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510(k) Data Aggregation
(68 days)
CASPIAN SPINAL SYSTEM
The CASPIAN OCT/MESA Mini/ DENALI Mini Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and indicated for the following:
· DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- · Spondylolisthesis
- Spinal stenosis
- · Fracture/dislocation
- · Revision of previous cervical spine surgery
- · Tumors
- · Atlantoaxial fracture with instability
- · Occipitocervical dislocation
The occipital bone screws are limited to occipital fixation only
The rod and hook components are in the cervical/upper thoracic (CI-T3) spine. The pedicle screws are limited to placement in the TI-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.
The CASPIAN OCT/MESA Mini/ DENALI Mini System can also be linked to the Range Spinal System using rod connectors or transitional rods.
The CASPIAN OCT/MESA Mini/ DENALI Mini System is a top-loading, multiple component, posterior (occipital-cervical-thoracic) spinal fixation system. The purpose of the current submission is to add 03.5 contoured rods to expand the rod offerings for the system.
Materials: The subject devices are manufactured from Ti6Al4V Eli per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization of stabilization of the posterior cervical and thoracic spine.
The provided document is a 510(k) summary for a spinal fixation system, not a study report for a medical device that uses AI or reports on acceptance criteria and performance data in the typical sense of a diagnostic or screening device.
Therefore, many of the requested categories for acceptance criteria and study design elements (such as sample size for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not applicable to this type of submission.
This 510(k) summary focuses on demonstrating substantial equivalence to previously marketed devices based on design, function, materials, and intended use, particularly for adding new rod sizes. The "acceptance criteria" here are implicitly related to mechanical testing and engineering rationale to ensure the new components maintain the same safety and effectiveness profile as the predicate devices.
Here's a breakdown of the relevant information from the document in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied by 510(k)) | Reported Device Performance (from document) |
|---|---|---|
| Mechanical Performance | Equivalence to predicate devices in mechanical strength and stability under relevant biomechanical loads (e.g., as per ASTM F1717). | "The worst case components of the CASPIAN OCT/MESA Mini/ DENALI Mini System were previously tested in accordance with ASTM F1717 and determined to be equivalent to predicate devices." |
| New components (03.5 contoured rods) do not represent a new worst-case scenario. | "The subject rods were determined not to represent a new worst case via finite element analysis and engineering rationale." | |
| Material Biocompatibility | Use of biocompatible materials known to be safe for implantation. | "The subject devices are manufactured from Ti6Al4V Eli per ASTM and ISO standards." |
| Functionality | Ability to provide immobilization and stabilization of the posterior cervical and thoracic spine as an adjunct to fusion. | "The system functions as an adjunct to fusion to provide immobilization of stabilization of the posterior cervical and thoracic spine." |
| Intended Use | Alignment with established indications for use in spinal fixation. | The Indications for Use statement in the document specifies conditions like DDD, Spondylolisthesis, Fracture/dislocation, etc. The device is deemed substantially equivalent for these uses. |
| Design Characteristics | No significant differences from predicate devices that would adversely affect use. | "There are no significant differences between the CASPIAN OCT/MESA Mini/ DENALI Mini System and other systems currently being marketed which would adversely affect the use of the product." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: This submission relies on mechanical testing standards (ASTM F1717) and engineering rationale/finite element analysis, not clinical 'test sets' of patient data in the context of AI or diagnostic devices. There is no mention of "patient data" test sets.
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: "Ground truth" in this context would relate to defining mechanical testing parameters and interpreting engineering analyses, handled by biomechanical engineers and regulatory specialists, rather than clinical experts establishing ground truth for diagnostic imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: This relates to clinical data adjudication, which is not part of this 510(k) submission.
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 submission for a spinal implant, not an AI-powered diagnostic or screening device, so MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a medical device (spinal implant), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the mechanical performance, the "ground truth" is established by adherence to recognized biomechanical testing standards (e.g., ASTM F1717) and engineering principles/ finite element analysis (FEA), indicating that the device meets defined physical strength and durability criteria. The overall ground truth for regulatory clearance is substantial equivalence to existing, legally marketed devices.
8. The sample size for the training set
- Not Applicable: This is a spinal implant, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable: No training set exists for this type of device.
In summary, the provided document is a regulatory submission for a spinal fixation system, cleared based on substantial equivalence demonstrated through mechanical testing and engineering rationale, not clinical study data in the context of diagnostic performance.
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(72 days)
CASPIAN SPINAL SYSTEM
The Caspian Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and is indicated for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Spinal stenosis
- Fracture/dislocation
- Revision of previous cervical spine surgery
- Tumors
- Atlantoaxial fracture with instability
- Occipitocervical dislocation
The occipital bone screws are limited to occipital fixation only.
The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.
The Caspian Spinal System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods.
The Caspian Spinal System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, and rod connectors.
Materials: The devices are manufactured from Ti6AI4V Eli and Cobalt Chrome per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization of the posterior cervical and thoracic spine.
The provided text is a 510(k) summary for the Caspian Spinal System, a medical device. It focuses on demonstrating substantial equivalence to previously marketed devices based on mechanical testing and design comparisons, rather than clinical efficacy studies with acceptance criteria, human readers, or ground truth.
Therefore, most of the requested information cannot be extracted from this document as it does not describe a study involving an AI device or a device whose performance is measured against acceptance criteria in a clinical context.
Here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as acceptance criteria in the context of clinical performance metrics. | "The Caspian Spinal System performed equally to or better than these systems in static compression, static torsion and dynamic compression in accordance with ASTM F1717." |
| "The design features and sizing of the components were also compared and the Caspian Spinal System was found to be substantially the same as these systems." | |
| "There are no significant differences between the Caspian Spinal System and other systems currently being marketed which would adversely affect the use of the product." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The study described is mechanical testing, not a clinical study with a test set of 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. There was no ground truth based on expert review for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication for a test set was mentioned.
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 document describes a spinal implant, not an AI device or a device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical spinal fixation system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The 'ground truth' for this mechanical testing would be the measured physical properties and performance of the device and its predicates, compared to established ASTM standards.
8. The sample size for the training set
Not applicable. There is no training set for an AI algorithm mentioned in this document.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI algorithm mentioned in this document.
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(168 days)
CASPIAN SPINAL SYSTEM
The Caspian Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and is indicated for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Spinal stenosis
- Fracture/dislocation
- Revision of previous cervical spine surgery
- Tumors
- Atlantoaxial fracture with instability
- Occipitocervical dislocation
The occipital bone screws are limited to occipital fixation only.
The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.
The Caspian Spinal System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods.
The Caspian Spinal System is a top-loading, multiple component, posterior (occipital-cervical-thoracic) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, rod connectors, and occipital components.
Materials: The devices are manufactured from Ti6Al4V (ASTM F1472), Ti6Al4V Eli (ASTM F136), and CP Titanium (ASTM F67).
Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior cervical and thoracic spine.
The Caspian Spinal System is a medical device intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction. The device's performance was evaluated through mechanical testing, with the acceptance criterion being that it performed "equally to or better than" predicate devices.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance in static compression | Performed equally to or better than predicate devices |
| Performance in static torsion | Performed equally to or better than predicate devices |
| Performance in dynamic compression | Performed equally to or better than predicate devices |
| Design features and sizing of components | Substantially the same as predicate devices |
Study Details
- Sample Size for Test Set: This information is not explicitly provided. The document states that the system was "mechanically tested," implying a set of samples were used for these tests, but the specific number is not given.
- Data Provenance: Not applicable. The study involved mechanical testing of the device itself, not human data.
- Number of Experts Used to Establish Ground Truth: Not applicable. Mechanical testing relies on established engineering standards (ASTM F2706) rather than expert consensus on individual cases.
- Qualifications of Experts: Not applicable.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This type of study is relevant for diagnostic or image-interpretation devices involving human readers, which is not the case for a spinal fixation system.
- Standalone (Algorithm Only) Performance: Not applicable. This is a mechanical device, not an algorithm.
- Type of Ground Truth Used: The "ground truth" for this device's performance is defined by the established mechanical testing standards, specifically ASTM F2706, and the performance of legally marketed predicate devices. The system was deemed acceptable if its mechanical performance met or exceeded that of these established devices.
- Sample Size for Training Set: Not applicable. The device is a physical implant, not an AI or machine learning model that requires a training set.
- How Ground Truth for Training Set Was Established: Not applicable.
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(30 days)
MODIFICATION TO CASPIAN SPINAL SYSTEM
The Caspian Spinal System is indicated for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Spinal stenosis
- Fracture/dislocation
- Revision of previous cervical spine surgery
- Tumors
The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.
The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.
The Caspian Spinal System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods.
The Caspian Spinal System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, and rod connectors.
Materials: The devices are manufactured from Ti6Al4V Eli and Cobalt Chrome per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization of spinal segments of the cervical and thoracic (T1-T3) spine.
The provided text describes the 510(k) summary for the Caspian Spinal System, a spinal fixation system. However, it does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, expert qualifications, adjudication methods, or comparative effectiveness studies.
The document focuses on:
- Identification of the device: Trade name, common name, classification, product code, regulatory class.
- Predicate devices: Listing similar legally marketed devices.
- Description of the device: Components, materials, function.
- Intended Use/Indications for Use: Specific conditions for which the device is intended.
- Substantial Equivalence Claim: Stating that the device is similar in design, material, and indications for use to predicate devices and is expected to be equivalent in safety and effectiveness.
- FDA Correspondence: Official letter acknowledging the 510(k) submission and determining substantial equivalence.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them, as the necessary information is not present in the provided text.
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(71 days)
CASPIAN SPINAL SYSTEM
The Caspian Spinal System is indicated for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Spinal stenosis
- Fracture/dislocation
- Revision of previous cervical spine surgery
- Tumors
The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.
The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.
The Caspian Spinal System can also be linked to the Range Spinal System using the 3.5mm rod connectors or transitional rods.
The Caspian Spinal System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, and rod connectors.
The provided text describes the 510(k) summary for the Caspian Spinal System, a spinal fixation system. However, it does not contain information about acceptance criteria, device performance from a study, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.
The document is a premarket notification to the FDA for a medical device and primarily focuses on:
- Device Description: What the system is made of and its components.
- Intended Use/Indications for Use: The medical conditions the device is designed to treat.
- Predicate Devices: Other similar devices already on the market.
- Substantial Equivalence: The claim that the new device is as safe and effective as existing ones.
This type of submission for a Class II device like a spinal fixation system typically relies heavily on predicate device comparison and mechanical testing (e.g., fatigue strength, torsional strength) to demonstrate safety and effectiveness, rather than clinical studies involving human participants with acceptance criteria based on accuracy metrics.
Therefore, I cannot fulfill your request for the specific points related to acceptance criteria and study details because the provided text does not contain that information.
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(175 days)
CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS
The Caspian Spinal System is indicated for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Spinal stenosis
- Fracture/dislocation
- Revision of previous cervical spine surgery
- Tumors
Hooks and Rods-The rod and hook components are also intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Rods and Pedicle Screws-The rods and screws are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3). The use of these screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Caspian Spinal System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, and rod connectors.
Materials: The devices are manufactured from Ti6Al4V per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization of spinal segments of the cervical and thoracic (T1-T3) spine.
The provided document is a 510(k) summary for the Caspian Spinal System, a medical device. It does not contain information about acceptance criteria or a study proving performance in the context of device performance metrics like sensitivity, specificity, accuracy, or any statistical measures typically associated with AI/software device evaluation.
Instead, this document focuses on establishing substantial equivalence to legally marketed predicate devices, a regulatory pathway for physical medical devices. The "study" mentioned here is the comparison to predicate devices, asserting similarities in design, material, and indications for use.
Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies (MRMC, standalone algorithm performance) is not applicable or cannot be extracted from this specific document.
I will fill in the table and address the questions to the best of my ability based on the provided text, indicating when information is "Not Applicable" or "Not Provided."
Description of the Acceptance Criteria and Study
The Caspian Spinal System seeks clearance through the 510(k) pathway by demonstrating substantial equivalence to legally marketed predicate devices. The "acceptance criteria" in this context are not performance metrics like accuracy or sensitivity, but rather the demonstration that the new device is as safe and effective as existing, legally marketed devices.
The "study" that proves the device meets "acceptance criteria" is the detailed comparison of its technological characteristics, materials, and intended use against those of the identified predicate devices. The conclusion of this comparative analysis is that the Caspian Spinal System is "substantially equivalent" to the predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (as inferred from 510(k)) | Reported Device Performance / Justification |
|---|---|---|
| Material Equivalence | Manufactured from Ti6Al4V per ASTM and ISO standards (matching predicate materials). | "The devices are manufactured from Ti6Al4V per ASTM and ISO standards." Implicitly equivalent to predicate devices. |
| Design Equivalence | Top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system, consisting of pedicle screws, rods, locking set screws, hooks, and rod connectors. | "The Caspian Spinal System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system... " Similar in design to predicates. |
| Intended Use Equivalence | Indicated for DDD, Spondylolisthesis, Spinal Stenosis, Fracture/dislocation, Revision of previous cervical spine surgery, Tumors, and stabilization as an adjunct to fusion for specific spinal segments. | Indications for use are listed and are presented as being analogous to, or within the scope of, predicate device indications. |
| Safety & Effectiveness | Expected to be equivalent in safety and effectiveness to predicate devices. | "The Caspian Spinal System is considered substantially equivalent to other legally marketed devices. They are similar in design, material, and indications for use and are expected to be equivalent in safety and effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not Applicable. This is a comparison to predicate physical devices, not a performance study on a test dataset.
- Data Provenance: Not Applicable.
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. "Ground truth" in the context of diagnostic or AI performance is not relevant for this type of 510(k) submission for a spinal implant system. The "ground truth" here is the established safety and effectiveness of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable.
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/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is implicitly the established safety and effectiveness track record of the predicate devices based on their prior regulatory clearance and market experience.
8. The sample size for the training set
- Not Applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not Applicable.
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