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When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass.

When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Spinal Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

The ORIA Spinal Clip System includes components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system for each of four defined indications and to fit the patient's anatomical and physiological requirements. The components include: Lumbar, thoracic, and pedicular hooks; Sacral screws; Pedicle screws; Set screws; Locking nuts; Rods in various lengths; Connectors with set screws (sacral, transverse, lateral); Connecting elements; Instruments and Sterilizer trays.

The provided text is a 510(k) summary for the ORIA Spinal Clip System. A 510(k) submission is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This document focuses on demonstrating substantial equivalence rather than proving device performance against specific acceptance criteria through a clinical study or a standalone algorithm evaluation.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from the provided text because it primarily describes the device, its intended use, and its substantial equivalence to a predicate device. Clinical performance data, often generated through detailed studies with specific acceptance criteria, are typically found in more comprehensive clinical sections of a PMA (Premarket Approval) or sometimes in 510(k) de novo submissions, but are not explicitly detailed in this summary.

Here's an attempt to populate the table and answer the questions based on the type of information present in a 510(k) summary, rather than a clinical trial report:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary focused on substantial equivalence, explicit "acceptance criteria" for device performance in a clinical study context and corresponding "reported device performance" are not typically presented in the way they would be for a novel device undergoing extensive clinical trials or an AI/ML algorithm. Instead, the "performance" demonstrated for substantial equivalence is primarily based on equivalence in design, materials, and function to a predicate device.

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 / Not Provided: The 510(k) summary does not describe a "test set" in the context of a clinical study or algorithm evaluation. The substantial equivalence determination is based on a comparison to a predicate device's existing regulatory clearance and established performance, not new clinical data specific to the ORIA Spinal Clip System detailed in this document.
• Data Provenance: Not provided, as no specific test set data is mentioned.

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 / Not Provided: No "ground truth" for a test set is described, as no clinical study data is presented. The determination of substantial equivalence relies on regulatory review and comparison by FDA experts to existing cleared devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable / Not Provided: No adjudication method is mentioned as there is no described test set or clinical study requiring one.

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 / Not Provided: This device is a mechanical spinal implant system, not an AI/ML-driven diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable / Not Provided: This device is a mechanical spinal implant system, not an algorithm. Standalone performance for an algorithm is not relevant or described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable / Not Provided: No "ground truth" is established or discussed as no new clinical performance data from a specific study is presented for the ORIA Spinal Clip System itself in this summary. The "ground truth" for showing safety and effectiveness is largely based on the predicate device's established performance and regulatory clearance.

8. The sample size for the training set

• Not Applicable / Not Provided: No "training set" is applicable or described, as this is a mechanical device, not an AI/ML system.

9. How the ground truth for the training set was established

• Not Applicable / Not Provided: No "training set" or method for establishing its ground truth is applicable or described.

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When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass.

When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Spinal Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

The ORIA Spinal Clip System includes components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system for each of four defined indications and to fit the patient's anatomical and physiological requirements. The components include: Lumbar, thoracic, and pedicular hooks: Sacral screws: Pedicle screws: Set screws; Locking nuts; Rods in various lengths; Connectors with set screws (sacral, transverse, lateral); Connecting elements; Instruments and Sterilizer trays.

The provided text is a 510(k) summary for the ORIA Spinal Clip System. It details the device's intended use, materials, and substantial equivalence to previously cleared devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews as requested in the prompt.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study proving the device meets them based only on the provided text.

The document focuses solely on establishing substantial equivalence for regulatory clearance, which typically relies on comparisons to predicate devices and adherence to relevant standards, rather than new multi-reader comparative effectiveness studies or detailed performance metrics.

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When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass.

When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Spinal Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

The ORIA Spinal Clip System includes components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system for each of four defined indications and to fit the patient's anatomical and physiological requirements. The components include: Lumbar, thoracic, and pedicular hooks; Sacral screws; Pedicle screws; Set screws; Locking nuts; Rods in various lengths; Connectors with set screws (sacral, transverse, lateral); Connecting elements; Instruments and Sterilizer trays.

The provided text is a 510(k) summary for the ORIA Spinal Clip System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results with specific acceptance criteria and outcome metrics. Therefore, many of the requested details about acceptance criteria, specific performance metrics, and study methodologies common in AI/Diagnostic device approvals are not present in this document.

However, I can extract the information that is available and explain why other details are missing.

Here's the analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

Explanation of Table Details: The "acceptance criteria" here are implied by the 510(k) process for substantial equivalence. For a 510(k) submission, the primary "acceptance criterion" is that the new device is "substantially equivalent" to a legally marketed predicate device. This is evaluated across various aspects like intended use, technology, materials, and safety/effectiveness. The document states that "Documentation was provided which demonstrated the ORIA Spinal Clip System Extended OmniAxial Connectors (CO05 & CO07) to be substantially equivalent..." based on these factors. No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or mechanical stress test results with defined pass/fail thresholds) are explicitly stated in this summary as "acceptance criteria."

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable/Not mentioned. This document describes a 510(k) for a spinal implant system, not a diagnostic or AI device that typically uses a "test set" of patient data for performance evaluation. The "study" here is a substantial equivalence comparison to a predicate device.
• Data Provenance: Not applicable/Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not mentioned. No "test set" requiring expert ground truth is described.

4. Adjudication method for the test set

• Not applicable/Not mentioned. No "test set" requiring adjudication is described.

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-assisted diagnostic device, so an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an AI or algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" in a 510(k) for a device like this is the established safety and effectiveness of the predicate device. The new device leverages this by demonstrating substantial equivalence. The document doesn't detail performance studies of the device itself, but rather its similarity to an already approved device.

8. The sample size for the training set

• Not applicable/Not mentioned. This device does not involve machine learning or a "training set."

9. How the ground truth for the training set was established

• Not applicable/Not mentioned. This device does not involve machine learning or a "training set."

Summary of the "Study" (Demonstration of Substantial Equivalence):

The "study" in this context is the submission of documentation to the FDA to demonstrate substantial equivalence of the ORIA Spinal Clip System Extended OmniAxial Connectors (CO05 & CO07) to a previously cleared predicate device, the OmniAxial Connector (CO04).

• Methodology: The manufacturer provided documentation comparing the new device components to the predicate device across several key attributes.
• Proof of Meeting Criteria: The FDA's letter (K030252) confirms that based on the submitted information, the device is determined to be "substantially equivalent." This means the FDA accepted the manufacturer's provided documentation as sufficient proof that the new device meets the implied "acceptance criteria" of being comparable to the predicate device in terms of:
  • Indications/Intended Use
  • Manufacturing Methods
  • Interconnection (attachment) mechanism
  • Basic Design
  • Materials (Titanium alloy ASTM F136-98)

This type of 510(k) summary typically does not include raw performance data, clinical trial results, or detailed statistical analyses that would be found for novel devices or AI/diagnostic systems. It focuses on the comparison to an already approved product.

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When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass.

When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Spinal Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

The ORIA Spinal Clip System includes components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system for each of four defined indications and to fit the patient's anatomical and physiological requirements. The components include: Lumbar, thoracic, and pedicular hooks; Sacral screws; Pedicle screws; Set screws; Locking nuts; Rods in various lengths; Connectors with set screws (sacral, transverse, lateral); Connecting elements; Instruments and Sterilizer trays.

The provided text is a 510(k) summary for the ORIA Spinal Clip System. It describes a medical device (spinal clip system) and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The summary states that the "ORIA Spinal Clip System Lengthened Lateral Connector (AL06)" was found substantially equivalent to a previously cleared device (Lateral Connector AL02). This equivalence is based on design principles, materials, manufacturing methods, and intended use, not on a performance study against specific acceptance criteria.

Therefore, I cannot fulfill your request for the detailed table and study information as it is not present in the provided text.

Here's why and what kind of information is present:

• Substantial Equivalence: The document is a 510(k) submission, a common pathway for medical device clearance in the US. This pathway relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive new clinical trials or performance studies with specific acceptance criteria in all cases.
• Focus on Design and Materials: The core of the substantial equivalence argument for this device revolves around the lengthened lateral connector being made of the same material (titanium alloy), having similar manufacturing methods, an equivalent interconnection mechanism, and a basic design similar to the previously cleared connector.

To directly answer your specific points based only on the provided text, many cannot be addressed:

1. Table of acceptance criteria and reported device performance: Not applicable. No specific performance acceptance criteria or reported performance metrics are mentioned. The comparison is based on substantial equivalence to a predicate device's design and materials.
2. Sample size for the test set and data provenance: No test set or associated data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is discussed.
4. Adjudication method for the test set: Not applicable. No test set requiring adjudication is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is not mentioned. The device is a spinal implant, not typically evaluated through MRMC studies in this context.
6. Standalone performance study (algorithm only without human-in-the-loop performance): Not applicable. This is a hardware device, not an algorithm.
7. Type of ground truth used: Not applicable. No ground truth determination for performance evaluation against acceptance criteria is described.
8. Sample size for the training set: Not applicable. This is a hardware device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable. No training set is involved.

The K030253 document is primarily a regulatory clearance document demonstrating substantial equivalence based on material, design, and intended use, not a performance study report with acceptance criteria.

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When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass.

When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Spinal Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

The ORIA Spinal Clip System includes components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system for each of four defined indications and to fit the patient's anatomical and physiological requirements. The components include: Lumbar, thoracic, and pedicular hooks; Sacral screws; Pedicle screws; Set screws; Locking nuts; Rods in various lengths; Connectors with set screws (sacral, transverse, lateral); Connecting elements; Instruments and Sterilizer trays.

The provided text describes a 510(k) summary for the ORIA Spinal Clip System. This document focuses on demonstrating substantial equivalence to a predicate device, as required for certain medical devices by the FDA. Such summaries typically do not include detailed performance studies with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case studies, which are more common for novel or higher-risk devices requiring more extensive clinical validation.

Therefore, many of the requested details cannot be found in the provided text.

Here's an analysis based on the information that is available:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity, or mechanical robustness thresholds). The acceptance criterion implicitly revolves around demonstrating "substantial equivalence" to a legally marketed predicate device.
• Reported Device Performance: The document states: "Documentation was provided which demonstrated the ORIA Spinal Clip System Polyaxial Screws to be substantially equivalent to the previously cleared Type "V" screws." This is the core "performance" reported – that it is equivalent to another device. No specific numerical performance metrics are provided for the ORIA Spinal Clip System itself beyond this statement of equivalence.

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: Not specified.
• Data Provenance: Not specified. The document refers to "documentation" being provided, but does not detail the nature of this documentation (e.g., specific study data, design comparisons, material testing results).

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/Not specified. The "ground truth" here is the established safety and efficacy of the predicate device, against which the new device is compared. There is no mention of a test set requiring expert ground truth establishment in the context of diagnostic accuracy or similar performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not specified.

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 device is a spinal implant system, not an AI-assisted diagnostic tool or imaging system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a spinal implant system, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for demonstrating substantial equivalence is the established regulatory status and safety/effectiveness profile of the predicate device. The documentation for the ORIA system likely focused on demonstrating similar materials, design, mechanical properties, and intended use to the predicate device, rather than patient outcomes or pathology related to the ORIA system itself.

8. The sample size for the training set

• Not applicable/Not specified. This is a medical device (spinal implant), not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. This device is a spinal implant system, not a machine learning algorithm.

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When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudoarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (1.3 and below); and (4) who are having the device removed after the development of solid fusion mass.

When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORLA Spinal Clip System is indication and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chromic instabilities of the thoracic. lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

System Components Include: Hooks Nuts Clips Rods Crosslinks Pedicle Screws Sacral Screws Unique Instrumentation
Materials: Certified implant grades of commercially pure titanium alloy and stainless steel are used to make the implants of the system.

The provided text describes the ORIA Spinal Clip System, a medical device for spinal fixation, and its substantial equivalence to other legally marketed devices. However, it does not contain information about acceptance criteria, a specific study proving device performance against such criteria, sample sizes for test/training sets, or details about ground truth establishment as typically found in AI/algorithm-based device submissions.

This document is a 510(k) premarket notification for a traditional medical device (a spinal implant). The evaluation for such devices primarily focuses on substantial equivalence to predicate devices, safety, and mechanical performance, rather than algorithm performance against specific diagnostic or prognostic outcome metrics.

Therefore, many of the requested details are not applicable or present in this specific submission. I will extract the relevant information that is available.

Here's a breakdown of what can be extracted from the document:

1. A table of acceptance criteria and the reported device performance

• Fatigue Tests: All samples fatigue tested according to a modified Cunningham model. Samples performed according to expectations.
• SN Curve: Established, with at least two run out points exceeding 5,000,000 load cycles at clinically useful loads. |
  | Biocompatibility | Compliance with biocompatibility standard | Implied as a special control, but no specific test results are reported in this summary. |
  | Labeling Requirements | Compliance with specific labeling | Yes, specific warnings and precautions outlined for pedicle screw systems. |
  | Sterilization | Achieving a Sterility Assurance Level (SAL) of at least 10^-6 | Validated steam gravity cycle at 250°F (121°C) for 30 minutes. |

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 for this type of device submission. The "test set" here refers to physical components undergoing mechanical and material testing, not a dataset for an algorithm. The document doesn't specify the number of samples used for static and fatigue testing, nor the origin of these samples (implied to be manufactured by Eurosurgical, S.A. in France).

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 the context of expert consensus, is related to evaluating diagnostic accuracy of an algorithm. This submission is for mechanical and material performance of an implant. The "ground truth" for mechanical testing would be the physical properties and performance metrics specified by engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods are used in consensus reading for image analysis or diagnostic decision-making.

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 pertains to the efficacy of AI/software in assisting human interpretation, which is not relevant to a spinal implant hardware submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this device's evaluation is primarily engineering specifications and recognized material/mechanical standards (e.g., ASTM, ISO). For sterilization, it's achieving a specified Sterility Assurance Level.

8. The sample size for the training set

• Not applicable. This submission does not involve an algorithm with a "training set."

9. How the ground truth for the training set was established

• Not applicable. As there is no training set for an algorithm, this question doesn't apply.

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