(140 days)
The Innovasis Box PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain.
Indications for use are as follows:
The Innovasis Box 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 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 an anterior or anterolateral (A-Box) or lateral (L-Box) approach.
This device is intended to be used with internal supplemental spinal fixation systems such as the Innovasis Excella" Spinal System. The interior of the Box implants is intended to be packed with autograft.
The Innovasis Box™ Peek IBF System consists of polyetheretherketone (PEEK) implants meant to be used with supplemental fixation and offered in a variety of different sizes, in order to accommodate the patient's anatomy and surgeon's preference for installation. The implants feature holes in the interior geometry in order to accommodate bone graft and maximize bone ingrowth. Tantalum (A-Box) or titanium (L-Box) radiographic markers are incorporated into the material to allow for visualization of the implant configuration during and after surgery. The surfaces of the implants have machined barbs meant to engage the vertebral endplates and prevent expulsion.
The A-Box device is an anatomically shaped IBF with two interior holes to allow for packed autograft. This device is designed to be inserted from an anterior or anterolateral approach.
The L-Box device is similar to the A-Box, but is longer and designed to be inserted from a lateral approach. It has a rounded nose which can be used to aid in placement.
Materials: The implants are machined from Medical Grade PEEK (Polyetheretherketone) Zeniva™ (Solvay) per ASTM F2026. Marker beads (A-Box) machined from implant grade Tantalum per ASTM F560. Marker pins (L-Box) machined from implant grade Titanium per ASTM F-67.
The system comes with reusable stainless steel surgical instruments designed to be cleaned and steam-sterilized between uses. These instruments aid in the preparation of the area and installation of the PEEK implants.
Here's a breakdown of the acceptance criteria and study information for the Box™ PEEK IBF System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Static Axial Compression (F2077-11) | Performance comparable to legally marketed predicate devices and established acceptance criteria for the test. | "The worst-case implants performed substantially equivalent to the predicates for multiple modes of loading and met all of the acceptance criteria." "The Innovasis Inc. A-Box and L-Box IBF will adequately stabilize the lumbar spine for an interbody fusion indication as it demonstrated favorable mechanical performance compared to legally marketed predicate device." |
| Static Torsion (ultimate torque) | Performance comparable to legally marketed predicate devices and established acceptance criteria for the test. | "The worst-case implants performed substantially equivalent to the predicates for multiple modes of loading and met all of the acceptance criteria." "The Innovasis Inc. A-Box and L-Box IBF will adequately stabilize the lumbar spine for an interbody fusion indication as it demonstrated favorable mechanical performance compared to legally marketed predicate device." |
| Offset Yield Torque (F2077-11) | Performance comparable to legally marketed predicate devices and established acceptance criteria for the test. | "The worst-case implants performed substantially equivalent to the predicates for multiple modes of loading and met all of the acceptance criteria." "The Innovasis Inc. A-Box and L-Box IBF will adequately stabilize the lumbar spine for an interbody fusion indication as it demonstrated favorable mechanical performance compared to legally marketed predicate device." |
| Expulsion (in-house method) | Performance comparable to legally marketed predicate devices and established acceptance criteria for the test. | "The worst-case implants performed substantially equivalent to the predicates for multiple modes of loading and met all of the acceptance criteria." "The Innovasis Inc. A-Box and L-Box IBF will adequately stabilize the lumbar spine for an interbody fusion indication as it demonstrated favorable mechanical performance compared to legally marketed predicate device." |
| Subsidence (F2267-04) | Performance comparable to legally marketed predicate devices and established acceptance criteria for the test. | "The worst-case implants performed substantially equivalent to the predicates for multiple modes of loading and met all of the acceptance criteria." "The Innovasis Inc. A-Box and L-Box IBF will adequately stabilize the lumbar spine for an interbody fusion indication as it demonstrated favorable mechanical performance compared to legally marketed predicate device." |
| Biocompatibility (LAL and MEM Elution) | Tests passed below the established cutoff limit. | "All tests passed well below the cutoff limit." |
| Sterilization Validation | Sterility assurance level (SAL) of 10^-6 for both A-Box and L-Box systems (biological indicator overkill method). | "Pre-vacuum and gravity steam sterilization per parameters in the Innovasis IFU were validated to a sterility assurance level (SAL) of 10^-6 using the biological indicator overkill method for both the A-Box and L-Box systems." |
Study Information:
The provided document describes non-clinical bench testing to demonstrate the substantial equivalence of the Box™ PEEK IBF System to predicate devices. It does not present a clinical study involving human patients or ground truth established by medical experts for diagnostic purposes.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Testing was conducted on "sterilized samples of the identified 'worst case' sizes from the Box™ PEEK IBF System (A-Box and L-Box)." The exact number of samples is not specified.
- Data Provenance: The data is from non-clinical bench testing performed by Innovasis Inc. (or a third-party for sterilization) in a laboratory setting. It is not clinical data from patients or a specific country of origin, nor is it retrospective or prospective in a clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the document describes non-clinical bench testing. There were no medical experts involved in establishing ground truth for a test set in the context of diagnostic accuracy or clinical outcomes. The "ground truth" here is defined by established engineering and biological standards.
4. Adjudication Method for the Test Set
This section is not applicable as the document describes non-clinical bench testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies to establish a consensus ground truth among multiple readers/experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document focuses on the mechanical and biological performance of an interbody fusion device, not on the diagnostic accuracy or interpretive capabilities of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable as the device is a physical intervertebral body fusion system, not an AI algorithm. Therefore, there is no "standalone" algorithm performance to report.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was established by:
- Recognized ASTM Standards: ASTM F2077-11 (for mechanical behavior like static axial compression, static torsion, offset yield torque) and ASTM F2267-04 (for subsidence).
- In-house method: For expulsion testing.
- Established biological cutoff limits: For Biocompatibility (LAL and MEM Elution).
- Sterility Assurance Level (SAL) of 10^-6: For Sterilization Validation by biological indicator overkill method.
Essentially, the ground truth is adherence to these established engineering, safety, and sterilization standards.
8. The Sample Size for the Training Set
This section is not applicable. There is no "training set" in the context of an AI device. The testing described is for a physical medical device.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no training set for 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.