(105 days)
The Innovasis Px HA™ 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 HA implant is intended to be packed with autograft.
The Innovasis Px HA™ PEEK IBF is designed for use in a posterior (PLIF) approach to the lumbar spine. Implants are manufactured by Innovasis from Invibio® PEEK-OPTIMA® HA Enhanced*. Hydroxyapatite (HA) is fully integrated into the PEEK-OPTIMA. 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 and after surgery.
The single use implant devices feature an open cavity in the interior geometry to accommodate bone graft and maximize bone in-growth, with anti-migration teeth to engage the vertebral endplates and prevent expulsion. The implants have a slightly convex profile and are offered in a variety of different sizes to fit the anatomical needs of a wide variety of patients. The implant has a tapered leading edge which aids in implant insertion due to limited anatomical space. Reusable instruments to support the PLIF surgery are provided with the implants in custom sterilization trays.
The provided document is a 510(k) summary for the Innovasis Px HA™ PEEK IBF System, an intervertebral body fusion device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data for a novel artificial intelligence/machine learning device.
Therefore, many of the requested categories for describing an AI study are not applicable to this document. The document primarily discusses the non-clinical performance testing of the physical device.
Here's the information that can be extracted and a clear indication of what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present explicit "acceptance criteria" in a numerical or categorical format for a defined study endpoint. Instead, it 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 HA PEEK IBF is capable of performing in accordance with its intended use." It implies that meeting the standards of these ASTM tests demonstrates acceptable performance. However, specific numerical thresholds or target performance metrics are not listed.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Capable of performing as intended per ASTM F2077-11 | Indicated to perform in accordance with intended use |
| Capable of performing as intended per ASTM F2267-04 | Indicated to perform in accordance with intended use |
| Withstand simulated aging | Performed on devices, followed by dynamic compression and torsion tests in accordance with ASTM 2077 |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document mentions "Performance testing" on "devices" and "new and artificially aged devices" but does not provide specific sample quantities used for these tests.
- Data Provenance: Not applicable in the context of clinical data. The performance tests are stated as non-clinical, likely mechanical and material testing conducted in a lab environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The ground truth for this device is based on standardized mechanical testing performed in a laboratory, not on expert interpretations of medical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable, as the evaluation is based on objective mechanical tests, not subjective interpretations requiring adjudication.
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 applicable, as this document is not about an AI device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
This information is not applicable, as this document is not about an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the non-clinical performance tests is based on established engineering and material science standards (ASTM F2077-11, ASTM F2267-04, ASTM F560-13, ASTM F983-86, ASTM F2026-14, ISO 17665-1:2006). These standards define the methodologies and expected performance characteristics for intervertebral body fusion devices.
8. The sample size for the training set:
This information is not applicable, as this document is not about an AI device.
9. How the ground truth for the training set was established:
This information is not applicable, as this document is not about an AI 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.