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The Reliance Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system devices are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The Reliance Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerative disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Reliance Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.

The Reliance Cervical IBF System is comprised of implant and instrument components. The implant component, the Reliance Cervical IBF device, is a spacer which inserts between vertebral bodies in the anterior column of the cervical spine. The subject Reliance Cervical IBF spacer is additively manufactured from Titanium 6A1-4V ELI as specified in ASTM F3001, with predicate spacers manufactured from PEEK Optima LT1 or PEEK Optima LT1-HA.

This document is a 510(k) Summary for a medical device called the "Reliance Cervical IBF System." It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices. Crucially, the document does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with clinical performance or efficacy studies.

Instead, the "Performance Data and Substantial Equivalence" section refers to engineering and manufacturing performance testing to demonstrate that the new device, which has a material modification (Titanium 6Al-4V ELI) compared to its predicates (PEEK Optima LT1 or PEEK Optima LT1-HA), is still substantially equivalent to the predicates. Therefore, many of the requested categories cannot be filled from this document as they pertain to clinical or diagnostic performance studies, which are not described here.

Here's an attempt to answer the questions based only on the provided text, acknowledging that much of the requested information regarding "acceptance criteria" and "study proving the device meets acceptance criteria" in a clinical performance context is not present.

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

The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy, or clinical success rates). Instead, it refers to compliance with engineering and manufacturing standards. Therefore, a table of clinical acceptance criteria and reported device performance cannot be generated from this text. The performance data mentioned relates to demonstrating substantial equivalence for engineering properties.

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 performance data described are related to engineering and manufacturing tests, not clinical test sets.

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 provided as there is no description of a clinical test set requiring expert ground truth.

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

This information is not provided as there is no description of a 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

There is no mention of an MRMC study or AI in this document. This device is an intervertebral body fusion system, not an AI/imaging diagnostic device.

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

This 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)

This information is not provided as there is no description of a clinical test set requiring ground truth. The "ground truth" for the engineering tests would be the specifications outlined in the referenced ASTM/ISO standards.

8. The sample size for the training set

This information is not provided as there is no mention of a training set, which is typically associated with AI/machine learning models or studies involving clinical data for training.

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

This information is not provided as there is no mention of a training set or how its ground truth would be established.

Summary regarding the device and the document:

This 510(k) summary focuses on demonstrating "substantial equivalence" of a modified medical device to existing, legally marketed predicate devices. The modification is primarily a change in material for the intervertebral body fusion spacer, from PEEK to Titanium 6A1-4V ELI.

The "study that proves the device meets the acceptance criteria" in this context refers to a battery of engineering and manufacturing tests (mechanical, packaging, cleaning, sterilization, biocompatibility) conducted according to recognized ASTM and ISO standards. The "acceptance criteria" are implied to be the successful compliance with these standards, demonstrating that the new material does not negatively impact the device's fundamental safety and effectiveness compared to the predicate, making it substantially equivalent.

The document does not describe any clinical trials, performance studies, or efficacy studies involving human subjects or clinical data in the form requested to directly assess performance metrics like sensitivity, specificity, or clinical outcomes. For intervertebral body fusion devices in the 510(k) pathway, such extensive clinical performance studies are often not required if substantial equivalence can be demonstrated through other means (e.g., material testing, biomechanical testing, and comparison of design/indications to predicates).

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The Reliance Spinal Screw System is a pedicle screw system 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 (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis). The Reliance Spinal Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft and having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used posteriorly, the Reliance Spinal Screw System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for: spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

The Reliance Spinal Screw System, when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

When used in a percutaneous, posterior approach with MIS instrumentation, the Reliance Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion in skeletally-mature patients.

The Posterior Reliance Spinal Screw System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, cannulated polyaxial screws, cannulated reduction screws, hooks, reduction hooks, set screws and transverse connectors.

The Anterior Reliance Spinal Screw System consists of spinal rods, monoaxial screws, staples, and set screws. The Anterior Reliance staples and screws are intended to the lateral aspect of the vertebral bodies from T5 to L4, and SHOULD NOT be attached to the anterior aspect. Furthermore, only Titanium components should be used anteriorly. (See Precautions section)

The Reliance Spinal Screw System components are available in titanium alloy conforming to ASTM F-136 specifications as well as stainless steel conforming to ASTM F-138 specifications. Furthermore, various rods of the Reliance Spinal Screw System are available in Cobalt-Chrome conforming to ASTM F-75 and ASTM F-1537 specifications. Components of the differing diameter rod systems are NOT interchangeable. The components of one material should not be used with components of another material, with the exception that the Cobalt-Chrome rods may be used with titanium alloy implants. The extension tabs on the reduction screw and hook components are intended to be removed intraoperatively.

The subject Reliance Spinal Screw offers two new fenestrated screw systems (single and circumferential) for use with saline or radiopaque dye only, a percutaneous screw system, and two barend rod systems. These additions will be available in similar sizes, material and configurations as the currently approved Reliance Spinal Screws.

This document is a 510(k) Premarket Notification from the FDA regarding the Reliance Spinal Screw System. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study to prove acceptance criteria for a new device's performance. Therefore, the requested information, which pertains to studies demonstrating a device's performance against defined acceptance criteria (common for AI/ML or diagnostic devices), is largely not applicable in this context.

However, I can extract the relevant information regarding acceptance criteria in the form of substantial equivalence and the type of data presented to support that equivalence.

Here's an analysis based on the provided text:

Device: Reliance Spinal Screw System

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

Since this is a 510(k) submission for a spinal screw system, the "acceptance criteria" are primarily related to substantial equivalence to predicate devices in terms of design, materials, intended use, and mechanical performance. There isn't a performance table in the typical sense of a diagnostic or an AI/ML device (e.g., sensitivity, specificity).

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

• Sample Size for Test Set: Not applicable. There is no "test set" in the context of clinical performance evaluation for this type of device in this document. The mechanical testing was done on the predicate device, and the current device is deemed to not require new testing due to no new worst-case scenario.
• Data Provenance: Not applicable for a typical clinical test set. The data cited are from non-clinical mechanical testing standards (ASTM F1717) applied to the predicate device. The information is retrospective in the sense that it relies on prior testing of the predicate.

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

• Not applicable. There is no "ground truth" established by experts in the context of a clinical test set from this document. The assessment is based on engineering principles, materials science, and regulatory comparison.

4. Adjudication method for the test set:

• Not applicable. No clinical test set requiring adjudication is described.

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 a diagnostic device or an AI-assisted 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:

• The "ground truth" in this context is implicitly the historical safety and effectiveness of the identified predicate devices as demonstrated by their prior FDA clearance and adherence to recognized mechanical testing standards (ASTM F1717). This is a regulatory "ground truth" for substantial equivalence.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device so there is no training set.

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

• Not applicable. No training set is described.

In summary: This 510(k) submission for the Reliance Spinal Screw System demonstrates substantial equivalence to predicate devices primarily through non-clinical assessment of design, materials, and existing mechanical testing data from the predicate device, rather than presenting a performance study against specific acceptance criteria for a new clinical performance claim.

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The Reliance Lumbar IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The Reliance Lumbar IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, 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 lumbar device is to be used in patients who have had six months of non-operative treatment.

The Reliance Lumbar IBF System is comprised of implant and instrument components. The implant component, the Reliance Lumbar IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the lumbar spine. The spacer is either made of PEEK OPTIMA LT1 with Tantalum markers or with PEEK OPTIMA LT1-HA with Tantalum markers.

The provided document is a 510(k) summary for the Reliance Lumbar IBF System, which is an intervertebral body fusion device. This type of regulatory submission usually does not include detailed studies on software performance or AI algorithms, as it primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device based on material, intended use, and mechanical/performance testing for the physical device itself.

Therefore, the information requested about acceptance criteria and studies proving the device meets those criteria, particularly pertaining to AI or software performance, is not present in this document. The document describes non-clinical testing for the physical implant components, specifically Finite Element Analysis to assess the effect of new sizes on structural properties, and sterilization validation.

Here's a breakdown of why the requested information cannot be provided from this document:

1. A table of acceptance criteria and the reported device performance: This document only states that "Finite Element Analysis has been carried out to access the effect of new sizes on the structural properties of the implant. Test results show the new components are not the new worst case when compared to the approved Reliance Lumbar IBF PEEK, 1-04-XXX, per K113540." It does not provide specific acceptance criteria or quantitative performance data from this analysis.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set sample size or data provenance is mentioned, as the testing described is primarily mechanical/structural analysis, not software validation on clinical 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): Not applicable, as this is not a study involving expert-derived ground truth for software or AI.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the type of testing described.

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 is for a physical medical implant, not an AI or imaging diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm or AI component described.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for the type of testing described (mechanical testing).

8. The sample size for the training set: Not applicable. No AI training is described.

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

In summary, this 510(k) submission relates to a physical intervertebral body fusion device and not a software or AI-powered medical device. Therefore, the detailed information about AI-related acceptance criteria, studies, and data provenance is not relevant to this document and is not present.

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The Reliance Lumbar IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level. Additional supplemental fixation is not necessary for the Lumbar IBF-S if the integrated screws are implanted.

The Reliance Lumbar IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, 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 lumbar device is to be used in patients who have had six months of non-operative treatment.

The Reliance Lumbar IBF System is comprised of lumbar intervertebral body fusion devices and associated surgical instruments. This submission adds a line extension, the Reliance Lumbar IBF-S devices, which consist of spacers made of PEEK Optima LT1 with Tantalum markers, and integrated screws, faceplates, and locking plates manufactured from titanium alloy.

The provided text describes a medical device, the Reliance Lumbar IBF System, and its regulatory clearance process (510(k)). It does not include details about acceptance criteria, device performance metrics, or any clinical studies involving human readers or AI algorithms. The "Performance Data and Substantial Equivalence" section only mentions mechanical testing performed on the device to establish substantial equivalence to predicate devices, focusing on physical properties rather than diagnostic performance.

Therefore, I cannot extract the requested information from the provided text as it is not present. The document focuses on regulatory approval based on substantial equivalence to existing medical devices, not on the diagnostic performance or AI-assisted interpretation of medical images.

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The Reliance LUMBAR IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The Reliance LUMBAR IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels int he lumbar spine, from L2 to S1, for the treatment of degenerative dise 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 radios. The lumbar device is to be used in patients who have had six months of non-operative treatment.

The Reliance Lumbar IBF System is comprised of implant and instrument components. The implant component, the Reliance Lumbar IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the lumbar spine. The spacer is either made of PEEK OPTIMA LT1 with Tantalum markers or with PEEK OPTIMA LT1-HA with Tantalum markers.

The provided text appears to be a 510(k) summary for a medical device called the "Reliance Lumbar IBF System." This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific clinical performance acceptance criteria in the way a diagnostic AI model might.

Therefore, much of the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies is not applicable to this document as it describes a structural intervertebral body fusion device, not a diagnostic algorithm.

The document primarily focuses on demonstrating substantial equivalence through non-clinical testing (mechanical and material properties) and comparison to predicate devices, rather than clinical efficacy involving human readers or AI.

Here's an attempt to answer the applicable questions based on the provided text:

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

This information is not presented in a table format in the document, nor are there explicit "acceptance criteria" for clinical performance in the sense of accuracy, sensitivity, or specificity for a diagnostic device. The document states that the "design verification testing results were equivalent to the identified predicate device" and "results show that the subject implants do not create a new worst case condition for mechanical testing, performance testing, sterilization, biocompatibility, cleaning or packaging."

The non-clinical testing involved various ASTM Standard tests and Finite Element Analysis (FEA).
The acceptance criterion for the FEA was that the new components "are not the new worst case when compared to the approved Reliance Lumbar IBF component."

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 device is an implantable medical device, and the testing described is non-clinical (mechanical, material, and sterilization). There are no "test sets" of patient data in the context of an AI or diagnostic study.

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 not a diagnostic device requiring expert interpretation of results. The "ground truth" for non-clinical testing would be the physical properties and performance metrics measured according to established engineering standards.

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

Not applicable. There is no "test set" or adjudication method in the context of clinical interpretation for this device.

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 device is 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 device is not an algorithm.

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

For the non-clinical testing, the "ground truth" would be established by:

• ASTM Standard Tests: Results measured according to specific, recognized engineering standards for material strength, fatigue, etc.
• Predicate Device Performance: The established mechanical and performance characteristics of the legally marketed predicate devices (K113540, K160463 & K173283).

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of device and testing.

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

Not applicable.

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The Reliance Lumbar IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The Reliance Lumbar IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative 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 lumbar device is to be used with patients who have had six months of non-operative treatment.

The Reliance Lumbar IBF System, originally cleared by FDA in K113540, is intended to be used as an intervertebral body fusion device. Reliance Lumbar IBF device is a spacer, which inserts between vertebral bodies in the anterior column of the thoracic and lumbar spine. The device is surgically implanted between vertebral bodies from an anterior, lateral, or posterior surgical approach. The Reliance Lumbar IBF device will be manufactured from PEEK. The PEEK device also contains Tantalum wires to aid in fluoroscopic visualization. The construct is not intended to be employed as a standalone device. The Reliance Lumbar IBF is to be used with supplemental fixation in all applications.

The provided text describes a 510(k) premarket notification for the "Reliance Lumbar IBF System" and does not contain information related to an AI/ML powered device, nor does it present acceptance criteria or a study proving device performance as typically expected for such devices.

The document is for an intervertebral body fusion device and outlines its indications for use, technological modifications (additional implant sizes and instruments), and claims substantial equivalence to a predicate device. The conclusion is based on a risk analysis and design verification testing, not on a clinical study evaluating diagnostic or prognostic performance of an AI/ML algorithm.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set size, as this information is not present in the provided context.

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The RELIANCE CERVICAL IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The RELIANCE CERVICAL IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The RELIANCE CERVICAL IBF System is to be used in patients who have six weeks of non-operative treatment.

The Reliance Cervical IBF System is comprised of implants and instrument components. The implant component, the Reliance Cervical IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the cervical spine. The spacer is made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The Reliance Cervical IBF System also includes bone screws to secure the device to the vertebral body.

This document is a 510(k) Premarket Notification from the FDA regarding the "Reliance Cervical IBF System." It is primarily a regulatory approval document and does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria in the format requested for AI/medical device performance evaluation.

The document pertains to an intervertebral body fusion device and confirms its substantial equivalence to previously marketed predicate devices (K120396, K131429, K142269 & K172489). The "Non-Clinical Testing" section mentions that the system has undergone mechanical testing according to ASTM standards (ASTM F-2077, ASTM F-2267, and ASTM Draft F-04.25.02.02). However, it does not provide specific acceptance criteria or performance results from these tests. These are standard tests for mechanical integrity of implants, not for AI performance.

Therefore, I cannot provide the requested information as it is not present in the provided text. The questions regarding sample size, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, and training set information are all relevant to the evaluation of AI models or diagnostic devices, which this document does not describe. This is a physical implant device, not an AI or diagnostic software.

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The Reliance Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The Reliance Cervical IBF and Reliance Cervical IBF-HA implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The Reliance Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical disc disease (defined at neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Reliance Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.

The Reliance Cervical IBF System is comprised of implant and instrument components. The Reliance Cervical IBF, the implant component, is a spacer which inserts between vertebral bodies in the anterior column of the cervical spine. The Reliance Cervical IBF spacer is either comprised of PEEK Optima HA with Tantalum markers, or from PEEK Optima LT1 with Tantalum markers. The Reliance Cervical IBF-S spacer (PEEK Optima LT1 or PEEK Optima HA) also incorporates screws to better fixate and stabilize the spine. These screws are manufactured from Titanium alloy as described by ASTM F-136. The device is intended for interbody fusion in the cervical spine and to aid in the surgical correction and stabilization of the spine.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance in the context of an AI/human reader comparative effectiveness study, standalone algorithm performance, ground truth establishment, or sample sizes for training and testing sets.

The document is a 510(k) premarket notification for the "Reliance Cervical IBF System," which is an implantable medical device for intervertebral body fusion. The FDA review letter and the 510(k) summary describe the device's classification, indications for use, substantial equivalence to a predicate device, and technological modifications (specifically, additional sizes for existing implant designs).

The critical information you requested, such as performance metrics, study design, or expert involvement, is not present in this regulatory submission for an implantable hardware device. Such information would be typical for AI-powered diagnostic or screening tools.

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The Reliance Spinal Screw System is a pedicle screw system 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis). The Reliance Spinal Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used posteriorly, the Reliance Spinal Screw System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis, and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar, and sacral spine.

The Reliance Spinal Screw System when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

When used in a percutaneous, posterior approach with MIS Instrumentation, the Reliance Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The Posterior Reliance Spinal Screw System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, cannulated polyaxial screws, cannulated reduction screws, hooks, reduction hooks, set screws and transverse connectors. The Anterior Reliance Spinal Screw System consists of spinal rods, monoaxial screws. staples, and set screws. The Anterior Reliance staples and screws are intended to be attached to the lateral aspect of the vertebral bodies from T5 to L4, and SHOULD NOT be attached to the anterior aspect. Furthermore, only Titanium components should be used anteriorly. (See Precautions section)

The Reliance Spinal Screw System components are available in titanium alloy conforming to ASTM F-136 specifications as well as stainless steel conforming to ASTM F-138 specifications. Furthermore, various rods of the Reliance Spinal Screw System are available in Cobalt-Chrome conforming to ASTM F-75 and ASTM F-1537 specifications.

Components of the differing diameter rod systems are NOT interchangeable. The components of one material should not be used with components of another material, with the exception that the Cobalt-Chrome rods may be used with titanium alloy implants. The extension tabs on the reduction screw and hook components are intended to be removed intraoperatively.

The provided document is a 510(k) premarket notification from the FDA for the Reliance Spinal Screw System. It details the device's indications for use, its description, and its substantial equivalence to previously marketed devices. However, it does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

The document discusses "Non-Clinical Testing" which includes "Static Compressive and Dynamic Compressive in accordance with ASTM F1717." This refers to mechanical testing standards for spinal implant constructs, not a clinical study involving human patients or a study validating an AI algorithm.

Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving an AI device meets them using the provided text. The document is about a traditional mechanical spinal implant, not an AI/ML medical device.

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The Reliance LUMBAR IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The Reliance LUMBAR IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative 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 lumbar device is to be used in patients who have had six months of non-operative treatment.

The Reliance Lumbar IBF System is comprised of implant and instrument components. The implant component, the Reliance Lumbar IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the lumbar spine. The spacer is made of PEEK OPTIMA LT1 with Tantalum markers.

The provided documents are a 510(k) Pre-market Notification from the FDA regarding the "Reliance Lumbar IBF System." This document primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study of its own performance against specific acceptance criteria.

Therefore, the requested information about acceptance criteria and a study proving the device meets them, particularly regarding AI or algorithm performance, cannot be extracted from this document because:

• The device is a physical medical implant (intervertebral body fusion device), not an AI/software device. This type of device does not have "acceptance criteria" in the sense of performance metrics for an algorithm (e.g., sensitivity, specificity, AUC). Its acceptance is based on meeting mechanical and material specifications, biocompatibility, and substantial equivalence to existing devices.
• The document describes "Non-Clinical Testing" which is Finite Element Analysis (FEA). This is a computational method to analyze the mechanical behavior of the additional components, ensuring they do not create a "new worst-case scenario" compared to the predicate device. It's not a study with a test set, ground truth, experts, or statistical performance metrics.
• There is no mention of an algorithm, AI, human readers, or any form of software performance evaluation.

The document does state:

• Device Name: Reliance Lumbar IBF System
• Regulation Number: 21 CFR 888.3080
• Regulation Name: Intervertebral body fusion device
• Product Code: MAX
• Predicate Devices: Reliance Lumbar IBF System (K113540) and Globus Patriot TransContinental System (K093242, K102313).
• Intended Use/Indications for Use: Intervertebral body fusion of the spine in skeletally mature patients, with autogenous bone graft, intended for the lumbar spine (L2 to S1) for treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis.
• Device Description: Made of PEEK OPTIMA LT1 with Tantalum markers.
• Non-Clinical Testing: Finite Element Analysis (FEA) was performed on additional components using Solidworks software and compared to test results of already approved components per K113540. No new components create a new worst-case scenario.

In summary, none of the requested information regarding algorithm-specific acceptance criteria, study design parameters (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), or training set details can be provided from this document as it pertains to a physical implant and not an AI/software medical device.

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