(56 days)
The Align Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
The Align Lumbar Interbody Fusion System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios.
The Align Lumbar Interbody Fusion System is intended to be used with supplemental spinal fixation system cleared for use in the lumbosacral spine.
The Align Lumbar Interbody Fusion System consists of several models of intervertebral body fusion devices. The Align ALIF unitary cages and Align fully round ALIF (FRA) cages are intended for anterior approaches. The Align AOLIF cages are intended for anterolateral approaches. The Align Lateral cages are intended for lateral approaches. The Align TLIF cages and Align Oblique TLIF cages are intended for transforaminal approaches. The Align PLIF cages are intended for posterior approaches.
Align Lumbar Interbody Fusion System devices are made from titanium alloy (Ti-6A1-4V ELI) per ASTM F3001 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion. Align Lumbar Interbody Fusion System devices are also made from polyetheretherketone (Zeniva ZA-500 PEEK®) per ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications. The PEEK devices contain radiopaque markers constructed from Tantalum per ASTM F560 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications to assist with intraoperative placement. The radiopaque markers are positioned so the implant can be visualized from an Anterior-Posterior (AP) and Lateral x-ray view.
Reusable instruments to support implantation of the subject device are provided with non-sterile implants in sterilization trays. Implants are also available sterile packaged.
This document is a 510(k) premarket notification for a medical device, the "Align Lumbar Interbody Fusion System." Within this specific type of regulatory submission to the FDA, detailed information regarding acceptance criteria and the study that proves the device meets those criteria, especially in the context of AI/ML performance, is generally not present.
The 510(k) pathway focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, primarily through non-clinical testing (bench testing, biocompatibility) and comparisons of technological characteristics. Clinical data is often not required for 510(k) submissions unless the device has new indications for use, different technological characteristics that raise new safety or effectiveness questions, or if the predicate device itself required clinical data.
Based on the provided document, I can primarily address the information regarding non-clinical testing acceptance criteria and studies. The questions related to AI/ML specific performance, such as MRMC studies, expert ground truth adjudication, and training/test set details, are not applicable to this specific submission as there is no mention of AI/ML components in the "Align Lumbar Interbody Fusion System."
Here's an analysis of what is available in the document regarding acceptance criteria and studies:
1. A table of acceptance criteria and the reported device performance:
The document broadly states that the device met acceptance criteria, especially for bench testing. However, it does not provide a specific table detailing numerical acceptance criteria and corresponding reported performance values. This level of detail is typically found in the full submission, not in the publicly available 510(k) summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Complies with ISO 10993-1, ISO 10993-5, ISO 10993-11 standards. | Met: Device was subjected to and complied with the listed ISO 10993 standards for biological evaluation. |
| Mechanical Strength (Bench Testing): Design features meet required mechanical strength criteria for intended use. Specifically, static compression, dynamic compression, static compression-shear, dynamic compression-shear (per ASTM F2077), and subsidence testing (per ASTM F2267) standards. Performance equivalence to predicate device. | Met: "the design features met the required mechanical strength criteria for their intended use." "Performance equivalence was shown through the verification comparison to the predicate device." "The results on the non-clinical testing demonstrated that the subject device met the acceptance criteria of the standard and is substantially equivalent to the predicate devices." |
| Sterilization & Packaging Validation: Validated. | Met: "The sterilization method and packaging of the subject device were validated and remain unchanged." |
2. Sample size used for the test set and the data provenance:
- Test Set (for physical device testing): Not explicitly stated in terms of a "sample size" like one would for a clinical study. For bench testing, typically a certain number of samples per configuration are tested (e.g., 6 or 12 per test type). This detail is not provided in a summary.
- Data Provenance: The studies are laboratory-based bench tests and biocompatibility tests, not clinical data from patients. Therefore, terms like "country of origin" or "retrospective/prospective" are not applicable in this context.
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 submission relies on engineering and material science standards (ASTM, ISO), not expert clinical reviews for "ground truth". The "ground truth" for these tests is generally defined by the parameters and methodologies outlined in the referenced standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for imaging interpretation, to resolve discrepancies between readers. This is not relevant for bench 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:
- No: The document states, "No clinical data was provided to demonstrate substantial equivalence." This implies no human reader studies of any kind were performed for this submission, negating the possibility of an MRMC study related to AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This device is an implantable medical device (intervertebral body fusion system), not a software algorithm or AI-powered system. No standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Bench Testing Standards & Specifications: For the non-clinical tests, the "ground truth" is adherence to the specified engineering standards (e.g., ASTM F2077, ASTM F2267) and biocompatibility standards (ISO 10993 series), and comparison to the performance of the predicate device. The goal is to show that the device performs mechanically as intended and is biocompatible, similar to existing devices.
8. The sample size for the training set:
- Not Applicable: As this is a physical medical device and not an AI/ML system, there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable: No training set exists for this device.
In summary: The provided document describes a 510(k) submission for a physical implantable device. The "acceptance criteria" and "proof" primarily stem from meeting established international and national standards for biocompatibility and mechanical performance, and demonstrating equivalence to predicate devices through laboratory bench testing. The questions related to AI/ML performance, clinical studies, and expert ground truth are not applicable to the information contained within this specific 510(k) summary.
§ 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.