(85 days)
The CONCORDE LIFT Expandable Interbody Device is a lumbar intervertebral body fusion device, and is indicated for use with autogenous bone graft and/or allograft comprised of cancellous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine, L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The CONCORDE LIFT Expandable Interbody Device can be implanted via posterior, transforaminal or lateral approach.
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had a six-month course of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.
The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
The CONCORDE LIFT Inserter is temporarily attached to the CONCORDE LIFT Expandable Interbody Fusion Device for implantation. A component of the CONCORDE LIFT Inserter, the driver, is then used to increase or decrease the height of the CONCORDE LIFT Expandable Interbody Fusion Device. The CONCORDE LIFT Inserter is intended to be used in conjunction with all sizes of the CONCORDE LIFT Expandable Interbody Device. The Inserter is fabricated from 17-4 PH Stainless Steel and 465 Stainless Steel that meets the requirements of ASTM F899. The inserter is provided non-sterile and is reusable.
The purpose of this submission is to capture the modifications made to the CONCORDE LIFT Expandable Interbody System Inserter.
The provided document, K173537, describes a 510(k) premarket notification for the CONCORDE LIFT™ Expandable Interbody Fusion Device. It focuses on modifications to the device's inserter. Therefore, the information provided primarily pertains to demonstrating substantial equivalence for an intervertebral body fusion device and its inserter, not an AI-powered diagnostic device.
As a result, many of the requested elements regarding acceptance criteria and study proving performance for an AI device (e.g., sample size for test/training sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance) are not applicable to this document. The document focuses on mechanical and material properties and indicates feasibility testing rather than clinical performance studies typical for AI/diagnostic devices.
Here's an analysis of the provided information in relation to your request, with a clear indication of what is not applicable based on the document's content:
1. A table of acceptance criteria and the reported device performance
The document does not detail specific quantitative acceptance criteria or detailed performance results in a table format as would be typical for an AI/diagnostic device. Instead, it states:
| Acceptance Criteria Category | Reported Device Performance/Statement |
|---|---|
| Technological Characteristics | "The technological characteristics, including material, design and performance of the CONCORDE LIFT Inserter are consistent with those of the predicate devices." (Page 4, Section G) |
| Material Compliance | "The Inserter is fabricated from 17-4 PH Stainless Steel and 465 Stainless Steel that meets the requirements of ASTM F899." (Page 4, Section E, and Page 4, Section H) |
| Design Modifications | "The minor modification to the design of the device and material change do not change the technological characteristics of the device. The design modification is supported by the results of feasibility testing." (Page 4, Section I) |
| Intended Use & Equivalence | The device is "substantially equivalent" to legally marketed predicate devices for its indicated use as a lumbar intervertebral body fusion device. (Page 0, Paragraph 2; Page 5, Section J) |
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. The document describes "feasibility testing" for a mechanical device inserter, not a clinical study involving a test set of patient data. Therefore, concepts like data provenance (country, retrospective/prospective) are not relevant here.
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. This is a mechanical device, not an AI/diagnostic device that requires expert-established ground truth from images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No ground truth establishment or adjudication for a clinical test set is described.
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 diagnostic device. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For a mechanical device inserter, "ground truth" would relate to its engineering specifications and functionality (e.g., proper engagement, force application, height adjustment), which are evaluated through "feasibility testing" against design specifications, not clinical "ground truth" from patients.
8. The sample size for the training set
- Not Applicable. This is not an AI device trained on data.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI device trained on data.
In summary, the provided FDA 510(k) document (K173537) is for a mechanical medical device and its modified component (an inserter), not an AI/diagnostic software. As such, the typical "acceptance criteria" and "study proving performance" questions relevant to AI devices, which rely on large datasets and human expert annotations, are entirely out of scope for this document. The "proof" of performance for this device rests on its "substantial equivalence" to a predicate device, supported by consistency in technological characteristics, material compliance, and successful "feasibility testing" of the minor design modifications.
§ 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.