(240 days)
The Alamo T is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via a transforaminal approach.
The Alamo T is used for spinal fusion surgery to provide support and structural stability at the fusion site following discectomy. The device is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560 for radiographic visualization.
The device footprint has a hollow centre to accommodate bone graft to facilitate bone integration and fusion between the end plates from a transforaminal (TLIF) surgical approach. The device is available in various heights to accommodate variability among patients and the inferior and superior surfaces are designed with ridges to improve fixation and stability and prevent back out and migration.
The provided text describes the "Alamo T" intervertebral body fusion device and its regulatory submission. It focuses on demonstrating substantial equivalence to predicate devices, primarily through design, material, and mechanical testing.
There is no information in the provided document about acceptance criteria and a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) or software-based medical device.
The document describes a physical medical device (an intervertebral body fusion device) and its regulatory clearance process through a 510(k) submission. This type of submission relies on demonstrating substantial equivalence to previously cleared devices (predicates) rather than establishing novel performance criteria through clinical studies in the way an AI diagnostic tool might.
Therefore, I cannot populate the requested table and answer the study-related questions as they pertain to AI or software device performance acceptance criteria and validation.
Regarding the device described (Alamo T):
The closest equivalent to "acceptance criteria" for this type of device, as indicated in the document, would be its ability to perform comparably to its predicate devices in terms of mechanical properties and material composition.
1. Table of Acceptance Criteria and Reported Device Performance (as pertains to the physical device):
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Alamo T) |
|---|---|
| Material: PEEK Optima LT1 and Tantalum | PEEK Optima LT1 per ASTM F2026 and Tantalum markers per ASTM F560 (Same as predicates) |
| Mechanical Performance: | Functional as intended, showing substantial equivalence to predicate devices in: |
| - Static Compression | Performance results demonstrate substantial equivalence to predicates (specific values not provided, but deemed acceptable by FDA) |
| - Dynamic Compression | Performance results demonstrate substantial equivalence to predicates (specific values not provided, but deemed acceptable by FDA) |
| - Subsidence | Performance results demonstrate substantial equivalence to predicates (specific values not provided, but deemed acceptable by FDA) |
| - Expulsion | Performance results demonstrate substantial equivalence to predicates (specific values not provided, but deemed acceptable by FDA) |
| Indications for Use: | Consistent with predicate devices: DDD at one or two contiguous levels of the lumbosacral spine (L2-S1), with supplemental fixation and autograft. |
| Footprint/Design Features: | Blocks with one length/width, variety of heights, axial/lateral openings, rows of teeth. Radiographic markers present. (Comparible to predicates) |
Regarding the study that proves the device meets the "acceptance criteria" (again, for the physical device):
The "study" or evidence provided is primarily mechanical testing and a demonstration of substantial equivalence to legally marketed predicate devices.
2. Sample size used for the test set and the data provenance:
- Test Set (for mechanical testing): The document states "worst case device" was used for mechanical testing. It does not specify the exact sample size (e.g., number of devices tested for each mechanical test).
- Data Provenance: Not applicable in the context of patient data. The mechanical testing would have been conducted in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Mechanical testing does not involve human expert ground truth. The "ground truth" is defined by the ASTM standards (F2077 and F2267) which specify the test methodologies and acceptable performance envelope for such devices.
4. Adjudication method for the test set:
- Not applicable. Mechanical testing results are quantitative and do not require expert adjudication in the same way clinical data might. The interpretation of whether the results meet the ASTM standards and demonstrate substantial equivalence is a regulatory assessment.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. This type of study is typically used for diagnostic devices involving human interpretation of images, often to assess the impact of AI assistance. This document describes a physical implantable device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm.
7. The type of ground truth used:
- For mechanical performance: The "ground truth" is effectively the established performance thresholds and methodologies detailed in the ASTM F2077 (Standard Test Methods for Intervertebral Body Fusion Devices) and F2267 (Standard Test Method for Measuring Load-Displacement Properties of Intervertebral Body Fusion Devices) standards, against which the device's performance is compared to ensure it is within acceptable limits and comparable to predicates.
- For substantial equivalence: The ground truth is the performance characteristics and indications for use of the predicate devices (Globus Medical Signature TLIF Spacer (K072970) and Genesys Spine Interbody Fusion System (K103034)).
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set of data.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of 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.