(61 days)
The Spineology PEEK Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices may be implanted via an open or a minimally invasive transforaminal approach. The Spineology PEEK Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
The Spineology PEEK Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The device is available in a range of lengths and heights and is made of PEEK Optima LT1. The device and associated instruments are provided non-sterile.
The document provided is a 510(k) Pre-market Notification for a medical device, the Spineology PEEK Lumbar Interbody Fusion Device. It describes the device, its intended use, and its substantial equivalence to a predicate device.
Crucially, this document is for a medical implant (an intervertebral fusion device), not a diagnostic algorithm or AI software, and therefore the concepts of "device performance," "test set," "training set," "ground truth," "experts," "adjudication," and "human-in-the-loop performance" as typically applied to AI/ML devices are not relevant here.
The acceptance criteria and the study performed for this device are related to its physical and mechanical performance and its safety and effectiveness as a physical implant for spinal fusion.
Here's an interpretation based on the provided text, re-framing the requests where appropriate for a physical medical device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Goal) | Reported Device Performance (Test Result) |
|---|---|
| Mechanical Strength: Must withstand static compression forces typical for its intended use in the lumbar spine. (Implicitly, to be at least equivalent to the predicate device.) | Static compression testing per ASTM F2077 was performed. The results showed that the device was substantially equivalent to the identified predicate devices. (This implies it met the mechanical strength criteria of the predicate.) |
| Material Biocompatibility: Made of PEEK Optima LT1. (Implicitly, the material is known to be biocompatible for implantable devices.) | Device is made of PEEK Optima LT1. |
| Functional Equivalence: Must perform the same function (facilitate fusion with autograft, intended for use with supplemental fixation) as the predicate device. | The device is shown to be substantially equivalent to the intended use, materials, configuration, and performance characteristics of the predicate products. |
| Safety and Effectiveness: Must be as safe and effective as the predicate device. | The submission concluded that the device is substantially equivalent in technological characteristics and intended use to the predicate devices, implying comparable safety and effectiveness. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the precise number of devices tested for the static compression testing. It only states that "Static compression testing per ASTM 2077 was performed." For mechanical testing, the "sample size" refers to the number of physical devices subjected to the test. Clinical data (like country of origin, retrospective/prospective) is not relevant here as the study is a bench-top mechanical test, not a clinical trial.
- Data Provenance: The data originates from bench-top mechanical testing conducted to ASTM F2077 standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This concept is not applicable. For physical device mechanical testing, "ground truth" is established by adherence to recognized engineering standards (like ASTM F2077) and the physical properties and behavior of the material/device under stress conditions. The evaluation of whether the test was performed correctly and the results interpreted accurately would fall under the purview of engineering and regulatory experts, but they are not establishing a "ground truth" in the diagnostic sense.
4. Adjudication method for the test set
- This concept is not applicable. Adjudication is relevant for subjective assessments or disagreements in diagnostic interpretation. Mechanical testing involves objective measurement and comparison to predefined 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
- This concept is not applicable. MRMC studies are used for evaluating the performance of diagnostic imaging devices or algorithms that involve human interpretation. This document is about a physical spinal implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This concept is not applicable. "Standalone performance" refers to the performance of an AI algorithm independent of human input. This device is a physical implant, not an algorithm.
7. The type of ground truth used
- The "ground truth" for the performance of this physical device is based on established engineering standards (ASTM F2077) and a comparison to the mechanical performance of a legally marketed predicate device. In essence, the predicate device's accepted mechanical performance serves as the benchmark for "truth."
8. The sample size for the training set
- This concept is not applicable. "Training set" refers to data used to train an AI model. For a physical medical device, there is no "training set" in this context. The design of the device is based on engineering principles and knowledge, not machine learning.
9. How the ground truth for the training set was established
- This concept is not applicable, as there is no training set for this type of device. The "ground truth" for the design and safety requirements of such implants is established through extensive biomedical engineering research, regulatory guidelines, and clinical experience with similar devices over many years.
§ 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.