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The ENNOVATE Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). The device is indicated for treatment of the following acute and chronic instabilities or deformities.

1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
2. Spondylolisthesis,
3. Trauma (i.e., fracture or dislocation)
4. Spinal Stenosis.
5. Deformities or Curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6. Tumor.
7. Pseudoarthrosis, and
8. Failed previous fusion

The ENNOVATE Spinal System is an implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. This system includes polyaxial screws of varying diameters and lengths, rod-to-rod and cross connectors of various styles and lengths. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V), conforming to ISO 5832-3.
The ENNOVATE Spinal System is a spinal rod and screw system. This system's polyaxial screws can be rigidly locked into a wide range of configurations, therefore allowing each construct to be formed to the needs of an individual patient. Rods of this system may be shaped intraoperatively to correct or maintain proper spinal curvature.

This document describes a spinal system, not a device that would typically have acceptance criteria and performance metrics in the way an AI/ML or diagnostic device would. This is a 510(k) premarket notification for a medical device called the "ENNOVATE Spinal System," which is a metallic implant system for spinal fusion.

The document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing novelty or specific performance criteria like sensitivity, specificity, or accuracy for a diagnostic tool.

Therefore, many of the requested categories are not applicable to this type of device and regulatory submission. I will explain why each category is not applicable and what information is provided in the document.

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

• Not Applicable. For a spinal implant system like the ENNOVATE Spinal System, "acceptance criteria" are typically related to mechanical and material performance standards, not diagnostic accuracy or clinical outcomes in the same way as an AI/ML device. The "performance" reported is compliance with these standards through mechanical testing.

Note: The document states that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable. In addition, testing per the guidance 'Spinal System 510(k)s May 3, 2004' was completed where applicable." This indicates that the device met the performance requirements outlined in these guidance documents, primarily through mechanical testing to demonstrate substantial equivalence.

The following sections are NOT APPLICABLE because this document describes a physical spinal implant system, not a diagnostic AI/ML device requiring clinical performance evaluation with ground truth.

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 is a mechanical device, not an AI/ML diagnostic. No 'test set' of clinical data for diagnostic performance is described. The 'test set' here refers to physical devices tested in a lab.

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 expert review, is for diagnostic devices or AI, not for mechanical spinal implants.

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

• Not Applicable. Adjudication methods are relevant for clinical endpoints or diagnostic interpretations, not for mechanical testing of an implant.

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 specific to AI/ML diagnostic tools, not an orthopedic implant.

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

• Not Applicable. This is specific to AI/ML diagnostic tools.

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

• Not Applicable. Ground truth refers to the definitive determination of a condition for diagnostic purposes. For a spinal implant, the "truth" is whether it meets engineering specifications and functions mechanically as intended.

8. The sample size for the training set

• Not Applicable. This is for AI/ML models. No training set is involved for this mechanical device.

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

• Not Applicable. As above, no training set or ground truth in this context.

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The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

Additional Component of the EXPEDIUM Spine System.

The EXPEDIUM Spine System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

This document is a 510(k) summary for the EXPEDIUM™ Spine System, specifically for additional components. It is a submission to the FDA for market clearance, not typically a publication of a clinical study with detailed performance metrics against acceptance criteria. Therefore, the information provided is limited to what's available in such a regulatory document.

Based on the provided text, a table of acceptance criteria and reported device performance from a clinical study cannot be constructed because the document does not describe acceptance criteria for diagnostic performance or a clinical study in the way typically seen for AI/software devices.

Instead, the document states:

"PERFORMANCE DATA:
Performance data were submitted to characterize the additional components of the EXPEDIUM Spine System."

This refers to engineering performance data for a physical medical device (spinal implants), not typically diagnostic performance as would be expected for an AI/software device. The FDA's 510(k) clearance in this context relies on demonstrating substantial equivalence to predicate devices, often through mechanical testing, biocompatibility, and material characterization, rather than clinical efficacy studies with ground truth.

Therefore, many of the requested details about acceptance criteria, sample sizes for test/training sets, expert qualifications, and adjudication methods are not applicable or not present in this type of regulatory submission for a physical implantable device.

Here's an attempt to answer the questions based only on the provided text, noting where information is missing or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable/Not provided. This document describes a physical medical device (spinal implant), not a diagnostic algorithm that would typically have a test set of data.
• Data Provenance: Not applicable/Not provided.

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

• Not applicable/Not provided. Ground truth establishment by experts is typically for diagnostic or AI devices, not for the performance data of a spinal implant.

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

• Not applicable/Not provided. This relates to diagnostic image interpretation or algorithm output, not the mechanical or material performance of a spinal implant.

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/Not provided. MRMC studies are for diagnostic interpretation (often with imaging and AI assistance), which is not the subject of this 510(k) summary.

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

• Not applicable/Not provided. This document is not about an algorithm or AI device.

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

• Not applicable/Not provided. The "performance data" mentioned would likely be based on physical measurements, material properties, and mechanical tests, not a clinical ground truth as defined for diagnostic studies.

8. The sample size for the training set

• Not applicable/Not provided. This document is not about an algorithm or AI device that would have a training set.

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

• Not applicable/Not provided. This document is not about an algorithm or AI device that would have a training set with established ground truth.

Summary based on the provided text:

The provided document is a 510(k) summary for a physical medical device, the EXPEDIUM™ Spine System, an implantable spinal fixation device. The performance data mentioned refers to engineering tests and characterization (e.g., mechanical strength, biocompatibility, material properties) to demonstrate substantial equivalence to previously cleared predicate devices, not clinical efficacy or diagnostic performance. Therefore, the typical criteria and study design elements requested for an AI/software device or a diagnostic device are not present in this document.

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The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM™ Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The subject EXPEDIUM Spine System components consist of 4.5mm and 6.35mm rods and are available in various geometries and sizes.

The provided text describes the EXPEDIUM Spine System, a medical device intended for spinal immobilization and stabilization. However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics in a way that would allow for a complete answer to your request regarding acceptance criteria and a study proving the device meets them.

The document is a 510(k) summary and FDA clearance letter, which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed performance study against pre-defined acceptance criteria.

Here's a breakdown of what can be gleaned and what is missing, structured as requested:

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

Explanation: The document states that "Performance data per ASTM F 1717 were submitted." ASTM F 1717 is a standard specification for spinal implant constructs in vitro, likely involving mechanical testing (e.g., fatigue, static strength). However, the specific acceptance criteria (e.g., "must withstand X cycles at Y load," or "static strength must exceed Z N-m") and the device's measured performance against those criteria are not provided in this summary. The summary confirms that data was submitted to characterize the device, implying that a study was conducted, but it does not present the results or the pass/fail thresholds.

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

• Sample Size: Not specified for any test set. The ASTM F 1717 standard would typically define the number of constructs to be tested, but this detail is not present in the summary.
• Data Provenance: Not specified. It's an in-vitro mechanical test, so "country of origin of data" is less relevant than for clinical data, but the location of the testing facility is not provided. Retrospective or prospective classification is not applicable to an in-vitro mechanical test.

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 question is not applicable to the device and performance data described. The device is a spinal implant system, and the performance data cited (ASTM F 1717) refers to mechanical properties, not diagnostic performance or clinical outcomes requiring expert interpretation to establish ground truth.

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

• Not applicable. As the performance data pertains to mechanical testing (ASTM F 1717), there is no need for expert adjudication. Mechanical tests follow standardized protocols.

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 a spinal implant system, not a diagnostic imaging or AI-assisted device. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

• Not applicable. This device is a physical spinal implant system, not a software algorithm.

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

• Not applicable in the typical sense of ground truth for diagnostic devices. For mechanical testing (ASTM F 1717), the "ground truth" is established by the physical properties and behavior of the device components under controlled test conditions, measured against the specifications of the standard. There is no expert consensus, pathology, or outcomes data used to establish "ground truth" for this type of performance assessment.

8. The sample size for the training set

• Not applicable. There is no "training set" for a physical medical device undergoing mechanical performance testing. This concept applies to machine learning algorithms.

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

• Not applicable. (See point 8).

Summary of available information:

The 510(k) summary indicates that the EXPEDIUM Spine System is a Class III medical device intended for spinal immobilization and stabilization. It states that "Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM™ Spine System components." This implies that a study was conducted to evaluate the mechanical properties of the device according to the ASTM F 1717 standard. However, the specific details of this study, including the acceptance criteria, the actual performance results, sample sizes, or any form of "ground truth" that would be applicable to diagnostic or AI devices, are not present in the provided document. The document primarily serves to demonstrate substantial equivalence to previously cleared predicate devices, allowing it to proceed to market without a full PMA.

Ask a specific question about this device

The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM™ Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The subject EXPEDIUM Spine System components consist of 5.5mm rods and are available in various geometries and sizes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EXPEDIUM Spine System, structured to answer your questions:

The provided document is a 510(k) summary for the EXPEDIUM Spine System, specifically for additions to the existing system. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove efficacy or performance against specific clinical acceptance criteria in the same way a PMA would. Therefore, the study details you're asking for, particularly concerning AI/algorithm performance and human reader improvement, are not applicable to this type of medical device submission. This document describes a surgical implant, not an AI/imaging device.

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

For a spinal implant system like the EXPEDIUM Spine System, "acceptance criteria" are not reported in terms of diagnostic performance metrics (like sensitivity, specificity, etc.). Instead, they relate to mechanical and material performance standards to ensure the device is safe and effective when implanted.

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

The document does not detail a "test set" in the context of clinical data, as it's not a clinical study designed to test diagnostic accuracy. The performance data relates to mechanical testing of the implant components. Therefore, information about sample size, country of origin, and retrospective/prospective nature of a clinical test set is not applicable to this submission.

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

This is not applicable. The ground truth for mechanical testing is established by engineering standards and measurement techniques, not by expert clinician consensus on clinical cases.

4. Adjudication method for the test set

This is not applicable. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish a ground truth from ambiguous cases.

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

This is not applicable. The EXPEDIUM Spine System is a physical surgical implant, not an AI or imaging device that would involve human readers or AI assistance.

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

This is not applicable. The EXPEDIUM Spine System is a physical surgical implant, not an algorithm or software.

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

For this device, the "ground truth" for its performance is based on engineering standards and material science properties (e.g., strength, fatigue resistance, biocompatibility) as defined by standards like ASTM F 1537 (for material) and ASTM F 1717 (for mechanical testing of spine fusion constructs). There are no clinical outcomes data, pathology, or expert consensus used as ground truth for this type of submission's performance data.

8. The sample size for the training set

This is not applicable. This is a physical implant, not an AI model, so there is no "training set."

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

This is not applicable.

Summary of what the document does provide:

• Device Type: Spinal implant system (rods, screws)
• Purpose of Submission: Special 510(k) for additions to an existing system, demonstrating substantial equivalence to predicate devices.
• Key Performance Data: Mechanical performance data per ASTM F 1717, and material characterization per ASTM F 1537. This data ensures the device meets established engineering standards for strength, durability, and biocompatibility suitable for its intended use.
• Intended Use: Immobilization and stabilization of spinal segments as an adjunct to fusion for various spinal conditions (degenerative disc disease, spondylolisthesis, trauma, stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion).
• Material: ASTM F 1537 implant grade cobalt-chromium-molybdenum alloy.

The document demonstrates that the new components for the EXPEDIUM Spine System are substantially equivalent to previously cleared devices based on their design, materials, and mechanical performance testing, not on clinical performance against diagnostic or AI-related metrics.

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The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The subject EXPEDIUM™ Spine System components are designed to accept a 5.5mm rod and are available in various geometries and sizes. The EXPEDIUM™ Spine System also contains Class I manual surgical instruments, trays and cases and are exempt from premarket notification. Manufactured from ASTM F 136 implant grade titanium alloy.

This is a 510(k) premarket notification for the EXPEDIUM™ Spine System, a medical device. The provided text is a summary of the application and the FDA's response, not a study report for an AI device. Therefore, I cannot extract the requested information concerning acceptance criteria and a study proving a device meets those criteria, especially details related to AI, ground truth, expert opinions, or sample sizes for testing and training sets.

The document describes a mechanical spine system and references characterization data per ASTM F 1798, which is a standard for fatigue testing of spinal implants. It does not involve AI or any form of image analysis.

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