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The Testa™ TP Pivoting Spacer System with TiCell® Nano Advanced Surface Technology is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Testa™ TP Pivoting Spacer System is to be used with autograft bone and/or allogenic bone graft composed of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Testa™ TP Pivoting Spacer System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The Testa™ TP Pivoting Spacer System consists of new interbody implants that are provided sterile and intended to be surgically implanted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar intervertebral body fusion. The system is provided in a range of sizes to accommodate the anatomic needs for range of patients and is designed with a central graft window to accommodate graft material. The implant features TiCell® Nano Advanced Surface Technology, a proprietary etched surface with micro and nano-scale features, on the superior and inferior latticed surfaces. This is intended to help with resistance to migration and to facilitate fusion. The components of the implant are fabricated from Titanium-6 Aluminum-4 Vanadium ELI (Ti-6Al-4V ELI) conforming to ASTM F3001 and ASTM F136.

The provided document, an FDA 510(k) Clearance Letter for the Testa TP Pivoting Spacer System, does not contain information regarding an AI/ML-based device. Instead, it describes a traditional medical device: an intervertebral body fusion device.

Therefore, many of the requests in your prompt, which are specific to the regulatory approval process for AI/ML medical devices (such as acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone AI performance, and AI ground truth establishment), cannot be answered from this document.

The document states: "Nonclinical testing was performed on the Testa™ TP Pivoting Spacer System to support substantial equivalence to the predicate device. The following testing was performed: Static and dynamic axial compression testing per ASTM F2077, Static and dynamic compression shear testing per ASTM F2077, Subsidence testing per ASTM F2267, Particulate and wear analysis per ASTM F1877. Clinical testing is not applicable." This indicates that the device was evaluated through bench testing and mechanical performance standards, not through AI/ML performance metrics or studies involving human readers or expert consensus on AI outputs.

Summary based on the provided document:

Since the device is a physical medical implant (intervertebral body fusion device) and not an AI/ML software, the requested information on AI-specific acceptance criteria and study methods is not applicable and is not present in the provided FDA 510(k) clearance letter. The document focuses on demonstrating physical and mechanical substantial equivalence to predicate devices through non-clinical bench testing.

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When used with pedicle screw fixation systems, the Annex® 2 Adjacent Level System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Annex® 2 Adjacent Level System can be linked to 4.75 mm, 5.5 mm, and/or 6.0 mm diameter rods of the following systems: CapSure®, Sniper® or Salvo® Spine Systems.

The Annex® 2 Adjacent Level System consists of a selection of non-sterile, single-use locking screws, adjacent level devices, and connectors for attachment to an existing pedicle spinal fixation construct to extend a rigid spinal construct. The Annex® 2 Adjacent Level System components are provided in a variety of sizes and shapes to accommodate variations in anatomy and spacing between existing screw and rod hardware. The implant components of this system are manufactured from titanium (ASTM F67)), titanium alloy (Ti-6Al-4V ELI (ASTM F136)), and cobalt-chromium (CoCr (ASTM F1537)).

The provided FDA 510(k) clearance letter pertains to a medical device, the Annex® 2 Adjacent Level System, which is a physical implant, not an AI/ML-driven software device. Therefore, the information requested regarding acceptance criteria and study design for AI/ML performance metrics (such as test set size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable to this document.

The document discusses non-clinical testing to support substantial equivalence for a physical medical implant. Here's a summary of the relevant information from the provided document:

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

The document mentions that non-clinical testing was performed, but it does not explicitly state specific pass/fail acceptance criteria or quantitative performance results in the provided text. It generally concludes that the device is "substantially equivalent" based on these tests.

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

• Sample size: Not specified in the document.
• Data provenance: Not applicable in the context of clinical data for a physical implant. The testing described is non-clinical mechanical testing.

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

This information is not applicable as the study involved non-clinical mechanical testing of a physical device, not expert interpretation of AI/ML output.

4. Adjudication method for the test set:

Not applicable as the study involved non-clinical mechanical testing of a physical device, not subjective interpretation requiring adjudication.

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

Not applicable, as this is a physical medical 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, as this is a physical medical device, not an AI algorithm.

7. The type of ground truth used:

For mechanical testing, the "ground truth" would be established by standardized testing methods and material properties, rather than expert consensus, pathology, or outcomes data. The document states testing was performed "per ASTM F1717," indicating adherence to a recognized standard for spinal implant testing.

8. The sample size for the training set:

Not applicable, as this is a physical medical device, not an AI/ML system requiring a training set.

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

Not applicable, as this is a physical medical device, not an AI/ML system.

In summary, the provided document is a 510(k) clearance letter for a physical orthopedic implant system. The study mentioned (non-clinical testing per ASTM F1717) focuses on establishing mechanical and material equivalence to predicate devices, not on AI/ML performance metrics.

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The Salvo® Robotic Navigation Instruments are indicated for use during the preparation and placement of Salvo® Spine System screws in open or minimally invasive procedures. The Salvo® Robotic Navigation Instruments are specifically designed for use with Globus Medical's ExcelsiusGPS® Robotic Navigation Platform, which is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures, provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.

The Salvo® Robotic Navigation Instruments are surgical instruments that are designed to be used with Globus Medical's ExcelsiusGPS® Robotic Navigation Platform. These instruments are intended to facilitate the placement of screws during spinal surgery. The instruments are reusable and offered as non-sterile, to be cleaned and steam sterilized by the end user.

The provided FDA 510(k) clearance letter describes the Salvo® Robotic Navigation Instruments and asserts their substantial equivalence to predicate devices. However, the document does not contain the detailed information required to fill out all requested sections about acceptance criteria, specific study results, sample sizes, expert qualifications, or ground truth details. The letter primarily focuses on the regulatory submission process and the conclusion of substantial equivalence based on dimensional analysis and geometric comparison and compatibility validation testing, rather than a comprehensive performance study that would typically include the requested metrics for AI-powered devices.

Specifically, this device appears to be surgical instruments used with a robotic navigation platform, not an AI or software algorithm itself that would typically have performance metrics like sensitivity, specificity, or AUC. The "dimensional analysis and geometric comparison" and "validation testing to demonstrate compatibility" are more aligned with traditional medical device testing for form, fit, function, and safety, rather than evaluating the diagnostic or predictive performance of an AI system.

Therefore, many sections below will state "Not applicable" or "Not specified in the provided document" because the input document does not detail these aspects as would be expected for an AI/ML-driven device study.

Acceptance Criteria and Device Performance Study Details

Given the nature of the device (robotic navigation instruments, not an AI diagnostic/predictive tool), the acceptance criteria and study detailed in the provided document focus on physical characteristics, compatibility, and safety rather than AI performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable/Not specified. The document refers to "dimensional analysis and geometric comparison" and "validation testing," which implies testing of instrument prototypes or production units, not a patient or image dataset.
• Data Provenance: Not applicable/Not specified.

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

• Not applicable/Not specified. The evaluation involved engineering analyses (dimensional, geometric, compatibility) of the instruments themselves, not interpretation of clinical data requiring expert consensus.

4. Adjudication Method for the Test Set

• Not applicable. As no clinical images or patient data were interpreted, no adjudication method was mentioned or implied.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.

• No. An MRMC study was not done. The device is a surgical instrument, not an AI-assisted diagnostic or interpretative system for human readers. "Clinical testing is not applicable" is explicitly stated.

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

• Not applicable. This is not an algorithm or AI system.

7. The Type of Ground Truth Used

• Engineering specifications and predicate device characteristics. The "ground truth" for the tests appears to be established engineering tolerances, mechanical specifications, and the established characteristics of the predicate devices for comparison. For compatibility, the ground truth would be the functional requirements of the ExcelsiusGPS® system's safety features.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a training set. The "design and dimensions" of the instruments would be engineered and iterated upon, not "trained" in the machine learning sense.

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

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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The Salvo® Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

When used in a percutaneous approach with minimally invasive surgery (MIS) instrumentation, the Salvo® Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Salvo® Spine System is a thoracolumbosacral pedicle screw system designed through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V EL) per ASTM F136, commercially pure titanium per ASTM F67, cobaltchromium alloy per ASTM F 1537, and PEEK-OPTIMA LT1 with BaSO4. The System consists of a variety of screws, rods, and connectors that create a rigid construct as an adjunct to fixation and stabilization of the thoracic, lumbar, and sacral spine.

The provided text describes the 510(k) premarket notification for the Salvo® Spine System, a medical device. It does not contain information about a study proving that the device meets acceptance criteria related to an AI-driven or diagnostic system. The document focuses on regulatory approval based on substantial equivalence to predicate devices, rather than performance metrics of an AI model or a new diagnostic tool.

Therefore, I cannot extract the requested information (performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) as the document does not contain this type of data. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states:

• "Nonclinical testing was performed on the Salvo® Spine System to support substantial equivalence to the predicate device. Dynamic axial compression bending testing per ASTM F1717 was performed."
• "Clinical testing is not applicable."

This indicates that the device's clearance is based on mechanical testing and comparison to existing devices, not on a study involving human readers, AI assistance, or the establishment of diagnostic thresholds.

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The Exceed™ Biplanar Expandable Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Exceed™ Biplanar Expandable Interbody System is to be used with autograft bone and/or allogenic bone graft composed of cancellous, and/or corticocancellous bone. The Exceed™ Biplanar Expandable Interbody System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The Exceed™ Biolanar Expandable Interbody System is a lumbar intervertebral body fusion device fabricated from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The implant is provided unexpanded with a nose tapered in both the lateral and vertical planes, and is expanded in situ using the Exceed™ Inserter. The implant has a microscopic roughened surface with micro and nano-scale features on the superior and inferior surfaces for resistance to migration and to facilitate fusion. The implant is provided in different heights, lengths, and lordotic angles to accommodate the anatomical needs for a range of patients, and is designed to accommodate autogenous and/or allogenic bone graft material.

The provided document is a 510(k) summary for a medical device called the "Exceed™ Biplanar Expandable Interbody System," which is an implant for spinal fusion. This document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing.

Therefore, the document does not contain information about:

• Acceptance criteria for an AI/CADe device. The device described is a physical implant, not an AI or CADe system.
• A study proving the device meets acceptance criteria related to AI/CADe performance.
• Sample sizes for test sets or data provenance for AI/CADe.
• Number of experts or their qualifications for AI/CADe ground truth establishment.
• Adjudication methods for AI/CADe.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies related to AI assistance.
• Standalone algorithm performance.
• Types of ground truth used for AI/CADe.
• Sample size for training sets or how ground truth was established for training sets in the context of AI.

Instead, the document details:

• Device Name: Exceed™ Biplanar Expandable Interbody System
• Intended Use: Intervertebral body fusion procedures for degenerative disc disease (DDD) in the lumbar spine.
• Materials: Titanium alloy (Ti-6Al-4V ELI)
• Mechanism: Expandable in situ, microscopic roughened surface for migration resistance and fusion.
• Predicate Devices:
  • Leva® Spacer System (Spine Wave, Inc., K153222)
  • DualX® Expanding Titanium Posterior Lumbar Interbody Fusion System (Amplify Surgical, Inc., K222203)
• Performance Data (Non-clinical testing):
  • Static and dynamic axial compression testing per ASTM F2077
  • Static and dynamic compression shear testing per ASTM F2077
  • Subsidence testing per ASTM F2267
  • Particulate and wear analysis per ASTM F1877

Conclusion of the document: The device is substantially equivalent to the predicate devices and does not present any new issues of safety or effectiveness, based on indications for use, technological characteristics, and non-clinical performance testing.

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The Salvo® Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Salvo® Spine System is a thoracolumbosacral pedicle screw system designed to be implanted through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136, commercially pure titanium per ASTM F67, cobalt-chromium alloy per ASTM F1537 and PEEK-OPTIMA. The Salvo® Spine System consists of a variety of screws, rods, and connectors that create a rigid construct as an adjunct to fusion for internal fixation and stabilization of the thoracic, lumbar, and sacral spine.

The provided text is a 510(k) summary for the Salvo® Spine System, which is a medical device. This type of document is a notification to the FDA of the intent to market a medical device, claiming substantial equivalence to an already legally marketed device.

Crucially, this document focuses on mechanical performance and substantial equivalence to a predicate device, not on AI-driven diagnostic or treatment algorithms that would typically involve acceptance criteria and study designs in the way your request outlines.

Therefore, most of the information you're asking for (sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable or present in this document.

The "Performance Data" section explicitly states: "The Salvo® Spine System demonstrated substantially equivalent mechanical performance to the predicate device through dynamic compression bending mechanical testing with reference to ASTM F1717 and a risk analysis compared to the predicate device."

Here's what can be extracted based on the document:

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

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/Provided. The performance data relates to mechanical testing of the physical device, not a test set of data like in an AI 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/Provided. Ground truth for mechanical testing would involve engineering standards and measurements, not expert clinician consensus on medical images or patient outcomes.

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

• Not applicable/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

• No. This is a mechanical device, not an AI diagnostic tool.

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

• Not applicable. There is no algorithm.

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

• For mechanical testing: Reference to ASTM F1717 standards would serve as the "ground truth" for evaluating the mechanical properties like dynamic compression bending. The "risk analysis" would also have its own internal criteria for evaluating safety.

8. The sample size for the training set

• Not applicable/Provided. The device is a physical pedicle screw system, not an AI model requiring a training set.

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

• Not applicable/Provided.

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The Salvo® Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Salvo® Spine System is a thoracolumbosacral pedicle screw system designed to be implanted through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, commercially pure titanium per ASTM F67, cobalt-chromium alloy per ASTM F1537, and PEEK-OPTIMA LT1 per ASTM F2026. The Salvo® Spine System consists of a variety of screws, rods, and connectors that create a rigid construct as an adjunct to fusion for internal fixation and stabilization of the thoracic, lumbar, and sacral spine.

This FDA 510(k) clearance letter and summary are for a spinal implant system (Salvo® Spine System), not an AI/ML medical device. Therefore, the information requested in your prompt (e.g., acceptance criteria for device performance in terms of AI metrics, sample sizes for AI training/test sets, ground truth establishment, MRMC studies) is not applicable or present in the provided text.

The document describes the Salvo® Spine System as a thoracolumbosacral pedicle screw system, which is a physical implant used in spinal fusion surgery. The "performance data" section refers to nonclinical (mechanical) testing of the implant itself, to ensure its structural integrity and comparability to a predicate device.

Therefore, I cannot provide the requested information based on the given text.

If you have a document related to an AI/ML medical device, please provide that, and I will be happy to extract the relevant details.

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The Spine Wave® Navigated Instruments are intended to be used during the preparation and placement of Spine Wave screws (Sniper® Spine System, CapSure® Spine System, Proficient® Posterior Cervical Spine System, or the Salvo™ Spine System) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. The Spine Wave® Navigated Instruments are designed for use with the Medtronic StealthStation® System.

The Spine Wave® Navigated Instruments are reusable, manual, surgical instruments made from stainless steel. These instruments are to be used with the Medtronic StealthStation® System via the Medtronic NavLock™ Tracker to facilitate screw placement during cervicothoracic and thoracolumbosacral surgeries. New instruments are being added to allow use with Salvo™ Spine System screws.

The provided text from the 510(k) submission (K192526) for the Spine Wave® Navigated Instruments focuses on demonstrating substantial equivalence to a predicate device based on shared technological characteristics, intended use, and materials. Crucially, this submission does not describe a study involving an AI/Machine Learning algorithm, human readers, or a test set with ground truth established by experts.

The "Performance Data" section (Section 8) explicitly states: "A dimensional analysis and characterization was performed for the new components to demonstrate substantial equivalence." This indicates that the performance verification was based on engineering measurements (e.g., dimensions, material properties), not on a clinical or algorithmic performance study with acceptance criteria related to accuracy, sensitivity, or specificity.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training data for an AI/ML device, as this specific document does not describe such a study.

The device described is a set of physical surgical instruments intended for use with a navigation system, not a software algorithm that processes images or clinical data to provide insights or diagnoses.

If you have a document describing an AI/ML device, please provide that, and I would be happy to analyze it against your criteria.

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The Salvo™ Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic. lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyhosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The modified Salvo™ Spine System is a thoracolumbosacral pedicle screw system designed to be implanted through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136, commercially pure titanium per ASTM F67, and cobalt-chromium alloy per ASTM F1537. The Salvo™ Spine System consists of a variety of screws, rods, and cross-connectors that create a rigid construct as an adjunct to fusion for internal fixation and stabilization of the thoracic, lumbar, and sacral spine.

I'm sorry, but this document does not contain the information required to answer your request. The provided text is an FDA 510(k) clearance letter and a 510(k) summary for the Salvo™ Spine System.

This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through comparison of design, materials, and performance testing data (e.g., mechanical tests like dynamic axial compression bend testing and static pull apart testing) to ensure the changed device meets existing standards. It does not typically involve:

• AI/Human-in-the-loop performance studies: The device is a thoracolumbosacral pedicle screw system, which is a physical implant, not an AI or software device.
• Acceptance criteria related to AI performance: There are no metrics like accuracy, sensitivity, specificity, or reader improvement to report.
• Sample sizes for AI training/test sets or ground truth establishment: These concepts are not applicable to a physical surgical implant.
• Expert adjudication or multi-reader multi-case studies: These are relevant for diagnostic devices interpreting medical images or data, not for orthopedic implants.

Therefore, I cannot extract any information related to acceptance criteria, study design, expert involvement, or AI performance as requested in your prompt. The document only confirms the device's clearance based on mechanical performance data demonstrating substantial equivalence to a predicate device.

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The Salvo™ Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Salvo™ Spine System is a thoracolumbosacral pedicle screw system designed to be implanted through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, commercially pure titanium per ASTM F67, and cobalt-chromium alloy per ASTM F1537. The Salvo™ Spine System consists of a variety of screws, rods, and cross-connectors that create a rigid construct as an adjunct to fusion for internal fixation and stabilization of the thoracic, lumbar, and sacral spine.

This document describes the FDA's 510(k) clearance for the Salvo™ Spine System, a thoracolumbosacral pedicle screw system. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than a standalone study proving novel acceptance criteria for an AI/CAD system. Therefore, I cannot provide information on AI/CAD specific acceptance criteria, sample sizes for test/training sets, expert qualifications, or MRMC studies as these are not relevant to this type of device clearance.

Here is the information directly available from the document regarding the acceptance criteria and study, interpreted for a non-AI medical device:

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

Note: The document states "Nonclinical testing was performed on the Salvo™ Spine System to support substantial equivalence to the predicate devices." Implied acceptance criteria for these tests would be that the Salvo™ Spine System performs comparably to or better than the predicate devices under these specific mechanical assessments, or meets predetermined minimum performance standards for spine implants.

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

The document does not specify the sample sizes (number of devices/components tested) for the nonclinical benchtop tests. It also does not mention data provenance as these are mechanical tests performed on manufactured devices, not clinical data sets from patients.

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 and expert review are not relevant for mechanical benchtop testing of a pedicle screw system. The "ground truth" for these tests are the physical measurements and standards defined by the ASTM protocols themselves.

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

Not applicable. Adjudication methods are relevant for human interpretation tasks, not 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

No. This document describes the clearance of a physical medical device (spinal implant), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant and was not performed.

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

No. This is not an AI algorithm; it is a physical implant.

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

The "ground truth" for the performance data presented (nonclinical testing) is based on the standardized test methods outlined in ASTM F1717 and ASTM F1798. These standards define the parameters and methods for evaluating the mechanical properties of pedicle screw spinal systems.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of a 510(k) submission for a physical medical device.

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

Not applicable. As above, there is no training set mentioned or relevant to this type of device clearance.

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