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The Aurora Spine SILO TFX MIS Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Aurora Spine SILO TFX MIS Sacroiliac Joint Fixation System includes the SILO TFX Cone, SILO TFX Screw, and the SILO TFX Locking Screw and associated manual surgical instruments. The SILO TFX Cone is comprised of titanium alloy and incorporates a hollow conical shaped barrel with two openings for bone screws for additional anchoring. During the procedure, the implant is inserted in line with the SI Joint via a posterior surgical approach, and bone graft material is placed in the barrel of the implant to facilitate additional bone incorporation after surgery.

The provided text is a 510(k) summary for a medical device (SILO TFX MIS Sacroiliac Joint Fixation System) seeking FDA clearance. It describes the device, its indications for use, and how it compares to predicate devices. However, this document does not contain the detailed acceptance criteria for a study or the results of a study designed to prove the device met those criteria.

The "Performance Testing Summary" section only briefly mentions that the device underwent some mechanical tests (static and dynamic axial compression, static and dynamic compressive shear, and static and dynamic vertical shear testing) and states that "The subject devices met all acceptance criteria for all tests." It also mentions a cadaver study that "demonstrated that the SILO TFX System provides comparable stability of the joint to the predicate."

Crucially, the document does not provide:

• A table of acceptance criteria and reported device performance (with specific numerical values).
• Sample sizes for test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts and their qualifications for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study details.
• Standalone algorithm performance details (as this device is hardware, not an AI algorithm).
• Type of ground truth used (beyond the implied "mechanical stability" in the cadaver study and compliance with ASTM standards in other tests).
• Sample size for the training set (not applicable for this type of device, which is not an AI/ML algorithm).
• How ground truth for the training set was established (again, not applicable).

Thus, I cannot answer the request with the provided information. The document confirms that testing was done and the device met criteria, but it does not detail those criteria or the specific results.

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The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), lumbar spinal stenosis, spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.

The Aurora Spine ZIP™ MIS Interspinous Fusion System is a bilateral locking plate system which attaches to the posterior noncervical spine at the spinous processes. The implants have superior and inferior surfaces and a central chamber for receiving bone graft. The devices are available in a variety of cylinders to accommodate variations in pathology and patient anatomy. The Aurora Spine ZIPTM MIS Interspinous Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic. lumbar and/or sacral spine.

The provided text describes a 510(k) premarket notification for the Aurora Spine ZIP™ MIS Interspinous Fusion System. This document is a regulatory submission for a medical device and does not contain information about clinical performance testing or studies evaluating the device's adherence to specific acceptance criteria for AI/ML performance.

Specifically, the "Clinical Performance Testing Summary" section states: "A literature review of was performed to support the expanded indications." This implies that no new clinical study was conducted for this specific 510(k) submission to assess performance against acceptance criteria. The submission focuses on demonstrating substantial equivalence to previously cleared devices based on design, materials, and a literature review for an expanded indication (lumbar spinal stenosis).

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, as this data is not present in the provided document.

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SOLO-L is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device system is designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space.

SOLO-L 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.

SOLO-L 2-screw cages may be used as a standalone device only when two vertebral body bone screws are used. SOLO-L 4-screw cages may be used as a standalone device only when at least two vertebral body bone screws are inserted in the two medial fixation holes with one inferior and one superior screw trajectory. If the physician chooses to use SOLO-L anterior cages with fewer than two screws in the two medial fixation holes with one inferior and one superior screw trajectory, then an additional supplemental spinal fixation system cleared for use in the lumbosacral spine must be used.

SOLO-L is an anterior lumbar interbody fusion device (ALIF) intended to improve stability of the spine while supporting fusion. The SOLO-L constructs are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1. The cages include a central graft window which may be packed with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft prior to implantation. Components are offered in different shapes and sizes to meet the requirements of the individual patient anatomy. SOLO-L is made from titanium alloy (Ti-6Al-4V ELI). An optional interbody component composed of polyetheretherketone (PEEK) with tantalum markers is available for modular cages.

The provided text does not contain information about acceptance criteria and a study proving a device meets them. Instead, it is an FDA 510(k) clearance letter for a medical device called SOLO-L, an intervertebral body fusion device.

The document states:

• "No additional non-clinical testing was provided to demonstrate substantial equivalence."
• "No clinical data were provided in order to demonstrate substantial equivalence."

This indicates that no new studies were conducted by Aurora Spine Inc. to demonstrate the performance of the SOLO-L device against specific acceptance criteria. The clearance was based on the device having identical technological characteristics (design, dimensions, materials, and manufacturing processes) to a previously cleared predicate device (A-Link Z, K201671).

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study or its effect size.
6. Standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The DEXA-C Cervical Interbody System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograff and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone to facilitate fusion and is to be implanted via an open, anterior approach.

The DEXA-C Cervical Interbody System is a porous 3D-printed intervertebral body fusion device that incorporates low-, mid-, or high-density lattice pattern options. The profile of the device is rectangular with a hollow core for bone graft to promote bone integration and fusion between the endplates. The device is available in various footbrints and heights to accommodate variability among patients and is manufactured from titanium alloy per ASTM F3001.

This document is a marketing clearance (510(k) summary) for a medical device called the DEXA-C Cervical Interbody System. It does not describe a study involving an AI/software device that requires intricate acceptance criteria and a detailed study proving the device meets those criteria, as typically seen with diagnostic or prognostic AI systems.

Instead, this document focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices. The "performance data" section refers to non-clinical mechanical testing of the physical interbody fusion device, not a software algorithm.

Therefore, many of the requested points are not applicable to this particular document. I will address the points that are relevant based on the provided text, and explicitly state when a point is not applicable.

Here's an analysis based on the provided document:

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

Not applicable in the context of an AI/software device's performance metrics (e.g., sensitivity, specificity, AUC). For this physical device, the "acceptance criteria" are implied by the mechanical testing standards, and the "performance" is that the device met these standards demonstrating sufficient strength.

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

This refers to mechanical testing of the physical device, not a human or image-based test set. The document does not specify the number of devices tested for each mechanical test mode, nor the provenance of "data" in the sense of patient data.

• Sample Size: Not explicitly stated for each mechanical test.
• Data Provenance: Not applicable in the context of clinical or image data. The tests are lab-based mechanical tests.

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 this context refers to meeting mechanical engineering standards, not medical diagnoses established by experts.

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

Not applicable. There's no human adjudication process described for mechanical testing.

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

Not applicable. This is a physical interbody fusion device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical interbody fusion device, not a standalone algorithm.

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

Not applicable in the typical AI/software sense. For this device, the "ground truth" for proving performance would be established by the adherence to industry mechanical testing standards (ASTM F2077, ASTM F2267) and demonstrating the mechanical strength and integrity required for its intended use, as compared to predicate devices.

8. The sample size for the training set

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

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

Not applicable.

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The APOLLO™ Anterior Cervical Plate (ACP) System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
· Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),

• · Spondylolisthesis,
• · Trauma (including fractures or dislocations),
• · Tumors,
• · Deformity (defined as kyphosis, lordosis, or scoliosis),
• · Pseudarthrosis,
• · Failed previous fusion,
• · Spinal stenosis

The APOLLO™ Anterior Cervical Plate (ACP) System is comprised of cervical plates and bone screws constructed of titanium alloy as described by ASTM F136. Plates are available in multiple levels and lengths, and screws are available in multiple diameters, lengths, and tip configurations to accommodate variations in patient anatomy. The Integrated screw locking mechanism is used to block the screw heads after the device construct has been attached to the anterior cervical spine.

The provided text is a 510(k) summary for the APOLLO™ Anterior Cervical Plate (ACP) System. This document describes a medical device (an implanted plate and screws for spinal fusion), not an AI/ML-driven device or diagnostic system.

Therefore, the requested information (acceptance criteria for AI/ML performance, study details for AI/ML device validation, such as sample size, ground truth establishment, MRMC studies, etc.) is not applicable to this submission. The "Performance Data" section explicitly states:

• "Non-clinical mechanical testing was performed consisting of the following test modes: Static and dynamic compression bending per ASTM F1717 . Static torsion per ASTM F1717"
• "The results of this non-clinical testing show that the strength of APOLLO™ device is sufficient for its intended use."
• "Clinical data and conclusions were not needed for this device."

This indicates that the clearance was based on mechanical bench testing demonstrating the structural integrity and equivalence to a predicate device, rather than a study evaluating diagnostic or predictive performance using patient data, which would be the case for an AI/ML device.

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The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (TI-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions: 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), and/or tumor. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.

The Aurora Spine ZIPIM MIS Interspinous Fusion System is a bilateral locking plate system which attaches to the posterior noncervical spinous processes. The implants have superior and inferior surfaces and a central chamber for receiving bone graft. The devices are available in a variety of cylinders to accommodate variations in pathology and patient anatomy. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine.

This document is a 510(k) premarket notification for a medical device called the "ZIP™ MIS Interspinous Fusion System" by Aurora Spine, Incorporated. It describes the device, its intended use, and claims substantial equivalence to previously cleared predicate devices.

Based on the provided text, the device is a mechanical implant, not an AI/ML-driven device or an imaging device, and therefore the concepts of acceptance criteria regarding accuracy, precision, sensitivity, specificity, MRMC studies, or standalone algorithm performance are not applicable in the way they would be for AI-based diagnostic tools.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical and biological performance of the implant and its substantial equivalence to a predicate device.

Here's an attempt to answer the questions based on what is available and extrapolate where necessary, acknowledging the nature of the device:

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

The document does not explicitly present a discrete table of acceptance criteria with corresponding performance metrics in a format typical for AI/ML device evaluations. Instead, the acceptance criterion is implicitly "substantial equivalence" to a predicate device in terms of safety and effectiveness.

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 for Test Set: Not applicable in the traditional sense of a clinical trial test set for software. The primary "test set" for this submission was the CAD models used for Finite Element Analysis (FEA) of the device's mechanical properties. The document does not specify the number of FEA models or simulations.
• Data Provenance: The FEA testing would be computational and likely performed by the manufacturer or a contract lab. Country of origin of data is not specified but would be related to the location of the FEA execution. This is a non-clinical 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)

• Ground Truth Experts: Not explicitly stated. For a mechanical device being evaluated via FEA, the "ground truth" for the FEA would be based on engineering principles, materials science data, and established biomechanical models. The expertise would lie with the engineers and scientists who designed the FEA models and interpreted the results. This doesn't involve medical experts in the way AI image analysis would.

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

• Adjudication Method: Not applicable. This concept is typically for resolving discrepancies in human expert interpretations of ground truth for diagnostic tests. For FEA, the results are computational and typically verified through engineering checks and comparisons to known benchmarks or predicate device performance.

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

• MRMC Study: No. This type of study is completely irrelevant for a mechanical interspinous fusion system. MRMC studies are for evaluating the diagnostic performance of AI algorithms, particularly in imaging.

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

• Standalone Performance: Not applicable. This device is a surgical implant, not an algorithm. Its performance is physical and biological, not computational in a diagnostic sense.

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

• Type of Ground Truth: For the non-clinical testing, the "ground truth" for the FEA simulations would be based on:
  • Engineering principles and material properties: Known physical laws and validated material data.
  • Predicate device performance data: The performance of the previously cleared predicate device serves as the benchmark against which the modified device is compared to establish substantial equivalence.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not use machine learning, so there is no "training set."

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

In summary, this 510(k) submission is for a modification to a mechanical surgical implant. The "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device, primarily through non-clinical mechanical testing (Finite Element Analysis) rather than clinical studies or evaluations of AI performance.

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The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions: 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), and/or tumor. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.

The Aurora Spine ZIP™ MIS Interspinous Fusion System is a bilateral locking plate system which attaches to the posterior noncervical spine at the spinous processes. The implants have superior and inferior surfaces and a central chamber for receiving bone graft. The devices are available in a variety of cylinders to accommodate variations in pathology and patient anatomy. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine.

The Aurora Spine ZIPTM MIS Interspinous Fusion System is a medical device that adds new sizes and configurations to the Aurora Spine ZIPTM MIS Interspinous Fusion System. This device is a posterior, non-pedicle supplemental fixation device. It is intended for use in the non-cervical spine (T1-S1). This device is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions: 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), and/or tumor.

Here's an analysis of the provided information regarding its acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary is for a Special 510(k) submission, which typically means adding new sizes and configurations to an already cleared device (predicate device K133091). For such submissions, the primary acceptance criteria revolve around demonstrating that the modifications do not alter the fundamental safety and effectiveness of the device compared to the predicate. This is often achieved through comparative analysis and engineering testing.

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

• Sample Size: Not applicable in the context of clinical or image-based test sets. The study involved finite element analysis (FEA) and engineering rationales of the modified components. This means computational models were used, not patient data or physical test samples in the traditional sense of a "test set" for AI/software.
• Data Provenance: Not applicable. This is a mechanical/computational study, not a clinical data study.

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

• Number of Experts & Qualifications: Not applicable. For FEA and engineering rationales, the "ground truth" is established by adherence to engineering principles, material science, and validated computational methods, often overseen by qualified engineers and biomechanics specialists. No human experts in the context of clinical review were used to establish ground truth for this type of study.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This was a mechanical/computational study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

• MRMC Study: No. This submission describes a mechanical engineering study, not an MRMC study related to AI or human reader performance. This device is a physical implant, not an AI diagnostic tool.

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

• Standalone Study: Not applicable. This is a physical medical device, not an algorithm, so the concept of standalone performance does not apply.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this engineering study is based on established mechanical engineering principles, material properties, and the validated performance of the predicate device. The FEA models are built upon these principles, and their results are compared against the expected performance derived from the predicate and relevant ASTM standards (ASTM F1717-13).

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This is not an AI/machine learning study that would involve a "training set." The "training" in this context is the validation of the FEA models and engineering methodologies against known physical properties and standards.

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

• How Ground Truth for Training was Established: Not applicable. There isn't a "training set" in the sense of data labeled by experts. The "ground truth" for ensuring the accuracy of the computational methods (FEA) would be established through:
  • Validation of FEA models: Comparing FEA predictions to physical test results of components (either the predicate or test coupons) where experimental data is available.
  • Adherence to ASTM standards: Ensuring the simulation parameters and failure criteria align with recognized industry standards for spinal implant testing (e.g., ASTM F1717-13).
  • Engineering principles: The underlying equations and assumptions in finite element analysis are based on well-established principles of mechanics and material science.

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