(97 days)
The Camber Spine Technologies SPIRA Open Matrix LLIF is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine Technologies SPIRA Open Matrix LLIF is intended to be used with additional FDA-cleared supplementary fixation systems. The Camber Spine Technologies SPIRA Open Matrix LLIF system must be used with autogenous bone graft material.
The Camber Spine Technologies SPIRA Open Matrix LLIF is an Interbody Fusion Device that has spiral support arches to allow for a hollow chamber to permit packing with autogenous bone to facilitate fusion. The superior and inferior surfaces of the device have a roughened surface to help prevent movement of the device while fusion takes place.
The provided text describes a 510(k) premarket notification for a medical device called the "SPIRA Open Matrix LLIF," an intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than a study proving the device meets specific performance criteria for an AI/algorithm-driven device.
Therefore, the prompt's request for information related to AI/algorithm performance, such as sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, cannot be answered based on the provided text. These elements are typically part of the regulatory review for diagnostic or AI-powered devices, not for an implantable device like the SPIRA Open Matrix LLIF, where the focus is on mechanical and material performance.
However, I can extract the information related to the device's mechanical performance testing as described in the document.
Here's an analysis based on the provided text, focusing on the mechanical acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance & Study Design:
The document states: "Testing performed indicate that the SPIRA Open Matrix LLIF is as mechanically sound as predicate devices. Testing included static compression, static compression-shear, dynamic compression, dynamic compression-shear, expulsion, and subsidence per ASTM F2077-14 and F2267-04. The results demonstrate that the acceptance criteria defined by predicate device performance were met."
While a table with exact numerical acceptance criteria is not explicitly provided, the criteria are implicitly defined by the performance of the predicate devices according to the specified ASTM standards. The study design involves testing the SPIRA Open Matrix LLIF against these standards to demonstrate equivalent mechanical performance to the predicates.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Static Compression (per ASTM F2077-14) | Met acceptance criteria defined by predicate device performance |
| Static Compression-Shear (per ASTM F2077-14) | Met acceptance criteria defined by predicate device performance |
| Dynamic Compression (per ASTM F2077-14) | Met acceptance criteria defined by predicate device performance |
| Dynamic Compression-Shear (per ASTM F2077-14) | Met acceptance criteria defined by predicate device performance |
| Expulsion (per ASTM F2077-14) | Met acceptance criteria defined by predicate device performance |
| Subsidence (per ASTM F2267-04) | Met acceptance criteria defined by predicate device performance |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size (e.g., number of devices tested) for the mechanical performance testing.
The data provenance is not explicitly mentioned as "country of origin," but given it's an FDA submission, the testing would typically be conducted in a laboratory accredited for such tests, likely in the US or a country with comparable standards. The nature of these tests (mechanical performance of an implant) makes them more akin to laboratory experiments than clinical data from patients (retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This question is not applicable to the type of safety and performance testing described. The "ground truth" for mechanical testing is established by the specified ASTM standards (F2077-14 and F2267-04) and the measured performance of predicate devices, not by human experts adjudicating medical images or clinical outcomes.
4. Adjudication Method for the Test Set:
This question is not applicable. Mechanical tests are objective measurements, not human interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This question is not applicable. An MRMC study is relevant for evaluating diagnostic accuracy or reader performance with AI assistance, not for the mechanical performance of an implantable device.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
This question is not applicable. The device is a physical intervertebral body fusion device, not an algorithm or AI-powered system.
7. The Type of Ground Truth Used:
The "ground truth" for the mechanical performance study is defined by:
- Established ASTM Standards: Specifically, ASTM F2077-14 ("Standard Test Methods for Intervertebral Body Fusion Devices") and ASTM F2267-04 ("Standard Test Method for Determining the Rate of Resorption of Porous Bioceramics for Surgical Implants and Bone Graft Substitutes").
- Performance of Predicate Devices: The new device's performance is compared against known characteristics and performance data of the identified predicate devices (SPIRA Open Matrix ALIF, 4WEB Medical LATERAL Spinal Truss System, Alphatec Spine Novel) to establish substantial equivalence.
8. The Sample Size for the Training Set:
This question is not applicable. There is no "training set" in the context of mechanical performance testing for an implantable medical device. This term is used for machine learning models.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reason as point 8.
§ 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.