(218 days)
The Amendia Cervical Interbody Fusion Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defines as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Amendia Cervical Interbody Fusion Devices are used to facilitate intervertebral body fusion in the C3 to C7 disc levels using autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.
The Amendia Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. Amendia Lumbar Interbody Fusion Devices are to be used with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The Amendia Interbody Fusion Devices consist of multiple components comprised of sterile and/or non-sterile, single-use implants fabricated from Titanium alloy (Ti6AI4V ELI, ASTM F136) or Invibio PEEK-Optima® LT1 or Solvay Advanced Polymers Zeniva™ ZA-500 PEEK (ASTM F2026) with tantalum (ASTM F560) x-ray markers. The Amendia Interbody Fusion Devices are used to provide structural stability and maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation.
The Amendia Interbody Fusion Devices are comprised of implants designed to treat the cervical and lumbar spine. The implants are available in a range of sizes and shapes to accommodate variations in surqical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion. The surface of the ridges on the titanium implants are roughened.
The provided text is a 510(k) Summary for Amendia Interbody Fusion Devices, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study proving the device meets specific acceptance criteria through clinical performance metrics like sensitivity, specificity, or reader improvement.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC comparative effectiveness studies cannot be extracted from this document. This document primarily addresses the mechanical and material equivalence of the device to previously approved devices.
Here's what can be inferred about "acceptance criteria" in the context of this 510(k) and the "study" that proves it:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implied for 510(k) Clearance): The primary acceptance criterion for a 510(k) submission is demonstrating substantial equivalence to a predicate device. This is typically achieved by showing similar intended use, indications for use, materials, performance (mechanical), and fundamental scientific technology.
- Reported Device Performance: The document states: "The substantial equivalence of the Amendia Lumbar Interbody Fusion Devices to the predicate is shown by similarity in intended use, indications for use, materials, performance and fundamental scientific technology."
- Performance aspects mentioned (though no specific numerical criteria or results are given): The device is made of specific materials (Titanium alloy, PEEK, Tantalum), has various sizes/shapes, a hollow center for bone graft, and ridges for gripping endplates. "Performance testing" is mentioned, implying mechanical and material characterization, but no results are provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. Clinical performance testing on a test set (as would be done for an AI device) is not detailed in this document. The "test set" here refers to the device itself and its components undergoing mechanical/material testing.
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)
- Not applicable/Not provided. Ground truth establishment by clinical experts for a performance study is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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/Not provided. This is a medical device (interbody fusion device), not an AI diagnostic/imaging device that would typically undergo MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not provided. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the purpose of substantial equivalence, the "ground truth" would be the established performance and safety profile of the predicate devices, along with adherence to relevant ASTM standards for material and mechanical properties. No clinical ground truth is discussed.
8. The sample size for the training set
- Not applicable/Not provided. The document does not describe a machine learning algorithm or training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
In summary: This document focuses on demonstrating substantial equivalence for a physical medical implant (Interbody Fusion Device) based on its design, materials, and mechanical properties compared to already cleared predicate devices. It does not present clinical performance data or details about studies that would evaluate diagnostic accuracy or compare human reader performance, which are typical for AI/software devices. The "studies" implied are likely non-clinical (e.g., bench testing for mechanical properties, material biocompatibility, etc.) to show consistency with predicate devices and relevant standards.
§ 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.