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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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Lucent intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems).

This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.

The Lucent® XP device is an intervertebral body fusion device for use in lumbar spinal surgery. It may also be referred to as an interbody device or interbody cage. The Lucent® XP device is comprised of two PEEK endplates with teeth for engaging the vertebral body endplates on the outside of the device and an internal titanium mechanism for expanding the PEEK endplates of the device. The device is generally box-shaped with various holes throughout its design to allow for the placement of autograft. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned. The device is made from PEEK-Optima® grade LT1 conforming to ASTM F2026 with or without a coating of commercially pure titanium conforming to ASTM F1580. The internal mechanism is made from titanium alloy conforming to ASTM F136.

This document describes the Lucent® Intervertebral Body Fusion Device (Lucent® XP and Lucent XP Ti-Bond®). However, it does not contain detailed acceptance criteria and a study proving a device meets them in the way typically seen for AI/ML-based medical devices.

Instead, this is a 510(k) Premarket Notification for a spinal implant, which relies on demonstrating substantial equivalence to a predicate device. The "performance data" section focuses on mechanical and physical testing rather than clinical performance or comparisons of human readers with and without AI assistance.

Therefore, I cannot provide all the requested information, specifically regarding AI-related aspects (like MRMC studies, standalone algorithm performance, AI training/test sets, expert qualifications for ground truth in an AI context).

Here's an breakdown of the available information based on your request, explicitly noting what is not applicable (N/A) or not provided (N/P) in this document for the requested AI-centric details:

Device Name: Lucent® Intervertebral Body Fusion Device (Lucent® XP and Lucent XP Ti-Bond®)

Device Type: Intervertebral Body Fusion Device (Spinal Implant)

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: For this type of device (spinal implant), acceptance criteria are primarily based on meeting the performance specifications outlined in relevant ASTM standards for mechanical integrity, rather than clinical efficacy metrics like sensitivity/specificity for an AI algorithm. The document states that "All data indicates that the device will perform as intended," implying successful adherence to these standards, but does not provide quantitative results or detailed pass/fail thresholds within this summary.

Regarding AI/ML-specific Study Information:

This document is for a physical medical device (spinal implant), not an AI/ML algorithm. Therefore, the following points are not applicable (N/A) or not provided (N/P) as they pertain to AI/ML device evaluations.

2. Sample size used for the test set and the data provenance: N/A (Not an AI/ML device)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Not an AI/ML device)
4. Adjudication method for the test set: N/A (Not an AI/ML 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: N/A (Not an AI/ML device)
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A (Not an AI/ML device)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (Not an AI/ML device; for spinal implants, "ground truth" would be related to physical properties and functionality confirmed by engineering tests and potentially predicate device history / clinical literature)
8. The sample size for the training set: N/A (Not an AI/ML device)
9. How the ground truth for the training set was established: N/A (Not an AI/ML device)

Summary of this Document's Approach:

This 510(k) submission leverages the concept of substantial equivalence. The manufacturer demonstrates that the Lucent® XP and Lucent XP Ti-Bond® device has the same indications for use, manufacturing method, raw materials, and operating principles as several legally marketed predicate devices. The "Performance Data" section confirms that the device has undergone standard mechanical tests (Static Compression, Dynamic Compression, Subsidence, Compression Shear) according to specific ASTM standards, and the results indicate it performs as intended. This type of testing is standard for implantable devices to ensure structural integrity and biocompatibility, rather than diagnostic accuracy as would be required for an AI/ML system.

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InFill™ is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ is designed for use with autogenous bone graft to facilitate fusion. InFill™ is 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 I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill™ is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The InFill™ intervertebral body fusion device is a radiolucent implantable device manufactured from PEEK and tantalum (marker material). The implant is available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill™ intervertebral body fusion device is provided sterile, for single use only.

The provided text describes the InFill™ Intervertebral Body Fusion Device, its intended use, and the regulatory pathway. However, it does not contain information about a study proving the device meets acceptance criteria in the way a diagnostic AI device would.

This document is a 510(k) summary for a medical implant (spinal fusion device), not a diagnostic AI/ML system. The "performance data" section refers to mechanical and material testing to ensure the device's physical integrity and equivalence to predicate devices, not clinical efficacy or diagnostic accuracy.

Therefore, many of the requested categories in your prompt (e.g., sample size for test set, data provenance, ground truth, experts, MRMC studies, standalone performance, training set details) are not applicable to this type of device and are not present in the provided text.

Here's an analysis based on the information that is available, and an explanation of why other requested information is absent:

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

For this device type, acceptance criteria are generally related to mechanical and material properties, demonstrating that the device is as safe and effective as previously cleared predicate devices. The document states:

Explanation: The document explicitly states that "All necessary performance testing, has been completed for the InFill™ intervertebral body fusion device including static/dynamic compression (ASTM F2077), static subsidence (ASTM F2267) and expulsion. to assure substantial equivalence to the predicate devices." The acceptance criteria for these tests would be defined in the standards themselves and by comparison to the predicate devices. The reported performance is that the device met these criteria, thus assuring substantial equivalence. Specific numerical performance values are not typically included in a 510(k) summary for this kind of mechanical device but would be in the full submission.

2. Sample size 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 a passive implantable medical device, not a diagnostic or AI system that processes data from a "test set" of patient cases, images, or records. The "test set" for this device would refer to the physical units of the device subjected to mechanical testing. The number of physical units tested is not specified in this summary.

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

Not applicable. Ground truth, in the context of diagnostic performance, is not relevant here. The "ground truth" for mechanical testing is established by engineering standards and comparison to predicate devices, not expert human interpretation.

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

Not applicable. Adjudication methods are typically used in clinical trial settings or for establishing ground truth in diagnostic studies.

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. MRMC studies are used to evaluate the diagnostic performance of systems, often AI-powered ones, by comparing human readers' performance with and without assistance. This is a physical implant, not a diagnostic tool.

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

Not applicable. The device is a physical implant; there is no "algorithm" to run in a standalone fashion.

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

For the mechanical performance, the "ground truth" is adherence to established ASTM standards (F2077, F2267) and demonstrating equivalence to predicate devices which have been previously cleared based on similar standards. It does not involve expert clinical consensus, pathology, or outcomes data in the sense of a diagnostic device.

8. The sample size for the training set

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

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary regarding the device and its compliance:

The InFill™ Intervertebral Body Fusion Device is a Class II medical device, which achieved 510(k) clearance by demonstrating "substantial equivalence" to predicate devices (NuVasive CoRoent System, K071795; Globus Medical Patriot Transcontinental LLIF Spacer K093242). This means that its intended use, principle of operation, technological characteristics, and safety/effectiveness profiles were found to be similar enough to already-marketed devices. The "study" mentioned refers to mechanical and material performance testing (static/dynamic compression, static subsidence, expulsion) conducted according to established ASTM standards (F2077, F2267). The device met these engineering performance criteria, allowing it to be deemed substantially equivalent.

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The PATRIOT® TransContinental™ M Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The PATRIOT® TransContinental™ M Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

The PATRIOT® TransContinental® M Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. The spacers are inserted using an anterior or lateral approach to the lumbar spine. The PATRIOT® TransContinental® M implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. PATRIOT® TransContinental™ M Spacers are made from PEEK radiolucent polymer, with an integrated titanium alloy nut and titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560.

Here's an analysis of the provided 510(k) summary regarding the PATRIOT® TransContinental™ M Spacer, focusing on acceptance criteria and supporting studies:

It's important to note that the provided document is a 510(k) summary for a medical device (an intervertebral body fusion device) seeking substantial equivalence. The "acceptance criteria" discussed in this context are not typically for an AI/ML diagnostic device's performance metrics (like sensitivity/specificity), but rather for the physical, mechanical, and biological properties of the implant itself, demonstrating that it is as safe and effective as a predicate device.

Description of Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

The PATRIOT® TransContinental™ M Spacer is an interbody fusion device. Its acceptance criteria and the study proving it meets them are focused on demonstrating that the new device is "substantially equivalent" to previously cleared predicate devices in terms of its design, materials, and mechanical performance.

1. Table of Acceptance Criteria and Reported Device Performance

• Static Compression
• Dynamic Compression
• Static Compression-Shear
• Dynamic Compression-Shear
• Subsidence | "Mechanical testing (static and dynamic compression, static and dynamic compression-shear, and subsidence) was conducted in accordance with ASTM F2077 and F2267, the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004, and 'Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device', June 12, 2007. Performance data demonstrate substantial equivalence to the predicate device." |
  | Material Composition and Biocompatibility:
• PEEK radiolucent polymer conformance
• Titanium alloy conformance
• Tantalum conformance | "PATRIOT® TransContinental™ M Spacers are made from PEEK radiolucent polymer, with an integrated titanium alloy nut and titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560." (Note: ASTM standards imply specific material properties and often biocompatibility requirements) |
  | Design and Indications for Use Similarity to Predicate Device | "The PATRIOT® TransContinental™ M Spacers are similar to the predicate systems with respect to technical characteristics, performance and intended use." |
  | Pre-clinical Testing Conformity | The device was tested according to relevant ASTM standards (F2077, F2267) and FDA guidance documents for spinal systems and intervertebral fusion devices. This implies conformity to established safety and performance benchmarks for spinal implants. |

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

• Sample Size for Test Set: Not explicitly stated in the summary. For mechanical testing of medical implants, the "sample size" refers to the number of physical devices or material specimens tested. These are generally small, statistically determined samples to ensure robust testing for design verification and validation.
• Data Provenance: The data is generated from in vitro mechanical testing studies performed under controlled laboratory conditions, not from human patient data. Therefore, notions of "country of origin" or "retrospective/prospective" do not apply.

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

• This question is not applicable in the context of this 510(k) summary. "Ground truth" for mechanical testing is established by engineering standards (e.g., ASTM F2077, F2267) and the results obtained from the tests themselves, measured by calibrated equipment. There is no human interpretation or expert consensus involved in establishing the "ground truth" for the mechanical performance of the device in this context. The experts involved would be the engineers and technicians conducting the testing and interpreting the results against established standards.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like "2+1" or "3+1" are used for interpreting ambiguous human-read data (e.g., medical images). Here, the "test set" consists of mechanical performance data, which is objectively measured and compared against predefined criteria (ASTM standards, FDA guidance).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic devices where human readers evaluate cases with and without AI assistance. The PATRIOT® TransContinental™ M Spacer is a physical implant, not a diagnostic AI tool, so this type of study is not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

• No, a standalone performance study was not done. This concept also applies to AI/ML diagnostic algorithms. This device is a passive implant; its "performance" is mechanical stability and biological integration, not diagnostic accuracy.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on established engineering standards (ASTM F2077, F2267) and FDA guidance documents for the mechanical properties and material specifications of intervertebral body fusion devices. The device is expected to meet or exceed the performance benchmarks defined by these standards, demonstrating equivalence to already-cleared devices.

8. The Sample Size for the Training Set

• Not applicable. There is no AI/ML "training set" associated with the development or testing of this type of passive medical implant. The design of the device is based on engineering principles, material science, and anatomical considerations, not machine learning from a dataset.

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

• Not applicable, as there is no training set in this context.

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