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510(k) Data Aggregation
(70 days)
Nautilus Spinal System
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 Thoracolumbar Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients and for pediatric patients to treat adolescent idiopathic scoliosis (4.75 systems only). It provides stabilization and immobilization of spinal segments as an adjunct to fusion. Pediatric pedicle screw fixation is limited to a posterior approach.
When used as a posterior spine thoracic/lumbar system, the NAUTILUS Thoracolumbar 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.
In order to achieve additional levels of fixation in skeletally mature patients, the NAUTILUS Thoracolumbar Spinal System 5.5 rod system may be connected to the Solstice-OccipitoCervicoThoracic Fixation System's 3.5mm rod.
The NAUTILUS Thoracolumbar Spinal System consists of an assortment of rods, screws, cross connectors, and axial and offset connectors. The bone screw, head, and taper lock are assembled together during manufacturing to create the NAUTILUS Thoracolumbar Spinal System screw assembly component. The cross, axial, and offset connectors are also assembled during manufacturing. The NAUTILUS Thoracolumbar Spinal System implant components are made from titanium alloy (Ti-6AI-4V ELI) as described by ASTM F136 and cobalt chrome per ASTM 1537. Do not use any of the NAUTILUS Thoracolumbar Spinal System components with the components from any other system or manufacturer.
The purpose of this submission is to add new screw iterations to the Nautilus Spinal System.
This document pertains to the Nautilus Spinal System, a medical device intended for spinal fixation, and is a 510(k) premarket notification. It describes the device, its intended use, and claims substantial equivalence to previously marketed predicate devices.Acceptance Criteria and Device Performance for Nautilus Spinal System (K151196)
This 510(k) submission for the Nautilus Spinal System does not describe an AI/algorithm-based device and therefore does not have acceptance criteria or a study proving that an algorithm meets such criteria. Instead, it is for a physical medical device (spinal fixation system) and relies on mechanical testing to demonstrate substantial equivalence to predicate devices.
However, based on the provided text, we can extrapolate the performance data mentioned for the physical device as meeting implied acceptance criteria related to mechanical integrity and safety.
Here's an interpretation based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (as per document) |
|---|---|
| Mechanical Strength and Durability | "Mechanical testing was included to demonstrate the substantial equivalency of the Nautilus Spinal System. The testing included static and dynamic compression and static torsion testing per ASTM F1717 as well as static axial grip, torsional grip and moment bending per ASTM F1798." |
| Biocompatibility of Materials | "The NAUTILUS Spinal System is 6AL-4V-ELI titanium manufactured according to ASTM F136 and cobalt chrome per ASTM 1537." (This implies the materials meet established standards for biocompatibility in implantable devices). |
| Device Configuration and Functional Equivalence | "The Nautilus Spinal System is substantially equivalent to the predicate system in terms of design, materials, indications for use and sizing." (This statement is the core claim of a 510(k) and implies the physical device functions equivalently to existing, legally marketed devices.) |
| Safety and Effectiveness (Implied by substantial equivalence) | The FDA's substantial equivalence determination ("we have determined the device is substantially equivalent... to legally marketed predicate devices") indicates that the device is considered as safe and effective as predicate devices that already exist on the market. The mechanical testing cited above supports this claim by demonstrating performance comparable to the predicates against recognized standards. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of devices or iterations. The testing involved various "screw iterations" and system components. The tests (static/dynamic compression, torsion, axial grip, torsional grip, moment bending) would have been performed on a sufficient number of samples of the Nautilus Spinal System components to satisfy the requirements of ASTM F1717 and ASTM F1798.
- Data Provenance: The document does not specify the origin (e.g., country) of the data, but it would have been generated in a controlled laboratory setting (likely in the US or a country with recognized testing standards). The study is prospective in the sense that the testing was conducted specifically for this submission to demonstrate the performance of the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable as the Nautilus Spinal System is a physical medical device, not an AI/algorithm. "Ground truth" in this context would refer to the physical and mechanical properties being measured by established testing methodologies rather than expert consensus on data interpretation. The "experts" involved would be engineers and lab technicians conducting the mechanical tests according to ASTM standards.
4. Adjudication Method for the Test Set
- This question is not applicable. Mechanical testing results are objective measurements (e.g., force, displacement, torque) against pre-defined engineering standards (ASTM F1717, ASTM F1798), not subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- This question is not applicable. An MRMC study is relevant for diagnostic imaging AI algorithms where human readers interpret medical images. This submission is for a physical spinal implant system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable. There is no algorithm described in this submission.
7. The type of ground truth used
- The "ground truth" for the performance of the Nautilus Spinal System is its mechanical properties as measured by standardized engineering tests (ASTM F1717 and ASTM F1798). These standards define the methods and expected performance characteristics for spinal implant devices. The "truth" is whether the device meets or exceeds the mechanical performance requirements outlined by these standards, indicating its structural integrity and comparability to predicate devices.
8. The sample size for the training set
- This question is not applicable. There is no algorithm or "training set" in the context of this device submission.
9. How the ground truth for the training set was established
- This question is not applicable. There is no algorithm or "training set" in the context of this device submission.
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(26 days)
Nautilus Spinal System
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 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 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 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, (8) spondylolisthesis.
The NAUTILUS Thoracolumbar Spinal System consists of an assortment of rods, screws, cross connectors, and axial and offset connectors. The bone screw, head, and taper lock are assembled together during manufacturing to create the NAUTILUS Thoracolumbar Spinal System screw assembly component. The cross, axial, and offset connectors are also assembled during manufacturing. The NAUTILUS Thoracolumbar Spinal System implant components are made from titanium alloy (Ti-6A1-4V ELI) as described by ASTM F136 and cobalt chrome per ASTM 1537. Do not use any of the NAUTILUS Thoracolumbar Spinal System components with the components from any other system or manufacturer.
The purpose of this submission is to add an additional cross connector component.
Based on the provided text, the document is a 510(k) premarket notification for the Nautilus Spinal System. The text describes the device, its intended use, and states that it has been determined to be substantially equivalent to predicate devices. However, the document does not contain any information about a study proving the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or F1 score, nor does it discuss AI or algorithm performance data.
The "Performance Data" section in the 510(k) Summary only states: "Engineering analysis was presented to demonstrate the substantial equivalency of the Nautilus Spinal System." This indicates that the performance data submitted for this device relates to its mechanical performance and substantial equivalence, not to the type of statistical performance metrics typically associated with AI/ML devices.
Therefore, for your request, I cannot provide the detailed information about acceptance criteria and a study proving device performance as it pertains to AI/ML devices, because the document describes a traditional medical device (a spinal implant system) and uses a "substantial equivalence" pathway for clearance, not a pathway that would involve performance metrics like sensitivity or specificity.
I cannot create the requested table or answer most of the questions because the provided text is for a physical medical device (spinal system) and does not discuss AI/ML device performance, acceptance criteria in the context of diagnostic accuracy, or studies involving test sets, ground truth, or expert review for AI algorithms.
The document states that the device is "substantially equivalent" to predicate devices based on design, materials, indications for use, sizing, and mechanical performance (engineering analysis). This is a different type of assessment than what is typically performed for AI/ML devices where specific performance metrics like sensitivity and specificity against a ground truth would be established.
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(276 days)
NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM
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 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 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, kyphosis, and/or lordosis), (4) spinal tumor. (5) failed previous fusion (6) pseudarthrosis. (7) spondylolisthesis.
Solstice OCT System:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the SOLSTICE OCT System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; fracture/dislocation; Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.
When used with occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.
The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The hooks, rods, and connectors are also intended to provide stabilization to promote fusion of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The Solstice OCT system can also be linked to the Conquest, Pilot, and Nautilus Spinal Systems through the use of transitional rods and rod connectors.
The NAUTILUS Thoracolumbar Spinal System consists of an assortment of rods, screws, cross connectors, and axial and offset connectors. The bone screw, head, and taper lock are assembled together during manufacturing to create the NAUTILUS Thoracolumbar Spinal System screw assembly component. The cross, axial, and offset connectors are also assembled during manufacturing. The NAUTILUS Thoracolumbar Spinal System implant components are made from titanium alloy (Ti-6AI-4V ELI) as described by ASTM F136 and cobalt chrome per ASTM 1537. Do not use any of the NAUTILUS Thoracolumbar Spinal System components with the components from any other system or manufacturer.
The SOLSTICE OCT System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), multiple component system comprised of a variety of non-sterile, single use implantable components. The system consists of an assortment of occipital plates, occipital bone screws, polyaxial screws, hooks, rods, locking caps, connectors and breakaways.
The purpose of this submission is to add transition connectors to both the Nautilus and Solstice Systems.
This document pertains to a 510(k) premarket notification for the Nautilus Spinal System and the Solstice OCT System, both spinal fixation devices. The submission focuses on adding transition connectors to these systems. The FDA letter confirms the substantial equivalence of the devices to legally marketed predicates.
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" for performance in a table format with corresponding reported device performance values against those criteria. Instead, it relies on the concept of substantial equivalence to predicate devices. This means that the new device (Nautilus Spinal System and Solstice OCT System with added transition connectors) performs comparably to devices already cleared by the FDA.
The "Performance Data" section states:
- "Mechanical testing was included to demonstrate the substantial equivalency of the Nautilus Spinal System and the Solstice OCT System."
- "The testing included static and dynamic compression and static torsion testing per ASTM F1717, static axial and torsional grip per ASTM F1798."
This implies that the acceptance criteria for these tests were that the performance of the Nautilus and Solstice systems (with the new connectors) had to be equivalent or superior to that of the predicate devices or meet the general requirements of the ASTM standards for spinal implant systems. However, specific numerical thresholds for these criteria are not provided in this document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Mechanical testing." This typically refers to laboratory testing of physical samples of the devices, not clinical data from human subjects. Therefore, the concept of "sample size for the test set" in the context of human data or "data provenance" (country of origin, retrospective/prospective) is not applicable here. For mechanical testing, the "samples" would be the physical devices tested according to the ASTM standards. The exact number of device samples tested is not specified in this document.
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)
This question is not applicable to this document. The device in question is a spinal implant system, and the "study" described is mechanical testing in a laboratory setting, not a study involving human interpretation of medical images or clinical outcomes that would require expert consensus for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable to this document. Adjudication methods like 2+1 or 3+1 refer to processes used in clinical studies, particularly for interpreting ambiguous findings, typically by multiple experts. The study mentioned here is mechanical testing.
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
This question is not applicable to this document. The device is a spinal implant system, not a diagnostic or AI-powered imaging device that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to this document. This question relates to AI algorithms operating independently, which is not relevant to a physical spinal implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This question is not applicable in the traditional sense for a medical device that undergoes mechanical testing. For mechanical testing, the "ground truth" is defined by the physical properties and performance characteristics measured by standardized test methods (ASTM F1717, ASTM F1798). The goal is to demonstrate that the device meets the performance requirements (e.g., strength, durability) as defined by these standards and is comparable to predicate devices.
8. The sample size for the training set
This question is not applicable to this document. "Training set" refers to data used to train machine learning models. This document describes mechanical testing of a physical medical device, not an AI or software device.
9. How the ground truth for the training set was established
This question is not applicable to this document for the same reasons as #8.
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(29 days)
NAUTILUS SPINAL SYSTEM
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 Thoracolumbar Spinal System consists of an assortment of rods, screws, cross connectors, and axial and offset connectors. The bone screw, head, and taper lock are assembled together during manufacturing to create the NAUTILUS Thoracolumbar Spinal System screw assembly component. The cross, axial, and offset connectors are also assembled during manufacturing. The NAUTILUS Thoracolumbar Spinal System implant components are made from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136 and cobalt chrome per ASTM 1537. Do not use any of the NAUTILUS Thoracolumbar Spinal System components with the components from any other system or manufacturer.
Here's an analysis of the provided text regarding the acceptance criteria and study for the NAUTILUS Spinal System:
The provided text does not contain information about acceptance criteria or a study with performance metrics in the way one would typically find for an AI/ML medical device. This document is a 510(k) summary for a traditional medical device (spinal implant system).
Therefore, I cannot populate most of the requested fields as they pertain to the performance evaluation of an AI/ML device. I will indicate where the information is not applicable (N/A) or not found (N/F) based on the context of this traditional device submission.
Acceptance Criteria and Study for NAUTILUS Spinal System
This 510(k) submission for the NAUTILUS Spinal System demonstrates substantial equivalence to a predicate device (NAUTILUS Spinal System K133564) primarily through performance testing based on established industry standards and engineering analysis. It is for a physical medical implant, not an AI/ML diagnostic or prognostic device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Mechanical Performance | Substantial Equivalence to Predicate Device (K133564) demonstrated through testing in accordance with ASTM F1717. | "Testing in accordance with ASTM F1717 in addition to engineering analysis was presented to demonstrate the substantial equivalency of the NAUTILUS Spinal System." (Implies the device met the performance requirements of ASTM F1717 to establish equivalency to the predicate, though specific numerical results or pass/fail thresholds are not detailed in this summary.) |
| Material Composition | Adherence to specified material standards: Titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136 and cobalt chrome per ASTM 1537. | "The NAUTILUS Spinal System is 6AL-4V-ELI titanium manufactured according to ASTM F136 and cobalt chrome per ASTM 1537." (This is a statement of material composition meeting the specified standard.) |
| Design Characteristics | Substantial Equivalence to Predicate Device (K133564) in terms of design, materials, indications for use and sizing. | "The NAUTILUS Spinal System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing." (This is a conclusion based on the overall assessment, including the mechanical testing.) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a "sample size" in the context of test subjects or data points for an algorithm. For a physical device like this, testing typically involves a set number of implants or components subjected to mechanical tests. The exact number of test articles is not provided in this summary.
- Data Provenance: N/A for AI/ML context. For mechanical testing, the "data" is generated in a lab environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This is a physical device, and "ground truth" for its performance is established by objective mechanical testing according to recognized standards (ASTM F1717), not by expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are relevant for subjective interpretations, typically in clinical studies or expert review of images/data, which is not the nature of this device's performance evaluation.
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:
- N/A. This is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, "ground truth" for performance relates to objective mechanical properties and structural integrity as measured by standardized engineering tests (e.g., fatigue strength, static load capacity, pull-out strength). The "truth" is whether the device meets the physical requirements outlined in the ASTM standard, demonstrating equivalence to the predicate.
8. The sample size for the training set:
- N/A. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- N/A. There is no "training set."
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(91 days)
MODIFICATION TO NAUTILUS SPINAL SYSTEM
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, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.
The NAUTILUS Thoracolumbar Spinal System consists of an assortment of rods, screws, cross connectors, and axial and offset connectors. The bone screw, head, and taper lock are assembled together during manufacturing to create the NAUTILUS Thoracolumbar Spinal System screw assembly component. The cross, axial, and offset connectors are also assembled during manufacturing. The NAUTILUS Thoracolumbar Spinal System implant components are made from titanium alloy (Ti-6AI-4V ELI) as described by ASTM F136 and cobalt chrome per ASTM 1537. Do not use any of the NAUTILUS Thoracolumbar Spinal System components with the components from any other system or manufacturer.
This document describes a spinal system called the NAUTILUS Spinal System and details its substantial equivalence to predicate devices, which is the basis for its 510(k) clearance. Because this is a spinal implant and not an AI/ML device, the typical AI/ML-focused acceptance criteria and study components requested in the prompt (e.g., sample size for test set, expert ground truth, MRMC study, training set details) are not applicable.
Here's a breakdown of the information provided in the context of the prompt:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from predicate device comparison) | Reported Device Performance (NAUTILUS Spinal System) |
|---|---|
| Design Equivalence | Substantially equivalent to predicate systems. |
| Material Equivalence | Composed of 6AL-4V-ELI titanium (ASTM F136) and cobalt chrome (ASTM 1537), same as predicates. |
| Indications for Use Equivalence | Identical indications for use as predicate systems. |
| Sizing Equivalence | Substantially equivalent to predicate systems. |
| Static Compression Testing (ASTM F1717) | Performance data presented to demonstrate substantial equivalency. |
| Static Torsion Testing (ASTM F1717) | Performance data presented to demonstrate substantial equivalency. |
| Dynamic Compression Testing (ASTM F1717) | Performance data presented to demonstrate substantial equivalency. |
| Axial Grip Testing (ASTM F1798) | Performance data presented to demonstrate substantial equivalency. |
| Torsional Grip Testing (ASTM F1798) | Performance data presented to demonstrate substantial equivalency. |
| Moment Bending Testing (ASTM F1798) | Performance data presented to demonstrate substantial equivalency. |
- Study that proves the device meets the acceptance criteria: The device's compliance with acceptance criteria is established through a substantial equivalence determination to predicate devices (NAUTILUS Spinal System K132760 and CD Horizon Spinal System K132471). This is supported by performance data from static, torsional, and dynamic compression testing per ASTM F1717, as well as axial grip, torsional grip, and moment bending testing per ASTM F1798. These tests demonstrate that the NAUTILUS Spinal System performs comparably to the predicate devices in terms of mechanical properties.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable (N/A). This is a submission for a medical device (spinal implant) based on substantial equivalence, not an AI/ML diagnostic or predictive device. There is no "test set" in the context of medical images or patient data to evaluate an algorithm. The "test set" here refers to the mechanical tests performed on the physical device components. The document does not specify sample sizes for the mechanical tests, nor does it provide details on data provenance beyond stating the tests performed to demonstrate substantial equivalency.
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 (N/A). As this is a mechanical device, ground truth is established by engineering standards and test results, not by expert medical review of images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable (N/A). Adjudication methods are relevant for subjective interpretations (e.g., image reading) by multiple experts. For mechanical testing, the results are objectively measured against established standards.
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 (N/A). This study is irrelevant for a spinal implant device. MRMC studies are used to evaluate the diagnostic accuracy of imaging or AI systems with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A). This study is irrelevant for a spinal implant device. "Standalone" performance refers to the accuracy of an AI algorithm without human input, which does not apply here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device is based on established engineering standards and material specifications (e.g., ASTM F136, ASTM 1537, ASTM F1717, ASTM F1798) and the performance characteristics of legally marketed predicate devices. The goal is to demonstrate that the new device's mechanical properties and safety are equivalent to those already accepted.
8. The sample size for the training set
- Not Applicable (N/A). This concept applies to AI/ML algorithms, not to the mechanical testing of a medical implant.
9. How the ground truth for the training set was established
- Not Applicable (N/A). This concept applies to AI/ML algorithms.
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(45 days)
NAUTILUS SPINAL SYSTEM
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 Thoracolumbar Spinal System consists of an assortment of rods, screws, cross connectors, and axial and offset connectors. The bone screw, head, and taper lock are assembled together during manufacturing to create the NAUTILUS Thoracolumbar Spinal System screw assembly component. The cross, axial, and offset connectors are also assembled during manufacturing. The NAUTILUS Thoracolumbar Spinal System implant components are made from titanium alloy (Ti-6A1-4V ELI) as described by ASTM F136. Do not use any of the NAUTILUS Thoracolumbar Spinal System components with the components from any other system or manufacturer.
This 510(k) summary for the NAUTILUS Spinal System describes a medical device and its substantial equivalence to predicate devices, rather than a study evaluating device performance against pre-defined acceptance criteria in terms of accuracy or clinical outcomes. The provided document is for a pedicle screw spinal system, which is a physical implant, not an AI/ML-driven diagnostic or prognostic device that typically involves performance metrics like sensitivity, specificity, or AUC.
Therefore, many of the requested categories for AI/ML device evaluation (like sample size for test/training sets, ground truth establishment by experts, adjudication methods, MRMC studies, standalone performance) are not applicable to this type of submission.
However, I can extract the relevant information regarding the performance data that was provided to demonstrate substantial equivalence for this physical device.
Acceptance Criteria and Study for NAUTILUS Spinal System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Dynamic Compression | Demonstrated substantial equivalency to predicate devices. (Details on specific force/displacement values or cycle counts are not provided in this summary, only the statement of equivalency.) |
| Material Composition | ASTM F136 compliant | Made from titanium alloy (Ti-6A1-4V ELI) as described by ASTM F136. |
| Indications for Use | Match Predicate Devices | Substantially equivalent to predicate systems in terms of indications for use. |
| Design | Match Predicate Devices | Substantially equivalent to predicate systems in terms of design. |
| Sizing | Match Predicate Devices | Substantially equivalent to predicate systems in terms of sizing. |
Explanation: For a traditional medical device like a spinal system, "acceptance criteria" primarily relate to engineering and material standards, as well as functional performance benchmarks established by recognized industry standards (e.g., ASTM). The "study" here refers to bench-top testing.
2. Sample Size used for the test set and the data provenance
- Sample Size (Test Set): Not explicitly stated as "sample size" in the context of clinical data. For bench-top mechanical testing, the "samples" would be the physical implants tested. The number of such implants tested is not specified in this summary.
- Data Provenance: N/A. Bench-top mechanical testing is performed in a laboratory setting. There is no patient data involved for this type of submission focused on substantial equivalence of a physical implant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. This information is not relevant to the evaluation of a physical implant's mechanical properties. Ground truth, in the context of AI/ML, refers to a definitive correct answer for a diagnostic or prognostic task, typically established by clinical experts.
4. Adjudication method for the test set
- N/A. Adjudication methods are used in clinical studies or expert reviews to resolve disagreements in ground truth labeling for AI/ML models. This is not applicable to a submission focusing on the mechanical equivalence of a spinal 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
- N/A. MRMC studies are used to evaluate the impact of AI on human readers' performance in diagnostic tasks. This device is a surgical implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. Standalone performance evaluation is for AI algorithms. This is a physical device.
7. The type of ground truth used
- Mechanical & Material Standards: For this device, the "ground truth" (or objective standard) for its performance is adherence to established engineering standards (e.g., ASTM F1717 for dynamic compression testing) and material specifications (e.g., ASTM F136 for titanium alloy). The comparison is against these standards and the performance of the predicate devices.
8. The sample size for the training set
- N/A. There is no "training set" in the context of a physical medical device's mechanical performance evaluation. Training sets are for AI/ML model development.
9. How the ground truth for the training set was established
- N/A. As there is no training set for this type of device submission, this question is not applicable.
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(29 days)
NAUTILUS SPINAL SYSTEM
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, kyphosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.
The NAUTILUS Thoracolumbar Spinal System consists of an assortment of rods, screws, cross connectors, and axial and offset connectors. The bone screw. head, and taper lock are assembled together during manufacturing to create the NAUTILUS Thoracolumbar Spinal System screw assembly component. The cross, axial, and offset connectors are also assembled during manufacturing. The NAUTILUS Thoracolumbar Spinal System implant components are made from titanium alloy (Ti-6A1-4V ELI) as described by ASTM F136. Do not use any of the NAUTILUS Thoracolumbar Spinal System components with the components from any other system or manufacturer.
The provided text describes the 510(k) Summary for the NAUTILUS Spinal System. This document is for a medical device (spinal implant system) and does not contain information about an Artificial Intelligence (AI) device or its performance criteria.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI device. The document explicitly states that the device is made from titanium alloy and concerns mechanical fixation for spinal fusion.
Here's why the requested information cannot be extracted from the provided text:
- No AI Device: The NAUTILUS Spinal System is a physical medical device (implants, screws, rods) made of titanium alloy. It is not an AI-powered diagnostic or assistive device.
- Performance Data Type: The "Performance Data" section specifically mentions "Dynamic compression testing per ASTM F1717" to demonstrate substantial equivalency, which are mechanical tests for physical implants, not AI algorithm performance metrics.
- No AI-related Criteria: The document does not discuss metrics like accuracy, sensitivity, specificity, AUC, or other parameters typically used to evaluate AI device performance.
- No "Ground Truth" for Algorithms: The concept of "ground truth" (expert consensus, pathology, outcome data) as it relates to training or testing an AI algorithm is not applicable to a physical spinal implant system.
In summary, the provided content is a regulatory submission for a non-AI medical device, and thus does not contain the information necessary to answer your questions about AI device acceptance criteria and studies.
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(125 days)
NAUTILUS SPINAL SYSTEM
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, kyphosis, and/or lordosis), (4) spinal tumor. (5) failed previous fusion (6) pseudoarthrosis, (7) spinal stenosis, (8) spondylolisthesis.
The NAUTILUS Thoracolumbar Spinal System consists of an assortment of rods, screws, cross connectors, and axial and offset connectors. The bone screw, head, and taper lock are assembled together during manufacturing to create the NAUTILUS Thoracolumbar Spinal System screw assembly component. The cross, axial, and offset connectors are also assembled during manufacturing. The NAUTILUS Thoracolumbar Spinal System implant components are made from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. Do not use any of the NAUTILUS Thoracolumbar Spinal System components with the components from any other system or manufacturer.
The provided text describes a 510(k) premarket notification for the NAUTILUS Spinal System, asserting its substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria in the typical sense of a diagnostic or AI device.
Therefore, many of the requested categories (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this type of submission.
The "acceptance criteria" here are based on demonstrating comparable mechanical performance to existing, legally marketed devices.
Here's a breakdown of the relevant information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Predicate Devices) | Reported Device Performance (NAUTILUS Spinal System) |
|---|---|
| Static Torsion (equivalent performance) | Static Torsion (presented to demonstrate substantial equivalence) |
| Static Compression Bending (equivalent performance) | Static Compression Bending (presented to demonstrate substantial equivalence) |
| Dynamic Compression Bending (equivalent performance) | Dynamic Compression Bending (presented to demonstrate substantial equivalence) |
| Material: Titanium Alloy (Ti-6Al-4V ELI) as per ASTM F136 | Material: 6AL-4V-ELI titanium manufactured according to ASTM F136 |
| Design (substantially equivalent to predicates) | Design (substantially equivalent to predicates) |
| Indications for Use (substantially equivalent to predicates) | Indications for Use (substantially equivalent to predicates) |
| Sizing (substantially equivalent to predicates) | Sizing (substantially equivalent to predicates) |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This is a mechanical performance study based on standardized tests (ASTM F1717) comparing the device to predicate devices, not a clinical study with patient data.
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 the established mechanical properties and performance standards outlined in ASTM F1717, which are not set by human experts in the same way clinical ground truth is.
4. Adjudication method for the test set:
- Not Applicable. The evaluation is based on meeting the specifications of ASTM F1717 and demonstrating equivalence to predicate devices, not on human adjudication of test results.
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 not an AI or diagnostic device and therefore no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This refers to a medical device's mechanical performance, not an algorithm's standalone performance.
7. The type of ground truth used:
- Engineering Standards and Predicate Device Performance. The "ground truth" for this submission is based on established engineering standards (ASTM F1717) and the known performance and characteristics of the predicate devices (K111953, K080767, K061600). The device seeks to demonstrate "substantial equivalence" to these benchmarks.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device. The device's design and manufacturing processes are likely informed by prior engineering knowledge and predicate device designs.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI model, this question is not relevant.
The Study that Proves the Device Meets the Acceptance Criteria:
The study proving the device meets the "acceptance criteria" (i.e., demonstrates substantial equivalence) is the "Performance Data" section described in the 510(k) summary. It states:
- "Static torsion, static compression bending, and dynamic compression bending testing per ASTM F1717 was presented to demonstrate the substantial equivalency of the NAUTILUS Spinal System."
The conclusion further reinforces this:
- "The information presented demonstrates the substantial equivalency of the Nautilus Spinal System."
This indicates that a series of mechanical tests, following the ASTM F1717 standard, were conducted on the NAUTILUS Spinal System. The results of these tests were then compared to the known performance of the predicate devices, and the FDA determined that the NAUTILUS Spinal System's performance was "substantially equivalent" for the stated indications for use.
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(393 days)
NAUTILUS SPINAL SYSTEM
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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