(174 days)
The Alamo® C is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment with an intervertebral cage. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.
The Alamo C is designed for use as a cervical intervertebral body fusion device. The device is manufactured from either PEEK Optima® LT1 per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization or titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
The profile of the device is rectangular with a hollow core for bone graft to promote bone integration and fusion between the vertebral end plates. The device is available in various axial footprints and heights to accommodate variability among patients and the inferior and superior surfaces are designed with ridges (teeth) to improve fixation and stability and prevent back out and migration.
This document is a 510(k) premarket notification for a medical device called Alamo® C, an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance data from a clinical or standalone study.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in the provided text because this is not the type of document that would typically contain such information. This 510(k) summary relies on non-clinical performance testing and comparison to predicate devices, explicitly stating that "No clinical studies were conducted."
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in the format of a table with quantitative thresholds and corresponding performance outcomes for a clinical study. Instead, it refers to performance testing conducted in accordance with specific ASTM standards to establish substantial equivalence with a predicate device.
The reported performance is qualitative:
- "The results obtained demonstrate the subject Alamo C device functions as intended and is substantially equivalent to the predicate Alamo C device."
The types of tests performed were:
- Static axial compression
- Dynamic axial compression
- Static torsion
- Subsidence
- Expulsion
These are non-clinical/bench testing results, not clinical performance metrics. The underlying acceptance criteria for these tests would be the pass/fail criteria defined within the referenced ASTM standards (ASTM F2077, ASTM F2267, and ASTM Draft Standard F-04.25.02.02) and likely internal company specifications for equivalence to the predicate.
2. Sample sized used for the test set and the data provenance
- Sample Size: Not specified in the document. This typically refers to the number of devices tested in the non-clinical performance evaluations.
- Data Provenance: The tests were conducted internally or by a contracted lab as part of the 510(k) submission process for the new titanium version of the Alamo® C device. It's not "data provenance" in the sense of clinical patient data (e.g., country of origin, retrospective/prospective), as no clinical studies were conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as no clinical study was conducted that would require expert-established ground truth for patient outcomes or image annotations. The "ground truth" for the non-clinical tests would be the established scientific principles of mechanical testing and material properties as defined by the ASTM standards.
4. Adjudication method for the test set
- Not applicable for non-clinical performance 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
- Not applicable. This device is an intervertebral body fusion device, not an imaging AI diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical performance tests, the "ground truth" is based on the engineering principles, material science, and mechanical testing standards (ASTM F2077, ASTM F2267, and ASTM Draft Standard F-04.25.02.02). The performance of the new device was compared to the predicate device, implying that the predicate's established performance served as a benchmark for equivalence.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.