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The BALTEUM™ and BALTEUM - ONE™ Lumbar Plate System are intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

The BALTEUM - ONE™ Lumbar Plate System consists of non-sterile, single use, rigid plates and bone screws of varying sizes and lengths to fit the anatomical needs of a wide variety of patients. The plate attaches by means of screws to the vertebral body of the thoracolumbar spine (T1-L5) either through an antero-lateral, or lateral approach and to the lumbar/lumbosacral spine (L1-S1) through an anterior approach. The system includes instrumentation which assists in the surgical implantation of the device.

This document is a 510(k) summary for the BALTEUM - ONE™ Lumbar Plate System. It describes the device, its intended use, and the studies performed to demonstrate its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, detailed study results, or information typically found in a clinical study report for evaluating performance in terms of diagnostic accuracy or similar metrics.

It focuses on non-clinical (mechanical) testing to demonstrate substantial equivalence for a medical implant device, not a diagnostic AI device. Therefore, many of the requested categories are not applicable to the information provided.

Here's an breakdown of the available information based on your request:

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

The document does not specify "acceptance criteria" in terms of statistical thresholds for diagnostic accuracy, sensitivity, specificity, etc. for a AI device. Instead, it states that "Non-clinical testing was performed to demonstrate that the subject BALTEUM - ONE™ Lumbar Plate System is substantially equivalent to the predicate device."

The reported performance is that the device "demonstrates that the BALTEUM - ONE™ Lumbar Plate System is substantially equivalent to the legally marketed predicate devices" based on the following tests conducted in accordance with ASTM F1717:

• Static compression
• Dynamic compression
• Static Torsion

A detailed table of acceptance criteria and specific numerical results for these mechanical tests is not provided in this summary. It only states that the device was found substantially equivalent based on these tests.

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

This information is not applicable and not provided. The testing described is non-clinical (mechanical) on the device itself, not on patient data.

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

This information is not applicable and not provided, as the study is not related to diagnostic accuracy or interpretation by experts.

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

This information is not applicable and not provided.

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 and not provided. This is a mechanical device, not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided.

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

For mechanical testing, the "ground truth" would be established by the physical properties and performance characteristics of the predicate devices under standardized testing conditions (ASTM F1717).

8. The sample size for the training set

This information is not applicable and not provided, as this is not an AI/machine learning study.

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

This information is not applicable and not provided, as this is not an AI/machine learning study.

In summary: This document is a regulatory submission for a physical medical device (spinal implant), not a diagnostic device or an AI product. Therefore, the details requested about acceptance criteria, study design for diagnostic accuracy, expert involvement, and ground truth for AI models are not present. The studies performed were non-clinical mechanical tests to demonstrate that the new device is "substantially equivalent" in its physical performance to already-approved predicate devices.

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The BALTEUM™ Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

The BALTEUM™ Lumbar Plate System consists of non-sterile, single use, rigid plates and bone screws of varying sizes and lengths to fit the anatomical needs of a wide variety of patients. The plate attaches by means of screws to the vertebral body of the thoracolumbar spine (T1-L5) either through an antero-lateral, or lateral approach and to the lumbar/lumbosacral spine (L1-S1) through an anterior approach. The system includes instrumentation which assists in the surgical implantation of the device.

The provided FDA 510(k) summary for the BALTEUM™ Lumbar Plate System describes a spinal implant and therefore does not concern an AI/ML powered medical device. As such, the requested information regarding acceptance criteria, study details, and AI/ML model performance is not applicable to this document.

The document focuses on non-clinical testing for substantial equivalence to predicate devices, which is typical for traditional hardware implants.

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The AEON-C™ Stand Alone System is a stand-alone anterior cervical intervertebral fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C™ Stand Alone System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach.

Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device.

The AEON-C™ Stand Alone System includes PEEK interbodies and titanium interbodies, which utilize a titanium alloy locking mechanism that is either integrated in an anterior fixation plate or within the interbody. Both PEEK interbodies and titanium interbodies, with or without fixation plates, are to be anchored to patient anatomy via two (2) titanium alloy bone screws. The implant design includes multiple footprints, heights and lordosis options and the screw design includes multiple diameters and lengths, to fit a variety of patient anatomies.

The provided text describes the 510(k) summary for the HUVEXEL Co., Ltd's AEON-C™ Stand Alone System. This is a medical device for orthopedic surgery, specifically for intervertebral fusion, and the information presented is related to its mechanical performance and substantial equivalence to existing devices, not an AI/ML algorithm.

Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth used, sample size for training set, and ground truth for training set) are not applicable to this type of device and study.

However, I can provide the acceptance criteria and reported device performance from a mechanical testing perspective, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Description of the Study that Proves the Device Meets Acceptance Criteria:

The study conducted to demonstrate the AEON-C™ Stand Alone System meets acceptance criteria was a non-clinical performance testing study. This study aimed to show that the subject device is substantially equivalent to legally marketed predicate devices.

Specifics of the Study:

• Type of Study: Non-clinical (mechanical) testing.
• Standards Followed: The testing was performed in accordance with ASTM F2077 (Standard Test Methods for Determining Durability of Intervertebral Body Fusion Device Materials and Constructs in a Corpectomy Model) and ASTM F2267 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression).
• Tests Performed:
  • Static & Dynamic compression
  • Static & Dynamic compression shear
  • Static & Dynamic Torsion
  • Subsidence
  • Expulsion
• Objective: To demonstrate that the AEON-C™ Stand Alone System is as safe, as effective, and performs as well as, or better than, the legally marketed predicate devices.
• Conclusion: The non-clinical tests demonstrated that the device is substantially equivalent to the predicate devices.

2. Sample Size used for the test set and the data provenance:

• Test Set Sample Size: Not applicable. This was mechanical testing of the device, not a study involving patient data or a "test set" in the context of AI/ML. The sample size would refer to the number of physical devices tested, but this detail is not provided in a 510(k) summary for mechanical testing as it is assumed to be adequate for the standards.
• Data Provenance: Not applicable, as this refers to mechanical testing results, not clinical data or data from a specific country of origin.

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. Ground truth as defined in this request (expert consensus, pathology) is relevant for clinical or diagnostic AI/ML studies. This study is mechanical performance testing against established engineering standards. The "ground truth" here is the performance metrics defined by the ASTM standards.

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

• Not applicable. Adjudication methods are used in studies where human judgment is involved in establishing ground truth for a clinical or diagnostic outcome. This was mechanical testing.

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

• Not applicable. This applied to AI/ML devices, not a physical intervertebral fusion device.

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

• Not applicable. This applies to AI/ML algorithms. The device itself is described as a "Stand Alone System" in the sense that it is a physical implant, but not in the context of an AI algorithm operating independently.

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

• Mechanical Performance Standards: The "ground truth" for this device's performance is compliance with established engineering and biocompatibility standards (e.g., ASTM F2077, ASTM F2267) and substantial equivalence to predicates as demonstrated through comparative mechanical testing and material characterization.

8. The sample size for the training set:

• Not applicable. This applies to AI/ML algorithms, not mechanical device testing.

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

• Not applicable. This applies to AI/ML algorithms, not mechanical device testing.

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The FaSet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of facet joints. The FaSet Screw Systems is indicated for posterior surgical treatment with or without bone graft at single or multiple levels from C2 to S1 (inclusive). For transfacet fixation, the screws are inserted posterior through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the superior side of the facet, across the facet joint, and into the pedicle. The FaSet Fixation System is indicated for any or all of the following:
· Spondylolisthesis
· Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity
· Spondylolysis
· Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability
· Trauma including spinal fractures and/or dislocations

The FaSet Fixation System consist of permanent implant devices manufactured from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, and F136. Various sizes and lengths of these implants are available to accommodate patient anatomy. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved.

This document is a 510(k) premarket notification from the FDA for the FaSet Fixation System, a medical device used for spinal fusion. It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices through mechanical testing and does not contain information about software or AI-based performance criteria, clinical study results with human readers, or ground truth establishment relevant to AI/ML device evaluations.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML device. The provided text is solely about a physical implant device and its mechanical performance.

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The UNITY Sacroiliac Joint Fixation System is indicated for use in skeletally mature patients for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The UNITY Sacroiliac Joint Fixation System consists of screws designed to enhance sacroiliac joint fusion. The UNITY Sacroiliac Joint Fixation System is offered in various diameters, lengths, and three screw types in cannualated form to accommodate patient anatomy. The three design types of the subject device are:

1. Standard Thread Screw (with and without slots)
2. Lag Screw (with and without slots) and
3. Washer Screw (with slots)

The provided text is a 510(k) premarket notification for the UNITY Sacroiliac Joint Fixation System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the way a diagnostic AI might.

Therefore, many of the requested fields regarding acceptance criteria and study details for an AI-based device are not directly applicable or available in this document. The document describes mechanical performance testing and biocompatibility.

Here's an analysis based on the provided text:

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

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

The document does not specify the exact sample sizes used for the mechanical tests. It states that "Three motion and stress tests were performed" and lists four tests, implying a set of samples for each test type. The data provenance is implied to be from the manufacturer (Huvexel Co., Ltd. in South Korea) through their testing activities. The nature of these tests (mechanical stress and motion) is inherently prospective as new devices would be manufactured and tested.

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 field is not applicable. The device is a physical implant, not a diagnostic AI system requiring expert interpretation for ground truth. The "ground truth" for the mechanical performance is defined by the standards and the physical properties observed during testing.

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

This field is not applicable. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies, not for mechanical device testing. The assessment of mechanical performance is based on adherence to engineering standards and observed physical behavior.

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 field is not applicable. The UNITY Sacroiliac Joint Fixation System is a physical implant, not an AI-assisted diagnostic tool.

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

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

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

For biocompatibility, the ground truth is established by referencing the prior FDA clearance of the Rexious Spinal Fixation System (K111362) which used similar materials, manufacturing processes, and sterilization. This is a form of historical data/pre-established safe use.

For mechanical testing, the ground truth is established by engineering standards (ASTM F2193-14 and ASTM F543-17) which define acceptable ranges and behaviors for the specified tests. The "functioned as intended" and "stability observed as expected" implies meeting these standards.

8. The sample size for the training set

This field is not applicable. The device is a physical implant, not an AI model requiring a training set.

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

This field is not applicable. The device is a physical implant, not an AI model.

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The Rexious Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Rexious Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists fixation system which consists of pedicle screws, rods, set screws, connectors, and transverse (cross) linking mechanisms.

The Rexious Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Rexious implant components are supplied non-sterile, single use and fabricated from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, F136, and F1295 and from Cobalt-Chromium-Molybdenum (CoCr) as specified in ASTM F1537. Various sizes of these implants are available.

This document describes a spinal fixation system, not an AI device. As such, the typical acceptance criteria and study designs relevant to AI (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) are not applicable here.

Instead, the document details the Rexious Spinal Fixation System, a medical device subject to FDA 510(k) clearance. The "acceptance criteria" for such a device are primarily demonstrated through substantial equivalence to a predicate device, supported by performance testing and engineering analysis.

Here's an interpretation of the request in the context of this device:

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

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

• Sample Size: The document does not specify a "sample size" in the context of clinical data for a "test set" as one would for an AI algorithm. Instead, it refers to the addition of components and various sizes of these implants. The testing (ASTM F1717) would have been performed on a statistically relevant number of samples of each component or construct configuration to demonstrate mechanical properties. The exact number of samples for each test (e.g., how many rods of each length, how many screws of each size) is not explicitly stated in this summary.
• Data Provenance: Not applicable in the context of clinical data as no clinical study is described for this 510(k) submission. The data provenance refers to material testing and engineering analysis.

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

• Not applicable. This device's clearance is based on mechanical performance testing and substantial equivalence, not on expert-adjudicated clinical "ground truth" data sets like an AI model would require.

4. Adjudication method for the test set:

• Not applicable. There is no human adjudication of a "test set" in the context of this device. Mechanical tests have objective pass/fail criteria based on standards (e.g., ASTM F1717).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, often with or without AI assistance. This is a spinal fixation system, not a diagnostic imaging or AI device.

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

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

• For a spinal fixation system, the "ground truth" for performance is typically established by:
  • Material specifications: Adherence to recognized ASTM standards for implant materials (e.g., ASTM F67, F136, F1295, F1537).
  • Mechanical test standards: Performance meeting the requirements of established international standards for spinal implants (e.g., ASTM F1717 for static and dynamic compression bending). These standards define the expected mechanical behavior and failure modes.
  • Engineering analysis: Demonstrating that design changes (like new rod lengths or materials) do not introduce new "worst-case" scenarios or negatively impact performance compared to the predicate.

8. The sample size for the training set:

• Not applicable. This is a medical device (hardware), not an AI algorithm, so there is no "training set."

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

• Not applicable. As above, there is no "training set" for this type of device.

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The FORTIS and HANA Anterior Cervical Plate System is intended for anterior fixation to the cervical spine C2-C7. The specific clinical indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The FORTIS and HANA Anterior Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, lock-plate and the associated instruments. The lock-plate is pre-assembled to the main plate and designed to prevent screws from backing out. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy. The plates range in length to accommodate one and two-level procedures for HANA and one, two, three, and four level procedures for FORTIS. Main plate is available from 13mm to 46mm for HANA and 10mm to 112mm for FORTIS. Screws are available in lengths from 12mm to 20mm for HANA and 10mm to 20mm in 2mm increments for FORTIS. The screws have either a 4.5mm or 5.1mm diameter for HANA and 4.0mm or 4.5mm diameter for FORTIS. They are fixed self-tapping, variable self-tapping screw, fixed self-drilling screw, variable self-drilling. The FORTIS and HANA Anterior Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium allow (Ti-6Al-4V ELI) that conforms to ASTM F136.

This document is related to a 510(k) premarket notification for a medical device called the "Fortis and Hana Anterior Cervical Plate System." This is a spinal implant, and the FDA letter indicates that the device has been found substantially equivalent to previously marketed devices.

Based on the provided text, the document describes performance testing for mechanical properties, not a clinical study involving human readers or AI. Therefore, most of the requested information regarding acceptance criteria and a study proving a device meets acceptance criteria as typically understood for AI/ML radiology devices is not present.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "Mechanical testing (Static compression bending, Dynamic compression bending, and Static torsion test) in accordance with the ASTM 1717 was performed." However, it does not provide specific acceptance criteria values or the reported performance values from these mechanical tests. It only states that the testing was done and that the device was found substantially equivalent, implying that it met the necessary performance standards to be considered equivalent to the predicate devices.

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

Not applicable. This was mechanical testing, not a study on a test set of data (e.g., medical images). The testing was performed on the physical device components.

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

Not applicable. Ground truth, in the context of AI/ML, refers to labels or diagnoses provided by experts. This document describes mechanical testing of a physical implant.

4. Adjudication Method:

Not applicable for a mechanical test.

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

Not applicable. This is not an AI/ML device for diagnostic interpretation.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is not an AI/ML algorithm.

7. Type of Ground Truth Used:

For this type of device, the "ground truth" for mechanical testing would be the engineering specifications and performance values derived from validated test methods (e.g., ASTM F1717). The document implies that the device met these engineering standards by stating "Mechanical testing (Static compression bending, Dynamic compression bending, and Static torsion test) in accordance with the ASTM 1717 was performed" and that the device was found "substantially equivalent."

8. Sample Size for the Training Set:

Not applicable. This is a physical implant, not an AI/ML model that requires a training set.

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

Not applicable.

Summary of Device and Study Information:

• Device: FORTIS and HANA Anterior Cervical Plate System (spinal intervertebral body fixation orthosis)
• Purpose: Anterior fixation to the cervical spine C2-C7 for various indications (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumor, pseudoarthrosis, failed previous fusion).
• Study Type: Mechanical testing.
• Tests Performed: Static compression bending, Dynamic compression bending, and Static torsion test.
• Standard Followed: ASTM F1717.
• Result: The device demonstrated substantial equivalence to predicate systems based on technical characteristics, performance, and intended use, implying it met the necessary mechanical performance criteria.

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

The IVA Cage (PLF, TLIF, DLIF, Ti PLIF, Ti TLIF, Ti DLIF and Ti ALIF) are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level of two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The IVA Cage Ti (ACIF, PLIF, TLIF, DLIF and ALIF) is intended for intervertebral body fusion in skeletally mature patients. The intended operation of these devices are concentrated around disc levels from the C2-C3 to the C7-T1 for the cervical spine, and from L2 to S1 for the lumbar spine.

The provided text does not contain information about the acceptance criteria and performance of a device based on a study with AI in the loop. The document is a 510(k) premarket notification for an intervertebral body fusion device (IVA Cage Ti) and focuses on demonstrating substantial equivalence to a legally marketed predicate device.

The document discusses:

• Device Name: IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)
• Regulation Number: 21 CFR 888.3080
• Regulatory Class: Class II
• Product Code: MAX, ODP
• Indications for Use: Intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical and lumbar spine, with specific disc levels mentioned.
• Performance Data: States "The addition of components to the system did not introduce a new worst case construct as evaluated based on an engineering analysis. Dynamic axial compression test per ASTM F2077 was performed."
• Predicates: IVA (ACIF, PLIF, TLIF, DLIF, and ALIF) Cage (K162220) and SUSTAIN® & SUSTAIN® - R (K130478).
• Substantial Equivalence Determination: Based on technical characteristics, performance, and intended use to the predicate system(s).

There is no mention of:

• Acceptance criteria for an AI-powered device.
• A study evaluating AI performance (standalone or with human-in-the-loop).
• Sample sizes for test or training sets related to AI.
• Experts or ground truth establishment for AI.
• MRMC comparative effectiveness study or related effect sizes.

Therefore, I cannot provide the requested information based on the given input text.

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