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The Anatase Spine Surgery Navigation System is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery.

Example procedures include but are not limited to:

Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.

The Anatase Spine Surgery Navigation System, also known as an Image Guided System, is comprised of a platform, clinical software, surgical instruments, and a referencing system. The system uses optical tracking technology to track the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient. The system helps guide surgeons during spine procedures such as spinal fusion. The software functionality in terms of its feature sets is categorized as imaging modalities, registration, planning, interfaces with medical devices, and views.

The modified Anatase Spine Surgery Navigation System, the subject of these 510(k) applications, introduces software, hardware and instruments modifications to the original Surgery Navigation System cleared in 510(k) K180523.

The Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-Spine2-V, is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not specify sample sizes for any test sets nor the data provenance (e.g., country of origin, retrospective/prospective). The studies are non-clinical, meaning they did not involve patient data.

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

This information is not provided in the document as these were non-clinical tests.

4. Adjudication method for the test set:

This information is not provided in the document as these were non-clinical tests.

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:

No clinical testing, including MRMC studies, was conducted. The document explicitly states: "No clinical testing has been conducted."

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

The provided information focuses on the entire system's performance, which is an image-guided navigation system that would inherently involve human interaction (a surgeon). While software verification and validation were performed, the document does not distinguish between human-in-the-loop and algorithm-only performance for a standalone assessment in a manner that would typically be seen for an AI diagnostic device. The "Accuracy" test implies an assessment of the system's ability to track and display positions, which is a standalone performance metric for the navigation component, but it's not described as an AI-specific algorithm performance.

7. The type of ground truth used:

For the accuracy testing, the ground truth would likely be established through precise physical measurements to determine the true positional accuracy of the system against a known standard. However, the document does not specify the exact methodology for establishing the ground truth beyond referencing ASTM F2554-18. For other tests like electrical safety, EMC, and sterilization, the "ground truth" is defined by compliance with the referenced standards.

8. The sample size for the training set:

As this is a navigation system and not explicitly an AI diagnostic device in the context of machine learning model training, the concept of a "training set" in that sense is not directly applicable or discussed in the document. Software verification and validation were performed, but details on data used for these processes are not provided.

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

Same as above, the concept of a "training set" with established ground truth as typically understood in AI/machine learning is not applicable here. Software verification and validation would use various testing methods to ensure the software performs as designed and meets requirements.

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The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).

When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

When used with the 3.5 mm/6.0mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems. When used with the 5.5 mm/6.0mm parallel or extension connectors, Synthes USS 5.5 mm rod systems can be linked to the Synthes USS 6.0 mm rod systems. 5.5 mm/5.5mm parallel or extension connectors can be used to link all Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0mm parallel or extension connectors can be used to link all Synthes USS 6.0 mm rod systems to one another.

Rod-to-rod connectors can be used to link all Synthes USS 5.5 mm rod systems to one another.

When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5mm and 4.0 mm/5.5 mm tapered rods, Synthes USS 5.5 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to Synthes USS 5.5 mm rod systems.

In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes USS 5.5 mm rod systems can be interchanged with all USS 5.5 mm rods and transconnectors.

This is an addition to Synthes' existing non-cervical spinal fixation devices intended for are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). The current system is comprised of monoaxial and polyaxial screws, rods, locking caps, transverse bars and connectors. The additional locking cap in this submission is manufactured of cobalt chrome (Cobalt- 28Chromium - 6Molybdenum per ASTM F1537 - 08).

The provided text describes a 510(k) Summary for a medical device called the "Synthes Matrix System," which is an addition to an existing line of non-cervical spinal fixation devices. The document explicitly states that clinical data and conclusions were NOT needed for this device. This means that the information requested regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, standalone performance, and training sets is not available in this document because a clinical study was not performed or deemed necessary for this 510(k) submission.

The acceptance criteria and proof of meeting them are based on non-clinical performance data (bench testing), which demonstrated equivalence or superiority to predicate devices.

Here's a breakdown of the available information:

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

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

• Sample Size for Test Set: Not specified. (Refers to mechanical testing specimens, not human subjects or a data set for an AI model).
• Data Provenance: Not applicable in the context of human data. The data comes from bench testing of the device components.

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

• Experts: Not applicable. Ground truth for mechanical testing is established by engineering specifications and direct measurement, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. This is mechanical bench testing, not a clinical study requiring adjudication of diagnostic outcomes.

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 device is a spinal implant, not an AI or diagnostic imaging device. No human reader studies were performed or relevant.

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

• Standalone Performance: Not applicable. This is a physical medical device (spinal implant), not an algorithm or AI.

7. The type of ground truth used

• Ground Truth: For mechanical testing, the ground truth is based on the physical properties and performance characteristics defined by engineering standards (e.g., ASTM F1717-11a) and compared against the performance of legally marketed predicate devices.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. There is no AI model or learning algorithm mentioned or relevant to this device.

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

• Ground Truth for Training Set: Not applicable. There is no AI model or learning algorithm mentioned or relevant to this device.

In summary, this 510(k) submission relied on non-clinical (bench) testing to demonstrate substantial equivalence to predicate devices, and explicitly stated that clinical data was not required. Therefore, all questions pertaining to clinical study design, human data, expert review, and AI model specifics are not addressed by the provided document.

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The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies): spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.

With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD HORIZON® SPIRE™ Plate is a posterior, single level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (TI-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined); spondylolisthesis; trauma; and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

A subset of CD HORIZON® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, CROSSLINK® Plates, and connecting components. Similarly to the CD HORIZON® implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

Certain components within the CD HORIZON® Spinal System are specifically excluded for use in pediatric patients. These include PEEK rods, Shape Memory Alloy Staples, SPIRE™ Plates and DYNALOK® bolts. All screws used in pediatric cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, and medical grade cobalt-chromium-molybdenum alloy.

Certain implant components from other Medtronic spinal systems can be used with the CD HORIZON® Spinal System in non-pediatric cases. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples, washers, GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK® PLUS and DYNALOK CLASSIC® bolts along with rod/bolt connectors; and Medtronic Multi-Axial rods and screws. Please note that certain components are specifically designed to connect to specific rod diameters, while other components can connect to multiple rod diameters. Care should be taken so that the correct components are used in the spinal construct.

CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and associated screws are intended for anterior use only. However, for patients of smaller stature and pediatric patients, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.

The CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, medical grade cobaltchromium-molybdenum alloy, or medical grade PEEK OPTIMA-LT1. Certain CD HORIZON® Spinal System components may be coated with hydroxyapatite. No warranties expressed or implied are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MDT Catalog for further information about warranties and limitations of liability.

Never use stainless steel and titanium implant components in the same construct.

Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromiummolybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct.

The CD HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt-chromium-molybdenum alloy. Do not use with stainless steel. These staples are not to be used in pediatric patients.

PEEK OPTIMA-LT1 implants may be used with stainless steel, titanium, or cobaltchromium-molybdenum alloy implants. CD HORIZON® PEEK Rods are not to be used with CROSSLINK® Plates or in pediatric patients.

To achieve best results, do not use any of the CD HORIZON® Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopaedic and neurosurgical implants, none of the CD HORIZON® Spinal System components should ever be reused under any circumstances.

The purpose of this 510(k) was to add additional components to the system, namely SOLERA™ LONGITUDE® 4.75mm. 5.5mm and 6.0mm diameter rods, 6.0mm diameter commercially pure titanium rods and longer CHROMALOY™ Plus 5.5mm and 6.0mm diameter rods. The rods are manufactured out of commercially pure titanium and cobaltchromium-molybdenum alloy.

The document provided is a 510(k) summary for the CD HORIZON® Spinal System, focusing on the addition of new rod components. The "system" being evaluated is a medical device, specifically spinal implants. Therefore, the "acceptance criteria" and "device performance" relate to the mechanical properties of these implants and their ability to function safely and effectively within the human body.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Implied" Criteria: The document states that "The results were compared to the previously listed predicate devices." and that the subject devices "demonstrated substantial equivalence to the previously listed predicate devices." This strongly implies that the acceptance criteria for the subject devices (new rods) were to perform at least as well as, or equivalently to, the predicate devices in these mechanical tests.

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

• Sample Size: The document does not explicitly state the numerical sample size (e.g., number of rods tested) for the non-clinical mechanical testing. It refers generally to "worst case subject devices."
• Data Provenance: The data is from "non-clinical testing" (mechanical testing) performed by the manufacturer, Medtronic Sofamor Danek USA, Inc. The country of origin and whether it was retrospective or prospective are not specified, but mechanical testing of medical devices is typically performed in a controlled laboratory setting and is prospective in nature for a 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• This is not applicable as the "ground truth" for this type of medical device (spinal implants) is established through standardized mechanical testing against performance benchmarks, not expert consensus on interpretations like with diagnostic images. The "ground truth" here is objective physical performance, measured in a lab.

4. Adjudication Method for the Test Set

• This is not applicable for mechanical testing. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data (e.g., image interpretation), not for objective mechanical test results.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This is not applicable. The device in question is a physical spinal implant system, not an AI-powered diagnostic or assistive tool for human readers.

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

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

7. The Type of Ground Truth Used

• The ground truth for evaluating these spinal implants is based on objective mechanical performance metrics defined by the ASTM F1798 standard and comparison to the established performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

• Not applicable. As this is a physical medical device and not a machine learning model, there is no "training set."

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

• Not applicable. There is no training set for this type of device.

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The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/ilium), posterior hook fixation (TI-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).

When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

When used with the 3.5 mm/6.0mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems. When used with the 5.5 mm/6.0mm parallel or extension connectors, Synthes USS 5.5 mm rod systems can be linked to the Synthes USS 6.0 mm rod systems. 5.5 mm/5.5mm parallel or extension connectors can be used to link all Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0mm parallel or extension connectors can be used to link all Synthes USS 6.0 mm rod systems to one another.

When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5mm and 4.0 mm/5.5 mm tapered rods, Synthes USS 5.5 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to Synthes USS 5.5 mm rod systems.

In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes USS 5.5 mm rod systems can be interchanged with all USS 5.5 mm rods and transconnectors.

Synthes USS
6.0 mm Rod Systems: USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix
5.5 mm Rod System: Matrix, MIRS
5.0 mm Rod System: USS Small Stature

CerviFix
3.5 mm Rod Systems: CerviFix, Axon, Synapse
4.0 mm Rod System: Synapse

This is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/ilium). posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). The current system is comprised of monoaxial and polyaxial screws, rods, locking caps, transverse bars and connectors. The new sagittal screw that is the subject of this submission is similar to the already-cleared polyaxial screw and is manufactured of TAN (Titanium-6 Aluminum-7 Niobium Alloy per ASTM F1295 - 05 ). These screws restrict head angulation to the direction parallel to the rod slot (typically the cranial/caudal direction).

The provided text describes a 510(k) summary for the Synthes Matrix System, a medical device for spinal fixation, and its substantial equivalence to predicate devices, rather than a study proving the device meets specific performance criteria.

Therefore, many of the requested categories for AI/algorithm performance and study design are not applicable as this document pertains to a medical device submission, not an AI or software study.

However, I can extract the relevant information regarding performance data and acceptance criteria based on the provided text.

Here's a breakdown of the requested information based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as numerical thresholds for specific performance metrics in the context of an AI study. Instead, it refers to the device demonstrating "equivalently or superiorly" to predicate devices.

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

Not Applicable (N/A) - This document describes non-clinical bench testing for a physical medical device (spinal fixation system), not a study with a test set of data (images, clinical records, etc.) for an AI algorithm. The performance data is from mechanical bench testing, not a clinical data set.

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

N/A - Ground truth as defined for an AI study (e.g., expert consensus on image interpretation) is not applicable here. The "ground truth" for mechanical testing would be the physical properties and performance metrics measured using established engineering standards.

4. Adjudication method for the test set

N/A - This concept is relevant for studies involving human judgment or interpretation (like image reading). For mechanical bench testing, data is typically collected directly from instruments and analyzed against engineering standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A - This is an AI-specific study type. The document describes a physical medical device and its mechanical testing.

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

N/A - This refers to AI algorithm performance. The Synthes Matrix System is a physical implantable device.

7. The type of ground truth used

For the non-clinical performance data, the "ground truth" (or reference standard) inherently comes from established engineering standards and physical measurements obtained during mechanical bench testing. Specifically, it adheres to ASTM F1717-11a, an American Society for Testing and Materials standard for spinal implant constructs.

8. The sample size for the training set

N/A - This document does not describe the development or testing of an AI algorithm, and therefore there is no "training set."

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

N/A - As there is no training set for an AI algorithm, this question is not applicable.

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