Search Results

The DicaTM Direction Changeable Lumbar Cage System is indicated for interbody fusion with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have six months of non-operative treatment prior to surgery. The devices are intended to be used with supplemental fixation.

The Halis™ Lumbar Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1 whose condition requires use of interbody fusion combined with supplemental fixation. These DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have had six months of non-operative treatment prior to surgery. The Halis™ Lumbar Cage System is intended to be used with autogenous bone graft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are intended to be used with supplemental fixation. The devices may be implanted through several surgical approaches: transforaminal, posterior, oblique, and direct lateral. When implanted through the direct lateral approach, the Halis™ Lumbar Cage System is only indicated for use in levels L2-L5.

The KEYSTONE Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2 to S1 whose condition requires use of interbody fusion combined with supplemental fixation. DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the KEYSTONE Cage System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. Patients should have had six months of non-operative treatment prior to surgery. The KEYSTONE Cage System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. When used for these indications, the KEYSTONE PEEK Cage System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These implanted via a minimally invasive lateral approach.

The Lydia™ Anterior Lumbar Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. 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 implanted via a laparoscopic or an open anterior approach. The devices are intended to be used with supplemental fixation. This device is not intended for cervical spine use.

The Shanghai Sanyou Cage System (K163422) consists of four different models of fusion devices -- Caro™ Cervical Cage System, Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System – that are intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. These previously cleared devices consist of PEEK cages of various heights, widths and lengths, which can be inserted between two lumbar or cervical vertebral bodies to give support and correction during interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft material.

Additionally, the KEYSTONE Cage System (K211689) consists of lumbar intervertebral body fusion devices (IBDs), provided in parallel or lordotic options with varying footprints to accommodate patient anatomy. The subject KEYSTONE cages (IBDs) contain serrations across both superior and inferior surfaces to allow the implant to grip the superior and inferior end plates to provide expulsion resistance. These previously devices are manufactured from medical grade polyetheretherketone (PEEK) material per ASTM F2026 and contain radiopaque tantalum pin markers per ASTM F560 for imaging purposes. Implants are to be inserted via a crenel-lateral (CLIF) approach.

The subject submission seeks to add additively manufactured versions of all families in the Shanghai Sanyou Cage System, except the Caro™ Cervical Cage System, along with the KEYSTONE cages. The subject cages are similar to the previously cleared devices above with the exception that they are additively manufactured from titanium alloy (Ti6Al4V ELI) per ASTM F3001 and the finished product conforms to ASTM F2924. The subject additively manufactured implants (also referred to as "metal additive manufacturing cages" or "MAM") are provided sterile via gamma irradiation. The additively manufactured cages will also be offered in an extended size range.

The provided document is a 510(k) premarket notification decision letter and related information for intervertebral body fusion devices. It describes the devices, their indications for use, and a summary of the testing performed to demonstrate substantial equivalence to predicate devices.

However, the document does not contain specific acceptance criteria for a device's performance (e.g., a software algorithm or diagnostic tool) or a comparative study proving an AI device's performance. The performance testing mentioned (static/dynamic axial compression, static shear compression, and subsidence testing) are mechanical tests for the physical interbody fusion cages, not for an AI or software-based device.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, adjudication methods, or MRMC studies, as these concepts are not applicable to the physical intervertebral body fusion devices described in this document.

The document pertains to the clearance of physical medical devices (interbody fusion cages), not an AI or software device.

Ask a specific question about this device

The Zeus Spinal System is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studes); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor, pseuudarthrosis; and/or failed previous fusion.

In addition, when used as a pedicle screw fixation system, the Zeus Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion

The Zeus Spinal System is a modification of the previously cleared Adena-Zina Spinal System which consists of a variety of shapes and sizes of screws and Ø5.35mm rods that can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. Fixation is provided via a posterior approach. The components are made from titanium alloy or cobalt chrome alloy. Components of the system include the originally cleared (K152781) straight and pre-bent rods, fixed and fixed angle reduction screws, multi-axial reduction screws, T-links, domino connectors, sacro-illiac connectors, as well as the Duetto dual headed screws and connectors, along with associated set screws (K212066). The subject submission seeks to add new Ø5.5mm pre-bend rods, single head and dual head polyaxial (multi-axial) screws, dual head reduction screws, polyaxial reduction screws (fixed polyaxial fixed screws, dual head monoaxial (fixed) screws, cannulated reduction screws (multiaxial and monoaxial), coronal and sagittal uniplanar screws, preferable angle screws, iliac screws, monoaxial Screw, associated set screws, connector and Ø5.5mm crosslinks, as well as additional sizes of existing components and cobalt chrome tulips for associated screws.

The provided text describes a 510(k) premarket notification for the "Zeus Spinal System," a thoracolumbosacral pedicle screw system. This document focuses on demonstrating substantial equivalence to predicate devices through bench performance testing of the device itself (implants), rather than evaluating the performance of an AI/software component in a human-in-the-loop or standalone study with a ground truth established by experts.

Therefore, many of the typical acceptance criteria and study details relevant to AI/software device performance (e.g., sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission as described.

Here's a breakdown based on the provided text:

Subject of Evaluation: Physical medical device (spinal implants and their mechanical performance), not an AI/software algorithm.

Type of Study: Bench performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that performance bench testing was performed "per ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model" and "per ASTM F1798 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanism and Subassemblies Used in Spinal Arthrodesis Implants."

While the specific numerical acceptance criteria and reported performance values are not explicitly detailed in this public summary, the conclusion states: "performance bench testing had been performed and shows that the subject Zeus Spinal System performs equivalent to or better than the primary predicate device."

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

• Sample Size: Not specified in the document. For bench testing of physical devices, sample sizes are typically defined by engineering standards (like ASTM) to ensure statistical significance for mechanical properties.
• Data Provenance: Not applicable in the context of clinical data. This is mechanical testing of manufactured devices in a lab setting.

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

• Not applicable. Ground truth for mechanical device performance is established by standardized testing protocols and measurements, not by expert interpretation of clinical data or images.

4. Adjudication Method for the Test Set:

• Not applicable. No expert adjudication of clinical data is involved.

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 not an AI-assisted diagnostic or clinical decision support device.

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

• Not applicable. This is not an algorithm.

7. The Type of Ground Truth Used:

• Bench Testing Standards/Specifications: The "ground truth" for the device's mechanical performance is defined by the requirements outlined in the ASTM F1717 and ASTM F1798 standards, and comparison to the performance of the predicate device. These standards specify how the device should perform under various loads and conditions.

8. The Sample Size for the Training Set:

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

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

• Not applicable. No training set is involved.

In summary: The provided document is a regulatory submission for a physical medical device (spinal system) based on material and mechanical performance equivalency to predicate devices, conducted via standardized bench testing. It does not involve AI or software performance evaluation, and thus, metrics related to clinical data, expert review, or machine learning model performance are not relevant or present in this specific regulatory summary.

Ask a specific question about this device

The Adena-Zina System is intended for posterior, non - cervical fixation as an adjunct to fusion for skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. In addition, when used as a pedicle screw fixation system, the Adena-Zina System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilum), who are having the device removed after the attainment of a solid fusion.

The Adena-Zina Spinal System consists of a variety of shapes and sizes of screws and Ø5.5mm and Ø6.35mm rods that can be rigidly locked in a variety of configurations, with each construct being tailormade for the individual case. Fixation is provided via a posterior approach. The components are made from titanium alloy or cobalt chrome alloy. Components of the system include the originally cleared (K152781) straight and pre-bent rods, reduction screws, fixed angle reduction screws, multi-axial screws, multi-axial reduction screws, T-links, domino connectors, sacro-illiac connectors, as well as the Duetto dual headed screws and connectors, along with associated set screws (K212066). The subject submission seeks to add ZINA II screws to the Adena-Zina Spinal System, along with associated class I instruments.

This FDA 510(k) Premarket Notification document describes the Adena-Zina Spinal System and the addition of ZINA II screws to this system. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing.

There is no information in this document regarding AI/ML device performance, human reader studies, or the establishment of ground truth for such studies. Therefore, I am unable to provide the requested information related to acceptance criteria and studies that prove a device meets those criteria in the context of AI/ML.

The document pertains to the physical and mechanical aspects of a spinal implant system. The "Performance Testing" section describes bench tests performed on the ZINA II screws:

Acceptance Criteria and Reported Device Performance

Note: The document states "Performance bench testing has been performed and shows that the subject ZINA II screws perform equivalent to or better than the primary predicate device." The explicit numerical acceptance criteria and reported values are not detailed in this summary, but the conclusion confirms they were met.

Regarding the other requested information (sample size, experts, adjudication, AI performance, ground truth, training set):

The provided document describes a medical device called the "Adena-Zina Spinal System" and the addition of "ZINA II screws" to it. This is a hardware device (spinal implant), not an AI/ML-driven software device. Therefore, the concepts of "test set," "data provenance," "experts to establish ground truth," "adjudication method," "MRMC study," "standalone algorithm performance," "training set," and "ground truth for the training set" as they relate to AI/ML devices do not apply to this submission.

The "studies" conducted for this device were mechanical bench tests per ASTM F1717, comparing the physical performance of the new components to predicate devices.

Ask a specific question about this device

The KEYSTONE PEEK Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2 toS1 whose condition requires use of interbody fusion combined with supplemental fixation. DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the KEYSTONE PEEK Cage System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. Patients should have had six months of non-operative treatment prior to surgery. The KEYSTONE PEEK Cage System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion. When used for these indications, the KEYSTONE PEEK Cage System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These implanted via a minimally invasive lateral approach.

KEYSTONE PEEK Cage System consists of lumbar intervertebral body fusion devices (IBDs), provided in parallel or lordotic options with varying footprints to accommodate patient anatomy. The subject KEYSTONE cages (IBDs) contain serrations across both superior and inferior surfaces to allow the implant to grip the superior and inferior end plates to provide expulsion resistance. Subject devices are manufactured from medical grade polyetheretherketone (PEEK) material per ASTM F2026 and contain radiopaque tantalum pin markers per ASTM F560 for imaging purposes. The subject implants are to be inserted via a crenel-lateral (CLIF) approach.

The provided text is a 510(k) premarket notification from the FDA for a medical device called the "KEYSTONE PEEK Cage System," which is an intervertebral body fusion device.

This type of document does not typically contain information about algorithmic performance, studies involving human readers, or detailed ground truth methodologies. It focuses on demonstrating substantial equivalence to previously cleared devices through material properties, design, and bench testing, rather than clinical efficacy studies with specific performance metrics like sensitivity or specificity.

Therefore, many of the requested items (acceptance criteria for algorithmic performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth types) are not applicable or extractable from this document.

However, I can extract information related to the device itself and the type of testing performed.

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

The document does not specify quantitative acceptance criteria or detailed reported performance values (e.g., specific load resistance in Newtons) for the bench testing. It broadly states that "Testing shows that the subject KEYSTONE PEEK Cage System performs equivalent to or better than the predicate devices."

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. The testing mentioned is "Bench performance testing" on the device, not a study involving patient data or a "test set" in the context of an AI/algorithm evaluation.

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. This is a medical device clearance, not an AI/algorithm study. "Ground truth" in this context would refer to material and mechanical properties, not expert-labeled data.

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

This information is not applicable.

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

This information is not applicable. This document pertains to a physical medical implant, not an AI diagnostic tool.

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

This information is not applicable. This document pertains to a physical medical implant, not an algorithm.

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

For the "Bench performance testing" of a physical device, the "ground truth" would be established by standardized testing methods and measurement instruments, as per the specified ASTM standard (ASTM F2077-14 for dynamic axial compression). It is objective measurement of physical properties, not expert consensus or clinical outcomes data.

8. The sample size for the training set

This information is not applicable. This document pertains to a physical medical implant, not an AI model.

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

This information is not applicable. This document pertains to a physical medical implant, not an AI model.

Ask a specific question about this device

The Adena-Zina System is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

In addition, when used as a pedicle screw fixation system, the Adena-Zina System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.

The Adena-Zina System consists of a variety of shapes and sizes of screws, 5.5mm and 6.35mm rods, and other connecting components that can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. Fixation is provided via a posterior approach. All implant components are made from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3 or cobalt chrome alloy per ASTM F1537-11/ISO 5832-12.

The purpose of this submission is to add the Duetto dual headed Screws and connectors, along with associated set screws to the Adena-Zina Spinal System.

The provided text pertains to an FDA 510(k) premarket notification for the "Adena-Zina System," a thoracolumbosacral pedicle screw system. This document outlines the regulatory clearance process for a medical device and describes its intended use, materials, and a declaration of substantial equivalence to predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to an AI/ML algorithm or software functionality. The "Performance Testing" section only mentions bench testing for mechanical properties (static compression, static torsion, and dynamic axial compression) of the screws, as per ASTM F1717-18, which is standard for spinal implants, not for software performance or diagnostic accuracy.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them concerning AI/ML performance, because the provided input does not contain this information. The document focuses on the physical device and its mechanical properties.

Ask a specific question about this device

The Carmen plate and bone screw components are intended for anterior interbody screw fixation from C2-T1. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior spine during the development of spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, or scoliosis), 5) pseudoarthrosis, and/or 6) failed previous fusions.

Carmen anterior cervical cage component is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyste formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This cage is to be used in patients who have had six weeks of non-operative treatment. The Carmen™ cage must be used with supplemental fixation. The Carmen™ cage is also required to be used with autogenous bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach.

When used together, the Carmen components can be used only to treat cervical disc disease.

Shanghai Sanyou Carmen™ Cervical Fusion System includes cervical plates and screws and interbody cages to stabilize and promote bone fusion during the normal healing process following surgical correction of disorders of the cervical spine. The interbody device is available in 2 widths (12 mm and 14 mm) and 4 heights (4, 5, 6 and 7 mm) and is composed of PEEK. The interbody device is offered with only one lordosis angle; each size is available with 7° lordosis. The plate is available in small or large with an integrated locking screw. The self-tapping screw is available in 3.5 or 4.0 mm diameter screws either 13 mm, 15 mm or 17 mm in length.

This document is a 510(k) Premarket Notification from the FDA regarding the Shanghai Sanyou CARMEN Cervical Fusion System. It primarily focuses on the regulatory clearance process and equivalency to predicate devices, rather than detailed acceptance criteria and a study proving device performance in a statistical sense for an AI/algorithm.

Therefore, many of the requested sections (2-9) cannot be answered from the provided text as they pertain to studies typically performed for AI/algorithmic devices, which is not the nature of this submission. The "Performance Testing" section describes mechanical testing for a spinal implant, not an AI model.

Here's an analysis based on the provided text, focusing on what can be extracted:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" in this context refers to demonstrating that the CARMEN Cervical Fusion System performs as intended and is substantially equivalent to legally marketed predicate devices. The study proving this comes in the form of performance testing as required for spinal implants.

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

• Similar sizes, materials, and geometry of system components.
• Same indications for use.
• Mechanical testing results. |

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

This information is not provided in the document. For mechanical testing of physical devices, "sample size" would refer to the number of devices tested, and "data provenance" might relate to where the testing occurred, but these details are not present.

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

This is not applicable as this document describes a physical medical device (spinal fusion system) and its mechanical testing, not an AI/algorithmic device requiring expert ground truth for image interpretation or diagnosis.

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

Not applicable for a physical medical device's 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 is for a physical medical device, not an AI-assisted diagnostic tool.

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

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

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

For the mechanical performance testing, the "ground truth" would be the engineering specifications and performance standards established by organizations like ASTM, determined by the mechanical properties and failure points observed in testing. For substantial equivalence, the predicates' established safety and effectiveness are the reference.

8. The sample size for the training set

Not applicable. This is about mechanical testing of a physical device, not an AI/algorithm with a training set.

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

Not applicable. There is no training set for a physical device in this context.

Ask a specific question about this device

The Halis™ Lumbar Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1 whose condition requires use of interbody fusion combined with supplemental fixation. These DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have had six months of non-operative treatment prior to surgery. The Halis™ Lumbar Cage System is intended to be used with autogenous bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are intended to be used with supplemental fixation. The devices may be implanted through several surgical approaches: transforaminal, posterior, oblique, and direct lateral. When implanted through the direct lateral approach, the Halis™ Lumbar Cage System is only indicated for use in levels L2-L5.

The Caro™ Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to surgery. Caro™ Cervical Cage System implants are placed via an anterior approach and is to be used with autogenous bone graft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are intended to be used with supplemental fixation.

The Lydia™ Anterior Lumbar Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogence 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 implanted via a laparoscopic or an open anterior approach. The devices are intended to be used with supplemental fixation. This device is not intended for cervical spine use.

The Dica™ Direction Changeable Lumbar Cage System is indicated for interbody fusion with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous 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. Patients should have six months of non-operative treatment prior to surgery. The devices are intended to be used with supplemental fixation.

The Shanghai Sanyou PEEK Cage System consists of four different models of fusion devices:

• Caro™ Cervical Cage System
• Halis™ Lumbar Cage System
• Lydia™ Anterior Lumbar Fusion System
• . Dica™ Direction Changeable Lumbar Cage System

All components are made of polyetheretherketone (PEEK). All fusion devices are intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the cervical or lumbar spine. These Fusion Devices consist of PEEK cages of various heights, widths and lengths, which can be inserted between two lumbar or cervical vertebral bodies to give support and correction during intervertebral body fusion surgeries. All components have serrations on the superior and inferior surfaces of the implant to aid in fixation. The hollow geometry of the implants allows them to be packed with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Radiopaque Markers manufactured from unalloyed tantalum have been embedded within the implant to allow for visualization in radiographic images. Associated instruments are available to facilitate the implantation of device.

The provided document is a 510(k) premarket notification from the FDA for the Shanghai Sanyou PEEK Cage System. This document focuses on demonstrating substantial equivalence of a new medical device to existing predicate devices, rather than proving a device meets specific acceptance criteria through a clinical study or AI performance evaluation.

Therefore, the information you've requested regarding acceptance criteria, study details (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), and ground truth establishment is not typically found in this type of regulatory submission for a PEEK cage system.

A 510(k) submission for an intervertebral body fusion device primarily relies on non-clinical performance testing to demonstrate that the new device is as safe and effective as a legally marketed predicate device.

Here's what can be extracted and what cannot be from the provided text:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical endpoints, but rather compliance with recognized standards. The acceptance criteria essentially boil down to meeting or exceeding the performance of predicate devices in mechanical testing and adherence to relevant ASTM standards.
• Reported Device Performance:
  • Mechanical Testing: Static and dynamic axial compression, static shear compression, static torsion.
  • Subsidence Testing: Completed according to ASTM F2267-04.
  • Overall Conclusion: "Performance testing demonstrates that the subject device meets or exceeds performance of predicate devices demonstrating that the subject devices are substantially equivalent to the predicate devices."

This is how the performance is generally reported in this context, focusing on equivalence rather than specific performance metrics against a defined standard (e.g., 90% accuracy, 0.9 AUC).

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

• Not Applicable. This document describes mechanical performance testing of the device itself, not clinical testing on human subjects with a test set of data. The "test set" would be the physical devices subjected to the mechanical tests.
• Data Provenance: Not applicable for a clinical study, but the manufacturing facilities are in Shanghai, China.

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. No human experts were used for adjudication of a ground truth for a clinical dataset. The "ground truth" here is established by the relevant ASTM standards for mechanical properties.

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

• Not Applicable. There's no adjudication method described as it refers to mechanical testing by standard protocols, not expert consensus on clinical data.

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 physical medical device (PEEK cage), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are irrelevant to this submission.

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

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

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

• For the performance testing, the "ground truth" is defined by the ASTM standards (ASTM F2077-14 for mechanical tests and ASTM F2267-04 for subsidence testing) and the established performance characteristics of the legally marketed predicate devices. The device is considered to meet acceptance criteria if its mechanical properties meet or exceed those of the predicates and comply with the specified ASTM standards.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning device. The "training" for the device's design and manufacturing implicitly comes from engineering principles, material science, and the design history of similar predicate devices.

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

• Not Applicable. As there's no training set in the context of AI, there's no ground truth establishment for it. The standards and predicate device characteristics guide the design and testing process, but not in the sense of a "training set" ground truth.

In summary, the provided document is a regulatory submission for a physical implantable device (intervertebral body fusion cage), not an AI/software as a medical device. The "acceptance criteria" and "study" are described in terms of compliance with regulatory standards and mechanical performance testing demonstrating substantial equivalence to predicate devices, rather than clinical efficacy studies on patient data or AI algorithm performance tests.

Ask a specific question about this device

The Adena-Zina System is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

In addition, when used as a pedicle screw fixation system, the Adena-Zina System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.

The Adena-Zina System consists of a variety of a variety of shapes and sizes of screws and 5.5 and 6.35 rods that can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. Fixation is provided via a posterior approach. The components are made from titanium alloy or cobalt chrome alloy. Components of the system include straight and pre-bent rods, fixed angle reduction screws, multi-axial and multiaxial reduction screws, T-links, domino connectors, and sacro-illiac connectors.

This document describes a 510(k) premarket notification for the Adena-Zina System, a pedicle screw spinal system. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than presenting a novel clinical study with acceptance criteria in the way a new drug or a more complex diagnostic device might.

Therefore, the requested information about acceptance criteria and a study proving the device meets them, specifically regarding device performance and human interpretation, is not applicable in the context of this 510(k) summary for a pedicle screw spinal system. This document primarily describes mechanical performance testing against established standards.

However, I can extract and present the information that is available concerning performance testing and the comparison to a predicate device.

Summary of Device Performance Testing (Not Acceptance Criteria in the context of a clinical study for AI/diagnostic devices):

The Adena-Zina System underwent mechanical performance testing to demonstrate its substantial equivalence to a predicate device.

Regarding the specific questions posed:

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

   • As shown in the table above, the "acceptance criteria" here are defined by meeting or exceeding the performance of the predicate device for specified mechanical tests according to ASTM standards. There are no specific quantitative acceptance criteria listed in this summary, but rather a comparative statement.

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 provided. The testing described is mechanical bench testing of components, not clinical data from patients. The manufacturer is Shanghai Sanyou Medical Company, Limited (China).

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

   • Not applicable. This is mechanical testing against engineering standards, not expert-based clinical ground truth assessment.

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

   • Not applicable for mechanical bench 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 is a medical device (implantable system) for spinal fixation, not an AI software or diagnostic imaging device that involves human readers.

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 (expert concensus, pathology, outcomes data, etc):

   • The "ground truth" for this type of submission is adherence to recognized industry standards (ASTM F1717-12, ASTM F1798-13) and comparable performance to a legally marketed predicate device (Medtronic CD Horizon Spinal System, K123809).

8. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of mechanical performance testing for substantial equivalence for this type of device.

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

   • Not applicable.

In conclusion: The provided document is a 510(k) summary for an orthopedic implant. The "performance testing" described refers to mechanical bench testing conducted to demonstrate that the device is substantially equivalent to a predicate device in terms of engineering characteristics. It does not involve clinical studies, human readers, or AI algorithms typically associated with the "acceptance criteria" and "study" questions posed.

Ask a specific question about this device

The Katia System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fixation of the cervical spine (C2 – T1). The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) trauma (i.e. fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis, lordosis, or scoliosis), 6) pseudarthrosis, 7) failed previous fusions, and/or 8) spinal stenosis.

The Katia System includes implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical fusion. The Katia system consists of a variety of shapes and sizes of bone plates, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The components are made from titanium alloy.

The provided text describes the Katia System, a medical device for anterior interbody screw fixation of the cervical spine, and its 510(k) summary. However, the document does not contain the specific information required to complete the table and answer all the questions regarding "acceptance criteria" and "device performance" in terms of clinical or algorithmic efficacy. The provided text focuses on regulatory approval, device description, indications for use, and mechanical performance testing against ASTM standards.

Therefore, for aspects related to clinical or algorithmic performance, acceptance criteria, sample sizes for test/training sets, expert qualifications, and ground truth establishment, the information is not available in the given document.

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

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

• Acceptance Criteria: The text states "Testing was completed according to ASTM F1717-12 and Guidance for Industry and FDA Staff: Spinal System 510(k)s issued May 3, 2004." While these documents define acceptance criteria for mechanical performance, the specific criteria (e.g., specific load limits, displacement thresholds) and the device's reported performance against these criteria are not detailed in the provided text. The 510(k) summary typically includes a statement that the device met these standards, but not the raw data or specific values. Without access to the full test report, this information cannot be provided.
• Reported Device Performance: As above, specific quantitative performance data for mechanical tests (e.g., cyclic loading, static compression, screw pull-out strength) against the ASTM standard are not included in this summary.

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 available in the provided text. The document refers to mechanical testing, not a clinical study involving a "test set" of patient data in the context of AI/diagnostic device evaluation.

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 available in the provided text. This device is a surgical implant, and the approval detailed here is based on substantial equivalence to predicate devices and mechanical performance testing, not on a diagnostic or AI-driven evaluation that would require expert-established ground truth.

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

• This information is not available in the provided text. (See point 3).

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 available in the provided text. This type of study is relevant for diagnostic imaging AI, not for a spinal implant like the Katia System.

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

• This information is not available in the provided text. (See point 5).

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

• This information is not available in the provided text. The "ground truth" for a spinal implant's approval typically revolves around manufacturing quality, biocompatibility, and mechanical strength/durability demonstrated through laboratory testing, not medical image interpretation or clinical outcomes data in the way an AI diagnostic device would.

8. The sample size for the training set

• This information is not available in the provided text. (See point 5).

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

• This information is not available in the provided text. (See point 5).

Summary of available information related to performance testing:

• Performance Testing Method: Testing was completed according to ASTM F1717-12 and Guidance for Industry and FDA Staff: Spinal System 510(k)s issued May 3, 2004.
• Device Type: Spinal intervertebral body fixation orthosis (implant).
• Approval Basis: Substantial equivalence to predicate devices (K081038, K111132, K031276, K971883) and adherence to mechanical testing standards.

Conclusion:

The provided document details regulatory information and mentions mechanical performance testing standards but does not provide the specific acceptance criteria or reported device performance data for these tests, nor does it contain any information relevant to the evaluation of an AI-driven or diagnostic device (e.g., clinical test/training sets, ground truth establishment, expert adjudication, MRMC studies).

Ask a specific question about this device