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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 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, 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 (C1-T3) spine. The pedicle screws are limited to placement in the 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 OCT/MESA Mini/ DENALI Mini Spinal System can also be linked to the RANGE® Spinal System using rod connectors or transitional rods.

The Caspian OCT/MESA Mini/ DENALI Mini Spinal System is a top-loading, multiple component, posterior (occipital-cervical-thoracic) spinal fixation system. The purpose of the current submission is to add modified rods, plates and screws to the system.

This document is a 510(k) premarket notification from the FDA for a spinal fixation system. It confirms that the device is substantially equivalent to legally marketed predicate devices. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML device. The document is about a mechanical spinal system, not a digital health product.

Therefore, I cannot provide the requested information.

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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

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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These Systems are intended for the following:

Hooks, Plate/Rods, Plates, Rods and Screws

When intended to provide stabilization as an adjunct to fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, plates, rod, hook and screw (3.2 mm cortex) components of the Synthes CerviFix, Axon; OC Fusion and Synapse Systems are indicated for skeletally mature patients using allograft and/or autograft for the following:

• Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with . degeneration of the disc as confirmed by patient history and radiographic studies)
• . Spondylolisthesis
• Spinal stenosis .
• Fracture/dislocation .
• Atlantoaxial fracture with instability .
• Occipitocervical dislocation .
• Revision of previous cervical spine surgery .
• Tumor .

When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws and Transverse Bars

The rods, clamps, screws, nuts, variable axis screws, locking screws and transverse bars are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (TI-T3).

The use of these screws (3.5 mm. 4.0 mm and 4.5 mm cancellous and 3.5 mm and 4.2 mm cortex) 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 Synthes CerviFix, Axon, and Synapse Systems can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm and 4.0 mm/6.0 mm paralle1 connectors from that system and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks; 4.2 mm screws, and the 5.0 mm/6.0 mm parallel connector.

Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine.

The Synapse System is a hook and pedicle screw spinal system which is designed to provide spinal fixation to allow for stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The Synapse System is composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Axon System and Cervifix System also included in the indications for use statement are additional hook and pedicle screw spinal systems. These systems consist of anchors including bone screws, pedicle screws and hooks: interconnection mechanisms including locking screws, set screws, parallel rod connectors, clamps, transverse bars, rod collars and nuts; longitudinal members including rods and rod/plates; and transverse connectors including transconnectors. These system components are implanted using class I surgical instruments.

This document describes a 510(k) premarket notification for the Synapse System, specifically focusing on proposed curved rods. It is a submission intended to demonstrate substantial equivalence to previously cleared devices, rather than a study proving performance against acceptance criteria for a novel device.

Therefore, many of the requested categories for a study proving device performance are not applicable (N/A) in this context, as this submission primarily relies on a "rationale" comparing the new components to existing ones, rather than new performance testing.

Here's an analysis based on the provided text, addressing your questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: N/A. No new test set involving patient data or specimens was described. The submission relies on a "rationale" for equivalence to predicate devices.
• Data Provenance: N/A. No new data from a test set (e.g., country of origin, retrospective/prospective) is presented. The "performance data" section explicitly states "A rationale is provided in place of performance testing."

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

• N/A. As no new test set data requiring ground truth establishment was presented, this is not applicable.

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

• N/A. No test set requiring expert adjudication was 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

• N/A. This device is a spinal fixation orthosis (physical implant system), not an AI-assisted diagnostic or treatment planning tool. Therefore, MRMC studies and AI effect sizes are not relevant to this submission.

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 or software device.

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

• N/A. No new ground truth establishment was described, as the submission focused on comparing the new components to established predicate devices based on design, materials, and existing performance data (implied from the predicates).

8. The sample size for the training set

• N/A. No training set for an algorithm was involved; this is a physical medical device.

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

• N/A. No training set or associated ground truth was established for this submission.

Summary of the Submission's Approach:

The K133698 submission for the Synapse System (specifically, proposed curved rods) is a substantial equivalence (SE) submission. This means the applicant demonstrated that the new device components (curved rods) are as safe and effective as a legally marketed predicate device.

Instead of conducting new performance studies, the manufacturer provided a "rationale" arguing that:

• The materials (Ti-6A1-7Nb (TAN)) are identical to those used in previously cleared components.
• The technological characteristics (design, intended use, indications for use) of the proposed curved rods are the same or similar to predicate devices (Synapse System, Sierra™ System, Altius™ OCT System).

This approach is common in 510(k) submissions where modifications to existing devices are minor and do not raise new questions of safety or effectiveness. The FDA's clearance (as indicated in the letter dated January 16, 2014) confirms their agreement that the device is substantially equivalent to predicates.

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When intended for stabilization as an adjunct to fusion of the cervical spine and occipito-cervicothoracic junction (occiput -T3), the Nextgen Altius OCT System is intended for use with allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); pseudoarthrosis; trauma, (i.e., fracture or dislocation); atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.

The occipital bone screws are limited to occipital fixation only.

The use of pedicle 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 Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's package insert for a list of indications for use for each system.

The Nextgen Altius OCT System is an occipito-cervico-thoracic spinal fixation system. This submission is a line extension to Altius OCT System to add CoCr rods and alternate styles of rods, and screws, as well as other system components to the system and to update the indications for use for the system as a whole.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

This 510(k) summary is for a spinal fixation system, which falls under the category of a medical device and not an AI/ML algorithm. Therefore, many of the requested points related to AI/ML studies (like MRMC, standalone algorithm performance, AI improvement over human readers, training set details) are not applicable to this document. The study described is a series of mechanical tests to demonstrate substantial equivalence to existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: This information is not explicitly stated in the summary. For mechanical tests, the "sample size" would refer to the number of constructs tested for each configuration.
• Data Provenance: The data is generated from mechanical laboratory testing of the device components, not from patient data. Therefore, concepts like "country of origin" or "retrospective/prospective" studies are not applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. As this is a mechanical testing study for a physical device, expert-established ground truth (in the clinical sense, e.g., for image interpretation) is not relevant. The "ground truth" here is adherence to established mechanical testing standards (ASTM standards) and the comparison of performance metrics against predicate devices.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert clinical assessments or diagnostic interpretations. This study involves objective mechanical performance measurements, not subjective expert reviews.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is relevant for evaluating the impact of an AI/ML system on human reader performance. This document describes mechanical testing of a spinal fixation device, which does not involve human readers for diagnostic interpretation.

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

• No. This is not an AI/ML algorithm. It is a physical medical device.

7. The Type of Ground Truth Used

• The "ground truth" in this context is based on established mechanical testing standards (ASTM F2706, F1717, F1798) and performance characteristics of legally marketed predicate devices. The goal is to demonstrate that the new device's components meet these engineering and regulatory benchmarks, indicating that they are at least as safe and effective as existing devices.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of mechanical testing for a spinal fixation system. This concept applies to the development of AI/ML algorithms.

9. How the Ground Truth for the Training Set was Established

• Not Applicable. As there is no training set, there is no ground truth established for one.

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The GSO PCT Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is intended to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The GSO PCT Spinal System should be removed after fusion.

The GSO PCT Spinal System is intended to promote fusion of the cervical spine and cervico-thoracic junction (C1-T3), and is indicated for the following:

1. Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
2. Spondylolisthesis
3. Spinal stenosis
4. Fracture or dislocation
5. Revision of previous cervical or cervico-throracic spine surgery
6. Tumors

The use of multi-axial pedicle screws is limited to placement in the upper thoracic spine (T1-T3) for the purpose of anchoring the construct. The multi-axial pedicle screws are not intended to be placed in the cervical spine.

The GSO PCT Spinal System consists of rods, screws, hooks, and connecting components that can be locked rigidly into various configurations to build a spinal construct specific to the needs of each individual patient. The implants are attached to the spine posteriorly by means of screws and/or hooks joined with rods. Cross connector components are used to attach two rods in parallel. The GSO PCT Spinal System can be installed with any suitable instrumentation.

The GSO PCT Spinal System components are manufactured from CP Titanium conforming to ASTM F67 and Ti-6A1-4V Titanium alloy conforming to ASTM F136. Devices are available in various diameters, lengths and sizes.

This appears to be a 510(k) premarket notification document for a spinal implant system, not an AI/ML medical device. Therefore, many of the requested categories related to AI/ML device performance and testing (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable.

However, I can extract information related to the acceptance criteria and the study performed to demonstrate "device meets acceptance criteria" in the context of a traditional medical device (spinal implant).

Acceptance Criteria and Reported Device Performance for GSO PCT Spinal System

Study Details (Non-AI/ML Medical Device)

• Sample sized used for the test set and the data provenance: Not applicable. For this type of device, mechanical testing is done on device samples, not patient data sets.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineering standards and measurements, not expert clinician consensus.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.
• The type of ground truth used:
  • For mechanical strength: Engineering standards (ASTM F1717) and physical measurements.
  • For substantial equivalence: Comparison against legally marketed predicate devices based on indications, design, and materials.
• The sample size for the training set: Not applicable. This is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary of the Study:

The primary study conducted for the GSO PCT Spinal System was non-clinical mechanical testing.

• Study Type: Mechanical performance testing.
• Methodology: The testing was conducted according to ASTM F1717. ASTM F1717, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model," typically evaluates the static and fatigue strength of spinal implant constructs under various loading conditions (e.g., compression, torsion, bending) to ensure they can withstand the anticipated physiological stresses without failure.
• Results: The mechanical testing demonstrated that the GSO PCT Spinal System possesses "sufficient strength for its intended use."

Additionally, the submission relies on demonstrating substantial equivalence to existing legally marketed devices (Mountaineer OCT Spinal System, Altius OCT System, and OASYS System). This comparison serves as a form of "study" to support the safety and effectiveness by showing similarity in:

• Indications for Use
• Design
• Materials of construction (CP Titanium conforming to ASTM F67 and Ti-6A1-4V Titanium alloy conforming to ASTM F136).

Clinical Testing: The document explicitly states: "Clinical testing was not necessary to demonstrate the substantial equivalence of the GSO PCT Spinal System to the predicate devices." This is common for 510(k) submissions where substantial equivalence can be established through non-clinical data and direct comparison to predicates.

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The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (C1 - T3). The intended indications are as follows:

• Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis
• Spinal Stenosis
• Fracture/Dislocation
• Tumors
• Pseudoarthrosis
• Revision of previous cervical and upper thoracic spine surgery

The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The Atoll Cervico-Thoracic System can also be linked to the Theken Coral Spinal System with the use of transitional rods and rod connectors.

The Atoll Cervico-Thoracic System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient physiology.

The Atoll Cervico-Thoracic System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F136 and ISO 5832-3.

To achieve the best results, unless otherwise specifically described in another Theken Spine document, do not use Atoll Cervico-Thoracic System components in conjunction with components for any other system or manufacturer.

The purpose of this submission is to add transition rods and rod connectors

This document is a 510(k) summary for a medical device called the Atoll Cervico-Thoracic System. It is a premarket notification to the FDA to demonstrate substantial equivalence to existing legally marketed devices.

It describes a spinal implant system and its intended use, rather than a diagnostic device or AI software. Therefore, the questions related to studies proving acceptance criteria for device performance, ground truth, expert involvement, and AI specific metrics (like MRMC studies) are not applicable in this context. These questions typically apply to diagnostic devices, particularly those involving image analysis or AI algorithms, where performance relies on measurable metrics against a 'ground truth'.

For this device, "acceptance criteria" are related to mechanical and material properties, and "substantially equivalent" claims. The study proving acceptance is typically mechanical testing and material characterization, not clinical studies with patients for diagnostic accuracy.

Here's an attempt to answer the relevant aspects based on the provided text, while explicitly stating where information is not applicable:

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

Note: The acceptance criteria for this type of medical device are typically defined by engineering standards for mechanical strength, biocompatibility, and manufacturing quality, and by demonstrating that the device is "substantially equivalent" to legally marketed predicate devices in terms of intended use, design, and materials.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as this is a 510(k) submission for a spinal implant, not a diagnostic device or AI algorithm that would typically involve a "test set" of data for performance evaluation in the way described. The "test" for this device would involve mechanical testing and material characterization, the specifics of which are not detailed in this summary.

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 information is not applicable. "Ground truth" in the context of expert consensus is typically relevant for diagnostic accuracy studies of image-based or clinical data, which is not the nature of this device submission.

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

This information is not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of data, which is not relevant to this device's 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

This information is not applicable. MRMC studies are specifically for evaluating diagnostic performance of imaging systems, often with AI assistance. This device is a surgical implant.

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

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

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

This information is not applicable in the context of data-driven performance evaluation. For this device, the "ground truth" would be related to established engineering standards for material properties and mechanical performance, and the clinical outcomes for the predicate devices that established their safety and effectiveness.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of this device submission.

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

This information is not applicable. There is no "training set" in the context of this device submission.

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The intended use of the Sierra spinal system is to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). The indications for use are as follows:

• degenerative disc disease (DDD) as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
• spondylolisthesis. .
• trauma (i.e., fracture or dislocation), .
• . spinal stenosis.
• atlantoaxial fracture with instability, .
• occipitocervical dislocation, .
• revision of previous cervical spine surgery, and/or
• . spinal tumor.

The occipital bone screws are limited to occipital fixation only.

The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

Rod connectors, crossbars and set screws are being added to the Sierra spinal system. All products are fabricated from titanium alloy. All products are supplied "NON-STERILE" and must be sterilized prior to use.

This document describes a 510(k) premarket notification for the Sierra™ spinal system, specifically referring to the addition of rod connectors, crossbars, and set screws. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study to prove novel efficacy or safety. Therefore, the provided information does not include details on acceptance criteria, a study proving performance against those criteria, or specific metrics like sensitivity, specificity, or reader improvement with AI.

Here's an analysis based on the provided text, highlighting the absence of the requested information due to the nature of a 510(k) submission:

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

• Acceptance Criteria: Not explicitly stated as performance metrics in the provided document. For 510(k) submissions, the “acceptance criteria” typically revolve around demonstrating substantial equivalence in terms of functionality, technological characteristics, and safety to a predicate device. This is often achieved through comparative testing (e.g., mechanical, material) and analysis rather than clinical performance metrics.
• Reported Device Performance: Not reported in terms of clinical outcomes or specific performance metrics (e.g., sensitivity, specificity, accuracy). The submission asserts that the new components have "substantially equivalent technological characteristics to the predicate devices."

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/not provided. This document does not describe a clinical study in the traditional sense involving a "test set" of patients or data for performance evaluation. The "testing" likely involved mechanical and material characterization of the new components against established standards or predicate device specifications.
• Data Provenance: Not applicable/not provided.

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. Ground truth establishment by medical experts is typically part of clinical performance studies, which are not detailed in this 510(k) submission.

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

• Not applicable/not provided. Adjudication methods are relevant for clinical studies that involve expert review of cases, which is not the focus of this document.

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

• MRMC Study: No. This document concerns a conventional medical device (spinal fixation system components), not an AI-powered diagnostic or assistive tool.
• Effect size of human reader improvement with AI: Not applicable, as no AI component is described.

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

• Not applicable, as no algorithm or AI component is described.

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

• Not applicable. The "ground truth" for a 510(k) submission like this would involve demonstrating that the new components meet established engineering and material standards, and perform comparably to predicate devices in mechanical and functional tests. It is not about clinical ground truth derived from patient data.

8. The sample size for the training set

• Not applicable. There is no mention of an algorithm or AI requiring a training set.

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

• Not applicable. There is no mention of an algorithm or AI requiring a training set or ground truth establishment in this context.

Summary of what the document does provide:

• Predicate Devices: SeaSpine, Inc.'s Sierra Spinal System (K062934) and Interpore Cross International's Altius OCT System (K022048, K033961 and K043229).
• Basis for Equivalence: "The overall designs of the rod connectors, crossbars and set screws in this submission are substantially equivalent to the predicate devices." and "The devices in this submission have substantially equivalent technological characteristics to the predicate devices."
• Materials: All products are fabricated from titanium alloy.
• Intended Use: Promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for various conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, atlantoaxial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and spinal tumor).
• Limitations: Occipital bone screws limited to occipital fixation; polyaxial screws limited to T1-T3 for thoracic conditions only, not for cervical spine.

In conclusion, this document is a 510(k) summary for a conventional medical device modification, which focuses on demonstrating substantial equivalence to existing devices based on technological characteristics and intended use, rather than presenting clinical study results with performance metrics or AI algorithm validation.

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The intended use of the Sierra spinal system is to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). The indications for use are as follows:

• degenerative disc disease (DDD) as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies,
• spondylolisthesis. .
• trauma (i.e., fracture or dislocation), .
• spinal stenosis, .
• atlantoaxial fracture with instability, .
• occipitocervical dislocation, .
• revision of previous cervical spine surgery, and/or .
• . spinal tumor.
  The occipital bone screws are limited to occipital fixation only.
  The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

A new occipital plate design is being added to the Sierra spinal system. All products are fabricated from titanium alloy and cobalt alloy. All products are supplied "NON-STERILE" and must be sterilized prior to use.

This document is a 510(k) premarket notification for the Sierra™ OCT Spinal System, specifically for the addition of a new occipital plate design. It is a submission to the FDA (Food and Drug Administration) for regulatory clearance. Since this is a submission for a Special 510(k) and the information provided points to substantial equivalence with existing predicate devices, the focus is on design and material equivalency, rather than clinical performance studies involving a test set, ground truth, or human-in-the-loop assessments as would be done for AI/ML-driven devices.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this type of submission. The "acceptance criteria" here refer to satisfying FDA's requirements for substantial equivalence based on design, materials, and intended use.

Here's the breakdown of the information based on the provided document:

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

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 (N/A). This submission is for a medical device (occipital plate) and relies on substantial equivalence to predicate devices, not clinical performance data from a test set of patients in the way an AI/ML device would. No patient data or test set in the traditional sense was used.

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)

• N/A. Ground truth establishment is not relevant for this type of submission, which focuses on engineering and design equivalency.

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

• N/A. No test set or human adjudication process as described is relevant.

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 not an AI/ML device, so no MRMC study or AI assistance evaluation was conducted.

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

• N/A. This is not an algorithm or AI system.

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

• N/A. The "ground truth" equivalent in this context is the regulatory acceptance of the predicate devices based on their established safety and effectiveness. The new device is deemed safe and effective because its characteristics are substantially equivalent to those already cleared devices.

8. The sample size for the training set

• N/A. No training set is relevant for this device.

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

• N/A. No ground truth for a training set was established.

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