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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 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 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 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 may be made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The Reliance Cervical IBF System may also include bone screws to secure the device to the vertebral body.

The provided text describes a 510(k) premarket notification for a medical device called the "Reliance Cervical IBF System." This document primarily focuses on demonstrating substantial equivalence to a predicate device through mechanical testing and an animal study, rather than establishing acceptance criteria and detailed performance against those criteria in a clinical study with human subjects.

Therefore, many of the specific details requested in your prompt (such as acceptance criteria, sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and detailed training set information) are not directly present in this regulatory submission.

However, I can extract and infer some information based on the provided text:

Key Takeaway from the Document:

The submission focuses heavily on substantial equivalence to previously cleared devices (K120396, K131429, and K142026) through mechanical testing and an animal study. It does not present detailed clinical efficacy or diagnostic performance data against specific acceptance criteria for a human clinical trial.

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

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

• Acceptance Criteria: Not explicitly stated as pass/fail criteria in terms of clinical outcomes for human subjects. However, the document mentions adherence to specific ASTM standards for mechanical testing. These standards implicitly define acceptance criteria for the mechanical performance of intervertebral body fusion devices.
• Reported Device Performance:
  • Mechanical Testing: Performed per ASTM F-2077 (Static and dynamic compression, static torsion, dynamic torsion), ASTM F-2267 (Expulsion), and ASTM Draft F-04.25.02.02 (Subsidence). The document states the device "was found to be substantially equivalent to itself" based on this testing, implying it met the performance expectations relative to its own prior clearance or the predicate devices. Specific quantitative results (e.g., maximum load, displacement) are not provided in this summary.
  • Animal Study: An "ovine fusion study was performed." No specific performance metrics or outcomes from this study are detailed in the provided text.

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

• Test Set Sample Size:
  • Mechanical Testing: Not specified in the summary. ASTM standards often specify the number of samples to be tested (e.g., n=6 for certain tests), but the exact count for this device is not here.
  • Animal Study: Not specified.
• Data Provenance: Not specified, but generally, studies for U.S. FDA submissions are conducted under appropriate Good Laboratory Practice (GLP) standards, which implies a controlled testing environment, likely in the US or a country with equivalent regulatory oversight. The animal study would be prospective in nature, as would the mechanical testing.

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 information is not relevant to the type of studies described (mechanical testing and animal fusion study). These studies do not involve human expert interpretation for "ground truth" in the way a diagnostic AI device would. Mechanical tests rely on objective physical measurements and engineering analysis. Animal studies have veterinary pathologists or researchers assess outcomes.

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

• Not Applicable: No adjudication method is mentioned or relevant for mechanical testing or a preclinical animal study as 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

• No: This is a mechanical device (cervical interbody fusion system), not an AI/diagnostic software. Therefore, an MRMC comparative effectiveness study for human readers with and without AI assistance is not applicable and was not performed.

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

• No: As this is a mechanical medical device, there is no "algorithm" or standalone AI performance to evaluate.

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

• Mechanical Testing: The "ground truth" is defined by the physical/mechanical properties and thresholds specified in the ASTM standards. Measurements are objective.
• Animal Study: The "ground truth" for fusion in the ovine study would typically be established through methods like histological analysis (pathology), radiographic evidence (e.g., CT scans), and potentially biomechanical testing of explanted specimens. The document does not specify which methods were used, but pathology/imaging are standard for fusion assessment.

8. The sample size for the training set

• Not Applicable: This is not an AI/machine learning device. Therefore, there is no "training set" in the context of algorithm development.

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

• Not Applicable: There is no training set for this device.

In summary, the provided document is a 510(k) summary for a cervical interbody fusion device, showcasing substantial equivalence primarily through non-clinical (mechanical) testing and a pre-clinical animal study. It does not include the types of clinical performance data, acceptance criteria, or study designs typically associated with AI/diagnostic devices that would involve human readers, ground truth consensus, or large human clinical cohorts.

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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 TI, 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 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 may be made of PEEK Optima LT1 with Tantalum markers. The Reliance Cervical IBF System may also include bone screws to secure the device to the vertebral body.

The provided text is a 510(k) Summary for the Reliance Cervical IBF System, which is a medical device for intervertebral body fusion. The document focuses on demonstrating substantial equivalence to already marketed predicate devices rather than providing detailed performance data from a clinical study with acceptance criteria.

Therefore, many of the requested categories for device performance and acceptance criteria are not applicable or not explicitly stated in this type of regulatory submission. This 510(k) summary primarily relies on mechanical testing and comparison of material, intended use, levels of attachment, size range, and use with supplemental fixation to predicate devices.

Here's the breakdown of the information that can be extracted and what cannot:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and the Reported Device Performance

• Compliant with ASTM F-2077
• Compliant with ASTM F-2267
• Compliant with ASTM Draft F-04.25.02.02 | Mechanical Performance:
• The Reliance Cervical IBF System was found to be substantially equivalent to the predicate devices with regard to mechanical performance, as demonstrated by testing per ASTM F-2077, ASTM F-2267, and ASTM Draft F-04.25.02.02. |
  | Biocompatibility:
• Substantially equivalent to predicate devices | Biocompatibility:
• The Reliance Cervical IBF System is substantially equivalent to the predicate devices in terms of biocompatibility. |
  | Sterilization:
• Substantially equivalent to predicate devices | Sterilization:
• The Reliance Cervical IBF System is substantially equivalent to the predicate devices in terms of sterilization. |
  | Material Equivalence | The device is comprised of PEEK Optima LT1 with Tantalum markers, similar to predicate devices. |
  | Intended Use Equivalence | The intended use is for intervertebral body fusion in the cervical spine (C3-T1) for cervical disc disease, consistent with predicate devices. |
  | Levels of Attachment Equivalence | One device per intervertebral space, C3-T1, consistent with predicate devices. |
  | Size Range Equivalence | Sizes are equivalent to predicate devices. |
  | Use with Supplemental Fixation Equivalence | Intended for use with legally cleared supplemental spinal fixation, consistent with predicate devices. |

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

• Sample Size: Not applicable/Not specified for a clinical test set. The performance data discussed refers to mechanical testing. For mechanical testing, the "sample size" would refer to the number of devices or components tested, which is not provided.
• Data Provenance: Not applicable for clinical data. The performance data is based on laboratory mechanical testing, not human data.

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

• Not applicable. This document describes mechanical and material equivalence testing, not a clinical study requiring expert ground truth for interpretation of patient data.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Not applicable. This is not a clinical study involving human readers or interpretation of 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

• No. An MRMC study was not conducted as this is a submission for a physical medical device (intervertebral body fusion system), not an AI/software device.

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

• No. This is not an algorithm or AI device.

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

• Not applicable. For mechanical testing, the "ground truth" would be the engineering specifications and performance limits defined by the ASTM standards, which the device's performance is compared against to demonstrate compliance/equivalence.

8. The Sample Size for the Training Set

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

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

• Not applicable. No training set is used for this type of device.

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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 degenerate 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 nonoperative 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 spacer is made of PEEK Optima LT1 with Tantalum markers.

The provided text describes the Reliance Cervical IBF System, an intervertebral body fusion device, and its a 510(k) submission (K120396). The submission focuses on demonstrating substantial equivalence to already marketed predicate devices through mechanical testing.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document refers to testing performed on "the worst case Reliance Cervical IBF device," implying a limited sample size, likely representative units for mechanical testing. No specific number of devices tested is provided.
• Data Provenance: The mechanical testing was performed following ASTM Standards (F2077-03, F2267-04, and Draft F-04.25.02.02). The context suggests this was conducted by the manufacturer (Reliance Medical Systems, LLC) as part of their 510(k) submission, likely in a laboratory setting. The country of origin of the data is not explicitly stated but is implied to be within the United States, given the FDA submission. This is a prospective test in the sense that the testing was carried out specifically for this submission.

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

• This device, an intervertebral body fusion system, does not involve a test set for diagnostic accuracy or human interpretation. Therefore, there are no "experts" in the sense of clinicians establishing ground truth on patient data.
• The determination of what constitutes "worst case" for mechanical testing would have been based on engineering principles and potentially input from mechanical engineers or materials scientists.

4. Adjudication Method for the Test Set

• Not applicable. The study is mechanical testing, not a diagnostic study requiring adjudication of expert interpretations. The "adjudication" in this context would be the interpretation and comparison of the mechanical test results against the established ASTM standards and data from predicate devices.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is used for diagnostic devices to assess the performance of human readers with and without AI assistance. This submission is for a physical implantable medical device and relies on mechanical testing to demonstrate substantial equivalence, not diagnostic accuracy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This isn't a software algorithm or AI-driven diagnostic device. The performance evaluated is the mechanical integrity of a physical implant.

7. Type of Ground Truth Used

• The "ground truth" for this type of submission is defined by established engineering standards (ASTM Standards) for mechanical performance and the mechanical performance data of legally marketed predicate devices. The device's performance is compared against these benchmarks to demonstrate substantial equivalence.

8. Sample Size for the Training Set

• Not applicable. This is not a study involving machine learning or AI, so there is no "training set." The device itself is the "product" being evaluated, not a system that needs to be trained on data.

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

• Not applicable. As there is no training set, there is no ground truth established for one. The "truth" for the product's performance is established through adherence to mechanical testing standards and comparison to predicate device performance.

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