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The Idys®-C ZP 3DTi device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one (1) or more levels from C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as radiculopathy and/or myelopathy with hemiated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had at least six (6) weeks of non-operative treatment. The Idys®-C ZP 3DTi device must be used with the integrated fixation screws provided. The Idys@-C ZP 3DTi device must be filled with autograft bone graft and/or allogeneic bone graft composed of cancellous bone. The Idys®-C ZP 3DTi device is to be implanted via an open, anterior approach.

The Idys® C ZP 3DTi is designed for use as a cervical intervertebral body fusion device. The device is manufactured from medical grade Titanium alloy and must be filled with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The device has a shape which restores the intervertebral height and lordosis. The device contains one (1) slot to receive the bone graft to promote the fusion process between the endplates. The Idys® C ZP 3DTi is a standalone system intended to be used with two (2) bone screws, bone graft and requires no additional supplementary fixation. The Idys® C ZP 3DTi cages are made of compliant ASTM F3001 and ASTM F136 Titanium alloy and screws are made of ASTM F136 Titanium alloy.

This document is a 510(k) Summary for a medical device (Idys®-C ZP 3DTi), which is a premarket notification to the FDA. It declares substantial equivalence to existing devices rather than proving performance against specific acceptance criteria in a study. Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in the provided text.

The document primarily focuses on establishing substantial equivalence through:

1. Indications for Use: Demonstrating similar intended uses to predicate devices.
2. Technological Characteristics: Showing similar design and materials.
3. Performance Data (Mechanical Testing, Biocompatibility, Sterility/Cleaning): Proving that the device meets established standards for safety and function, aligning with predicate devices.

Here's a breakdown of what is available concerning performance and testing, and where the requested information is absent:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance in the manner typically found in a clinical study. Instead, it refers to compliance with established standards and comparison to predicate devices.

This section does not provide specific numerical metrics or thresholds for "acceptance criteria" and "reported device performance," but rather states that the device met the requirements implied by the testing standards and showed equivalence to predicates.

Study Information (Based on Available Text)

• Sample size used for the test set and the data provenance: Not applicable/Not provided. The document describes mechanical and validation testing, not a clinical study with a "test set" of patients or data in the usual sense. The testing is for the physical device itself.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth establishment with experts is relevant for diagnostic or AI-driven devices, which is not the case for this intervertebral fusion device.
• Adjudication method for the test set: Not applicable/Not provided.
• 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-driven diagnostic tool.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this type of device is compliance with engineering standards (e.g., ASTM, ISO) and comparison to the mechanical properties of an established predicate device. There is no biological or diagnostic "ground truth" in the clinical sense.
• The sample size for the training set: Not applicable/Not provided. This refers to a machine learning context, which is not relevant here.
• How the ground truth for the training set was established: Not applicable/Not provided.

In summary, the provided document is a 510(k) submission for an intervertebral body fusion device, focusing on substantial equivalence to predicate devices through technical and performance testing rather than clinical study results demonstrating efficacy against specific acceptance criteria for a diagnostic or AI-based device.

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The Idys® LLF 3DTi system is intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous level(s) of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment.

The Idys® LLF 3DTi system is intended to be used with bone graft composed of cancellous and/or corticocancellous bone and with cleared supplemental fixation to the integrated plate and screws.

The Idys® LLIF 3DTi is designed for use as a lumbar intervertebral body fusion system. The device is manufactured from medical grade Titanium alloy using an additive manufacturing method and is to be used with bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The cage has a shape which restores the intervertebral height and lordosis. The cage contains two (2) slots to receive the bone graft to promote the fusion process between the endplates. The Idys® LLIF 3DTi is a system intended to be used with a plate and two (2) bone screws, bone graft and supplemental fixation that has been authorized for surgical use in the lumbar spine. The Idys® LLF 3DTi components are made of compliant ASTM F136 Titanium alloy.

The provided text is a 510(k) summary for the Idys® LLIF 3DTi device, which is an intervertebral body fusion device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to prove effectiveness. Therefore, the information requested in the prompt, particularly regarding acceptance criteria from a study, sample sizes, expert ground truth, adjudication methods, MRMC studies, and training set details, is largely not applicable or explicitly stated in this document for the present device.

However, based on the provided text, here's what can be extracted and inferred regarding performance and "acceptance criteria" in the context of a 510(k) submission primarily relying on mechanical testing and comparison to predicates:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" in a 510(k) context for a mechanical device like this relate to meeting established standards and demonstrating performance comparable to predicate devices. The document references specific ASTM standards for mechanical testing and comparisons to predicate devices' material and design characteristics.

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

The document does not detail specific "sample sizes" for a clinical test set in the way one might expect for an AI algorithm study or a traditional clinical trial.

• Mechanical Testing: While mechanical tests were performed (e.g., static and dynamic axial compression, shear, expulsion, torsion), the sample sizes for these engineering tests (e.g., number of devices tested for each mechanical property) are not specified in the 510(k) summary. These are typically simulated or bench tests, not involving human subjects.
• Data Provenance: Not applicable in the context of mechanical testing or a 510(k) premarket notification for this type of device, which does not involve clinical data collected from patients for the current submission. The "provenance" refers to the device's design, manufacturing, and R&D conducted by CLARIANCE, SAS in France.

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

Not applicable. This is a medical device approval based primarily on mechanical engineering testing and substantial equivalence to existing devices, not on the interpretation of medical images or patient data by human experts for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. As no human expert interpretation of a "test set" for ground truth was involved, no adjudication method was necessary.

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

No. An MRMC study is relevant for diagnostic imaging AI devices, where multiple readers interpret cases with and without AI assistance. This document is for an implantable intervertebral body fusion device and does not involve such studies.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Not applicable. The Idys® LLIF 3DTi is a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant here.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Engineering Standards: Adherence to recognized ASTM and ISO standards for material properties, sterility, and mechanical performance (e.g., ASTM F2077, ASTM F2267, ISO 11737, ISO 11137).
• Comparison to Predicate Devices: Demonstrating that the new device's technological characteristics, mechanical performance, and safety/effectiveness profile are substantially equivalent to previously cleared devices.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in this 510(k) summary for the Idys® LLIF 3DTi itself; such data might exist for the predicate devices or in post-market surveillance.

8. The Sample Size for the Training Set

Not applicable, as this is a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable, as this is a physical medical device.

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Erisma®-LP Navigated Instruments are intended to be used in the preparation and placement of Erisma® Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Erisma®-LP Navigated Instruments are manual, non-sterile, reusable surgical instruments for use with the Medtronic StealthStation™ Navigation System to assist the surgeon in locating anatomical structures in either open, minimally invasive or percutaneous procedures for preparation and placement of the Clariance Erisma®-LP, Erisma®- MIS pedicle screw implants. The Erisma®-LP Navigated Instruments include the following instruments: Drivers, Tap, Bone Awl, Probes. The instrumentation is designed for use with the Medtronic StealthStation™ Navigation System hardware and software. These instruments are made of medical quality stainless steel according to the ASTM F899 and titanium alloy according to the ASTM F136.

The provided text is a 510(k) premarket notification for the Erisma®-LP Navigated Instruments. This document outlines the manufacturer's claim of "substantial equivalence" of their device to a legally marketed predicate device.

It's crucial to understand that a 510(k) submission primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive de novo clinical trials.

Unfortunately, the provided text does not contain the level of detail typically found in a clinical study report for AI-powered or diagnostic devices regarding acceptance criteria and performance data. The "Performance Data – Non-Clinical" section explicitly states that mechanical tests were performed, not a clinical study involving human patients or complex AI algorithms.

Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI or diagnostic performance (e.g., sensitivity, specificity, human reader improvement with AI) cannot be extracted from this document.

Here's an analysis of the provided information relative to your request:

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

Not applicable in the context of this 510(k) submission.
The document describes non-clinical performance data for mechanical and compatibility aspects of a surgical navigation instrument, not a diagnostic or AI-driven performance study with acceptance criteria like accuracy, sensitivity, or specificity. The "Performance Data – Non-Clinical" section mentions:

• Compatibility between Erisma®-LP Navigated Instruments and Medtronic Naclock Tracker.
• Ability of Erisma®-LP Navigated Instruments to be registered by Medtronic StealthStation™ System.
• Simulation of pedicle insertion.

The reported performance is that these tests "demonstrated the substantial equivalence of the system to legally marketed devices." No specific numerical "acceptance criteria" or "reported device performance" metrics (e.g., within X mm accuracy) are provided, as this is a general statement of equivalency for mechanical function.

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

Not applicable for a clinical test set.
The testing described is non-clinical/mechanical. There is no mention of a "test set" of patient data.

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

Not applicable.
There was no clinical test set requiring expert ground truth.

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

Not applicable.
There was no clinical test set 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

No.
This device is a navigated surgical instrument, not an AI-powered diagnostic or interpretive device for human readers. Therefore, an MRMC study and AI assistance improvement are irrelevant to its nature.

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

No.
This is a physical surgical instrument system used in conjunction with "human-in-the-loop" (a surgeon) and the Medtronic StealthStation™ Navigation System. It is not a standalone algorithm.

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

Not applicable in a clinical sense.
For the mechanical tests, the "ground truth" would be engineering specifications and the performance of the predicate device.

8. The sample size for the training set

Not applicable.
This device likely does not use machine learning in a way that requires a "training set" of data in the common sense of AI/ML software. Its functionality relies on physical design and interface with the navigation system.

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

Not applicable.
As above, no training set data.

In summary: The provided document is a 510(k) for a navigated surgical instrument (Erisma®-LP Navigated Instruments) intended to assist surgeons in spine surgery by precisely locating anatomical structures when used with the Medtronic StealthStation® System. The regulatory pathway is based on substantial equivalence to an existing predicate device (Medtronic Navigated CD Horizon Solera Screwdriver/Taps).

The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical mechanical tests and compatibility assessments rather than clinical performance trials or AI/diagnostic performance studies. The document states these non-clinical tests "demonstrated the substantial equivalence of the system to legally marketed devices," which is the fundamental "acceptance criterion" for a 510(k) submission. No detailed quantitative acceptance criteria or clinical performance metrics (like accuracy, sensitivity, or human reader performance) are provided, nor would they typically be for this type of device and regulatory submission.

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The Idys® ALIF ZP 3DTi devices (Anterior Lumbar Interbody Fusion) are intended for use in patients with degenerative disc disease (DDD) at one (1) or (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain in discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys® ALIF ZP 3DTi cages should be used with the integrated fixation screws provided.

The Idys® ALIF ZP 3DTi cages are intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion

The Idys® ALIF ZP 3DTi consists of interbody fusion devices intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the lumbar spine.

The Idys® ALIF ZP 3DTi cages, which have various widths and heights, are designed for use as lumbar intervertebral body fusion devices. The device has shape which restores the intervertebral height and lordosis. The device contains two slots to receive bone graft to promote the fusion process between the endplates. The device has to be used with bone graft.

The Idys® ALIF ZP 3DTi cage is manufactured from medical grade Ti-6Al-4V ELI Titanium alloy compliant with ASTM F3001 and ASTM F136. The screws are made from Ti-6AI-4V ELI per ASTM F136 and are anodized in different colors, according to their length, Idvs® ALIF ZP 3DTi cages are positioned using a set of surqical instruments common for anterior lumbar approach. It is essential to insert implants with instrumentation specifically designed for this purpose. The cages are provided sterile and are for single use only.

This document is a 510(k) summary for the Idys® ALIF ZP 3DTi intervertebral body fusion device. It details product information and demonstrates substantial equivalence to a predicate device, rather than describing a study with acceptance criteria for device performance in detecting or diagnosing a condition. Therefore, the requested information (acceptance criteria, study details, expert involvement, and ground truth characteristics) related to diagnostic performance cannot be extracted from this text.

The document focuses on the mechanical and biocompatibility performance of the device and its substantial equivalence to a previously cleared predicate device due to minor modifications (change in screw design and addition of cage sizes).

Here's what can be extracted regarding the performance data provided for the device itself:

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

2. Sample size used for the test set and the data provenance: Not applicable. These tests are laboratory-based mechanical and biocompatibility evaluations, not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this refers to mechanical and biocompatibility testing, not expert-adjudicated clinical performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: 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: Not applicable. This document does not describe an AI medical device or a reader study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to the presented performance data, which are based on established ISO and ASTM standards for materials and mechanical testing.

8. The sample size for the training set: Not applicable. This is not a study involving machine learning or AI models with training data.

9. How the ground truth for the training set was established: Not applicable.

Summary of Device and Changes:

The document describes a Special 510(k) notice for the Idys® ALIF ZP 3DTi device.

• Original Device: Idys® ALIF ZP 3DTi (K192168)
• Modifications:
  • Change in the screw's design.
  • Addition of new cage sizes (with identical design and shape as previously cleared cages).
• Purpose of Testing: To demonstrate that these modifications do not raise new issues of safety or effectiveness and that the modified device remains substantially equivalent to the predicate device.

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The Idys® ALIF ZP 3DTi devices (Anterior Lumbar Interbody Fusion) are intended for use in patients with degenerative disc disease (DDD) at one (1) or (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain in discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys® ALIF ZP 3DTi cages should be used with the integrated fixation screws provided.

The Idys® ALIF ZP 3DTi cages are intended to be used with autograft.

The Idys® ALIF ZP 3DTi consists of interbody fusion devices intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the lumbar spine.

The Idys® ALIF ZP 3DTi cages, which have various widths and heights, are designed for use as lumbar intervertebral body fusion devices. The device shape restores the intervertebral height and lordosis. The device contains two slots to receive the autologous bone graft to promote the fusion process between the endplates. The device has to be used with autograft.

The Idys® ALIF ZP 3DTi cage is manufactured from medical grade Ti-6Al-4V ELI Titanium alloy compliant with ASTM F3001 and ASTM F136 and is used with autograft. The screws are made from Ti-6Al-4V ELI per ASTM F136 and are anodized in different colors, according to their length. Idys® ALIF ZP 3DTi cages are positioned using a set of surgical instruments common for anterior lumbar approach. It is essential to insert implants with instrumentation specifically designed for this purpose. The cages are provided sterile and are for single use only.

The provided text is related to a 510(k) premarket notification for a medical device called "Idys® ALIF ZP 3DTi", an intervertebral body fusion device. The document describes the device, its intended use, and states that it has been determined to be substantially equivalent to previously cleared predicate devices.

However, the information required to fully answer the request, particularly regarding acceptance criteria and a study proving a device meets these criteria for an AI/algorithm-based medical device, is not present in the provided text.

The text focuses on hardware modifications (material change from PEEK to Titanium alloy), biocompatibility, and mechanical testing of an implantable device, comparing it to existing predicate devices based on structural and functional equivalence, not on performance metrics of an AI or algorithm.

Therefore, I cannot extract the following information from the provided document:

• A table of acceptance criteria and reported device performance for an AI/algorithm.
• Sample size used for a test set and data provenance related to an AI/algorithm study.
• Number of experts and their qualifications used to establish ground truth for an AI/algorithm test set.
• Adjudication method for an AI/algorithm test set.
• Results or even the conduct of a multi-reader multi-case (MRMC) comparative effectiveness study for an AI/algorithm.
• Results or even the conduct of a standalone (algorithm only) performance study.
• The type of ground truth used for an AI/algorithm (e.g., expert consensus, pathology, outcomes data).
• Sample size for the training set of an AI/algorithm.
• How ground truth for the training set of an AI/algorithm was established.

The document discusses "Performance Data" but this refers specifically to:

• Biocompatibility: "The modified device has been demonstrated to be biocompatible in accordance with ISO 10993-1 Part 1."
• Mechanical Testing: "Bench mechanical testing according to ASTM F2077 and ASTM F2267 were used to support the decision of substantial equivalence... Specifically, CLARIANCE performed static and dynamic axial compression testing, static and dynamic compression shear testing, subsidence testing, expulsion testing, static torsion testing (titanium particles), all of which demonstrated the substantial equivalence of the system to legally marketed devices."

These are engineering and material science tests, not performance studies of an AI or algorithmic medical device.

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The Idys™ ALIF (Anterior Lumbar Interbody Fusion) TiVac System is intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys™ ALIF TiVac System should be used with the integrated fixation screws provided. The Idys™ ALIF TiVac System is intended to be used with autograft.

The Idys™ ALIF TiVac consists of interbody fusion devices intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the lumbar spine.

The Idys™ ALIF TiVac System is designed for use as a lumbar intervertebral body fusion device. The device is manufactured from medical grade polyetheretherketone (INVIBIO PEEK OPTIMA LT1) coated with titanium on its superior and inferior surfaces and is to be used with autograft.

The device has a shape which restores the intervertebral height and lordosis. The device contains two slots to receive the autologous bone graft to promote the fusion process between the endplates. The superior and inferior surfaces of the implant coated with titanium are designed with teeth which interact with the surface of the vertebral endplates and helps in resisting back out. The Idys™ ALIF TiVac System is a standalone system intended to be used with plate and four bone screws, autogenous bone graft and requires no additional supplementary fixation. The Idys™ ALIF TiVac System cages are made of ASTM F2026 compliant polyetheretherketone (PEEK) coated with compliant ASTM F1580 titanium and, markers made of Tantalum according to ASTM F560, the plate and screws are made of ASTM F136 titanium alloy. It is essential to insert implants with instrumentation specifically designed for this purpose. The cages, plates and screws are provided sterile and are for single use only.

This document describes the marketing clearance for a medical device implant, specifically an intervertebral body fusion device, not an AI/Software as a Medical Device (SaMD). Therefore, the typical "acceptance criteria" and study designs related to diagnostic accuracy, sensitivity, specificity, or reader performance for AI/SaMD are not directly applicable.

The performance criteria for this device, a physical implant, are primarily based on biocompatibility and mechanical testing to demonstrate its safety and effectiveness compared to a previously cleared predicate device.

However, I can extract the relevant information from the provided text regarding the closest equivalent to "acceptance criteria" and "proof of meeting these criteria" for this specific type of medical device.

Key Information regarding Device Evaluation:

• Device Name: Idys™ ALIF TiVac
• Product Type: Intervertebral Body Fusion Device (Implantable)
• Regulatory Class: Class II
• Product Code: OVD
• Regulatory Mechanism: 510(k) Premarket Notification (demonstrates substantial equivalence to a legally marketed predicate device, rather than requiring de novo clinical trials for novel devices).

Based on the provided text, here's a breakdown of the information, adapting the requested categories to fit the context of an implantable medical device undergoing 510(k) clearance:

1. Acceptance Criteria and Reported Device Performance (Adapted for an Implantable Device)

For this type of device, "acceptance criteria" are not framed as diagnostic accuracy metrics but rather as meeting established performance standards for implants to demonstrate functional equivalence and safety to a predicate device.

• Static and dynamic axial compression testing
• Static and dynamic compression shear testing
• Subsidence testing
• Expulsion testing
• Static torsion testing
• Wear testing (PEEK and titanium particles) |
  | Coating Integrity & Performance | The added plasma-sprayed titanium coating must meet established standards for adhesion, strength, and durability. This includes:
• Static tensile strength
• Static shear strength
• Shear fatigue strength
• Abrasion resistance
• Coating porosity/thickness |
  | Clinical Equivalence (Indications for Use) | The device must have the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device, with any differences not raising new safety or effectiveness issues. |

Reported Device Performance:

• Biocompatibility: "The modified device has been demonstrated to be biocompatible in accordance with ISO 10993-1 Part 1."
• Mechanical Testing (Device Functionality): "The results of these studies were determined to be substantially equivalent to legally marketed devices." (Referring to functional tests such as axial compression, shear, subsidence, expulsion, torsion, and wear).
• Mechanical Testing (Coating Performance): Coating tests (static tensile, static shear, shear fatigue, abrasion resistance, porosity/thickness) were performed "with satisfactory results."
• Clinical Equivalence: "The Idys™ ALIF TiVac is as safe and effective as the Idys™ ALIF (K172083). The Idys™ has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Idys™ ALIF TiVac and its predicate device do not raise any new issues of safety or effectiveness. Performance data demonstrate that the Idys™ ALIF TiVac is as safe and effective as its predicate."

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

• Sample Size: Not applicable in the context of human patient data for an AI test set. This device's performance was evaluated via bench testing of physical prototypes/samples. The specific number of mechanical test specimens used for each test (e.g., how many devices were subjected to axial compression) is not stated in this summary but would be detailed in the full premarket notification.
• Data Provenance: The data primarily originates from laboratory bench testing performed by the manufacturer, CLARIANCE SAS, in France ("Beaurains, France"). This is not retrospective or prospective human patient data.

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

• Not Applicable. For a physical implantable device, "ground truth" is not established by human expert interpretation of medical images or clinical outcomes in the same way as for AI/SaMD. Instead, it's based on objective, quantifiable physical and mechanical properties measured in a lab setting against established ASTM/ISO standards.
• The "experts" involved would be engineers, material scientists, and quality assurance personnel conducting the mechanical and biocompatibility tests.

4. Adjudication Method for the Test Set

• None. Adjudication methods like "2+1" or "3+1" are specific to establishing ground truth from multiple human readers for diagnostic AI/SaMD. In this context, the "ground truth" for the device's performance relies on direct physical measurements and compliance with engineering standards.

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

• No. This type of study is specifically designed for AI systems that aid human readers in diagnostic tasks. It is not relevant for an implantable medical device.

• Effect Size of Human Readers Improvement: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No. This refers to the evaluation of AI algorithm performance. This product is a physical implant, not an algorithm.

7. Type of Ground Truth Used

• The "ground truth" for this device's performance is based on objective, quantifiable physical and mechanical properties measured through bench testing against established industry standards (e.g., ASTM, ISO) and comparison to the mechanical properties of the predicate device.
• Biocompatibility: In vitro and in vivo (animal, if applicable, though not specified here) testing against ISO 10993-1.

8. Sample Size for the Training Set

• Not Applicable. This is not an AI/machine learning device that requires a "training set." The device itself is the product, evaluated based on its physical properties.

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

• Not Applicable. As there is no AI training set, there is no ground truth establishment for it.

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The Idys™ TLIF TiVac cages are indicated for use with autologous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplementation, which has been cleared by FDA for use in the lumbar spine.

The Idys™ TLIF TiVac consists of interbody fusion devices intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the lumbar spine.

The Idys™ TLIF TiVac cages, which have various widths and heights, are designed for use as lumbar intervertebral body fusion devices. The device has a shape which restores the intervertebral height and lordosis. The device contains two slots to receive the autologous bone graft to promote the fusion process between the endplates. The device has to be used with autograft.

The superior and inferior surfaces of the implant are designed with "teeth" to help prevent the device from migrating once it is positionally, the rough plasma-sprayed titanium surface interacts with the surface of the vertebral endblates and helps resist back out. The Idys™ TLIF TiVac cages are made of compliant ASTM F2026 polyetheretherketone (PEEK Optima®) with markers made of compliant ASTM F560 Tantalum and are coated with plasma-sprayed titanium compliant with ASTM F1580. Idys™ TLIF TiVac cages are positioned using a set of surgical instruments common for transforaminal lumbar approach. It is essential to insert implants with instrumentation specifically designed for this purpose. The cages are provided sterile and are for single use only.

The provided text is a 510(k) summary for the Idys™ TLIF TiVac intervertebral body fusion device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results of new device performance against acceptance criteria. Therefore, much of the requested information regarding detailed acceptance criteria, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and stand-alone algorithm performance is not typically part of a 510(k) submission for this type of device and is not present in the provided text.

However, based on the information available, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence of the Idys™ TLIF TiVac are primarily based on demonstrating comparable performance to the predicate devices through mechanical testing and biocompatibility assessments. The "reported device performance" is essentially the statement that the device met these comparability goals.

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

• Sample Size: Not specified in terms of number of devices or clinical cases. The tests described are bench mechanical and biocompatibility tests, not clinical performance tests on human subjects.
• Data Provenance: The tests are described as "bench mechanical testing" and "biocompatibility testing," implying laboratory-based studies. The context suggests these were conducted by the manufacturer, Clariance SAS, a French company. Therefore, the data would be from non-clinical, prospective laboratory testing (meaning the tests were designed and conducted to evaluate the device as part of the submission process).

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

Not applicable. The "ground truth" for mechanical and biocompatibility testing is defined by the standards (ASTM and ISO) and the physical properties of the materials and device under test, not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically for clinical studies where human interpretation or classification is involved.

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

No. This type of study is for evaluating diagnostic or screening devices involving human readers interpreting medical images. The Idys™ TLIF TiVac is an intervertebral body fusion device (implant), not an imaging diagnostic tool.

6. Standalone Performance (i.e. algorithm only without human-in-the-loop performance)

Not applicable. This device is an implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for these tests is the quantitative and qualitative outcomes expected under the specified ASTM and ISO standards for mechanical stability, durability, and biocompatibility. For example, "satisfactory results" for coating tests imply meeting predefined thresholds or performance levels dictated by the standards.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI device. The submission is based on engineering testing and comparison to predicate devices.

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

Not applicable for the same reason as above.

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The Idys™ TLIF 3DTi cages are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a posterior and/or transforaminal approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

The Idys™ TLIF 3DTi cages, which have various widths and heights, are designed for use as a lumbar intervertebral body fusion device. The device has to be used with autograft. The device has a shape which restores the intervertebral height and lordosis. The device contains a slot to receive the autologous bone graft to promote the fusion process between the endblates. The Idvs™ TLIF 3DTi cages are made of compliant ASTM F136 Titanium alloy. The device is manufactured using an additive manufacturing process to result in a porous material with tightly defined structure. It is essential to insert implants with instrumentation specifically designed for this purpose.

The provided text describes CLARIANCE's Idys™ TLIF 3DTi, an intervertebral body fusion device. Here's an analysis of the acceptance criteria and study proving the device meets them:

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

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it refers to industry standards (ASTM F2077 and ASTM F2267) and states that the device's performance was found to be "substantially equivalent" to legally marketed predicate devices.

Here's a summary based on the provided text:

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

The document mentions "Performance testing was conducted according to ASTM F2077 and ASTM F2267." It does not specify the exact sample size for each test performed (e.g., number of devices tested for axial compression, expulsion, etc.).

• Sample Size: Not explicitly stated as a number (e.g., "n=5" for each test). The ASTM standards themselves would specify minimum sample sizes for such tests.
• Data Provenance: The testing was conducted by CLARIANCE, SAS, located in France. The provenance of the test data is, therefore, from their internal testing. It's a prospective set of tests designed specifically for this regulatory 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 information is not applicable to this type of device and study. The "ground truth" for a mechanical device like an intervertebral fusion cage is established through physical and mechanical testing against predefined standards or comparison to a predicate device's performance, not by expert consensus on clinical findings or images.

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

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving interpretative tasks (e.g., image reading) where multiple experts assess cases to reach a consensus for ground truth. For mechanical performance testing, the results are objectively measured against established criteria or predicate device performance.

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 orthopedic implant (an intervertebral body fusion device), not an imaging analysis or AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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. Standalone performance for an algorithm would assess its accuracy in tasks like disease detection or measurement without human intervention.

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

The "ground truth" for this device's performance evaluation is based on:

• Compliance with recognized testing standards: ASTM F2077 (for static and dynamic compression, shear, and torsion) and ASTM F2267 (for subsidence). These standards define the methodologies and acceptable performance envelope.
• Mechanical equivalence to predicate devices: The device's performance was compared directly to that of legally marketed predicate devices, meaning the established mechanical characteristics of those predicates served as the benchmark for "ground truth" in terms of what constitutes safe and effective mechanical performance for this type of implant.

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI or algorithm development. The "training" for such devices typically refers to the iterative design and development process, which doesn't involve a quantifiable "training set" of data in the same way.

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

This information is not applicable for the same reason as point 8; there is no "training set" in the sense of machine learning for this physical device. The "ground truth" for the design and development process would be established through engineering specifications, material science principles, clinical needs, and regulatory requirements that guide the creation of the device.

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The Idys™ ALIF (Anterior Lumbar Integrated Fusion) System is intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys™ ALIF System should be used with the integrated fixation screws provided.

The Idys™ ALIF System is intended to be used with autograft.

The Idys™ ALIF System is manufactured from medical grade polyetheretherketone (INVIBIO PEEK OPTIMA LT1) and is to be used with autograft. The device has a shape which restores the intervertebral height and lordosis. The device contains two slots to receive the autologous bone graft to promote the fusion process between the endplates. The superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates and helps resist back out.

The Idys™ ALIF System is connected to a plate with four screws for a standalone implantation. The Idys™-ALIF System are made of ASTM F2026 compliant polyetheretherketone (PEEK) and markers made of Tantalum according to ASTM F560, the plate and screws are made of ASTM F136 titanium alloy.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text describes bench testing for mechanical performance. Therefore, typical "test set sample sizes" for clinical or image-based studies, and "data provenance" (country of origin, retrospective/prospective) are not applicable here. The "test set" would refer to the number of devices tested for each mechanical assessment, but this specific number is not provided.

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

This information is not applicable as the studies described are bench tests for mechanical performance, not clinical studies or studies requiring expert interpretation of data.

4. Adjudication Method for the Test Set

This is not applicable for the type of bench testing performed. Adjudication methods are typically used for clinical endpoints or image interpretation where human judgment is involved.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a series of bench tests comparing the physical and mechanical properties of the device to predicate devices and standards.

6. Standalone (Algorithm Only) Performance Study

No, this is not applicable. The device is an intervertebral body fusion system, not an algorithm or AI software for which standalone performance would be assessed.

7. Type of Ground Truth Used

The "ground truth" for the performance studies primarily consisted of:

• Established ASTM (American Society for Testing and Materials) standards: F2077, F2267.
• Established ISO (International Organization for Standardization) standards: 11137-1, 11137-2, 11607-1, 11607-2.
• Performance of legally marketed predicate devices: DIVERGENCE-L (K150135) and Idys LIF (K131178) serve as the benchmark for "substantial equivalence."

8. Sample Size for the Training Set

This is not applicable. The device is a physical medical implant, not an AI model that requires a training set.

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

This is not applicable, as there is no training set for this device.

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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft and/or autograft, the Erisma® LP Spinal Fixation System is indicated as an adjunct to fusion for the following indications:

• Deqenerative Disc Disease (discogenic pain with degeneration of the disc confirmed by history and radiographic . studies):
• . Degenerative spondylolisthesis with objective evidence of neurologic impairment;
• Severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; .
• Fracture ●
• . Dislocation
• Scoliosis .
• Kyphosis .
• . Spinal tumor
• . Failed previous fusion (pseudarthrosis)

The Erisma® LP instrumentation is designed for the surgical treatment of spinal pathologies. The treatment consists in the fusion of two or several vertebrae in order to restore spinal stability, with or without any other endocanalar concomitant surgical procedure.

The Erisma® LP spinal system is composed of rods (straight or pre-bent) fixed on the spine with pedicle screws. The Erisma® LP includes monoaxial and polyaxial pedicle screws (cannulated or not), monoaxial and polyaxial pedicle screws with breaking tabs, as well as transverse link which connects two rods altogether.

The implants used in the Erisma® LP system are available in a variety of diameters and lengths to accommodate patient anatomy and are made of medical grade titanium alloy per ASTM F136 or cobalt-chromium allov per ASTM F1537.

The Erisma® LP procedures are performed using a set of surgical instruments common for posterior spinal fixation approach. Most of the instruments provided are common surgical tools used in these types of posterior fixation of the spine.

This document describes the Clariance SAS Erisma® LP Spinal Fixation System, a medical device for spinal surgery. The information provided is from an FDA 510(k) summary. I will extract the requested information based on the provided text.

Based on the provided text, the Erisma® LP Spinal Fixation System is a mechanical device (spinal fixation system), not an AI/ML-driven diagnostic or assistive device. Therefore, many of the typical acceptance criteria and study characteristics for AI/ML devices (like human reader performance, ground truth establishment, training sets, etc.) are not applicable to this submission.

The acceptance criteria and study described here relate to the mechanical performance and material characteristics of the spinal fixation system.

Here's the breakdown of the requested information, adapted for a mechanical device:

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

   Acceptance Criterion	Reported Device Performance
   Dynamic Axial Compression per ASTM F1717	Performed and characterized the modification. The submission indicates the performance demonstrates the modified device is as safe and effective as the predicate device. Specific numerical results are not provided in this summary.
   Substantial Equivalence to predicate devices (K153326 and K130877)	Achieved. The modified device has the same intended use, similar indications, principles of operation, and technological characteristics. Performance data supports that it is as safe and effective.
   Material Composition	Cobalt-chromium alloy per ASTM F1537 (for new rods); medical grade titanium alloy per ASTM F136 (for other components).
   Dimensions and Design	Rods have similar dimensions and design as those already cleared under K153326 for the Erisma® LP predicate device.

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

   • Sample Size for Test Set: Specific numbers are not provided in this summary. Mechanical testing typically involves a set number of samples required by the standard (ASTM F1717).
   • Data Provenance: Not explicitly stated, but mechanical testing is typically performed in a laboratory setting. There is no indication of country of origin for the test data or whether it was retrospective or prospective, as these terms are usually applied to clinical studies.

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. For mechanical testing of a spinal fixation system, "ground truth" is established by the test standard (e.g., ASTM F1717) and the physical properties of the materials and design, not by expert consensus in the typical sense of clinical image review. The acceptance is based on meeting the performance requirements defined by the standard.

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

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert opinions in clinical studies (e.g., image interpretation). This is a mechanical device performance study, where acceptance is based on objective measurements against a standard.

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 mechanical device, not an AI/ML device, so MRMC studies involving human readers are not relevant.

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

   • Not Applicable. This is a mechanical device, not an algorithm.

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

   • Mechanical Standard Compliance/Predicate Equivalence: The "ground truth" for this device's performance is its compliance with recognized mechanical testing standards (e.g., ASTM F1717) and demonstrating substantial equivalence in performance and characteristics to legally marketed predicate devices.

8. The sample size for the training set

   • Not Applicable. This is a mechanical device, not an AI/ML 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 a mechanical device, this question is not relevant.

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