the device to allow implant visualization during the procedure.
The single use implant devices feature an open cavity in the interior geometry to accommodate bone graft and maximize bone in-growth, as well as a convex shape with anti-migration teeth to engage the vertebral endplates and prevent expulsion. The implants are offered in a variety of different sizes to fit the anatomical needs of a wide variety of patients. Reusable instruments to support the PLIF surgery are provided with the implants in custom sterilization trays.
Based on the provided text, the device in question is the Innovasis Px™ PEEK IBF System, an intervertebral body fusion device. The text describes non-clinical performance testing for this device, not a study involving human subjects or AI. Therefore, most of the requested information regarding AI acceptance criteria, human reader studies, and ground truth establishment (as typically applied to AI/imaging diagnostics) is not applicable to this document.
However, I can extract the relevant information concerning the device's acceptance criteria and the study that proves it meets them, based on the non-clinical performance data presented.
Here's the breakdown:
1. A table of acceptance criteria and the reported device performance
The document highlights performance testing against specific ASTM standards. These standards implicitly set the "acceptance criteria" through their methodologies for demonstrating capability for intended use.
| Acceptance Criteria (Measured Performance Aspect) | Standard | Reported Device Performance |
|---|---|---|
| Static Axial Compression | ASTM F2077-11 | Capable of performing in accordance with its intended use. |
| Dynamic Axial Compression | ASTM F2077-11 | Capable of performing in accordance with its intended use. |
| Subsidence | ASTM F2267-04 | Capable of performing in accordance with its intended use. |
| Expulsion | ASTM F2077-11 | Capable of performing in accordance with its intended use. |
Note: The document states that "Performance testing per ASTM F2077-11 and F2267-04 for Static Axial Compression, Dynamic Axial Compression, Subsidence and Expulsion, indicates that the Px™ PEEK IBF is capable of performing in accordance with its intended use." It does not provide specific numerical results of these tests, but a qualitative statement of meeting the standard's requirements.
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. For mechanical testing of medical devices per ASTM standards, the sample size is usually determined by statistical requirements of the specific test method and regulatory guidelines, but not detailed here.
- Data Provenance: The data is from "Performance testing" conducted by Innovasis as part of their 510(k) submission. It is non-clinical (ex-vivo/in-vitro) testing rather than collected from human subjects. The country of origin of the data is implied to be the US, where Innovasis is based. It is prospective testing designed to demonstrate device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is non-clinical mechanical testing of a physical device, not an imaging or diagnostic study requiring expert human interpretation or "ground truth" establishment in the context of clinical accuracy for AI. The "ground truth" for these tests is the physical performance measured against the parameters defined by the ASTM standards.
4. Adjudication method for the test set
- Not Applicable. As this is mechanical testing, there's no "adjudication" in the sense of reconciling expert opinions. Test results are measured objectively against defined criteria within the ASTM standards.
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 document describes the performance testing of an intervertebral body fusion device, not a diagnostic imaging AI algorithm. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or is relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used
- Mechanical Performance Standards. The "ground truth" is defined by the requirements and methodologies outlined in the referenced ASTM standards (ASTM F2077-11, ASTM F2267-04). These standards specify the mechanical properties and behaviors that the device must exhibit to be considered suitable for its intended use. This is a form of engineering or performance 'ground truth'.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/machine learning study.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" or associated ground truth establishment for a training set in this context.
§ 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.