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The CYLOX® ST implants are interbody fusion devices intended for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies.

The cervical device is to be used in patients who have had at least six (6) weeks of non-operative treatment. The devices are to be used with autograft bone graft composed of cancellous, cortical, and / or corticocancellous bone and implanted via an anterior approach.

When used as a standalone system, CYLOX® ST is intended to be used as an adjunct to spinal fusion procedures at one level (C3-T1) and must be used with the CYLOX® ST bone screw fixation or connecting plate and must be secured with the corresponding locking screw.

When used with supplemental fixation, such as anterior cervical plates, CYLOX® ST is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C3-T1).

The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system. The system is comprised of interbodies, plates, and screws. The interbody device can be used as a standalone implant with screw holes for integrated fixation, or as a construct fixed with a plate and screws. The interbody implants are additively manufactured from titanium alloy (Ti-6Al-4 V ELI). The plates and screws are traditionally machined from titanium alloy (Ti-6Al-4V).

The SIGNUS CYLOX® ST Interbody System is placed in the C3 – T1 spinal region via the Cloward or Smith-Robinson approach. The interbody is available in four different footprints, with multiple heights and angulations. The standalone interbody contains a central holes angulated for fixation with screws into the cranial and caudal vertebral body. The construct interbody contains a central hole and indentation features to mate with the anterior plate.

The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The provided text is a 510(k) summary for a medical device (CYLOX® ST) and does not contain information about an AI/ML powered device, nor does it include a study proving a device meets acceptance criteria related to AI/ML performance.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because these elements are specific to the evaluation of AI/ML devices, which is not the subject of this document.

The document describes the non-clinical performance testing conducted for the CYLOX® ST intervertebral body fusion device to demonstrate substantial equivalence to a predicate device. This testing focused on mechanical properties and structural integrity according to ASTM standards.

Here's the relevant information that could be extracted and how it relates to the request (even though it's not AI/ML related):

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

Notes on the above table: The text states, "Substantial equivalence was supported by the results of verification testing to confirm that features, geometry and performance of the subject device performs as well as the predicate system, including: [list of tests]." This implies that the acceptance criteria were the successful completion and meeting of the requirements stipulated by each listed ASTM standard. The reported performance is that the device met these standards, thus demonstrating "substantial equivalence."

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

• Sample Size: Not specified in the provided text. The ASTM standards would define the required sample sizes for each test.
• Data Provenance: Not applicable. These are non-clinical (mechanical) tests, not clinical data or patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable as this is not an AI/ML study involving expert ground truth.

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

• Not applicable as this is not an AI/ML study involving human adjudication.

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. This is a non-clinical evaluation of an interbody fusion device, not an AI/ML diagnostic or assistive tool.

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

• Not applicable. This device is not an algorithm.

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

• Not applicable. Ground truth for these non-clinical tests would be the physical measurements and observations of the device's behavior under controlled testing conditions, compared against the specified parameters of the ASTM standards.

8. The sample size for the training set:

• Not applicable. There is no training set mentioned as this is not an AI/ML device.

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

• Not applicable.

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When used as an intervertebral fusion device, the TETRIS™ ST devices are intended for use at one level in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. The devices are intended for use with a supplemental internal fixation system and with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6AI-4V). Each device is available in a single footprint, with multiple heights and angulations.

The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 - S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Here's an analysis based on the provided document, addressing the acceptance criteria and study information.

This document describes a 510(k) submission for an intervertebral body fusion device (Signus Tetris™ ST / Tetris™ R ST). For such devices, clinical studies and AI/human reader performance studies are generally not required for clearance, especially when the submission focuses on manufacturing process changes for a previously cleared product. The emphasis is on non-clinical (mechanical) testing to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested points, particularly those related to clinical studies, AI performance, and human reader studies, will be answered as "not applicable" or "no clinical testing was performed" based on the provided text.

Acceptance Criteria and Device Performance

For this specific device (intervertebral body fusion device), the "acceptance criteria" are primarily related to mechanical performance demonstrating equivalency to a predicate device, rather than diagnostic accuracy or AI performance.

Study Information

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

   • Test Set (for clinical or AI performance): Not applicable. Clinical testing was not performed to support this 510(k) submission. Mechanical testing involves samples of the device itself (e.g., a certain number of implants) to perform the specified ASTM tests, but the document does not specify the exact number of physical samples used for mechanical testing.
   • Data Provenance: Not applicable for clinical data. The mechanical testing would have been conducted by the manufacturer (SIGNUS Medizintechnik GmbH) or their designated testing facility.

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

   • Not applicable. No clinical test set requiring expert ground truth was used for this 510(k) submission.

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

   • Not applicable. No clinical test set requiring adjudication was used.

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

   • Not applicable. This device is an implantable medical device, not an AI diagnostic or assistance tool. No MRMC comparative effectiveness study was performed.

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

   • Not applicable. This device is an implantable medical device, not an algorithm.

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

   • Not applicable for clinical ground truth. For mechanical testing, the "ground truth" is adherence to established industry standards (ASTM standards) and comparison of performance metrics (e.g., stiffness, displacement) against the predicate device.

7. The sample size for the training set:

   • Not applicable. There is no AI component that requires a training set.

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

   • Not applicable. There is no AI component or training set.

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The COSY Cervicothoracic Occipital Rod-Screw System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7), and the thoracic spine from T1-T3: traumatic spinal fraumatic dislocations; instabilities or deformity; failed previous fe.g., pseudoarthrosis); tumors involving the cervical spine; degenerative disease, including intractable radioulopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The COSY cervicothoracic occipital rod-screw system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage turnors involving the cervical spine in whom life expectancy is of limited duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the COSY Cervicothoracic Occipital Rod-Screw System may be connected to the components of the DIPLOMAT System or MONOPOLY System using the rod-to-rod connectors or transition rods.

The COSY Cervicothoracic Occipital Rod-Screw is a multiple component, posterior spinal fixations system which consists of solid screws, cannulated screws, standard tulips, angulated tulips, curved rods, straight rods, hybrid rods, parallel connectors, inline connectors, occipital plates, occipital bone screws, hooks, and offset connectors. All implants, except of variations of the rods, are available in Ti-6AL-4V ELI per ASTM F136. Rods are available in Ti-6AL-4V ELI per ASTM F136 or Co-Cr28-Mo6 per ASTM F1537. The pedicle screws consist of a tulip and a pedicle screw shaft. The shaft has a prominent thread, to provide anchorage of the screw in the pedicle section of the vertebrae. Each tulip is securely attached to the rod via a set screw. The shafts of the pedicle screws are provided in different lengths, diameters, fully or partially threaded, and with a symmetric anqulation to provided adaptability to the patient's anatomy. The rods can be shortened on site by the surgeon. The occipital plate is available with four or five holes and areas to be bent for better fixation to the occipital part of the skull. The plate is fixed via bone screws and as two gliding tulips to provided anchoring of the rod. The gliding tulips are constructed similar to the tulips of the pedicle screws in the area of the rod- set screw -tulip intersection.

It seems there's a misunderstanding. The provided document is an FDA 510(k) clearance letter for a medical device called the "COSY Cervicothoracic Occipital Rod-Screw System." This document is related to spinal implants, not a diagnostic AI device.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/Machine Learning device (which would involve test sets, expert consensus, ground truth, etc.) is not applicable to this document.

The document describes mechanical testing performed to demonstrate the safety and effectiveness of the spinal implant system, compared to a predicate device. It addresses:

• Indications for Use: What the device is designed to treat.
• Device Description: What the components are made of and how they function.
• Comparison to Predicate Device: How it's similar to and different from devices already on the market.
• Mechanical Testing: Listing of ASTM standards used for dynamic and static testing related to compression, bending, and torsion.

There is no information within this document that aligns with the questions asked about AI/ML device validation.

If you have a document related to an AI/ML diagnostic or prognostic device, please provide that document, and I will do my best to answer your questions based on its content.

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The SIGNUS SACRONAIL® Transsacral Stabilization System is intended for fixation of fractures of the posterior pelvis, in areas of superior posterior inferior inferior iliac spine, for sacral fractures and fracture-dislocations of the sacro-iliac joint.

The SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractures and sacral fractures through its intraosseous location and its direct, bi-iliac symmetric anchorage. The implant consists of a nail of various lengths from 135mm to 194mm with a constant diameter of 8mm and 2 locking screws in different lengths. This variation ensures adaptation to the respective anatomy of the patient. The intersections of the screw axes to the implant axis have a distance of 15mm to the respective end face of the nail. This ensures a solid support on the lateral cortex of the Ilia. The angle of the screw axes to the implant axis corresponds to the anatomical conditions and is 70°. The locking screw ensures a stable connection of the components. The tips of the locking screws are rounded to facilitate insertion into the nail while the dorsal ends of locking screws are a hexagon. The caps serve to close the instrument connection of the nail. The implants are made from the Titanium alloy (Ti6Al4V) according to ASTM F 136 / ISO 5832-3, with a Type II anodization according to AMS 2488. There are Instruments which are specific to the implantation of the SACRONAIL device. These include, but are not limited to, the Guide Frame, the Guide Bracket, the Fixation Bracket, various Instrument Guides, various dilators and drills, screwdrivers as well as the specific tools for revision of the device.

This FDA 510(k) submission for the SIGNUS SACRONAIL® Transsacral Stabilization System does not contain information about acceptance criteria or a study proving the device meets those criteria in a traditional sense of clinical performance or diagnostic accuracy.

Instead, this submission is for a medical device (an implantable hardware system) where the primary focus for substantial equivalence is on mechanical performance, biocompatibility, and intended use comparison to predicate devices.

Therefore, I cannot populate most of the requested fields as they pertain to studies typically performed for diagnostic devices or AI algorithms.

Here's a breakdown of what can be extracted from the provided text, and where gaps exist based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (spinal implant), "acceptance criteria" are generally related to demonstrating mechanical equivalence to predicate devices and biocompatibility, rather than a clinical performance metric like sensitivity or specificity.

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

• Sample Size: Not applicable in the context of clinical performance or AI algorithm testing. Mechanical testing would involve specific numbers of test articles, but these are not analogous to a "test set" of patient data.
• Data Provenance: Not applicable for clinical/AI test sets. For mechanical testing, the articles are new devices and the comparative data would come from published standards or predicate device testing.

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

• Not applicable. This device's evaluation relies on mechanical and biocompatibility testing, not clinical "ground truth" derived from expert review of patient data.

4. Adjudication Method for the Test Set

• Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This is a hardware device, not a diagnostic or AI-assisted system for interpretation.

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

• Not applicable. This is not an algorithm.

7. The Type of Ground Truth Used

• For mechanical testing: Engineering standards (e.g., ASTM F1264-16, ASTM F1717-15, ASTM F543) serve as the "ground truth" or benchmark for performance.
• For biocompatibility: ISO 10993 standards and established literature on medical-grade titanium alloy.

8. The Sample Size for the Training Set

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

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

• Not applicable.

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The DIPLOMAT® Spinal System, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:

• Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis
• Spinal stenosis
• Fracture
• Dislocation
• Scoliosis
• Kyphosis
• Spinal tumor
• Pseudoarthrosis
• Failed previous fusion

In addition, the DIPLOMAT® Spinal System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

The DIPLOMAT® Spinal System is intended to be used with autograft and/or allograft.

The DIPLOMAT® Spinal System is a multiple component posterior spinal fixation system which consists of pedicle screws, rods, and connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are manufactured from Ti-6AL-4V ELI per ASTM F136 and cobalt chrome per ASTM F75. The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use with poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye

This document is a 510(k) Premarket Notification for the DIPLOMAT® Spinal System, a medical device for spinal fixation. It describes the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of human patient data or a clinical study. The performance evaluation is based on non-clinical mechanical testing. Therefore, information regarding human sample size and data provenance (country of origin, retrospective/prospective) is not applicable or provided.

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

This information is not applicable. The study is a non-clinical mechanical testing study, not a study involving expert assessment of patient data.

4. Adjudication Method

This information is not applicable for a non-clinical mechanical testing study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes mechanical testing of a spinal implant, not a study evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. This document focuses on the mechanical performance of a physical medical device, not an algorithm or AI.

7. Type of Ground Truth Used

The "ground truth" for this study is established by engineering standards and specifications as defined in the ASTM F1717-14 test methodology. The performance of the DIPLOMAT® Spinal System is compared against the expected mechanical properties for devices of its type and against predicate devices.

8. Sample Size for the Training Set

This information is not applicable. There is no concept of a "training set" in a non-clinical mechanical testing study.

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

This information is not applicable, as there is no training set mentioned in the context of this non-clinical mechanical testing.

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The MOBIS®II ST Spinal Implant is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). MOBIS®II ST Spinal Implants are to be used with autogenous bone graft and implanted via an open posterior or transforaminal approach. The MOBIS®II ST Spinal Implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The MOBIS®II ST Spinal implants have a hollow, slightly curved frame with areas of an open-pore titanium grid structure. Restoration of the intervertebral space can be achieved by the large selection of implants that, at the same time, offers a high degree of intraoperative flexibility. In addition to straight implants, the MOBIS®II ST cage is also available with a 5° lordotic angle. Due to its design, the implant can be aligned with the anterior curvature of the intervertebral body and so is suited for unilateral, dorsal access (TLIF) in the L2 to S1 region of the spine.

This document is a 510(k) summary for the MOBIS®II ST Spinal Implant. It does not describe a study involving an AI/ML powered device, but rather a medical device (spinal implant). As such, many of the requested categories in the prompt are not applicable.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not directly applicable in the terms of typical AI system performance metrics (e.g., sensitivity, specificity, AUC). For this medical device, acceptance criteria are based on mechanical safety and performance, demonstrating equivalency to predicate devices.

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

Not applicable as this is a mechanical engineering study, not a study involving a "test set" of data in the AI/ML sense. The "sample size" would refer to the number of devices tested, which is not specified but would typically follow ASTM standards for such tests.

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

Not applicable. "Ground truth" in this context refers to the physical properties and performance measured by standardized tests, not expert interpretation of data.

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

Not applicable. Mechanical tests have objective outputs based on engineering principles and standards, not adjudication among human observers.

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

Not applicable. This is not an AI-powered device, and no human reader study was conducted.

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

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

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

Not applicable. The "ground truth" for mechanical testing is established by the specified ASTM (American Society for Testing and Materials) standards and the physical measurements obtained during the tests.

8. The sample size for the training set

Not applicable. There is no training set for a physical medical device.

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

Not applicable. There is no training set.

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When used as a vertebral body replacement, the TASMIN® R devices are indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumaffracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation.

When used as an intervertebral fusion device, the TASMIN® R devices are intended for use at one level in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. The devices are intended for use with a supplemental internal fixation system and with autograft to facilitate fusion.

The basic shape of the TASMIN® R devices is a hollow structural frame having a rounded, tapered leading face. The upper and lower aspects of the implant are open with peaked teeth that assist in anchoring and seating the implant between the vertebral bodies. There are lateral fenestrations for bony in-growth. The device is available in a variety of sizes and angulations thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.

The TASMIN® R device is a spinal intervertebral body fixation orthosis and intervertebral body fusion device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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: The documentation refers to "worst case TETRIS™ and TASMIN® R devices" for finite element analysis and "worst case TASMIN® R devices" for physical testing. It does not specify the exact number of devices or scenarios considered. It is implied that representative "worst-case" configurations were selected for the evaluation.
• Data Provenance: The studies are described as "Finite element analysis simulations" and "Static and dynamic compression testing." This indicates the data was generated from engineering analyses and laboratory bench testing performed by the sponsor, SIGNUS Medizintechnik GmbH. The country of origin of the data is not explicitly stated, but the sponsor is based in Germany. The data is prospective in the sense that it was generated specifically for the premarket submission.

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

This information is not applicable as the studies performed were bench testing and finite element analysis, not clinical studies requiring expert consensus on patient data. The "ground truth" for these types of studies is established by adherence to recognized ASTM standards and engineering principles.

4. Adjudication Method for the Test Set

This information is not applicable for bench testing and finite element analysis. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of imaging or clinical 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

An MRMC comparative effectiveness study was not conducted. The device is a medical implant, not an AI-assisted diagnostic or therapeutic tool.

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

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

7. The Type of Ground Truth Used

The ground truth used for these studies was derived from:

• Recognized Industry Standards: ASTM F2077 (for compression, torsion, compression-shear) and ASTM F2267 (for subsidence properties). These standards define the methodology and expected performance for intervertebral body fusion devices.
• Engineering Principles: Finite element analysis relies on established biomechanical and engineering principles to simulate mechanical behavior.
• Material Specifications: ASTM F2026 for PEEK-OPTIMA® LT1 and ASTM F560 for Tantalum, defining the accepted properties of the materials.

8. The Sample Size for the Training Set

This information is not applicable. The studies performed were bench testing and simulations, not machine learning studies that require a training set.

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

This information is not applicable as there was no training set for a machine learning algorithm. The "ground truth" for the device's performance was established by adherence to ASTM standards and engineering principles as described in point 7.

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When used as an intervertebral fusion device, the MOBIS® II devices are intended for use at one or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. Patients with previous nonfusion spinal surgery at the involved level may be treated with the device. The devices are intended for use with a supplemental internal fixation system and with autograft to facilitate fusion.

The basic shape of the MOBIS® II devices is a hollow structural frame having a rounded, tapered leading face. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is available in a variety of sizes and two angulations thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, focusing on what's available and noting what's not explicitly stated:

Based on the provided 510(k) summary for the MOBIS® II intervertebral fusion device, the acceptance criteria and study details are primarily focused on mechanical performance testing to demonstrate substantial equivalence to predicate devices, rather than clinical efficacy or AI performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for MOBIS® II (Implicit from substantial equivalence claim):
The device's mechanical performance, specifically for static and dynamic compression and subsidence properties, must be equivalent to or better than previously cleared predicate devices (MOBIS®, PEEK TETRIS™, and Python) when tested according to relevant ASTM standards.

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

• Sample Size: Not explicitly stated for each mechanical test. The text mentions "worst case MOBIS® II" was tested, implying a representative sample but not a specific number of units tested.
• Data Provenance: The study was conducted by the device manufacturer, SIGNUS Medizintechnik GmbH, based in Alzenau, Germany. The testing was likely performed in a lab setting, not using patient data.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable: This device is an intervertebral fusion device, not an AI or diagnostic imaging device. The "ground truth" for its performance is established through objective mechanical testing against engineering standards. Experts were not involved in establishing a "ground truth" in the way they would be for evaluating diagnostic accuracy or clinical outcomes.

4. Adjudication Method

• Not Applicable: As this is a mechanical performance study, there's no "adjudication method" in the context of human expert review of cases. The results are quantitative measurements against predefined standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No: This is not an MRMC study. MRMC studies are typically performed for diagnostic imaging devices to assess how AI assistance impacts human reader performance.

6. Standalone (Algorithm Only) Performance Study

• No: This device is a physical implant, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant. The performance study focused on the mechanical integrity of the implant itself.

7. Type of Ground Truth Used

• Mechanical Engineering Standards: The "ground truth" for the device's performance is objective mechanical measurements validated against established ASTM standards (ASTM F2077 for static and dynamic compression; ASTM F2267 for subsidence properties). The performance is then compared to accepted limits or to the performance of predicate devices that have already met regulatory requirements.

8. Sample Size for the Training Set

• Not Applicable: There is no "training set" as this is a physical medical device undergoing mechanical validation, not a machine learning model.

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

• Not Applicable: (See point 8).

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When used as a vertebral body replacement, the TETRIS™ II devices are indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation.

When used as an intervertebral fusion device, the TETRIS™ II devices are intended for use at one level in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. The devices are intended for use with a supplemental internal fixation system and with autograft to facilitate fusion.

The basic shape of the TETRIS™ II devices is a hollow structural frame having a rounded, tapered leading face. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is available in a variety of sizes and angulations thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.

The information provided in the document describes the TETRIS™ II devices, which are spinal vertebral body replacement and intervertebral fusion devices. The FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in a clinical setting.

Instead, the performance data provided is related to bench testing and finite element analysis (FEA), which compares the new device to its predicates.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance for TETRIS™ II Devices

The primary acceptance criteria for the TETRIS™ II devices in this submission hinge on demonstrating that their technological characteristics and mechanical performance are equivalent to predicate devices, ensuring they are "as safe and as effective."

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 notification does not detail a clinical test set with human or animal subjects. The "test set" in this context refers to the simulated models used in the finite element analysis. The specific number of models or simulations is not provided, but it states "Finite element analysis simulations of the worst case TETRIS™ and TETRIS™ II devices were compared."
• Data Provenance: The data provenance is from finite element analysis (FEA) simulations, which are computational models. It is not clinical data, and thus concepts like "country of origin" or "retrospective/prospective" don't apply in the traditional sense.

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

• Number of Experts: Not applicable. The "ground truth" for the FEA simulations is based on engineering principles, material properties (ASTM F136 for Ti-6Al-4V, ASTM F2026 for PEEK-OPTIMA® LT1, ASTM F560 for Tantalum), and the defined ASTM F2077 standards for mechanical testing of spinal implants. There's no indication of human experts establishing a ground truth in a diagnostic or clinical sense for these engineering simulations.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As this involves engineering simulations and comparison to established ASTM standards, a human adjudication method (like 2+1, 3+1 consensus) is not relevant. The outcome is determined by adherence to engineering analysis principles and the resulting numerical data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission relies on engineering bench testing and FEA, not human reader studies of clinical cases.

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

• Standalone Performance: Not applicable in the context of an algorithm or AI. The "performance" assessment refers to the mechanical integrity and equivalence of the physical device design via FEA.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth is based on established engineering standards and material properties. Specifically, the mechanical performance is evaluated against the requirements set forth in ASTM F2077 (Standard Test Methods for Static, Dynamic, and Torsional Axial Compression, Distraction, and Shear Testing of Spinal Arthrodesis Implants) and the material specifications of ASTM F136, ASTM F2026, and ASTM F560. The "ground truth" is that the device, when subjected to these simulated load conditions, performs comparably to the predicate devices and does not create a new "worst case."

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This submission does not involve machine learning or AI, so there is no "training set." The FEA models are built based on geometries and material properties, not trained on data.

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

• Ground Truth for Training Set: Not applicable, as there is no training set.

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When used as a vertebral body replacement, the MOBIS®, SEMIAL®, and PEEK and Titanium TETRIS™ devices are indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation.

When used as a vertebral body replacement, the KIMBA® and KIMBA® mini devices are indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The devices are intended for use as a vertebral body replacement in the lumbar spine (from L1 to L5) and are intended for use with supplemental internal fixation.

When used as an intervertebral fusion device in skeletally mature patients, the KIMBA® KIMBA® mini, MOBIS®, NOVAL®, SEMIAL®, and PEEK and Titanium TETRIS™ devices are intended for use at one level in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the involved level may be treated with the device. The devices are intended for use with a supplemental internal fixation system and with autograft to facilitate fusion.

The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL®, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™ devices is a hollow structural frame. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.

Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested structure:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes mechanical testing of the "worst-case device (PEEK TETRIS™)". It does not refer to a "test set" in the context of patient data or clinical performance. Therefore, information about a sample size for a test set or data provenance (country of origin, retrospective/prospective) is not applicable here as the study is a benchtop mechanical performance evaluation.

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

This information is not applicable as the study is a mechanical performance evaluation against established ASTM standards, not a clinical study requiring expert ground truth for patient data.

4. Adjudication Method for the Test Set

This information is not applicable as the study is a mechanical performance evaluation, not a clinical study requiring adjudication.

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. The device is an implantable spinal interbody fusion device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the mechanical performance study was established by recognized industry standards (ASTM F2077 and ASTM F2267) and the performance of legally marketed predicate devices. The acceptance criteria were met if the tested device performed "as well as or better than the predicate devices" according to these standards.

8. The Sample Size for the Training Set

This information is not applicable. This is a mechanical performance study, not a machine learning study requiring a training set.

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

This information is not applicable for the same reason as above (not a machine learning study).

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