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The Elegance® Anterior Cervical plate is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies)
2. Spondylolisthesis
3. Spinal stenosis
4. Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
5. Pseudoarthrosis
6. Revision of previous surgery

The Elegance® Anterior Cervical plate is designed for use as a cervical plate system. The device has a shape which restores the intervertebral height and lordosis. The Elegance® Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw's holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are self-drilling or self-tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Elegance® plates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy.

The provided document is a 510(k) summary for the Clariance Elegance® Anterior Cervical plate, which is a medical device for spinal fixation. This document does NOT describe the acceptance criteria and study for a software device or an AI/ML device. Therefore, it does not contain the specific information requested in the prompt about sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

Instead, the document details the non-clinical performance testing conducted for a physical medical device. Here's a breakdown of what the document does provide, aligning with the spirit of the request but recognizing the device type:

1. Table of Acceptance Criteria and Reported Device Performance

The detailed numerical results for these tests, which would constitute the specific "reported device performance" and the "acceptance criteria" (e.g., minimum load, maximum displacement) set by the ASTM F1717 standard, are not explicitly provided in this summary document. The summary only states that the results demonstrate substantial equivalence to the predicate device.

Remaining Information (Not applicable for this type of device/document):

Since this is a physical medical device (spinal plate) and not a software/AI device, the following points are not addressed in the provided text:

2. Sample size used for the test set and the data provenance: Not applicable. Tests are typically on physical prototypes, not "test sets" of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through engineering and material science testing, often against established standards.
4. Adjudication method: Not applicable. Material tests follow standardized protocols.
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 pertains to AI/software evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This pertains to AI/software evaluation.
7. The type of ground truth used: For a physical device, the "ground truth" would be the measured physical properties and performance characteristics against established engineering standards (like ASTM F1717).
8. The sample size for the training set: Not applicable. This pertains to AI/software development.
9. How the ground truth for the training set was established: Not applicable. This pertains to AI/software development.

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The Idys® PLIF cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L3 to S1. The Idys® PTLIF, Idys® TLIF 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 by the FDA for use in the lumbar spine.

The Idys®-LIF cages, which have various widths and heights, are designed for use as a lumbar interbody fusion device. The device has to be used with autograft. The device has a shape which restores the intervertebral height and lordosis. The device can contain one or more 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 a rough surface which interact with the surface of the vertebral endplates and help in resisting back out. The Idys®-LIF cages are made of compliant ASTM F2026 polyetheretherketone (PEEK) with markers made of compliant ASTM F560 Tantalum for PLIF and PTLIF, made of compliant ASTM F560 Tantalum and made of compliant ASTM F136 Titanium alloy for TLIF. It is essential to insert implants with instrumentation specifically designed for this purpose.

The provided text describes a 510(k) premarket notification for a medical device called "Idys® LIF," an intervertebral body fusion device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical studies with acceptance criteria for device performance as would be seen in a de novo or PMA submission for a novel device or software.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning AI/software performance.

Here's a breakdown of why the requested information is absent and what is provided:

Why the requested information is not present:

• No AI/Software Component: The device is a physical intervertebral body fusion cage. There is no mention of any AI or software component in its design, operation, or intended use that would require the types of performance studies (e.g., diagnostic accuracy, reader study) implied by your prompt.
• Submission Type: A 510(k) demonstrates substantial equivalence. For physical devices like this, performance testing typically involves bench testing (mechanical, biocompatibility) against recognized standards to ensure the device performs as intended and is comparable to predicate devices. It does not involve human reader studies or ground truth establishment in the way AI/software performance studies would.
• Focus of Performance Data: The "Performance Data" section explicitly states that testing was "conducted per ASTM F2077 and ASTM F2267," which are standards for intervertebral body fusion devices, involving "static and dynamic axial compression testing, static and dynamic compression shear testing, subsidence testing, expulsion testing, and wear testing." These are all mechanical and material property tests.

What information is available in the document related to "performance":

• Acceptance Criteria and Reported Performance (Table): Not applicable for the type of performance evaluation conducted here. The 'acceptance' is based on meeting the ASTM standards and demonstrating comparable mechanical properties to the predicate.
• Sample Size for Test Set and Data Provenance: Not applicable in the context of diagnostic accuracy/AI performance. The "test set" would be the manufactured devices undergoing mechanical testing. The provenance is from the manufacturer's testing.
• Number of Experts, Qualifications, and Adjudication Method for Ground Truth: Not applicable. Ground truth as typically understood for AI or diagnostic studies (e.g., diagnoses, disease presence) is not established through expert consensus for this physical device.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not a diagnostic device or AI software.
• Standalone Performance: The "Performance Data" describes mechanical standalone performance (device in isolation, under simulated physiological loads).
• Type of Ground Truth: For a physical implant, the "ground truth" would be engineering specifications and successful mechanical performance under stress, measured against industry standards.
• Sample Size for Training Set and How Ground Truth was Established for Training: Not applicable. This is not a machine learning model.

In summary, the provided document describes a physical medical device (intervertebral fusion cage) and its 510(k) submission, which relies on demonstrating substantial equivalence through mechanical performance testing against established standards, not through studies involving AI, human readers, or diagnostic accuracy.

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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 System is indicated 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 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 modified Erisma® Lp Spinal Fixation System device is designed for use in the surgical treatment of spinal pathologies as outlined in the device's indications for use, which remains the same from the cleared Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System device (K240872). The treatment consists of the fusion of two or several vertebrae in order to restore spinal stability, with or without any other endocanalar concomitant surgical procedure.

The cleared Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System is composed of cannulated and non-cannulated monoaxial and polyaxial screws, crosslinks, rods, Offset Connectors, screw sets and associated instruments. Further, the implants used in the cleared Erisma® Lp Spinal Fixation System device and modified Erisma® Lp Spinal Fixation System are both made of Ti6Al4V alloy per ASTM F136.

The modified Erisma® LP MIS is designed for use in the surgical treatment of spinal pathologies as outlined in the device's indications for use, which remains the same from the cleared Erisma® LP MIS device (K162367). The Erisma® LP MIS device is indicated 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 subject of this submission is the extend to the Erisma® Lp Spinal Fixation System and the Erisma® LP MIS, with the addition of new components: 'Uniplanar Screws'

The provided text describes a 510(k) premarket notification for a spinal fixation system, not an AI/ML powered device. Therefore, it does not contain the specific information requested about acceptance criteria and studies related to AI/ML device performance.

The document focuses on demonstrating substantial equivalence to predicate devices for a modified Erisma® Lp Spinal Fixation System and Erisma® LP MIS. The performance data presented are for mechanical tests, not clinical studies involving AI or human interpretation.

Therefore, I cannot provide the requested information for acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this submission is not for an AI/ML powered medical device.

The "Performance Data" section explicitly states: "Dynamic compression bending test and Static torsion mechanical verification test according to ASTM F1717 and static torsional grip test according to ASTM F1798 were performed to characterize the subject modification addressed in this notification." These are mechanical tests for a physical implant, not a study of an AI algorithm's diagnostic or predictive capabilities.

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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® Deformity Spinal System is indicated 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 lumbarfirst sacral (L5-S1) vertebral joint; deformities (Scoliosis); spinal tumor; failed previous fusion (pseudarthrosis).

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 System is indicated as an adjunct to fusion for the following indications: Degenerative 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® Deformity Spinal System device is designed for use in the surgical treatment of spinal pathologies as outlined in the device's indications for use, which remains the same from the cleared Erisma® Lp Spinal Fixation System device (K170163). The treatment consists of the fusion of two or several vertebrae in order to restore spinal stability, with or without any other endocanalar concomitant surgical procedure. The Erisma® Deformity Spinal System device is an extension of the already cleared Erisma® Lp Spinal Fixation System.

The cleared Erisma® Lp Spinal Fixation System are composed of cannulated and non-cannulated monoaxial and polyaxial screws, crosslinks, rods, screw sets and associated instruments. Further, the implants used in both the cleared Erisma® Lp Spinal Fixation System device and Erisma® Deformity Spinal System are made of Ti6Al4V allov per ASTM F136.

The subject of this submission is the extend to the Erisma® Lp Spinal Fixation System, with the addition new components 'Closed Offset Connectors' and commercialization of the 'Open Offset Connectors' provided in the Erisma® Deformity Spinal System range.

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

Disclaimer: The provided FDA 510(k) clearance letter and its associated summary are for a spinal fixation system, which is a physical medical device. This document does not describe a software algorithm or AI device. Therefore, many of your requested points regarding AI/algorithm performance criteria, sample sizes for training/test sets, expert ground truth, MRMC studies, and standalone performance are not applicable to the information provided.

The document focuses on demonstrating substantial equivalence of a modified physical device (Erisma® Deformity Spinal System) to a legally marketed predicate device, primarily the Erisma® Lp Spinal Fixation System (K170163). This is achieved through engineering performance testing, not clinical studies involving patient data or AI analysis.

Analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that "Static axial load gripping tests and static axial torque gripping tests per ASTM F1798 was performed to characterize the subject modification addressed in this notification." While specific numerical acceptance criteria and precise performance values are not detailed in this summary, the conclusion indicates that these tests were sufficient to demonstrate substantial equivalence in terms of safety and effectiveness. This implies that the device met the performance expectations set by the standard for these tests.

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

Not applicable. This is a physical device clearance based on mechanical testing, not a study involving patient data or an algorithm's performance on a dataset. The "test set" would refer to the physical units subjected to the mechanical tests, but the quantity is not specified in this summary.

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 device performance, typically refers to expert interpretation of data for diagnostic or prognostic devices. For a spinal fixation system, "ground truth" relates to the fundamental mechanical properties and performance under stress, evaluated against established engineering standards (ASTM F1798). This does not involve clinical experts establishing ground truth in the way it would for an AI diagnostic tool.

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

Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in image analysis, neither of which are described here. The evaluation is based on engineering test results 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 clearance for a physical spinal implant, not an AI or software device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

Not applicable. This is a clearance for a physical spinal implant, not an AI or software device.

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

For this physical device, the "ground truth" for demonstrating substantial equivalence is based on:

• Adherence to established international and national standards for medical device materials and mechanical testing (e.g., ASTM F136 for Ti6Al4V alloy, ASTM F1798 for static gripping tests).
• Demonstrating that the modified device's performance aligns with, or is equivalent to, the performance of the legally marketed predicate devices. The acceptance of the test results by the FDA is based on this engineering comparison.

8. The sample size for the training set

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

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

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

Summary of the K240872 Submission:

The K240872 submission is for the Erisma® Deformity Spinal System: Erisma® Lp Spinal Fixation System. It's classified as a Class II medical device (Thoracolumbosacral Pedicle Screw System, 21 CFR 888.3070).

The core of the submission is to demonstrate substantial equivalence to existing predicate devices, primarily the Erisma® LP Spinal Fixation System (K170163) manufactured by CLARIANCE SAS. The current submission extends the previously cleared system by adding new components: 'Closed Offset Connectors' and commercializing 'Open Offset Connectors'.

The study mentioned to prove the device meets acceptance criteria is the Performance Data section, which states:

• "Static axial load gripping tests and static axial torque gripping tests per ASTM F1798 was performed to characterize the subject modification addressed in this notification."

The conclusion then asserts:

• "Performance data demonstrate that the subject devices have a substantially equivalent safety and effectiveness profile compared to the Erisma® Lp Spinal Fixation System (K170163). Thus, the modified Erisma® Lp Spinal Fixation System and Erisma® Deformity Spinal System are substantially equivalent."

Therefore, the "acceptance criteria" were the performance requirements stipulated by the ASTM F1798 standard, and the "study" was the mechanical testing conducted according to that standard. The successful performance in these tests, demonstrating similarity to the predicate device, led to the conclusion of substantial equivalence and FDA clearance.

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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 herniated 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 and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone graft. The Idys®-C ZP 3DTi device is to be implanted via an open, anterior approach.

The Idys® C ZP 3DTi device consists of a cervical intervertebral body fusion system. The device is manufactured from medical grade Titanium alloy and is to be used with autograft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone graft. 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 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. It is essential to insert implants with instrumentation specifically designed for this purpose.

The Idys® C ZP 3DTi device consists of cages and screws, as well as associated surgical instruments.

This document describes the regulatory clearance of a medical device and, as such, focuses on substantial equivalence rather than a clinical study evaluating an AI device's performance against acceptance criteria. Therefore, most of the requested information regarding AI device performance (like MRMC studies, standalone performance, ground truth, and training set details) is not applicable or cannot be extracted from this type of document.

The document primarily discusses the Idys® C ZP 3DTi intervertebral body fusion device and its substantial equivalence to a legally marketed predicate device (IDYS® C ZP 3DTi, K212562). The "Performance Data" section specifically details non-clinical testing for the screws of the device.

Here's the breakdown of the information that can be extracted or commented on, based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner for clinical efficacy. Instead, it refers to non-clinical testing to demonstrate substantial equivalence for the screws' mechanical properties. The acceptance is based on the subject device performing at least as well as the predicate device.

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

• Sample Size for Test Set: Not specified in terms of number of screws or tests, but it refers to "the subject Idys® C ZP 3DTi screws".
• Data Provenance: The testing is "non-clinical testing," implying laboratory-based mechanical testing, not human-derived patient data. Therefore, country of origin or retrospective/prospective does not apply in the typical sense.

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

Not applicable. This is not a study involving expert-established ground truth for clinical outcomes or image interpretation. It's a mechanical performance test.

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

Not applicable. This is not a study requiring adjudication of expert interpretations.

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 pertains to a physical medical device (intervertebral fusion system), not an AI-based diagnostic or assistive software.

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

Not applicable, as it's not an AI algorithm.

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

For the mechanical testing, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate device, against which the subject device's performance (e.g., axial pullout load) is compared to demonstrate substantial equivalence.

8. The sample size for the training set

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

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

Not applicable.

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The Aggeris™-C device is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies)
2. Spondylolisthesis
3. Spinal stenosis
4. Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
5. Pseudoarthrosis
6. Revision of previous surgery

The Aggeris™-C is designed for use as a cervical plate. The device is manufactured from medical grade Titanium alloy. The device has a shape which restores the intervertebral height and lordosis. The device consists of a variety of bone screws and cervical plates provided in a variety of shapes and sizes of with rounded corners, bone screw holes, and a screw locking system. The plates are provided in a variety of lengths, allowing treatment from 1 to 5 levels. The Aggeris™-C plates, as well as the bone screws, are made from Ti alloy conforming to ASTM F136.

This document describes the Clariance Aggeris™-C device, specifically a spinal intervertebral body fixation orthosis. However, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for software-based medical devices or AI/ML components.

The text focuses on hardware-related regulatory submission details for a physical medical device (spinal implant), including:

• Device name, classification, and regulation details.
• Indications for use for a cervical plate.
• Technological characteristics (materials, design).
• Performance data related to biocompatibility, sterility, cleaning, and mechanical testing (static and dynamic axial compression, static torsion) of the physical implant.
• Comparison to a predicate device for substantial equivalence, again for the physical implant.

There is no mention of an AI/ML component, software, or any study involving human-in-the-loop performance, standalone algorithm performance, or ground truth establishment for diagnostic or predictive purposes.

Therefore, I cannot provide the requested information based on the provided text. The questions posed in your prompt (e.g., sample size for test/training set, number of experts for ground truth, MRMC study, standalone performance) are relevant to AI/ML medical devices, not to the type of physical device and regulatory submission described here.

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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® ALIF 3DTi (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 level. 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 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 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 3DTi 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 autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion process between the endplates.

The device has to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone graft.

The Idys® ALIF 3DTi cage is manufactured from medical grade Ti-6Al-4V ELI Titanium alloy compliant with ASTM F3001 and ASTM F136 and is used with bone graft. The insert for fixation of the plate is made of ASTM F2026 compliant polyetheretherketone (PEEK). The screws and plates are made from Ti-6Al-4V ELI per ASTM F136 and are anodized in different colors, according to their length. Idys® ALIF 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 a 510(k) summary for the Idys® ALIF 3DTi device, which is an intervertebral body fusion device. The document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove acceptance criteria for device performance in terms of clinical outcomes or diagnostic accuracy.

Therefore, the following information cannot be fully extracted from the provided text:

• A table of acceptance criteria and the reported device performance (in a clinical context for diagnostic/prognostic devices)
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study existence or effect size
• Standalone algorithm performance
• Type of ground truth used (for clinical outcomes)
• Sample size for the training set (for an AI/ML device)
• How ground truth for the training set was established

The document primarily describes bench mechanical testing and biocompatibility to demonstrate that the new device (Idys® ALIF 3DTi) is as safe and effective as its predicate devices, despite changes in material and manufacturing processes. It does not refer to a clinical study establishing performance against specific acceptance criteria in the manner typically seen for diagnostic AI/ML devices.

Here's an attempt to structure the available information relevant to the prompt, highlighting what is present and what is not:

Acceptance Criteria and Study for Idys® ALIF 3DTi Device

This 510(k) summary for the Idys® ALIF 3DTi focuses on demonstrating substantial equivalence to predicate devices (Idys® ALIF (K172083) and Idys® ALIF ZP 3DTi (K192168)) through performance data derived primarily from bench mechanical testing and biocompatibility assessments. The goal is to show that material and manufacturing changes do not raise new safety or effectiveness concerns compared to the already cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable for a clinical test set from this document. For mechanical testing, the sample sizes would be defined by the ASTM standards (F2077, F2267) but are not explicitly stated in this summary.
• Data Provenance: The mechanical and biocompatibility testing was performed by CLARIANCE, the manufacturer. The document does not specify a country of origin for a clinical test set, as no new clinical test set appears to have been generated for this 510(k). The clinical performance reference points to a "pivotal clinical study" previously conducted for the predicate device. The information is retrospective to the predicate's clearance regarding clinical data.

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

• This information is not applicable as the summary does not detail a clinical study with human readers to establish ground truth for a diagnostic or prognostic device. Ground truth for mechanical testing would be the measured physical properties against established standard requirements.

4. Adjudication Method for the Test Set

• Not applicable as no clinical images or diagnostic assessments requiring adjudication are part of this 510(k) summary for the Idys® ALIF 3DTi.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Improvement with AI vs. Without AI Assistance

• Not applicable. This is not an AI/ML device, and no MRMC study is mentioned.

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

• Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

• Mechanical Testing: Ground truth is based on the requirements and pass/fail criteria defined by the relevant ASTM standards (F2077, F2267) for various mechanical properties.
• Biocompatibility: Ground truth is based on the risk assessments and testing requirements of ISO 10993-1.
• Clinical Performance (reference to predicate): The "pivotal clinical study" for the predicate device would have established clinical outcomes data relevant to fusion, pain relief, and adverse events. The specific type of ground truth for that original study (e.g., radiographic fusion assessment, patient-reported outcomes) is not detailed here.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device that requires a training set.

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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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