(7 days)
The Moss Miami Spine System is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Moss Miami Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The Moss Miami Spine System is also a hook and sacral/illiac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The CrossOver Cross Connector is designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes the torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement.
The provided 510(k) summary for the Moss Miami Spinal System does not include information about acceptance criteria or a study proving the device meets said criteria in the way typically found for AI/ML-driven devices (e.g., performance metrics against a clinical standard).
Instead, the documentation describes a traditional medical device submission for a spinal implant system. The "performance data" mentioned refers to engineering tests to characterize the physical properties and functionality of the device components, rather than clinical efficacy measured against specific performance metrics like sensitivity or specificity.
Therefore, many of the requested bullet points, particularly those related to clinical performance, ground truth, expert review, and sample sizes for AI/ML models, are not applicable to this type of submission.
Here's a breakdown of the information that is available, and why other requested information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document in the format requested for AI/ML devices.
For this device (a spinal implant):
- Acceptance Criteria (Implied): The device (CrossOver Cross Connector) would need to meet biomechanical performance standards and demonstrate equivalence in design and materials to its predicate devices (MOSS MIAMI Spinal System Transverse Connector and EZ-Link Transverse Connector). This would involve tests for strength, fatigue, torsional forces, and material compatibility. These specific numerical criteria are not detailed in the summary.
- Reported Device Performance: The summary states: "Performance data were submitted to characterize the CrossOver Cross Connector." However, the actual results of these characterization tests (e.g., specific load capacities, fatigue cycles, torque resistance) are not reported in this summary document. The summary only confirms that such data "were submitted."
2. Sample size used for the test set and the data provenance
- Not Applicable in the traditional sense for a clinical performance study. For a mechanical device, "test set" refers to physical samples of the manufactured device components. The specific number of physical units tested is not mentioned in this summary.
- Data Provenance: Not applicable in the context of clinical data for AI/ML. The "performance data" would have been generated in engineering labs, likely within the manufacturer's facilities or accredited testing labs, characterizing the mechanical properties of device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. "Ground truth" in this context refers to clinical diagnoses or outcomes, which is relevant for AI/ML devices analyzing medical images or data. For a spinal implant, "ground truth" might relate to established engineering standards or material science properties, which would be validated by engineers and metallurgists rather than clinical experts.
4. Adjudication method for the test set
- Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human reviewers (e.g., radiologists) when establishing ground truth for AI/ML performance studies. This is not relevant for the mechanical testing of a physical implant.
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 a type of study specifically for AI/ML diagnostic or assistive devices, comparing human performance with and without AI aid. The Moss Miami Spinal System is a physical implant, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This refers to the performance of an AI/ML algorithm independently. The Moss Miami Spinal System is a physical implant, not an algorithm.
7. The type of ground truth used
- Not Applicable in the clinical sense. For this device, "ground truth" would derive from established engineering principles, material science specifications (e.g., ASTM F-136 for titanium alloy), and biomechanical testing standards. This would not be "expert consensus, pathology, or outcomes data" in the clinical AI/ML context.
8. The sample size for the training set
- Not Applicable. There is no "training set" for a physical spinal implant device in the AI/ML context. The device design is based on engineering principles, predicate device designs, and material science, not machine learning from a dataset.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
Summary of what can be gleaned from the document regarding "performance":
- The submission included "Performance data... to characterize the CrossOver Cross Connector." This implies a series of mechanical and material tests.
- The device is "Manufactured from ASTM F-136 implant grade MATERIALS: titanium alloy," indicating adherence to a recognized standard for implant materials.
- The FDA's 510(k) clearance (K013296) indicates that the device was found "substantially equivalent" to predicate devices (K983583, K001372, K001470). This substantial equivalence is based on similar intended use, technological characteristics, and safety and effectiveness, which includes evaluation of the submitted performance data.
In conclusion, the provided document describes a much earlier and different type of device submission than one for an AI/ML medical device, and therefore the requested information categories are largely not applicable.
§ 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.