(59 days)
The Innovasis 'Excella-M' Spinal System is intended for use in the non-cervical area of the spine.
The Innovasis 'Excella-M' Spinal System, when used for pedicle screw fixation is intended only for patients:
a) Having severe spondylolisthesis (Grade 3&4) at the LS-S1 joint;
Who are receiving fusion using autogenous hone graft only; し)
Who are having the device fixed or attached to the lumbar sacral spinc (L3 and below); and c)
Who are having the device removed after the development of a solid fusion mass. ()
The Innovasis 'Excella-M' Spinal System, when used as a pedicle screw system in skeletally mature patients, is intended to provide inunobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic. lumbar, and sacral spine: a) Degenerative spondylolisthesis with objective evidence of neurologic impairment; b) Fracture; c) Dislocation; d) Scoliosis; e) Kyphosis; f) Spinal tumor; and g) Previous failed fusion (pseudarthrosis).
The Innovasis 'Excella-M' Spinal System, when used for anterolateral non-pedicle fixation, is intended for the following indications:
a)Degenerative disease (DDD) ( defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies); b) Spondylolisthesis; d) Spondylolisthesis; d) Spinal deformities (i.e. scollosis, kyphosis, and/or lordosis); e) Pseudarthrosis; 1) Tumor: g) Trauma (i.e. fracture or dislocation); and h) Previous failed fusion.
The Innovasis *Excella-M' Spinal System, when used for posterior non-pedicte screw fixation to the noncervical spine, is intended for the following indications:
a) Degenerative disc disease (DDD) (defined as back pain of disogenic origin with degenerative disc confirmed by patient history and radiographic studies); b) Spinal stenosis; c) Spondylolisthesis; d) Spinal deformities (i.e. scoliosis, kyphosis and/or lordosis); e) Pseudarthrosis; 1) Tumor; g) Trauma (i.e. fracture or dislocation); and h) Previous failed fusion
The INNOVASIS 'Excella-M' Spinal System is a 6-4 Titanium Alloy device comprised of a variety of non-sterile, single use components of 2 size diameters (6.5 & 7.5mm) and various lengths of monoaxial Pedicle Screws with an assortment of various lengths 6.0mm Rods.
The INNOVASIS 'Cross Link' is a modification to the 'Excella-M' Spinal System that allows the surgeon to build a spinal implant construct to increase rotational stability.
The system is attached to the vertebral body by means of screws to the non-cervical spine.
The INNOVASIS 'Excella-M' Spinal System consists of an assortment of screws, rods, cross-connector and related instrumentation as implant offerings specific to this system.
The provided text is a 510(k) Summary for a spinal system, which is a premarket notification to the FDA to demonstrate that a device is as safe and effective as a legally marketed device (predicate device). This type of submission does not typically involve or require clinical studies with acceptance criteria in the manner of a new drug or novel medical device requiring pre-market approval (PMA).
Instead, the "acceptance criteria" for a 510(k) submission are met by demonstrating substantial equivalence to predicate devices. This is primarily established through:
- Comparison of technological characteristics: This involves showing that the new device has similar design, materials, and intended use as the predicate device.
- Performance data: For spinal systems, this almost exclusively refers to mechanical testing to demonstrate that the device meets established industry standards for strength, durability, and other relevant physical properties. There are no "reported device performance" metrics in terms of clinical outcomes or diagnostic accuracy in this document for this type of device.
Given this context, I will address your questions based on the information provided, noting where specific criteria (like "acceptance criteria" for performance in a clinical study) are not applicable to a 510(k) for a spinal implant device.
1. A table of acceptance criteria and the reported device performance
As this is a mechanical spinal implant device undergoing a 510(k) clearance, the "acceptance criteria" are not reported as clinical performance metrics (e.g., sensitivity, specificity, accuracy) but rather as compliance with recognized mechanical testing standards. The device performance is primarily assessed through robust mechanical testing.
| Acceptance Criterion (Implicit) | Reported Device Performance (as demonstrated by study) |
|---|---|
| Compliance with mechanical testing standards for spinal systems (e.g., fatigue strength, static strength, construct rigidity). | Mechanical testing performed in accordance with "Guidance for Industry and FDA Staff Spinal System 510(k)s", issued May 3, 2004. |
| Biocompatibility of materials. | Device made from 6-4 Titanium Alloy (ASTM F 136), which is stated as "proven to be biocompatible as implant materials." |
| Substantial equivalence to predicate spinal fixation systems regarding technical characteristics and performance. | Substantially equivalent to Blackstone Spinal Fixation System (K994217), DePuy Acromed Moss Miami system (K992168), Synthes Universal Spinal System (K990745), and Interpore Cross Synergy IQ Spinal System (K012871). |
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: Not applicable in the context of clinical test sets. The "test set" here refers to the physical devices subjected to mechanical testing. The document does not specify the number of devices or components tested.
- Data provenance: Not applicable for a clinical test set. The mechanical testing data would be generated in a laboratory setting, typically in the country where the manufacturer performs its testing (likely the US, given the FDA submission). The document does not specify if the testing was performed internally or by a third-party lab.
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. For a spinal implant 510(k), ground truth is established by engineering standards and validated mechanical testing methodologies, not by expert clinical consensus on a biological dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for clinical studies or diagnostic accuracy assessments. For mechanical testing, the results are typically quantitative measurements against predefined engineering specifications.
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 device is a passive mechanical implant, not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating diagnostic accuracy, often in imaging, and are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. There is no algorithm or AI component to this mechanical spinal implant. It is a physical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Mechanical Engineering Standards: The ground truth for the "Excella-M" Spinal System is based on established mechanical engineering standards (e.g., ASTM F136 for material, and FDA guidance for spinal system testing) that dictate the expected performance and safety characteristics of such implants. This includes properties like fatigue life, static strength, and appropriate material biocompatibility.
8. The sample size for the training set
- Not applicable. This device does not use machine learning or AI, so there is no training set in that context. The "training" for such a device involves adherence to manufacturing specifications and quality control procedures.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is not relevant. The safety and effectiveness are established via mechanical testing confirming adherence to recognized standards and through a comparison to predicate devices.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.