Search Results

The EVOS Cabling System is intended to be used in general orthopaedic repair procedures including patellar fractures, general cerclage, trochanteric reattachment, femoral and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nail and screw fixation techniques.

The EVOS Cabling System is used in orthopedic trauma and reconstructive surgeries to reduce and stabilize fractures and osteotomies. The EVOS Cabling System may be used for supplementary fracture fixation when used with bone plates or screws. The EVOS Cabling System includes a sterile, stainless-steel cable implant (ASTM F1314) packaged together with a stainless-steel crimp (ASTM F138). Non-sterile, reusable instruments are also provided to facilitate proper implantation of the cable-crimp implant.

This is a 510(k) summary for a medical device (EVOS Cabling System), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and sample sizes for AI/ML evaluation is not applicable and not present in the provided text.

The document discusses the substantial equivalence of the EVOS Cabling System to predicate devices based on non-clinical evidence. It outlines mechanical performance testing, MR safety evaluation, packaging and sterilization testing, biological safety evaluation, and pyrogenicity evaluation. However, these are standard device evaluation methods and not related to AI/ML performance.

Ask a specific question about this device

The Tritium® Sternal Cable Plate System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

The Tritium® Sternal Cable Plate System includes implants of various sizes; plates and cable plugs comprised of commercially pure titanium, Grade IV (ASTM F67), and cables and screws comprised of Titanium 6AI 4V Alloy (ASTM F136). The system also includes needles comprised of Custom 470 stainless steel, 420 stainless steel (ASTM F899, Custom 470 SST) and leader comprised of Titanium 3AI/ 2.5V Alloy (ASTM F2146).

The system is designed to enhance the stability and strength of traditional sternal closure techniques. Utilizing a unique load sharing concept, the device can be implanted to distribute lateral force across the osteotomy. The system can be used with traditional monofilament wire or Pioneer Sternal Cable. The device system should be implanted using only the manual surgical instruments designed specifically for this system of implants, which may be implanted via an open or minimally invasive approach.

The provided document is an FDA 510(k) clearance letter for the Tritium® Sternal Cable Plate System. It is a premarket notification for a medical device and not for a digital health/AI device. Therefore, the content does not describe acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML-based medical device.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K161876 Tritium® Sternal Cable Plate System), primarily based on:

• Same indications for use.
• Same materials, manufacturing processes, and biocompatibility.
• Same principles of operation and fundamental technology.
• Same instrumentation and general surgical technique.
• Same sterility, shelf life, packaging, and bacterial endotoxin evaluation.
• Same mechanical performance.

The "Purpose of submission" states: "Obtain clearance for the following modification to the predicate K161876 Tritium® Sternal Cable Plate System: add magnetic resonance (MR) conditional safety labeling based on completed non-clinical testing." This indicates the primary study performed was related to MR compatibility.

Therefore, it is not possible to extract the requested information (acceptance criteria for AI/ML performance, study details for an AI/ML device, ground truth establishment, etc.) from this document.

The document describes non-clinical testing for MR safety. Below is a summary of the MR safety testing mentioned, which is not related to AI/ML device performance or clinical outcomes:

Acceptance Criteria and Study for MR Safety (Non-Clinical)

Study Details (for MR Safety - Non-Clinical):

1. Sample size used for the test set and the data provenance: Not applicable in the context of a typical clinical test set for AI. The "test set" here refers to the physical device components tested in an MR environment. The document does not specify the number of devices tested, but implied it was sufficient to meet the ASTM standards. Data provenance is not described as it is a non-clinical, in-vitro test.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for MR safety is established by adherence to international standards (ASTM) and measurable physical phenomena. No human experts are involved in establishing ground truth for these physical tests.
3. Adjudication method: Not applicable for non-clinical physical testing.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this was a non-clinical MR safety study, not a clinical effectiveness study.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
6. The type of ground truth used: Ground truth for MR safety is defined by the physical principles of magnetic resonance and the quantitative limits set by ASTM standards (e.g., displacement force, torque, temperature rise, artifact size).
7. The sample size for the training set: Not applicable. This is not an AI/ML device requiring training data.
8. How the ground truth for the training set was established: Not applicable.

Summary of why the requested information cannot be provided:

The provided FDA document is for a physical medical device (Tritium® Sternal Cable Plate System) used for bone fixation, and the clearance is based on substantial equivalence and non-clinical MR safety testing. It is not for a digital health product, an AI/ML device, or any software as a medical device. Therefore, the questions related to AI/ML device performance, human reader studies, ground truth establishment for AI, and training/test set sizes for AI algorithms are not relevant to this document.

Ask a specific question about this device

The Streamline TL Spinal Fixation System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw (T1-S2), posterior hook (T1-L5) or sacral/iliac screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudarthrosis, and failed previous fusion.

The Streamline TL Spinal System consists of a variety of rods, screws (poly-axial, fixed, and reduction), rod connectors, crosslinks, set screws, hooks and other connecting components used to build a spinal construct. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The Streamline TL Spinal System includes Class I manual instrumentation to facilitate implantation of the device components.

The provided document is a 510(k) premarket notification letter from the FDA regarding a spinal fixation system. It details the device's indications for use, its description, and a summary of performance testing.

However, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled medical device. The device in question is a physical spinal fixation system, not a software or AI/ML product.

Therefore, I cannot provide the requested information for the acceptance criteria and the study that proves the device meets them, as the provided text pertains to a mechanical medical device and not an AI/ML system.

To answer your request, I would need a document describing the validation activities for an AI/ML-enabled medical device.

Ask a specific question about this device

The CervAlign Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion.

The CervAlign Anterior Cervical Plate System is designed to promote cervical fusion by providing temporary resistance to flexion, extension, lateral bending, and axial rotation with strength and stiffness in the cervical spine (C2-C7). The system includes implants of various sizes of screws and plates to accommodate varying patient anatomies. The plates have integrated cover-style locking mechanisms that actuate to cover each screw. Implants are manufactured from titanium alloy, Ti-6Al-4V ELI instrumentation necessary to facilitate the insertion and removal. The implants and instruments are provided non-sterile and must be sterilized before use. Sterilization cases and trays are provided to facilitate proper sterilization and storage.

The provided text describes a medical device, the CervAlign™ Anterior Cervical Plate System, and its regulatory clearance. However, it does not contain the specific information requested regarding AI/CADe device acceptance criteria or related studies. The document is a 510(k) summary for a physical orthopedic implant, not an AI-powered diagnostic or assistive device. Therefore, I cannot provide the details about acceptance criteria, clinical study specifics, ground truth establishment, or sample sizes in the context of AI/CADe devices based on this input.

The document discusses non-clinical mechanical testing and MR safety evaluations to demonstrate substantial equivalence to predicate devices, which is typical for physical implants.

If you have a document related to an AI/CADe device, please provide that, and I will be happy to extract the requested information.

Ask a specific question about this device

The Streamline OCT Occipito-Cervico-Thoracic System is intended to provide immobilization of spinal segments as an adjunct to fusion when using autograft for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/ or traumatic dislocations; instabilitity of deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Streamline OCT System may be connected to the Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System using connectors and/or transition rods.

The Streamline OCT System consists of a variety of rods, hooks, polyaxial screws, high-angle screws, locking caps, occipital plates, occipital screws, and connecting components used to build an occipito-cervico-thoracic spinal construct. System components are manufactured from ASTM F136 medical grade titanium alloy and ASTM F1537 medical grade cobalt chromium molybdenum alloy. Medical grade titanium alloy and medical grade cobalt chromium molybdenum alloy may be used together. The system should be implanted using only the surgical instruments designed for the system. Cases and caddies are supplied for sterilization and transport of the implants and instruments. The purpose of this submission is to modify and add components to the system.

This document is a 510(k) premarket notification for a medical device called the "Streamline OCT Occipito-Cervico-Thoracic System." This kind of document focuses on demonstrating that a new device is "substantially equivalent" to existing legally marketed devices, rather than establishing acceptance criteria and proving performance against them in the same way one might for a novel device or software.

Therefore, the requested information, particularly regarding acceptance criteria, specific performance metrics, sample sizes for training/test sets, ground truth establishment by experts, and MRMC studies, is not typically found or required in a 510(k) submission for this type of device (spinal fixation system). The demonstration of substantial equivalence relies more on comparing the new device's design, materials, indications for use, and mechanical performance to existing predicate devices.

However, I can extract the information that is available in the document that somewhat aligns with your request:

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

There isn't a table of "acceptance criteria" and reported device performance in the sense of accuracy, sensitivity, or specificity for an AI/software device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence through non-clinical mechanical testing. The "reported device performance" refers to the results of these mechanical tests compared to predicate devices.

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 context of this 510(k) for a spinal fixation system. There isn't a "test set" of clinical data or images as typically understood for AI/software. The testing involved mechanical tests of the devices themselves.
• Data Provenance: Not applicable. The "data" comes from mechanical testing conducted in a laboratory setting, not clinical patient data.

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

Not applicable. Ground truth as established by clinical experts for a test set is not relevant for this type of device's 510(k) submission. Mechanical testing relies on engineering standards and measurements.

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

Not applicable. This concept is for clinical data review, not 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 device is a physical spinal fixation system, not an AI or software device that assists human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For the mechanical testing, the "ground truth" is established by validated engineering test standards (ASTM F1798, ASTM F1717, and ASTM F2706) and the results derived from those specified testing protocols.

8. The sample size for the training set

Not applicable. There is no "training set" for a physical medical device. Device design and refinement are based on engineering principles, materials science, and testing, not machine learning training.

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

Not applicable (as there's no training set). The design and development of the device components are informed by established engineering practices and biomechanical understanding of spinal anatomy and mechanics.

Ask a specific question about this device

The Streamline OCT Occipito-Cervico-Thoracic System is intended to provide immobilization of spinal segments as an adjunct to fusion when using autograft for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/ or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Streamline OCT System may be connected to the Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System using connectors and/or transition rods.

The Streamline OCT System consists of a variety of rods, hooks, polyaxial screws, high-angle screws, locking caps, occipital plates, occipital screws, and connecting components used to build an occipito-cervico-thoracic spinal construct. System components are manufactured from ASTM F136 medical grade titanium alloy and ASTM F1537 medical grade cobalt chromium molybdenum alloy. Medical grade titanium alloy and medical grade cobalt chromium molybdenum alloy may be used together. The system should be implanted using only the surgical instruments designed for the system.

The purpose of this submission is to: expand the use of the system to include the use of screws in the posterior cervical spine, add line extension components and modify an existing component.

This document is a 510(k) premarket notification for a medical device called the "Streamline OCT Occipito-Cervico-Thoracic System." It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices. The information provided is about the device itself and its regulatory clearance process, rather than a study proving performance against specific acceptance criteria for AI or diagnostic performance metrics.

Therefore, many of the requested sections about acceptance criteria and study details for an AI-powered diagnostic device cannot be extracted from this document.

However, I can extract information related to the non-clinical testing performed for this physical medical device.

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

The document does not provide a table of precise acceptance criteria with numerical thresholds for performance (e.g., tensile strength > X, fatigue life > Y), nor does it report specific measured values for device performance against such criteria. Instead, it generally states that engineering analysis and re-creation testing demonstrated improvements and confirmed that the physical components met regulatory expectations.

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

For the non-clinical mechanical testing, the document does not specify the sample size used for each test (e.g., number of constructs tested for fatigue or static loading). It simply refers to "engineering analysis" and "re-creation testing."

The term "data provenance" (e.g., country of origin, retrospective/prospective) is not applicable here as the testing is physical mechanical testing on device components, not clinical data from patients.

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

This question is not applicable to the non-clinical mechanical testing of this physical medical device. "Ground truth" in this context would typically refer to clinical diagnoses or outcomes, which are not part of the described engineering or mechanical testing.

4. Adjudication method for the test set

This question is not applicable to the non-clinical mechanical testing of this physical medical device. Adjudication methods like "2+1" or "3+1" are used in clinical studies to resolve discrepancies in expert interpretations of medical data, which is not what was performed for this submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data, often with AI assistance, to assess improvements in reader performance. This document is about a spinal implant system.

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

No, a standalone (algorithm only) performance study was not done. This is also not applicable to a physical spinal implant system.

7. The type of ground truth used

For the non-clinical mechanical testing described, the "ground truth" would be established by the physical properties and behavior of the materials and constructs under specific, controlled loading conditions, as defined by engineering standards (e.g., ASTM F1717, ASTM F2706). It is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.

8. The sample size for the training set

This concept is not applicable as this document is not describing an AI/machine learning device that requires a training set. The "training set" refers to data used to train an algorithm.

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The Release® Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Release® Laminoplasty Fixation System is used to hold the graft material in place in order to prevent the graft material from expulsion, or impinging the spinal cord.

The Release Laminoplasty Fixation System consists of a variety of sizes of implantable plates and screws that are attached to the lamina after a laminoplasty or laminectomy procedure. The implantable components are manufactured from medical grade ASTM F 136 Titanium alloy. The system also contains Class I manual surgical instruments and cases that are considered exempt from premarket notification.

The provided text describes a 510(k) premarket notification for a medical device called the "Release® Laminoplasty Fixation System." It includes information about the device's intended use, classification, and a summary of performance data. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI-powered device or diagnostic.

This document is a regulatory submission for a physical implantable device (plates and screws for spinal fixation), not an AI/ML-driven diagnostic or medical device. Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or ground truth establishment is not applicable to the content provided.

The "Non-Clinical Performance Data" section mentions:

• ASTM F543 (screw insertion torque, torque to failure, pull-out)
• ASTM F2193 cantilever bend testing
• Finite Element Analysis

These are standard mechanical and material performance tests for physical orthopedic implants, not software or AI-based diagnostics. The document explicitly states: "Clinical performance data was not provided in this submission for a determination of substantial equivalence." This further indicates that no clinical study (which would be relevant for establishing performance characteristics in the context of AI) was conducted or reported in this submission.

Therefore, I cannot fulfill the request as the provided text does not contain the pertinent information for an AI/ML device.

Ask a specific question about this device

The Tritium Sternal Cable Plate System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

The Tritium Sternal Cable Plate System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures to aid in the alignment and stabilization of bone. The Sternal Cable Plate System can be used with traditional monofilament wire or Pioneer Sternal Cable. Instrumentation has been designed specifically for use with this system of implants, which may be implanted via an open or minimally invasive approach. The purpose of this submission is to add an additional implant to the predicate Tritium Sternal Cable Plate System.

This document describes the Tritium Sternal Cable Plate System, a medical device intended for stabilizing fractures of the anterior chest wall, including sternal fixation after sternotomy and sternal reconstructive surgical procedures.

Here's an analysis of the acceptance criteria and study aspects based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document explicitly states: "The determination of substantial equivalence was not based on clinical performance data."

Therefore, there was no test set of clinical data (e.g., patient samples, images, or real-world outcomes) used to prove the device meets acceptance criteria. The evaluation was based on non-clinical performance data (engineering analysis and mechanical testing).

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

Since no clinical test set was used, there were no experts involved in establishing ground truth for a clinical test set. The evaluation relied on engineering principles and comparison to predicate devices.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used.

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

No, an MRMC comparative effectiveness study was not done. The evaluation was based on non-clinical performance data and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.

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

Not applicable. This is a physical medical device (sternal cable plate system), not an algorithm or AI system.

7. The type of Ground Truth Used:

The "ground truth" in this context refers to established engineering principles, material standards (ASTM F-67, ASTM F-136), and the performance characteristics of previously cleared predicate devices. The determination of device performance was based on:

• Engineering analysis: Demonstrating that the design met specified requirements.
• Non-clinical performance testing: Specifically, "static and dynamic tensile strength testing."
• Comparison to predicate devices: Establishing that its characteristics were "equivalent or comparable" and performed "as well as or better than the predicate."

8. The Sample Size for the Training Set:

Not applicable. As this is not an AI or machine learning device, there is no "training set."

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

Not applicable, as there is no training set.

Ask a specific question about this device

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery.

The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine.

The hooks, connectors, and rods are also intended to provide fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.

The Streamline OCT System can also be linked to FDA cleared pedicle screw systems (e.g., Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System) using connectors.

The Streamline OCT System consists of a variety of rods, hooks, polyaxial screws, high-angle screws, locking caps, occipital plates, occipital screws, and connecting components used to build an occipito-cervico-thoracic spinal construct. The purpose of this submission is to add components to the predicate K133374 Streamline OCT System.

The provided text is a 510(k) summary for the Streamline OCT Occipito-Cervico-Thoracic System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on design, materials, technological characteristics, and performance.

However, the document does not contain the specific information required to answer your questions regarding acceptance criteria, device performance, and study details like sample size, ground truth establishment, expert qualifications, or multi-reader multi-case studies.

The section "Non-Clinical Performance Data" states: "Engineering analysis was sufficient to demonstrate that the subject components do not introduce new worst-case components. Previously completed Streamline OCT System testing is sufficient to support the performance of the subject product and therefore, no new testing was required for the determination of substantial equivalence."

This indicates that no new performance studies were conducted for this specific 510(k) submission (K150254). Instead, it relies on prior testing of the predicate device (K133374 Pioneer Streamline OCT Occipito-Cervico-Thoracic System) and engineering analysis.

Therefore, many of your questions cannot be answered from the provided text.

Here's an attempt to answer based on the available information and highlight what's missing:

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

The document does not provide a table of acceptance criteria or specific reported device performance metrics for the Streamline OCT Occipito-Cervico-Thoracic System. It generally states that "Previously completed Streamline OCT System testing is sufficient to support the performance of the subject product."

2. Sample sized 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 in the document. As no new testing was reported for this submission, there is no mention of a test set sample size or data provenance.

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. The device is a spinal fixation system, and the "ground truth" would relate to its mechanical performance and biocompatibility. Expert review might be part of the engineering analysis, but details are not given.

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

This information is not provided.

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 device is a medical implant (spinal fixation system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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. Standalone performance for an algorithm is not relevant here.

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

The document implies that the ground truth for the predicate device's performance was established through engineering analysis and testing, which would typically include mechanical testing (e.g., fatigue, static strength), material characterization, and potentially pre-clinical studies or cadaveric testing. It does not refer to expert consensus, pathology, or outcomes data in the context of establishing performance for this 510(k).

8. The sample size for the training set

This information is not provided and is not relevant as this is a physical medical device, not an AI/ML device requiring a training set in that context.

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

This information is not provided and is not relevant for the same reasons as #8.

Ask a specific question about this device