Search Results

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.

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Erisma® LP MIS components are intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications:

• Degenerative disc disease (Define as back pain of discogenic origin 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 MIS device is intended to be used for the surgical treatment of spinal pathologies by percutaneous access. The treatment consists of the stabilization of two or several vertebrae in order to restore spinal stability, with or without any other endocanalar concomitant surgical procedure.
The Erisma® LP MIS consists of cannulated extended pedicle screws and straight or pre-bent rods that can be used via posterior percutaneous surgical approach to provide the immobilization and the stabilization of spinal segments in mature patients as an adjunct to fusion in the treatment of instabilities or deformities of the thoracic, lumbar and sacral spine.
The components are available in a variety of diameters and lengths to accommodate patient anatomy and are made from ISO 5832-3 or ASTM F136 medical grade Titanium alloy.
The Erisma® LP MIS also contains surgical instruments common for posterior percutaneous spinal fixation approach. The primary purpose of this submission is to extend the breakoff tabs of the pedicle screws to allow for minimally invasive surgery.

The provided document is a 510(k) premarket notification decision letter from the FDA for the Erisma® LP MIS device. This type of submission is for medical devices and their physical performance characteristics and safety, not for AI-powered diagnostic tools or software as a medical device (SaMD) that typically have acceptance criteria focused on diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC).

Therefore, the document does not contain the information requested regarding acceptance criteria related to a study proving the device meets those criteria in the context of diagnostic performance (e.g., sensitivity, specificity, F1 score).

Instead, the "Performance Data" section mentions:

• Bench Testing: This refers to physical and mechanical testing of the device.
  • Dynamic ASTM F1717 testing: This is a standard for spinal implant constructs in a simulated in-vivo environment to assess their mechanical integrity and fatigue life. The acceptance criteria would be defined by the stress and cycle limits set in the standard for equivalence to the predicate device.
  • Sterilization validation: This ensures the device can be properly sterilized, meeting specific sterility assurance levels, which are critical for patient safety.
• Substantial Equivalence: The primary "proof" is that the device is substantially equivalent to legally marketed predicate devices in terms of material, design, and indications for use, and that the minor change (extended breakoff tabs for MIS insertion) does not raise new safety or effectiveness questions.

In summary, the document does not provide the type of information requested for an AI/diagnostic device, such as acceptance criteria for diagnostic performance, sample size for test/training sets, expert qualifications, adjudication methods, or MRMC studies. The "study" referenced is bench testing to demonstrate mechanical and sterilization equivalence to predicate devices, which is typical for physical medical implants.

Ask a specific question about this device