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510(k) Data Aggregation
(393 days)
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.
The NAUTILUS Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion.
When used as a posterior spine thoracic/lumbar system, the NAUTILUS Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.
The NAUTILUS Spinal System consists of an assortment of rods, screws, and cross connectors. The bone screw, head, and taper lock are assembled together during manufacturing to create the NAUTILUS Spinal System screw assembly component. The cross connectors are also assembled during manufacturing. Do not use any of the NAUTILUS Spinal System components with the components from any other system or manufacturer.
The NAUTILUS Spinal System is a medical device and its "acceptance criteria" and "study that proves the device meets the acceptance criteria" are based on demonstrating substantial equivalence to predicate devices, rather than clinical performance metrics typical of AI/software devices. Therefore, the questions related to AI/software performance metrics (like sample size for test set, experts for ground truth, MRMC study, standalone performance) are not applicable in this context.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Substantial Equivalence) | Reported Device Performance (Means of Demonstration) |
|---|---|
| Design Substantial Equivalence | Same basic design principle (pedicle screw system for posterior spinal fixation). |
| Material Substantial Equivalence | Manufactured from 6AL-4V-ELI titanium according to ASTM F136; variety of non-sterile, single-use components. |
| Indications for Use Substantial Equivalence | Intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients as an adjunct to fusion, for conditions like degenerative disc disease, trauma, curvatures, spinal tumor, failed previous fusion, pseudarthrosis, spinal stenosis, and spondylolisthesis. This perfectly matches the predicate devices. |
| Sizing Substantial Equivalence | Not explicitly detailed, but stated as being substantially equivalent in sizing to predicate systems. Implies similar range and types of components. |
| Performance (Mechanical) Substantial Equivalence | Static compression, static torsion, and dynamic compression testing per ASTM F1717 presented. These tests demonstrate substantial equivalency to the mechanical performance of the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable: This is a mechanical device, not an AI/software device. There is no "test set" in the context of image analysis or algorithm performance. The data provenance would relate to the mechanical testing, which is performed in a laboratory setting. The document only states "Static compression, static torsion, and dynamic compression testing per ASTM F1717 was presented". The specific number of samples for each test type is not provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable: There is no "ground truth" in the clinical or image analysis sense for this type of device submission. Substantial equivalence is established through comparison of design, materials, indications, and mechanical testing against recognized standards (ASTM F1717) and predicate devices.
4. Adjudication Method for the Test Set
- Not Applicable: See point 3.
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 physical spinal system, not an AI or software device that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This is a physical spinal system; there is no algorithm or standalone performance in the context of AI.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable (in the conventional sense): The "ground truth" for this device's acceptance is its compliance with recognized mechanical testing standards (ASTM F1717) and its similarity in design, materials, and indications for use to already legally marketed predicate devices (CONQUEST Spinal System K080767, Pilot Spinal System K063601, ARX Spinal System K061600). The "truth" is established by showing it performs comparably and is structurally similar to devices already deemed safe and effective.
8. The Sample Size for the Training Set
- Not Applicable: There is no "training set" for this type of medical device submission.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: See point 8.
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(64 days)
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.
The CONQUEST Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion.
When used as a posterior spine thoracic/lumbar system, the CONQUEST Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.
The CONQUEST Spinal System is a titanium alloy multiple component system comprised of a variety of non-sterile, single use implantable components. When assembled, the components create a rigid structure providing stabilization and promote spinal fusion. The system consists of an assortment of rods, screws, and locking caps.
This 510(k) summary describes a spinal implant system, not an AI/ML powered medical device. Therefore, many of the requested criteria related to AI/ML device studies (such as sample size for test sets and training sets, expert consensus, MRMC studies, standalone performance, etc.) are not applicable in this context.
However, I can provide the available information regarding the device's acceptance criteria and the study performed as described in the provided text.
Acceptance Criteria and Device Performance for CONQUEST® Spinal System
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biomechanical performance in accordance with ASTM F1717 | Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalence. |
| Substantial equivalence to previously cleared devices in indications for use, design, function, and materials used. | The CONQUEST® Spinal System was shown to be substantially equivalent to previously cleared devices (ARX Spinal System (K061600) and Life Spine Cross Connector (K073430)) in indications for use, design, function, and materials used. |
Explanation for AI-specific questions (Not Applicable for this Device):
This device, the CONQUEST® Spinal System, is a traditional medical implant, specifically a spinal fixation system. The provided 510(k) summary focuses on demonstrating its mechanical properties and equivalence to existing, legally marketed devices. It does not involve any artificial intelligence or machine learning components for diagnosis, prognosis, or treatment decisions. Therefore, the following information is not provided nor applicable:
- Sample size used for the test set and the data provenance: Not applicable. The "test set" for this type of device would refer to physical prototypes undergoing mechanical testing, not a dataset for an algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is irrelevant here. The "ground truth" for a spinal implant's performance would be derived from mechanical test standards (ASTM F1717) and engineering principles.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 does not involve human readers interpreting data with or without AI assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the biomechanical performance, the "ground truth" is adherence to established engineering standards (ASTM F1717) and functional equivalence to predicate devices, rather than clinical outcomes or diagnostic ground truth.
- The sample size for the training set: Not applicable. This device does not involve a training set.
- How the ground truth for the training set was established: Not applicable.
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