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510(k) Data Aggregation
(24 days)
The NOVA Minimally Invasive System is 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis,
- Trauma (i.e., fracture or dislocation),
- Spinal stenosis.
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- Tumor,
- Pseudoarthrosis, and
- Failed previous fusion
The NOVA Minimally Invasive System consists of cannulated polyaxial screw, straight and pre-bent rods and set screws. The components are manufactured from titanium alloy per ASTM F136. The screws range in diameter from 5.5 mm to 7.0 mm and in length from 20 mm to 70 mm. The implants are not compatible with components or metal from any other manufacturer's system. The NOVA Minimally Invasive System can be used for both percutaneous and mini-open surgery
The provided text is a 510(k) summary for the NOVA Minimally Invasive System. It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared predicate device (K182416).
This document does not contain any information about acceptance criteria or a study proving the device meets those criteria for algorithmic performance. The device described is a medical implant (thoracolumbosacral pedicle screw system), not a software or AI-based diagnostic device. The "Performance Characteristics" section explicitly states: "The mechanical testing performed for the subject NOVA Minimally Invasive System with its components and the predicate devices is in accordance with ASTM F1717. There are no design change are involved for the design verification tests. The performance data for design control activities are unnecessary this time."
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, or MRMC studies, as the document does not pertain to the validation of an algorithmic or AI-based device. The 510(k) submission primarily focuses on mechanical performance and substantial equivalence to an existing physical device.
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(280 days)
The NOVA Minimally Invasive System is intended to provide immobilization 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies),
- Spondylolisthesis,
- Trauma (i.e., fracture or dislocation)
- Spinal stenosis,
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- Tumor,
- Pseudoarthrosis, and
- Failed previouis fusion
The NOVA Minimally Invasive System consists of cannulated polyaxial screws, straight and pre-bent rods, and set screws. The components are manufactured from titanium alloy per ASTM F136. The screws range in diameter from 5.5 mm to 7.0 mm and in length from 20 mm to 70 mm. The implants are not compatible with components or metal from any other manufacturer's system. The NOVA Minimally Invasive System can be used for both percutaneous and mini-open surgerv.
The provided document (K182416) is a 510(k) summary for the NOVA Minimally Invasive System, a thoracolumbosacral pedicle screw system. It focuses on demonstrating substantial equivalence to a predicate device, primarily through mechanical performance testing.
This document does NOT contain information about any study involving human readers, AI assistance, or the establishment of ground truth for a test set or training set for an AI/algorithm. The performance testing described is purely mechanical, comparing the device's physical properties to established standards and a predicate device.
Therefore, for most of your requested information (related to AI performance, human readers, ground truth, sample sizes for test/training sets, and expert qualifications/adjudication), the provided document does not contain the answer.
Here's the information that is available:
1. A table of acceptance criteria and the reported device performance
The document states: "The following tests were performed on the subject components per ASTM F1717: static compression bending, static torsion, and dynamic compression bending. Results of these mechanical tests demonstrate substantially equivalent mechanical performance to predicate devices."
As specific acceptance criteria (e.g., "must withstand X N of force") and exact reported performance values are not detailed in this summary, the table below provides a generalized summary based on the provided text.
| Test Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Static Compression Bending (per ASTM F1717) | Substantially equivalent mechanical performance to predicate devices. | Demonstrates substantially equivalent mechanical performance to predicate devices. |
| Static Torsion (per ASTM F1717) | Substantially equivalent mechanical performance to predicate devices. | Demonstrates substantially equivalent mechanical performance to predicate devices. |
| Dynamic Compression Bending (per ASTM F1717) | Substantially equivalent mechanical performance to predicate devices. | Demonstrates substantially equivalent mechanical performance to predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The testing was mechanical, not on human subjects or clinical data.
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 device is a pedicle screw system, and the testing was mechanical. There was no "ground truth" to be established by experts in a clinical context within this submission summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was mechanical testing, not a clinical study requiring human 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
No. This is a pedicle screw system, and the submission does not mention any AI component or MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device (pedicle screw system), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for mechanical testing is typically defined by engineering specifications and material properties, against which the device's performance is measured. It's not a clinical "ground truth."
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/algorithm device submission.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set as this is not an AI/algorithm device submission.
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