(105 days)
RANGE/DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications:
Non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion.
Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors. The purpose of this submission is to add Mesa Hooks to the system.
Materials: The proposed devices are manufactured from Titanium Alloy per ASTM F136 and ASTM F1472.
Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.
Purpose of Submission: To add Mesa Hooks.
The provided text is a 510(k) summary for a medical device, the Range/Mesa/Denali Spinal System. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for proving 'acceptance criteria' in the rigorous, quantitative sense of a new, novel AI-powered device or a drug.
For a medical device like a spinal fixation system, the "acceptance criteria" are primarily related to biocompatibility, mechanical performance, and substantial equivalence to existing, legally marketed devices. The "study that proves the device meets the acceptance criteria" refers to the pre-clinical mechanical testing and the comparison to predicate devices, rather than clinical trials or AI-specific performance metrics.
Therefore, many of the requested points are not applicable to this type of regulatory submission and device. I will address the relevant points based on the provided document and note where information is not present or not applicable.
Acceptance Criteria and Study Proving Device Meets Criteria
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate device performance and ASTM standards) | Reported Device Performance |
|---|---|---|
| Material Biocompatibility | Manufactured from materials with established biocompatibility for implant use. | Manufactured from Titanium Alloy per ASTM F136 and ASTM F1472. |
| Mechanical Performance | - Static compression strength | Constructs representing worst-case components were tested in static compression and dynamic compression bending in accordance with ASTM F1717. |
| - Dynamic compression bending endurance | Determined to be substantially equivalent to predicate devices. | |
| Design & Function | - Similar design features and sizing to predicate devices. | The Range Spinal System was found to be substantially the same as predicate systems in design features and sizing. |
| Intended Use | - Indications for use consistent with predicate devices and established clinical practice. | Indications for use listed are consistent with those of the predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document states "Constructs representing the worst case components were tested." It does not specify the exact number of samples tested for static and dynamic compression bending.
- Data Provenance: The testing was conducted in accordance with ASTM F1717, which are recognized standards for mechanical testing of spinal implant constructs. The location of the testing is not specified, but it would typically be a lab qualified to perform such tests on medical devices. The data is prospective, generated specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to a submission for a mechanical spinal fixation system. "Ground truth" in this context refers to the defined mechanical properties and performance standards (e.g., ASTM F1717) and the performance of predicate devices. Expert consensus in the traditional sense of clinical interpretation (like image reading) is not part of this evaluation.
4. Adjudication method for the test set
Not applicable. The "test set" here refers to mechanical testing results, which are objectively measured against defined standards, not subject to human interpretation requiring 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 device is a mechanical implant, not an AI-powered diagnostic or assistive tool. MRMC studies are related to clinical interpretation and AI assistance, which is irrelevant for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by:
- Engineering Standards: Adherence to recognized ASTM standards (F136, F1472 for materials; F1717 for mechanical testing).
- Performance of Legally Marketed Predicate Devices: The key "ground truth" for substantial equivalence is that the new device performs at least as well as, and has similar characteristics to, devices already cleared for market (K2M Range/Mesa/Denali Spinal System (K052398, K042635 K070229, K121630, K140529), Medtronic CD Horizon (K091445)).
8. The sample size for the training set
Not applicable. This device is a mechanical implant, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. As above, there is no "training set" for this type of device.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.