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The Genesys Spine AIS-C Cervical Anchored Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one-disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The system is designed for use with supplemental fixation (i.e. cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.

The Genesys Spine AIS-C Cervical Anchored Interbody System includes PEEK interbodies and titanium interbodies, which utilize an integrated titanium alloy locking mechanism. Both PEEK interbodies and titanium interbodies are to be anchored to patient anatomy via two (2) titanium allov bone anchors. The Cervical Anchored Interbody System (AIS-C) was designed to provide additional biomechanical strength to traditional ACDF procedures through integrated fixation combined with supplemental fixation.

The provided text describes a 510(k) premarket notification for a medical device, the Genesys Spine AIS-C Cervical Anchored Interbody System. This document focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical (mechanical) testing. It does not contain information about a study involving human-in-the-loop performance, AI assistance, or the establishment of ground truth by medical experts for a diagnostic or AI-powered device. Therefore, many of the requested items (e.g., sample size for test/training sets, expert qualifications, MRMC studies, standalone AI performance) are not applicable or cannot be extracted from this document.

However, I can extract information related to the acceptance criteria and the (mechanical) study that proves the device meets those criteria.

Here's a breakdown of the available information:

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

The acceptance criterion for the mechanical tests was set as follows:

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 explicitly stated as a numerical sample size. The document mentions "all possible configurations of the AIS-C System constructs were analyzed in order to determine the worst case to be used for testing." This implies a selection of specific configurations for mechanical testing rather than a statistical sample size in the context of human data.
• Data Provenance: The data is from non-clinical mechanical testing, not human or patient data. Therefore, country of origin or retrospective/prospective classification is not applicable in the typical sense. The testing was conducted to U.S. standards (ASTM).

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 describes mechanical testing of a medical implant, not a diagnostic device or AI system that requires expert-established ground truth from medical images or patient data. The "ground truth" here is the physical performance against established industry standards and predicate device performance.

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

• Not Applicable. Pertains to human review of data, not mechanical 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:

• No. This was not an MRMC study and did not involve human readers or AI assistance.

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

• No. This device is a physical implant, not an algorithm.

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

• The "ground truth" for this device's performance is objective mechanical testing per established ASTM standards (F2077-11 for static and dynamic axial compression, compressive-shear, and torsion; F2267-04 for static subsidence; and ASTM draft standard F-04.25.02.02 for expulsion testing). The "truth" is whether the device meets or exceeds the mechanical performance of predicate devices.

8. The sample size for the training set:

• Not Applicable. This is not an AI or machine learning device.

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

• Not Applicable. This is not an AI or machine learning device.

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The Genesys Spine Apache® Anterior Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The intent of this Special 510(k) is to add new components to the currently cleared Genesys Spine Apache® Interbody Fusion System (K103034 and K153123). This submission will offer various device configurations based on surgical approach and patient anatomy, and consist of a Genesys Spine lumbar interbody fusion device, which may be implanted as a single device via an Anterior or Anterolateral approach.

The Genesys Spine Apache® Anterior Lumbar Interbody Fusion System is comprised of various device configurations designed to accommodate patient anatomy and provide the surgeon with different surgical approach options.

The Genesys Spine Apache® Anterior Lumbar Interbody Fusion System implant components are made of polyetheretherketone (Invibio PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device. The additional implant offering being proposed has similar technological characteristics and identical indications as the currently cleared product line.

This document is a 510(k) premarket notification for the Genesys Spine Apache® Anterior Lumbar Interbody Fusion System. It states that the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your questions, noting that this is a medical device with mechanical testing, not an AI/Software as a Medical Device (SaMD), so many of your requested items pertaining to AI model validation (like sample size of test sets, ground truth establishment, MRMC studies, training set details) are not applicable to this document.

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

The document does not explicitly state "acceptance criteria" in a numerical or categorical format for performance, as would be expected for a diagnostic device. Instead, the performance is demonstrated through biomechanical testing to show substantial equivalence to predicate devices.

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

• Test Set Sample Size: Not explicitly stated in terms of a "sample size" of patients or cases. The testing refers to mechanical tests (Static Push-out Test and Finite Element Analysis) which are typically performed on a set of physical devices or computational models, not patient data.
• Data Provenance: Not applicable in the context of patient data. The testing is non-clinical, focusing on the mechanical properties of the device itself.

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 is not applicable to this type of device submission. Ground truth and expert consensus are relevant for diagnostic devices that interpret patient data. For a spinal implant, the "ground truth" is typically defined by engineering standards, material specifications, and biomechanical principles, which are evaluated by engineers and materials scientists.

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

• This is not applicable to this type of device submission. Adjudication methods are used for resolving discrepancies in expert interpretations, primarily for diagnostic devices.

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

• This is not applicable. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic tools and the impact on human reader performance. This document concerns a physical spinal implant.

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

• This is not applicable. This question refers to the standalone performance of an AI algorithm. The Genesys Spine Apache® Anterior Lumbar Interbody Fusion System is a physical medical device, not an AI algorithm.

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

• The "ground truth" (or basis for evaluation) for this device is its adherence to established engineering standards (e.g., ASTM F2026 for materials, ASTM Draft Standard F-04.25.02.02 for push-out testing), and its demonstrated mechanical equivalence to predicate devices through non-clinical testing (Static Push-out Test and Finite Element Analysis).

8. The sample size for the training set

• This is not applicable. Training sets are used for machine learning models. This is a physical interbody fusion system.

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

• This is not applicable. As above, training sets and their ground truth are concepts for machine learning, not for physical medical device submissions like this one.

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The Genesys Spine Apache™ Lateral Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The intent of this Special 510(k) is to add new components to the currently cleared Genesys Spine Apache® Lateral Lumbar Interbody Fusion System (K130913). This submission will offer various device configurations based on surgical approach and patient anatomy, and consist of a Genesys Spine Lumbar Interbody Fusion Device, which may be implanted as a single device via a lateral approach.

The Genesys Spine Apache® Lateral Lumbar Interbody Fusion System is comprised of various device configurations designed to accommodate patient anatomy and provide the surgeon with different surgical approach options.

The Genesys Spine Apache® Lateral Lumbar Interbody Fusion System implant components are made of polyetheretherketone (Invibio PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device. The additional implant offering being proposed has similar technological characteristics and identical indications as the currently cleared product line.

This document describes a medical device submission (K161404) for the "Genesys Spine Apache® Lateral Lumbar Interbody Fusion System," which is a Spinal Intervertebral Body Fusion Device.

The provided text does not contain information about a study proving the device meets acceptance criteria related to an AI/ML-driven medical device. Instead, it is a 510(k) summary for a physical medical implant. The performance data presented focuses on mechanical and engineering analyses (cross-sectional area analysis, Finite Element Analysis (FEA), and projected area calculations) to demonstrate substantial equivalence to existing predicate devices, rather than clinical performance or user studies for a diagnostic or AI-assisted system.

Therefore, I cannot provide the requested information about acceptance criteria, human reader studies, or ground truth establishment relevant to an AI/ML device. The document explicitly states that "The overall technology characteristics and mechanical performance data lead to the conclusion that Genesys Spine Apache® Lateral Lumbar Interbody Fusion System is substantially equivalent to [predicate devices]."

To answer your prompt with the information provided, I would have to state that the document does not contain the type of study and data you are asking for.

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The nvª, nvº, and nv are intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device systems must be used with supplemental fixation and autograft to facilitate fusion and are implanted via an anterior, posterior, or transforaminal approach.

The nv4, nv9, and nvb are intervertebral body fusion devices used in the lumbar spine following discectomy. All devices are manufactured from PEEK Optima® LT1 per ASTM F2026 and include tantalum markers per ASTM F560 for radiographic visualization.

The nv4 and nv2 devices have multiple footprints to adapt to the general shape of the vertebral endplates. The nv , nv , and nv are available in multiple heights to accommodate patient variability and have a hollow centre to accommodate bone graft. The devices are implanted via a variety of surgical approaches which include anterior, and transforaminal. There are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability, and prevent back out and migration.

This document is a 510(k) summary for medical devices (nvª, nvP, and nv*) from Nvision Biomedical Technologies, LLC. It outlines the device's characteristics and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the manner requested (i.e., performance metrics like sensitivity, specificity, accuracy, etc., typically associated with AI/ML devices).

The document focuses on:

• Device Description: Intervertebral body fusion devices made from PEEK Optima® LT1 with tantalum markers.
• Intended Use: Lumbar spinal fusion for degenerative disc disease (DDD) in conjunction with supplemental fixation and autograft.
• Substantial Equivalence: Claims substantial equivalence to listed predicate devices (Genesys Spine ApacheTM System and SeaSpine Spacer System – PacificaTM) in terms of intended use, materials, design, technological characteristics, mechanical safety, and performance.
• Mechanical Testing: Mentions performance testing was conducted according to standardized tests (Static and Dynamic Axial Compression per ASTM F2077, Subsidence per ASTM F2267, Expulsion) and that these results "demonstrate substantial equivalence."

Therefore, I cannot provide the requested information regarding acceptance criteria and studies proving device performance against those criteria, as this document does not contain that type of data. The information provided is primarily for regulatory clearance based on substantial equivalence to existing devices, focusing on design, materials, and mechanical safety, rather than a clinical performance study with specific acceptance criteria that would be relevant for devices like AI/ML products.

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The Cezanne II Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade l spondylolisthesis or retrolisthesis at the involved level(s). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Cezanne II Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy. The Cezanne II System consists of XLIF, TLIF and ALIF implants.

The System implant components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.

Note: The provided text describes a 510(k) premarket notification for a medical device, the "Accel Spine Cezanne II Interbody Fusion System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical testing (mechanical tests). It does not involve clinical studies or AI algorithm performance, which are the typical contexts for the acceptance criteria and study design questions you've posed.

Therefore, many of the requested fields are not applicable to the information provided in this 510(k) summary. I will answer based only on the information present in the document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. The study involved non-clinical mechanical testing of the device, not a test set of data such as images or patient records.
• Data Provenance: Not applicable. The "data" comes from engineering tests performed according to specific ASTM standards in a lab setting, not from patients or a specific country of origin. The tests were "non-clinical."

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

• Not applicable. Ground truth, in the context of expert review, is not relevant for this type of non-clinical mechanical testing. The "ground truth" for these tests is defined by the objective physical properties and performance measured according to the specified ASTM standards.

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

• Not applicable. Adjudication methods are used in studies involving expert review or subjective interpretation of data, which is not the case here.

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 510(k) submission for an interbody fusion system, not an AI-powered diagnostic device. No MRMC 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 medical device (interbody fusion system), not an algorithm or AI.

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

• The "ground truth" for the non-clinical testing is defined by the objective measurements and pass/fail criteria established by the specific ASTM standards (F2077-11, F2267-04, F-04.25.02.02, F2026, F560, F899). It is a form of empirical measurement against established engineering standards.

8. The sample size for the training set

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

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The SYNSTER CERVICAL CAGE is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The SYNSTER (ALIF, PLIF, PTLIF and TLIF) CAGE is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels 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 device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE will be offered in various device configurations based on surgical approach and patient anatomy, and consist of:

• 1. Cervical Interbody Fusion Device (SYNSTER® CERVICAL CAGE), which may be implanted as a single device via an anterior approach.
• 2. Lumbar Interbody Fusion Device [SYNSTER® (ALIF, PLIF, PTLIF and TLIF) CAGE], which may be implanted
  • As a single device via an Anterior or Anterolateral or Lateral (ALIF) approach; ।
  • Bi-laterally via a posterior (PLIF) approach; ।
  • As a single device via a posterior transforaminal (PTLIF) approach; -
  • As a single device via a transforaminal (TLIF) approach. -

The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain titanium makers (ASTM F136) to assist the surgeon with proper placement of the device.

The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE is implanted by using the (SCCI, SACI, SPCI, SPTCI and STCI) instruments manufactured from stainless steel materials that conform to ASTM F899.

This submission describes the SYNSTER® CERVICAL CAGE and SYNSTER® (ALIF, PLIF, PTLIF and TLIF) CAGE, intervertebral body fusion devices. The devices are made of PEEK Optima LT1 with titanium markers and are intended for intervertebral body fusion in skeletally mature patients with degenerative disc disease. The testing described for these devices primarily focuses on mechanical performance rather than AI/software performance. Therefore, many of the typical AI/ML-related questions are not applicable to this submission.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in terms of number of devices tested, but the testing refers to "non-clinical tests" conducted in accordance with specific ASTM standards. These standards typically involve a defined number of samples for each test type. The document does not specify the exact number of units tested.
• Data Provenance: Not applicable in the context of clinical data. The data originates from benchtop mechanical testing performed according to ASTM standards. There is no information regarding country of origin or retrospective/prospective nature as it's not clinical data.

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

Not applicable. The ground truth for this type of device (mechanical performance) is established by adherence to recognized national/international standards (ASTM F2077-03, ASTM F2267-04, and ASTM Draft Standard F 04.25.02.02) and engineering principles, not by expert consensus on clinical interpretation. The "experts" would be materials scientists and mechanical engineers performing and interpreting the tests according to the standards.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of human interpretations. Mechanical test results are objective measurements compared against specified criteria from 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

Not applicable. This submission is for a physical medical device (intervertebral cage), not an AI/ML software device.

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

Not applicable. This submission is for a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for demonstrating the device's acceptable performance is defined by the mechanical properties and criteria stipulated in the referenced ASTM standards. These standards provide objective measures and acceptance thresholds for static and dynamic compression, shear, torsion, subsidence, and expulsion.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; therefore, there is no training set in the conventional sense.

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

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

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