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When used in conjunction with the CD HORIZON® Fenestrated Screws, KYPHON HV-R® Fenestrated Screw Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. KYPHON HV-R® Fenestrated Screw Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.

When used in conjunction with KYPHON® HV-R Fenestrated Screw Cement, the CD HORIZON® Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD HORIZON® Fenestrated Screws augmented with KYPHON HV-R® Fenestrated Screw Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

1. KYPHON HV-R® Fenestrated Screw Cement is self-curing PMMA based (high viscosity, radiopaque) bone cement. KYPHON HV-R® Fenestrated Screw Cement will be provided sterile in two components: 20 grams of powder and nine grams of liquid. The powder contains methylmethacrylate-styrene co-polymer, barium sulfate as a radiopacifier, and di-benzoyl peroxide as an initiator. This liquid contains methylmethacrylate monomer, N, N dimethyl-p-toluidine as a promoter and hydroquinone as a stabilizer. The powder and liquid components are mixed, in the provided liquid-to-powder proportions, into a homogenous paste, to initiate the polymerization reaction of monomer into polymer.

2. The CD HORIZON® Fenestrated Screw Set consists of a variety of cannulated multi-axial screws (MAS) with fenestrations offered in diameters ranging from 4.5mm to 10.5mm, with lengths ranging from 30-100mm based on CD HORIZON® LEGACY™ and CD HORIZON® SOLERA™ implants contained in the CD HORIZON® Spinal System. The CD HORIZON® Fenestrated Screws are specifically designed to connect to 4.75mm, 5.5mm, and 6.0mm diameter rods and associated connecting components contained within the CD HORIZON® Spinal System. The screws contain six fenestrations near the distal tip of the screw which provides a controlled means to deliver a small amount of polymethylmethacrylate (PMMA) bone cement into a targeted vertebral body. These screws are provided non-sterile.

The provided document is a 510(k) premarket notification for the KYPHON HV-R® Fenestrated Screw Cement and CD HORIZON® Fenestrated Screw Set. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a study with specific metrics like sensitivity, specificity, or reader performance.

Therefore, many of the requested details about acceptance criteria, study design for performance measurement, ground truth, and expert involvement are not available in this type of regulatory document.

However, I can extract information regarding performance data and the overall conclusion.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Not Applicable. The document explicitly states "Clinical data and Non-Clinical testing were provided in support of substantial equivalence of the subject device." This indicates that the performance data was used to demonstrate that the new device is as safe and effective as the predicate devices, rather than meeting predefined acceptance criteria for diagnostic performance metrics (like sensitivity/specificity) for a specific task (e.g., detecting a condition). The performance data cited would likely be mechanical properties, biocompatibility, or other engineering parameters relevant to medical devices, not diagnostic accuracy.

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

• Not Available. The document does not specify test set sample sizes or data provenance. The "clinical data" mentioned would typically be focused on patient outcomes and safety profiles compared to predicate devices, not on a "test set" for an AI algorithm's performance.

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. This device is a medical implant and bone cement system, not an AI diagnostic tool. Therefore, there is no "ground truth for a test set" in the context of expert review for diagnostic accuracy as there would be for an AI algorithm. Ground truth, if applicable in a clinical study for an implant, would relate to patient outcomes, imaging results post-procedure, or pathology reports after explantation, which are typically assessed by treating physicians or pathologists, not necessarily a panel of experts specifically for "ground truth establishment" in the way it's described for AI.

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

• Not Applicable. As explained above, this is not an AI diagnostic device and therefore, adjudication methods for a test set based on expert review are not relevant to 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

• Not Applicable. This is a medical device (cement and screws), not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described in this document.

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

• Not Applicable. This is not an algorithm or AI system.

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

• Outcomes Data/Substantial Equivalence to Predicates: While not framed as "ground truth" for an AI, the "Performance Data" and "Clinical Data and Non-Clinical testing" would have relied on various forms of data to demonstrate safety and effectiveness. For implants, this typically includes:
  • Mechanical Testing Data: Demonstrating the physical properties (strength, fatigue, etc.) of the cement and screws.
  • Biocompatibility Testing: Ensuring the materials are safe for implantation.
  • Clinical Outcomes Data: Potentially from studies comparing the device to existing treatments, or from safety monitoring, though detailed clinical trial results are not provided in a 510(k) summary. The primary "ground truth" here is often the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not Applicable. This is a medical device, not an AI model requiring a training set.

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

• Not Applicable. This is a medical device, not an AI model.

Summary of Relevant Information from the Document:

While the document doesn't fit the typical "AI performance study" framework, it does describe its substantial equivalence to predicate devices based on presented data.

Device(s) being reviewed:

• KYPHON HV-R® Fenestrated Screw Cement
• CD HORIZON® Fenestrated Screw Set

Predicate Devices:

• KYPHON® HV-R® Bone Cement (K150460)
• CD HORIZON® Spinal System (K042025 and K113174)

Basis of Substantial Equivalence (implied "performance criteria" for a 510(k) device):
The substantial equivalence is based on demonstrating that the new device has the same intended use, similar technological characteristics, and comparable performance to the legally marketed predicate devices. The document explicitly states:

• KYPHON HV-R® Fenestrated Screw Cement: "identical in composition, method of manufacture and sterilization to the primary predicate Kyphon® H-VR® Bone Cement... The only differences between the subject and predicate cement are the method in which the cement is delivered and that the subject cement is limited to patients with advanced stage tumors..."
• CD HORIZON® Fenestrated Screw Set: "have the same or similar indications, intended use, fundamental scientific technology, and are manufactured from similar materials as the pedicle screws found in the following FDA cleared CD HORIZON® Spinal System applications... The primary difference is the subject screws contain fenestrations which allow PMMA cement to flow in a controlled manner through the screw and into the targeted pedicle."

Conclusion:
"Based on the provided performance data, the subject KYPHON® HV-R Fenestrated Screw Cement is substantially equivalent to the KYPHON® HV-R® Bone Cement (K150460, SE 04/28/15) and the CD HORIZON® Fenestrated Screw Set is substantially equivalent to the CD HORIZON® Spinal System (K042025 (SE 08/25/2004) and K113174 (SE 11/21/2011))."

Performance Data Mentioned:
"Clinical data and Non-Clinical testing were provided in support of substantial equivalence of the subject device." (Details of this data are not provided in this summary.)

Ask a specific question about this device

The CD HORIZON® Spinal System without SEXTANT® instrumentation is intended for posterior, non-ecryical fixation as an adjunct to fusion for the following indications: degencrative 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, 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 degeneralive discase, the CD HORIZON® LEGACY™ 3,5mm rods and the CD HORUZON® 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 indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatic patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolishesis spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. 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 (T1-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 tailormade 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.

The purpose of this Special 510(k) is the modifications of implants for the CD HORIZON® Spinal System. The modifications to the implants are adding additional sizes of cannulated multi-axial screws (MAS), print updates for a rebaselining of existing closed lateral connectors, and adding additional sizes of SEXTANT® pre-bent rods with different tip geometries and connection types.

This document is a 510(k) Summary for the Medtronic CD HORIZON® Spinal System. It is a premarket notification to the FDA to demonstrate substantial equivalence to previously cleared devices. Therefore, it does not describe a study to prove a device meets acceptance criteria in the typical sense of a clinical trial or performance study for a novel AI/software medical device.

Instead, this document focuses on demonstrating that the modified CD HORIZON® Spinal System is substantially equivalent to existing, legally marketed predicate devices. The "acceptance criteria" here are met by showing that the modified device has the same indications, intended use, fundamental scientific technology, materials, and sterilization method as the predicates, and that design modifications do not introduce new issues of safety or effectiveness.

Here's an analysis based on the provided document, addressing your points where applicable:

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

Since this is a 510(k) for a spinal implant system aiming for substantial equivalence to predicates, the "acceptance criteria" are not performance metrics like sensitivity, specificity, or AUC as one might find for an AI device. Instead, they relate to material properties, design equivalency, and safety.

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 is a 510(k) for an updated spinal implant system, not an AI/software device that requires a test set of data. The "test" consists of analytical methods (risk analysis, engineering rationales, material equivalency) rather than performance on a data set.

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. This document does not describe a study involving expert review for ground truth establishment.

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

Not applicable, as there is no "test set" in the context of an AI/software device performance study.

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

Not applicable. This document is for a spinal implant, not an AI-assisted diagnostic or therapeutic device.

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

Not applicable. This document describes an updated spinal implant system, not a standalone algorithm.

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

Not applicable. The "ground truth" for this submission is whether the modified device remains functionally and materially equivalent to its predicates, which is established through engineering analysis and comparison to existing regulatory clearances, rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device requiring a training set.

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

Not applicable. This is not an AI/machine learning device.

Ask a specific question about this device

The CD HORIZON® Spinal System with or without SEXTANT® intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis); 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 pediatic indications noted below.

When used for posterior non-cervical pediatic 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 pediatic patients diagnosed with the following conditions: spondylolysis and fracture caused by tumor and/ or trauma. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CDHORIZON® SPIRE™ Plate is a posterior, single level, non-pedicle supplemental fixation device intended for use in the noncervical 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.

The CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium alloy, medical grade cobalt chromium molybdenum alloy, or medical grade PEEK OPTIMA-LTI. Certain CD HORIZON® Spinal System components may be coated with hydroxyapatite.

The purpose of this 510(k) is to add additional non-sterile rods to the CD HORIZON® Spinal System. The type of rods includes a series of tapered and straight rods. The subject rods are manufactured out of medical grade cobalt-chromium-molybdenum alloy.

The subject rods along with other components such as metal screws, hooks and other connecting components are intended to help provide immobilization of spinal segments as an adjunct to fusion of thoracic, lumbar, and/or sacral spine.

This document is a 510(k) premarket notification for the CD HORIZON® Spinal System and primarily focuses on establishing substantial equivalence for new, additional non-sterile rods being added to an existing system. It describes mechanical testing performed to demonstrate that these new rods do not introduce new risks and meet predetermined acceptance criteria, thereby making them substantially equivalent to previously cleared predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies, adhering to your requested format:

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)

• Sample Size: The document does not specify the exact number of test samples (e.g., number of rods tested) for each mechanical test. It only states that "Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices."
• Data Provenance: The data provenance is internal to Medtronic, a U.S.-based company (Memphis, TN). This is a premarket submission to the FDA, indicating it's part of a regulatory approval process conducted by the manufacturer. The testing described is prospective, as it was performed specifically for this 510(k) submission.

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 document describes mechanical testing of a spinal implant. It does not involve human anatomical data, image analysis, or clinical evaluation requiring expert medical interpretation to establish "ground truth." Therefore, this section is not applicable. The "ground truth" here is adherence to engineering standards and predetermined mechanical performance criteria.

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

As this study is mechanical testing of a medical device against engineering standards, an "adjudication method" in the context of expert review of clinical data (like 2+1 or 3+1) is not applicable. The "adjudication" is determined by whether the test results meet predefined physical and mechanical thresholds outlined in the ASTM 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

No MRMC study was performed. This document relates to the mechanical testing of spinal system components (rods) and not to an AI/imaging device requiring human reader interpretation studies.

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

No standalone algorithm performance study was done. This document is for a physical medical device (spinal rods), not a software algorithm.

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

The "ground truth" for this study is defined by established engineering standards and predetermined acceptance criteria outlined in ASTM F1798 and ASTM F1717. The device passes if its mechanical properties (e.g., static and fatigue properties) meet these specified thresholds.

8. The sample size for the training set

Not Applicable. This document describes mechanical testing for a physical device, not an AI or machine learning algorithm that requires a "training set."

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

Not Applicable. As there is no training set for an AI algorithm, the ground truth establishment method for a training set is not relevant here.

Ask a specific question about this device

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 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 (T)-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.

The system also includes various instruments used to assist in the implantation of the system via minimally invasive approaches.

The purpose of this submission is to modify Medtronic's CD HORIZON® Spinal System to add additional lined rods to the system, specifically, 4.75mm lined rods in cobaltchromium-molybdenum alloy.

Here's an analysis of the provided text regarding the CD HORIZON® Spinal System's acceptance criteria and studies:

Analysis of the Provided Text

The provided text (a 510(k) summary) describes an addition of "lined rods" to an existing spinal system. It does not describe a study involving an algorithm, AI, or human readers. Instead, it describes a submission for a traditional medical device (spinal implant components), where the acceptance criteria and supporting "study" are focused on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices through non-clinical testing.

Therefore, many of the requested categories (like AI performance, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone AI performance, etc.) are not applicable to this type of device submission and are not present in the document.

Acceptance Criteria and Device Performance (Based on "Substantial Equivalence")

Detailed Responses to Specific Questions:

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

   • See the table above. It is crucial to understand that for a 510(k) submission for a modification to a traditional medical device, "acceptance criteria" are not typically quantitative performance metrics like sensitivity/specificity. Instead, they are around proving "substantial equivalence" to a predicate device, which involves demonstrating that the new device is as safe and effective as the predicate without introducing new questions of safety or effectiveness. This is primarily done through non-clinical (bench) testing, material comparisons, and analysis of design changes.

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

   • N/A. This submission focuses on non-clinical (bench) testing of physical components. There is no "test set" of patient data in the context of an algorithm or diagnostic device. The evaluation is based on material properties, dimensional comparisons, and mechanical testing of the rods themselves. No patient data (country of origin, retrospective/prospective) is involved.

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, in the context of expert consensus, is not relevant for this type of device. The "truth" for this device modification is established through engineering and material science principles, comparing the new component to existing, cleared components.

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

   • N/A. Adjudication methods are typically associated with human reviewer disagreements in diagnostic or AI studies. This is a submission for physical device components based on non-clinical testing.

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

   • N/A. This is a physical spinal implant, not an AI or diagnostic tool. MRMC studies are not relevant here.

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

   • N/A. This device has no algorithm. It is a physical implant.

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

   • For the device itself: The "ground truth" or standard for safety and effectiveness is established by the performance and safety profile of the legally marketed predicate devices (CD HORIZON® Spinal System K131321, K091974, K042025). The non-clinical tests demonstrate that the modified device performs equivalently to these predicates in terms of mechanical properties and material composition. There is no "ground truth" in the diagnostic sense (e.g., pathology report).

8. The sample size for the training set:

   • N/A. This is not an AI or machine learning device and therefore has no training set.

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

   • N/A. As there is no training set, this question is not applicable.

In summary: The provided document is a 510(k) summary for a minor modification (adding lined rods) to an existing spinal implant system. The "study" involves non-clinical (bench) testing and analysis to demonstrate that the new component is substantially equivalent to previously cleared components, without introducing new safety or effectiveness concerns. It does not pertain to AI, algorithms, or studies involving patient data or human readers in the way these questions are posed.

Ask a specific question about this device

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; pseudarthritis; 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 CD HORIZON SPIRE™ Plate is a posterior, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (as previously defined); spondylolisthesis, trauma; and/or tumor.

In order to achieve additional levels of fixation as an adjunct to fusion, 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.

Certain implant components from other Medtronic spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washer, 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 03.5mm, 04.5mm, 05.5mm rods or 06.35mm rods, while other components can connect to both Ø5.5mm rods and Ø6.35mm rods. 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, 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.

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 provided document is a 510(k) summary for the
CD HORIZON® Spinal System. This type of regulatory submission is for a medical device and is not a study that proves a device meets acceptance criteria in the typical sense of a clinical trial or algorithm performance study.

Instead, the document focuses on demonstrating substantial equivalence to previously approved predicate devices, which is the primary requirement for 510(k) clearance. Substantial equivalence means the new device is as safe and effective as a legally marketed device (predicate device).

Therefore, the requested information categories related to acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training sets are not directly applicable to this type of document because it is not a clinical study or an AI/algorithm performance study.

However, I can extract information related to the demonstration of substantial equivalence, which serves a similar purpose in the regulatory context of this device.

Here's a breakdown of the available information in the context of your request:

I. Acceptance Criteria and Device Performance

The "acceptance criteria" in this context are not quantitative performance metrics as in a clinical trial. Instead, the acceptance criterion for a 510(k) submission is to demonstrate substantial equivalence to predicate devices. This is achieved by showing that the new device has "similar technological characteristics" and is "as safe and effective" as the predicate.

The "reported device performance" is not given as numerical results from a clinical study, but rather implied through mechanical testing and risk analysis compared to predicate devices.

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

• Test Set Sample Size: Not applicable. This document refers to mechanical testing and risk analysis, not a clinical "test set" of patients or data in the way an AI algorithm study would. The focus is on the new components themselves.
• Data Provenance: The document does not specify country of origin for the mechanical test data. It is a regulatory submission to the US FDA. The "study" is a collection of engineering tests and a risk analysis, not a clinical data study. It is retrospective in the sense that it evaluates new components against established predicate devices and materials.

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

• Number of Experts: Not applicable. This is not a study requiring expert clinical review to establish ground truth. Substantial equivalence is determined by regulatory bodies (FDA) based on submitted engineering data and comparison to predicates.
• Qualifications of Experts: N/A.

IV. Adjudication method for the test set

• Adjudication Method: Not applicable. No clinical test set or subjective interpretations requiring adjudication are mentioned.

V. 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: Not applicable. This is a spinal implant system, not an AI diagnostic tool.

VI. 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.

VII. The type of ground truth used

• Ground Truth Type: Not applicable in the traditional sense of a clinical study. For a medical device 510(k), the "ground truth" for demonstrating safety and effectiveness relies on established engineering principles, material science, biomechanical testing standards, and the history of safe and effective use of the predicate devices.

VIII. The sample size for the training set

• Training Set Sample Size: Not applicable. No training set is relevant for this type of device submission.

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

• Ground Truth Establishment for Training Set: Not applicable.

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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint: (2) who are receiving fusions using autogenous bonc 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 a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: { }) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion,

When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthritis; and/or failed previous fusion.

For anterior use only the TSRH® System has the additional indication of: spondylolysis.

The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, staples, plates, 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.

Certain implant components from other Medtronic spinal systems can be used with the TSRH® Spinal System. These components include GDLH® rods, rod/bolt connectors, Variable Angle Tbolts, set screws and locking screws; DYNALOK® PLUS bolts, CD HORIZON® Low Profile MULTI-SPAN® CROSSLINK® Plates, VANTAGE™ Anterior Fixation System screws, as well as CD HORIZON® rods, screws, set screws and locking screws.

The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D® and TSRH-3DX™ connectors, and TSRH-3D® and TSRH-3DX™ screws are intended for posterior use only. All CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well.

The TSRH® Spinal System components are fabricated from stainless steel. Alternatively, they may be fabricated from medical grade titanium alloy or medical grade titanium. Never use stainless steel and titanium implant components in the same construct. The TSRH® Spinal System may be sold sterile or non-sterile.

The purpose of this submission is to add TSRH® Anterior L-Plates to the TSRH® Spinal System. Indications for the TSRH® Spinal System will be updated in this submission.

This document describes the TSRH® Spinal System, specifically focusing on the addition of TSRH® Anterior L-Plates. It is a 510(k) summary, which means it describes how the new components are substantially equivalent to previously cleared devices rather than providing a study for novel acceptance criteria.

Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance, as typically found in clinical validation studies for AI/software devices, is not applicable to this submission.

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to predicate devices. This is achieved through engineering and preclinical testing to ensure the new components meet established performance standards for medical implants in terms of "Indications for Use" and "Technological Characteristics," typically through mechanical testing.

Here's how the document addresses the concept of "acceptance criteria" and "proof" in the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a spinal implant system component, the "acceptance criteria" are not reported as specific performance metrics and thresholds like sensitivity, specificity, or AUC, as would be the case for an AI/software device. Instead, the acceptance criteria are based on demonstrating that the TSRH® Anterior L-Plate and VANTAGE™ Screws are substantially equivalent to existing, legally marketed predicate devices.

The document states:
"Documentation, including mechanical test results, provided has demonstrated that the TSRH® Anterior L-Plate and VANTAGE™ Screws are substantially equivalent to similar previously cleared devices such as the TSRH® Spinal System (K072317 SE 9/18/07) and CD HORIZON® Spinal System (K042025 SE 8/25/04). The VANTAGE™ Screws were previously cleared in K023797 (SE 12/16/02)."

This implies that the acceptance criteria are met if the mechanical performance of the new components is comparable to the predicate devices. Specific quantitative values for these mechanical tests (e.g., fatigue strength, pull-out strength, bending stiffness) are not provided in this summary but would have been part of the full 510(k) submission.

The Study that Proves the Device Meets Acceptance Criteria

The "study" undertaken is a preclinical engineering study (mechanical testing) comparing the new components to predicate devices.

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

• Sample Size (Test Set): Not specified in this summary. For mechanical testing of implantable devices, the sample size would typically be determined by engineering standards (e.g., ASTM, ISO) to ensure statistical significance for the performance characteristics being evaluated.
• Data Provenance: The data would originate from laboratory bench testing conducted by Medtronic Sofamor Danek USA. It is prospective in the sense that the tests were specifically conducted for this submission, but it's not "clinical" prospective data. The "country of origin" would be the manufacturing/testing location, likely the USA.

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

• Number of Experts/Qualifications: This is not applicable. The "ground truth" for mechanical performance of a medical device implant is established through standardized engineering tests, not expert consensus on clinical data. The tests are designed and interpreted by qualified engineers.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Mechanical test results are objective measurements against predefined engineering standards or comparative data from predicate devices. There is no expert adjudication process in this context.

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 is a spinal implant, not an AI/software device.

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

• Standalone Performance: Not applicable. This is a spinal implant, not an AI/software device.

7. The type of ground truth used

• Type of Ground Truth: The ground truth for this device's performance is based on objective mechanical measurements obtained from laboratory testing (e.g., strength, fatigue, material properties), demonstrating compliance with relevant industry standards and comparability to predicate devices.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable. There is no "training set" in the context of a 510(k) submission for a mechanical implant. The design and manufacturing processes are informed by existing engineering knowledge, standards, and previous device experience.

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

• Ground Truth for Training Set: Not applicable. There is no "training set" or "ground truth" in the AI/ML sense for a mechanical implant. Device design and manufacturing follow established engineering principles and regulatory guidelines.

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When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment. (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (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 a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion.

For anterior use only the TSRH® Spinal System has the additional indications of: (1) spinal stenosis and/or, (2) spondylolysis.

The TSRH® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.

The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, 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.

Certain implant components from other Medtronic spinal systems can be used with the TSRH® Spinal System. These components include GDLH® rods, rods, rod/bolt cometions, Variable Angle T-Bolts, set screws and locking screws; DYNALOK® PLUS holts, CD HORIZON® Low Profile MULTI-SPAN® CROSSLINK® Plates, as well as CD® HORIZON rods, screws, setscrews and locking screws.

The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D® connectors and TSRH-3D® screws are intended for posterior use only. All CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Officet Plates may be used anteriorly as well.

The TSRH® Spinal System components are fabricated from stainless steel. Alternatively, they may be fabricated from medical grade titanium alloy or medical grade. tittanium. The TSRH® Spinal System may be sold sterile or non-sterile.

The purpose of this 510(k) submission is to add modified connectors and setscrews to the TSRH® Spinal System. Additionally, the package insert was modified to include references to the ability of certain CD HORIZON® Spinal System components to be used with the TSRH® Spinal System.

This document is a 510(k) summary for the TSRH® Spinal System, specifically an amendment to add modified connectors and setscrews. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study for performance against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and performance studies for a device that relies on AI or diagnostic capabilities is not present in this type of submission.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as performance metrics. The core "acceptance criteria" for a 510(k) submission are demonstration of substantial equivalence to predicate devices. This is achieved through analysis of materials, design principles, and intended use as compared to devices already on the market.
• Reported Device Performance: Not reported in terms of quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical test results compared against thresholds). The submission asserts that the modified components are substantially equivalent.

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

• Sample Size: Not applicable. This submission doesn't describe a 'test set' in the context of a performance study with human or image data. It pertains to a physical medical device.
• Data Provenance: Not applicable.

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

• Number of experts/Qualifications: Not applicable. There is no 'ground truth' established by experts in this type of submission. The evaluation is based on regulatory review of design, materials, and intended use.

4. Adjudication method

• Adjudication Method: Not applicable.

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

• MRMC Study/Effect Size: No. This device is a physical spinal implant system, not an AI-powered diagnostic tool.

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

• Standalone Performance: No. This is a physical medical device.

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

• Type of Ground Truth: Not applicable. For this device, the "truth" being established is that the modified components are safe and effective for their intended use and are substantially equivalent to existing predicate devices. This is assessed through engineering analysis and regulatory review, not by establishing 'ground truth' from clinical data in the traditional sense of a diagnostic device.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. There is no machine learning "training set" for this physical device.

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

• Ground Truth for Training Set: Not applicable.

Summary of available information from the document:

• Device Type: Spinal System (implants for fixation and stabilization of spinal segments).
• Regulatory Mechanism: 510(k) Premarket Notification, seeking to add modified connectors and setscrews to an existing system.
• Primary "Acceptance Criteria" implicitly met: Substantial Equivalence to legally marketed predicate devices.
• Predicate Devices cited: K030285, K011029, K050282, K982290, K041282, K020699, K022778, K022778, K042025, K052054, and K062807.
• Study Proving Acceptance: The document states: "Documentation, including a risk analysis, was provided which demonstrated the subject rods to be substantially equivalent to predicate TSRH® components previously cleared..." This documentation would typically include engineering analyses, material biocompatibility data, and potentially mechanical testing (though specific results for the modified components against defined thresholds are not in this summary). The "study" here is a regulatory comparison and risk analysis, not a clinical trial or performance study against specific, quantitative acceptance criteria for a diagnostic device.

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When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (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 a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion.

For anterior use only the TSRH® Spinal System has the additional indications of: (1) spinal stenosis and/or, (2) spondylolysis.

The purpose of this 510(k) submission is to add modified TSRH® components along with previously cleared ARROWHEAD® Spinal System, CD HORIZON® Spinal System and COLORADO II® Spinal System components to the existing TSRH® Spinal System.

The TSRH® Spinal System is intended to help provide immobilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.

The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, and connecting components. In addition, GDLH® rods, DYNALOK PLUS™ bolts, CD HORIZON® Low Profile MULTI-SPAN® CROSSLINK® Plates, GDLH® rod/bolt connectors, GDLH® Variable Angle T-Bolts, and GDLH® and CD HORIZON® set screws and locking screws may be used with the TSRH® Spinal System.

The TSRH® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D® connectors and TSRH-3D® screws are intended for posterior use only.

The TSRH® Spinal System components are fabricated from stainless steel. Alternatively, they may be fabricated from medical grade titanium alloy or medical grade titanium. The TSRH® Spinal System may be sold sterile or non-sterile.

This document pertains to the Medtronic Sofamor Danek TSRH® Spinal System and is a 510(k) summary for regulatory clearance, not a study evaluating device performance against acceptance criteria in the typical sense of a clinical or AI-based study. It focuses on demonstrating substantial equivalence to previously cleared devices through mechanical testing and comparison of indications for use.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this type of regulatory submission. However, I can extract the relevant information where possible and indicate when a category is not relevant or not provided in the document.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to predicate devices, which is largely met through mechanical testing and comparison of indications for use. The document refers to "mechanical test results" as the primary evidence. Specific quantitative acceptance criteria or detailed performance metrics are not given in this summary.

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

• Sample Size: Not specified in terms of the number of specific test articles or components. The document refers to "mechanical test results" in general.
• Data Provenance: The document does not specify the country of origin for the mechanical test data. Given it's a US FDA submission, it's typically assumed such testing is conducted in a compliant manner, often in the US or in accredited labs elsewhere. The testing is for pre-market notification, so it is, in effect, prospective for the purposes of this submission, though the testing itself would have been conducted prior to submission.

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

This concept is not applicable to a mechanical testing submission for substantial equivalence. "Ground truth" in this context refers to the defined engineering specifications, material properties, and mechanical load requirements that the device must meet, which are established by engineering standards and regulatory guidance for spinal implants.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically relevant for human interpretation tasks or clinical outcome assessments, not for mechanical testing of an engineering device.

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 medical device (spinal implant) submission, not an AI or imaging device submission that would involve multi-reader studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a spinal implant, not an algorithm.

7. The Type of Ground Truth Used

For mechanical testing, the "ground truth" implicitly refers to engineering specifications, material standards, and biomechanical performance metrics established for spinal instrumentation. These are often derived from industry standards (e.g., ASTM, ISO) and biomechanical literature for spinal stability and fixation.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of a mechanical device submission. This term applies to machine learning/AI models.

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

Not applicable (see point 8).

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