(78 days)
The Ardis™ Spacer is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment.
The Ardis™ Spacer is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.
Ardis™ Spacer is a hollow device intended for use as an intervertebral body fusion device in the lumbosacral region (L2-S1) of the spine.
The provided text is a 510(k) summary for a medical device called the Ardis™ Spacer. It describes the device, its indications for use, and states that substantial equivalence was demonstrated through engineering evaluations and bench testing.
However, the document does not contain any information regarding acceptance criteria, reported device performance metrics (like sensitivity, specificity, or accuracy), or details about a study that would demonstrate the device meets such criteria in terms of clinical performance.
Here's why the requested information cannot be fully provided from the given text:
- Type of Device: The Ardis™ Spacer is a physical implant (intervertebral body fusion device), not an AI/software-as-a-medical-device (SaMD) or diagnostic device that would typically have performance metrics like sensitivity or specificity.
- Study Type: The submission focuses on demonstrating "substantial equivalence" to a predicate device primarily through "engineering evaluations and bench testing" to assess "physical and mechanical properties." It's not a clinical effectiveness study in the way one would assess a diagnostic algorithm.
- Clinical Performance Data Absence: There's no mention of a study involving human subjects, data sets for training or testing algorithms, expert opinions for ground truth, or statistical measures of diagnostic performance.
Therefore, most of the requested fields are not applicable or cannot be extracted from this document.
Based only on the provided text, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Mechanical Properties as compared to other available intervertebral body fusion devices. | "These results demonstrate that the performance of the Abbott Spine Ardis™ Spacer, when compared with other available intervertebral body fusion devices with similar indications, intended use and materials of manufacture is substantially equivalent." (Implicitly, the device met the criteria by being substantially equivalent.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The submission refers to "engineering evaluations and bench testing," not a clinical test set with human data. Therefore, there's no sample size in this context, nor data provenance.
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. Ground truth, in the context of clinical performance for diagnostic or AI devices, is not discussed in this submission. The "ground truth" here would relate to the successful physical and mechanical performance defined by engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. There is no clinical test set described that would require adjudication.
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 is not an AI-assisted device. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The implicit "ground truth" for the substantial equivalence claim is based on engineering standards and established performance characteristics of predicate intervertebral body fusion devices.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device, so there is no training set or associated ground truth establishment.
§ 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.