(133 days)
The aprevo™ anterior lumbar interbody fusion and aprevo™M lateral lumbar interbody fusion devices are intended for interbody fusion in skeletally mature patients and are to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo™ anterior lumbar interbody fusion and aprevo™ lateral lumbar interbody fusion devices are indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches may include anterior lumbar interbody fusion or lateral lumbar interbody fusion.
The aprevo™ ALIF and LLIF devices are designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo™ devices incorporate patient specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient. The individualized surgical correction plan and device configurations are developed using patient CT scans. Aprevo™ devices are additively manufactured and made from Titanium Alloy (Ti-6Al-4V) per ASTM F3001, and have a cavity intended for the packing of bone graft.
The provided text describes a 510(k) premarket notification for the "aprevo™ Intervertebral Body Fusion Device." This document focuses on demonstrating substantial equivalence to legally marketed predicate devices through mechanical performance testing, rather than a study evaluating device performance against pre-defined clinical acceptance criteria.
Therefore, many of the requested elements for a study proving device performance (such as sample size for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies) are not applicable or cannot be extracted from this document, as it pertains to a mechanical device and not an AI/diagnostic software.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of clinical outcomes or performance metrics for the device in a clinical setting. Instead, it relies on demonstrating mechanical properties that are sufficient for its intended use and comparable to predicate devices. The "reported device performance" refers to the results of various mechanical tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Static axial compression strength sufficient for intended use | Results demonstrate sufficient mechanical performance per ASTM F2077. |
| Static compression shear strength sufficient for intended use | Results demonstrate sufficient mechanical performance per ASTM F2077. |
| Dynamic axial compression durability sufficient for intended use | Results demonstrate sufficient mechanical performance per ASTM F2077. |
| Dynamic compression shear durability sufficient for intended use | Results demonstrate sufficient mechanical performance per ASTM F2077. |
| Resistance to subsidence for intended use | Results demonstrate sufficient mechanical performance per ASTM F2267. |
| Accuracy and Usability (Design Process): | |
| Cadaver accuracy validation acceptable | Results from Cadaver Accuracy Validation and Usability Study were acceptable. |
| Inter- and Intradesigner variability for segmentation, planning, and implant design acceptable | Results from Inter- and Intradesigner Variability Testing were acceptable. |
| Substantial Equivalence: | |
| Equivalent to predicate devices in mechanical performance, indications for use, and technological characteristics. | Tested to be substantially equivalent to predicate devices (K191391, K182158, K133455). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: This information is not explicitly provided in the document. Mechanical tests typically use a certain number of device samples, but the specific quantity is not stated here. For the "Cadaver Accuracy Validation and Usability Study" and "Inter- and Intradesigner Variability Testing," the sample size (e.g., number of cadavers or number of designers/cases) is not detailed.
- Data Provenance: Not specified, as the data predominantly refers to mechanical testing of the physical device samples. It is not clinical data from patients or countries.
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)
This is not applicable as the document describes mechanical testing of an intervertebral body fusion device, not an AI/diagnostic software that requires expert ground truth for image interpretation or diagnosis. The "Cadaver Accuracy Validation" likely involved medical professionals, but their number and specific qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the type of mechanical device testing 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
This is not applicable. The device is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical implant, not an algorithm. The "patient-specific adaptable features" and "individualized surgical correction plan" are developed using patient CT scans, which implies a human-in-the-loop design process based on AI/software, but the core device performance evaluation is mechanical.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical testing, the "ground truth" is typically defined by engineering standards (e.g., ASTM standards) and the physical properties of the material and design. For the "Cadaver Accuracy Validation," anatomical landmarks or surgical measurements would serve as the "ground truth." For the "Inter- and Intradesigner Variability Testing," consistency and deviation from a "gold standard" design or a human expert's optimal design would be evaluated. Detailed specifics are not provided in the document.
8. The sample size for the training set
This is not applicable as the document is about a manufactured medical device and its mechanical properties, not an AI/machine learning model that requires a "training set." While the device design process involves patient CT scans to create patient-specific implants, these likely serve as input data for design software (which may incorporate AI), rather than a training set for algorithm development that is being evaluated in this 510(k).
9. How the ground truth for the training set was established
This is not applicable for the same reasons as #8.
§ 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.