(132 days)
Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF® TL-PEEK Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.
The CoAlign Innovations AccuLIF TL-PEEK Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF TL-PEEK Cage may be used with autogenous bone graft.
The CoAlign AccuLIF TL-PEEK Cage is expandable in-situ via a hydraulic system comprising two piston and cylinder arrangements. The device is expanded to the desired height by injecting saline into the cylinders. The device locks in 1mm increments as it expands. The device is provided non-sterile and must be sterilized prior to use.
The CoAlign AccuLIF TL-PEEK Cage device comes in two sizes, a 6mm height which expands up to 9mm and an 8mm height which expands up to 12 mm. Both sizes have a 12mm wide by 25mm long footprint. The device has fixation ridges on the top and bottom surface. It also has a graft opening window which extends from the bottom surface. The device has a proximal boss which has a threaded connection port for connecting to the inserter and a fluid port for transporting the expansion fluid. The device is expanded by using a disposable tubing set and pressure syringe. The device may be implanted through a standard anterior, posterior or transforaminal approach.
The provided text describes a medical device, the AccuLIF® TL-PEEK Cage, and its regulatory submission (K112095) to the FDA. The document outlines the device's indications for use, description, technological characteristics, and importantly, the testing performed to demonstrate substantial equivalence to predicate devices.
However, the information required to fully answer the user's request, specifically regarding a study that proves the device meets acceptance criteria in the context of typical AI/software medical device evaluations (e.g., sample size, ground truth, expert adjudication, MRMC studies, standalone performance), is not present in this document.
This document details non-clinical (mechanical) testing, not clinical studies or AI/software performance evaluations. The device is a physical implant, not a software algorithm. Therefore, many of the requested categories are not applicable.
Here's an attempt to answer based on the provided text, highlighting what is available and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Specific Value/Standard) | Reported Device Performance (Value/Outcome) |
|---|---|---|
| Dynamic Compression | Adherence to ASTM F2077-03 | Device performance evaluated in accordance with ASTM F2077-03; deemed acceptable for substantial equivalence to predicates. |
| Dynamic Shear | Adherence to ASTM F2077-03 | Device performance evaluated in accordance with ASTM F2077-03; deemed acceptable for substantial equivalence to predicates. |
| Static Compression | Adherence to ASTM F2077-03 | Device performance evaluated in accordance with ASTM F2077-03; deemed acceptable for substantial equivalence to predicates. |
| Static Shear | Adherence to ASTM F2077-03 | Device performance evaluated in accordance with ASTM F2077-03; deemed acceptable for substantial equivalence to predicates. |
| Static Subsidence | Adherence to ASTM F2267-04 | Device performance evaluated in accordance with ASTM F2267-04; deemed acceptable for substantial equivalence to predicates. |
| Static Expulsion | Adherence to ASTM Draft Standard F-04.25.02.02 | Device performance evaluated in accordance with ASTM Draft Standard F-04.25.02.02; deemed acceptable for substantial equivalence to predicates. |
| Surgical Technique Validation | Same manner as predicate surgical technique validation | Validated in the same manner as the predicate surgical technique validation; deemed acceptable for substantial equivalence to predicates. |
Note: The document states the tests were "conducted in accordance with" specific ASTM standards and that "any minor differences do not impact device performance as compared to the predicates." This implies the device met the performance characteristics demonstrated by the predicate devices, which are implicitly acceptable as per the standards. Specific numerical acceptance values are not provided in this summary, but rather the adherence to the testing methodologies.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not applicable and not present in the document. The testing described is non-clinical, mechanical testing of physical device specimens, not a clinical study involving patients or data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable and not present in the document. Ground truth in the context of clinical data or image interpretation is not relevant for the described mechanical device testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not present in the document. Adjudication methods are typically used in clinical studies or expert reviews of data, not for mechanical testing.
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 and not present in the document. An MRMC study is relevant for AI-powered diagnostic/interpretive devices, not for a physical spinal implant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable and not present in the document. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing, the "ground truth" or reference performance is adherence to the specified ASTM standards and comparison to the performance of the legally marketed predicate devices. The document concludes that "The non-clinical test results demonstrate that any minor differences do not impact device performance as compared to the predicates."
8. The sample size for the training set
This information is not applicable and not present in the document. This concept applies to AI/machine learning models, not to a physical medical device undergoing mechanical testing.
9. How the ground truth for the training set was established
This information is not applicable and not present in the document. This concept applies to AI/machine learning models, not to a physical medical 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.