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The CORUS™ Navigation System-GX for use with the CORUS™ Spinal System is intended to be used during spinal surgery to assist the surgeon in locating and preparing facet joints in either open, or minimally invasive procedures. The CORUS™ Navigation System-GX is specifically designed for use with the Globus Medical ExcelsiusGPS™ 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 CORUS™ Navigation System-GX disposable instruments are used during the preparation and usage of CORUS™ Spinal System during spinal surgery to assist the surgeon in locating anatomical structures, such as the facet joint, in either open or minimally invasive procedures. The Navigation Access Chisel-G and Navigation Chisel Rasp-G are specifically designed for use with Globus Medical ExcelsiusGPS™ for navigation of the instruments to the facet joint. The instrument set provides access to the posterior spinal facet joint and decortication for bone preparation.

The provided FDA Clearance Letter and 510(k) Summary for the CORUS™ Navigation System-GX (K251060) do not contain detailed information about specific acceptance criteria, study methodologies (like sample sizes for test/training sets, data provenance, ground truth establishment, or expert involvement), or the results of a multi-reader multi-case (MRMC) comparative effectiveness study.

The document states that the device was evaluated through "an engineering analysis and geometric comparison to predicate devices to establish the safety and efficacy for accuracy performance." It also mentions "a functional assessment was conducted to evaluate compatibility and simulated use testing." However, it does not provide the quantitative acceptance criteria or the specific performance metrics achieved in these evaluations.

Therefore, based solely on the provided text, I cannot complete many sections of your request. I will indicate where the information is not present.

Here's a breakdown of the available information:

Acceptance Criteria and Device Performance

Due to the lack of quantitative performance data in the provided document, I cannot create a table of acceptance criteria and reported device performance. The document states:

• "The CORUS™ Navigation System-GX instruments have been evaluated through an engineering analysis and geometric comparison to predicate devices to establish the safety and efficacy for accuracy performance."
• "A functional assessment was conducted to evaluate compatibility and simulated use testing."
• "The results of these engineering analysis and evaluations show that the subject is substantially equivalent to the cleared predicate."

This language indicates that the device met the necessary performance for clearance by demonstrating substantial equivalence, but it does not disclose the specific numerical thresholds or achieved performance metrics.

Study Information Based on Provided Text:

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

Not Available in the Provided Text. The document generally states that "engineering analysis and evaluations show that the subject is substantially equivalent to the cleared predicate," implying that performance criteria were met, but does not list specific criteria or results.

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

Not Available in the Provided Text for "accuracy performance" or "functional assessment" studies. The document mentions "engineering analysis and geometric comparison" and "functional assessment" and "simulated use testing," but it does not specify sample sizes or data provenance (e.g., retrospective/prospective, country of origin).

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

Not Applicable/Not Available. The device is a "Stereotaxic Instrument" intended to assist surgeons in locating anatomical structures. The described evaluations ("engineering analysis," "geometric comparison," "functional assessment," and "simulated use testing") suggest a focus on mechanical accuracy, compatibility, and functionality rather than diagnostic interpretation requiring human expert ground truth. Therefore, the concept of "experts establishing ground truth for a test set" in the context of image interpretation is not directly applicable here. The ground truth might be defined by engineering specifications or physical measurements.

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

Not Applicable/Not Available. Given the nature of the device and the described evaluations, an adjudication method for image interpretation or diagnosis is not relevant.

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. The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. This device is a navigation system instrument, not an AI-assisted diagnostic tool that would typically undergo such a study.

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

Partially Applicable / Inferred. The evaluations described ("engineering analysis and geometric comparison," "functional assessment," "simulated use testing") would inherently involve testing the device's performance in a standalone or controlled environment, ensuring its mechanical and functional specifications are met, independent of a specific surgical procedure on a live patient. The device "does not include its own navigation platform" but works with the Globus Medical ExcelsiusGPS™. The testing would focus on the navigation instruments' accuracy and compatibility with this platform.

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

Inferred to be Engineering/Physical Specifications. For a stereotaxic instrument, the ground truth for "accuracy performance" would typically be derived from engineering specifications, physical measurements using highly precise measurement tools, or established anatomical models/phantoms. It is not expert consensus on images, pathology, or outcomes data.

8. The sample size for the training set

Not Applicable / Not Available. The document describes "engineering analysis and geometric comparison" and "functional assessment," and "simulated use testing." This type of evaluation is typically for mechanical devices and does not describe a machine learning algorithm that would require a "training set" in the conventional sense.

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

Not Applicable. See point 8.

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1. CAVUX Facet Fixation System (CAVUX FFS):
   CAVUX Facet Fixation System (CAVUX FFS) is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments.

• CAVUX FFS is placed bilaterally through a posterior surgical approach and spans the interspace with points of fixation at each end of the construct.
• CAVUX FFS is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients.
• CAVUX FFS is indicated for patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft.

2. CORUS-LX Implant:
   CORUS-LX Implant is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments.
   CORUS-LX is placed bilaterally through a posterior surgical approach and spans the facet interspace with points of fixation at each end of the construct.
   CORUS-LX is intended to provide temporary stabilization as an adjunct to a 1 or 2 level interbody lumbar fusion with autogenous and/or allogenic bone graft and must be accompanied with an FDA cleared intervertebral body fusion device implanted at the same spinal level(s), and may be used with a pedicle screw and rod system implanted at the same spinal level(s).
   CORUS-LX is indicated for the treatment of patients with lumbar degenerative disc disease (DDD) from L4 to S1 in skeletally mature patients who have failed conservative care.

CAVUX FFS and CORUS-LX Implant are posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments. CORUS-LX LevelOne is a kit that contains CORUS-LX Implant and accessories.

The devices are placed through a posterior surgical approach and achieve facet fixation by spanning the facet interspace at each level with points of fixation at each end of the construct. The devices are manufactured from medical grade titanium alloy (6Al4V) and supplied sterile for single use only with pre-attached disposable delivery instruments. The implants are fenestrated and to be used with autogenous bone and/or allogenic bone graft. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone.

This document is an FDA 510(k) Clearance Letter for the CAVUX Facet Fixation System and CORUS-LX Implant. It is important to note that a 510(k) clearance is based on a determination of substantial equivalence to existing legally marketed predicate devices, not on a new demonstration of safety and effectiveness through clinical trials with specific acceptance criteria and performance data.

Therefore, the input document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The letter explicitly states:

"No new performance testing was supplied in this submission given that the subject implants have been previously cleared for the same intended use."

And further, the "Basis of Substantial Equivalence" section clarifies:

"The purpose of this submission is to modify the indications for use of the subject devices (originally cleared under K220951 and K230840) to align with language used in a more recent predicate clearance (K241035). The subject and predicate devices have similar indications for use, and the same intended use, technological characteristics, materials of construction, principles of operation, and design features and characteristics."

This means that the clearance is based on the devices being sufficiently similar to devices already on the market (the predicates) for which safety and effectiveness have been established. It does not provide details of a new study with specific acceptance criteria for the devices mentioned in this letter.

Based on the provided document, the requested information cannot be extracted. The document focuses on regulatory clearance via substantial equivalence, not on a primary study demonstrating performance against specific acceptance criteria for a new device.

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PMT Posterior Cervical Stabilization System (PCSS) is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments.

PMT PCSS is placed through a posterior surgical approach in up to 3 consecutive levels of the cervical spine (C3-C7) and achieves bilateral facet fixation by spanning the facet interspace at each level with points of fixation at each end of the construct.

PMT PCSS is intended as an adjunct to posterior cervical fusion (PCF) and is only intended to be used in combination with an anterior cervical discectomy and fusion (ACDF) at the same level(s).

PMT PCSS is indicated for skeletally mature patients with degenerative disc disease (DDD). DDD is defined as radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies.

PMT PCSS is to be used with autogenous bone and/or allogenic bone graft.

PMT PCSS is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments. The device is placed through a posterior surgical approach in up to 3 consecutive levels of the cervical spine (C3-C7) and achieves bilateral facet fixation by spanning the facet interspace at each level with points of fixation at each end of the construct.

The device is manufactured from medical grade titanium alloy (6A14V) and supplied sterile for single use only with a pre-attached disposable delivery instruments. The implant is fenestrated and is to be used with autogenous bone and/or allogenic bone graft. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone.

CORUS® Spinal System is used to access and prepare the site for posterior fusion.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PMT Posterior Cervical Stabilization System (PCSS).

It's important to note that the provided FDA 510(k) summary focuses primarily on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed acceptance criteria and performance data in the way a clinical trial publication might. Much of the information requested, particularly specific numerical acceptance criteria and detailed study design elements, is not explicitly present in this document.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Crucial Note: The document lacks explicit, numerical acceptance thresholds for most performance metrics. The primary clinical "acceptance" is framed as demonstrating a "superior fusion rate" compared to the control, sufficient for establishing substantial equivalence.

Study Design Elements

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

• Sample Size: "Over 200 subjects"
• Data Provenance:
  • Country of Origin: Not specified in the provided text.
  • Retrospective or Prospective: Prospective.
  • Study Type: Multicenter, randomized, clinical trial.

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

• Not explicitly stated in the provided text. The document describes "Radiographic evaluations" in the clinical trial, which would typically involve expert readers (e.g., radiologists, spine surgeons) for assessing fusion. However, the number and qualifications of these experts are not detailed.

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

• Not explicitly stated in the provided text. While radiographic evaluations were performed, the method for adjudicating discrepancies among readers (if multiple readers were used) is not described.

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 document describes the clinical performance of a medical device (surgical implant) and not an AI algorithm. Therefore, an MRMC study related to AI performance or human reader improvement with AI assistance is not relevant to this submission.

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

• Not applicable. This pertains to a medical device (surgical implant), not an AI algorithm.

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

• For the primary endpoint of fusion success, the ground truth would have been established through radiographic evaluations (e.g., CT scans, X-rays) at 12 months. This typically involves expert assessment of bone bridging and stability.
• Other assessments included "peri-operative findings" and "patient reported outcomes," which are direct clinical data and patient surveys, respectively, serving as ground truth for safety and effectiveness metrics.

8. The sample size for the training set

• Not applicable/Not provided. This refers to a medical device (surgical implant), not an AI algorithm that would have a distinct training set. The "over 200 subjects" refers to the clinical trial participants.

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

• Not applicable/Not provided. As above, this is for a medical device, not an AI algorithm. The clinical trial data serves as the basis for assessing the device's performance against its stated indications.

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The CORUS™ Navigation Access System for use with the CORUS™ Spinal System is intended to be used during spinal surgery to assist the surgeon in locating and preparing facet joints in either open, or minimally invasive procedures. The CORUSTM Navigation Access System is specifically designed for use with the Medtronic StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

The CORUS™ Navigation Access System is a manually operated disposable instrument set to be used with the Medtronic StealthStation™ System to assist the surgeon in precise site preparation during open or minimally invasive spinal surgery. The CORUS™ Navigation Access System includes the Navigated Access Chisel, Guide Tube, and Trephine Decorticator. The instruments are manufactured from stainless steel.

The provided text is a 510(k) summary for the CORUS™ Navigation Access System. It describes the device, its intended use, and its technological characteristics. However, it does not contain specific acceptance criteria, performance metrics, or detailed study results that would typically be presented in a clinical validation or performance study.

Instead, the performance data section states:

"The CORUS™ Navigation Access System has been evaluated though an engineering analysis and geometric comparison to the predicate device. A validation was also conducted to demonstrate navigation compatibility with the Medtronic StealthStation™ System. The results show that the subject device is substantially equivalent to the cleared predicates."

This indicates that the manufacturer performed:

• Engineering analysis: Likely involved design reviews, material compatibility, and structural integrity assessments.
• Geometric comparison: Compared the dimensions and design of the CORUS™ system to existing, cleared predicate devices.
• Navigation compatibility validation: This would have assessed if the CORUS™ Navigation Access System correctly interfaces and functions with the Medtronic StealthStation™ System as intended.

Therefore, based only on the provided text, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9, as this information is not present. The document focuses on demonstrating substantial equivalence through engineering analysis and compatibility rather than a clinical performance study with defined criteria and metrics.

If this were a typical clinical performance study, the requested information would be available. Since it is not, the response must reflect the absence of such data in the provided document.

Summary of missing information based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: Not provided. The document states "evaluated though an engineering analysis and geometric comparison" and "A validation was also conducted to demonstrate navigation compatibility," but no specific criteria or results are listed.
• 2. Sample sized used for the test set and the data provenance: Not mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• 4. Adjudication method: Not mentioned.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not mentioned. No human reader interaction is implied or detailed.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a "manually operated disposable instrument set" that "assists the surgeon." It is not an "algorithm only" device. The validation focused on navigation compatibility.
• 7. The type of ground truth used: Not applicable in the context of the described engineering and compatibility validations.
• 8. The sample size for the training set: Not applicable; this is not an AI/ML device requiring a training set.
• 9. How the ground truth for the training set was established: Not applicable.

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For Cervical Fusion:

CORUSTM System-X is a set of instruments indicated to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease.

For Lumbar Fusion:

CORUSTM Spinal System-X is a set of instruments indicated to be used to perform posterior lumbar fusion in patients with lumbar degenerative disc disease.

The CORUS™ Spinal System-X is a set of instruments indicated for performing posterior cervical or lumbar fusion. The instruments will be supplied sterile and single use only. The system consists of:

• Access Chisel
• Access Chisel Handle
• Trephine Decorticator
• Guide Tube
• Rasp Decorticator
• Rotary Decorticator
• Bone Graft Tamp
• Multi-Tool
• Guide Tube Adapter

These instruments allow the user to access the posterior cervical or lumbar spine to perform posterior fusion by decortication of bone surfaces, including the posterior lateral mass and facet joints, combined with application of autograft or allograft.

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification clearance letter from the FDA for the CORUS™ Spinal System-X, which is an arthroscope regulated under 21 CFR 888.1100.

The content mainly focuses on:

• FDA Clearance: Stating that the device is substantially equivalent to legally marketed predicate devices.
• Indications for Use: Posterior cervical fusion in patients with cervical degenerative disc disease and posterior lumbar fusion in patients with lumbar degenerative disc disease.
• Device Description: A set of instruments for accessing the posterior cervical or lumbar spine to perform posterior fusion by decortication of bone surfaces, combined with application of autograft or allograft.
• Technological Characteristics: Emphasizing that the fundamental operational principles, surgical approach, design, materials, and performance are essentially the same as the predicate devices, raising no new safety and effectiveness questions.
• Summary of Performance Testing (Non-clinical):
  • Simulated use cadaveric testing: Demonstrated instruments can be used for posterior cervical or lumbar fusion.
  • Bench testing: Demonstrated safety, efficacy, strength, and integrity against impaction, insertion, removal, and rotational loads.
  • Shelf life and package performance testing: Demonstrated safety and reliability for a two-year shelf life.
  • Compliance with FDA consensus standards for sterilization, microbiological methods, packaging, biological evaluation, and metallic materials for surgical instruments.
• Basis of Substantial Equivalence: Comparing the CORUS™ Spinal System-X to predicate devices (Providence Medical Technology, Inc. CORUS™ Spinal System (K190201) and Vertos Medical, Inc. Vertos medical mild™ Device Kit (K093062)) based on similar technological characteristics, design features, materials, principles of operation, and performance data.

The 510(k) process for arthroscopes like this device typically involves demonstrating substantial equivalence to a predicate device, which usually relies on non-clinical performance testing and comparison of technological characteristics, rather than extensive clinical studies with specific acceptance criteria related to diagnostic performance metrics (e.g., sensitivity, specificity, AUC) that are common for AI/ML devices. Therefore, the requested information about acceptance criteria, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance is not present in this document, as it pertains to a different type of device (surgical instruments, not an AI/ML diagnostic or prognostic tool).

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The PMT Facet Screw is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The PMT Facet Screw is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels, from C2 to S1. The PMT Facet Screw is indicated for treatment of any or all of the following:

1. Pseudoarthrosis and failed previous fusion
2. Spondylolisthesis
3. Spondylolysis
4. Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies
5. Degeneration of the facets with instability; and
6. Fracture
   The PMT Facet Screw is intended for conventional or tissue-sparing surgical placement.

The PMT Facet Screw is available in fully threaded configurations with diameters of 3.5 mm, 3.75 mm and 4.0 mm and lengths of 13 mm to 25 mm (in 2 mm increments). The PMT Facet Screw is constructed of Titanium-6 Aluminum- 4 Vanadium ELI alloy (conforming to ASTM F136-13) and supplied sterile for single use only.

The provided text describes the 510(k) summary for the PMT Facet Screw and details the performance testing conducted to demonstrate its substantial equivalence to predicate devices. It does not describe an AI/ML powered device, but rather a medical implant. As such, information regarding AI/ML-specific acceptance criteria, the study proving the device meets those criteria, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable or available in this document.

However, based on the provided text, I can extract information relevant to the non-AI device's performance testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "In all instances, the PMT Facet Screw functioned as intended and met all pre-determined acceptance criteria and do not raise new issues of safety or effectiveness; thus demonstrating that the PMT Screw is substantially equivalent to the legally marketed predicate device."

While specific numerical acceptance criteria for each test (e.g., minimum bending strength, torque values) are not explicitly detailed in the provided text, the successful completion of the tests against established ASTM standards and FDA guidance implicitly defines these criteria.

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 used for each of the mechanical performance tests (e.g., number of screws tested for bending, torsion, pull-out, or drive torque). It also does not mention data provenance as these are laboratory-based physical tests, not clinical data.

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

Not applicable. The "ground truth" for the performance testing of this medical device is based on established engineering standards (ASTM) and regulatory guidance, not expert interpretation of clinical data in the traditional sense. These tests are objective measurements of physical properties.

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

Not applicable. This is not a study involving human adjudication of results, but rather objective mechanical and biological compatibility testing against predefined specifications.

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 surgical implant, not an AI-powered diagnostic tool, and therefore MRMC studies are irrelevant here.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for the performance tests are the specifications and requirements defined by the referenced ASTM standards (F2193-14, F543-17) and FDA guidance documents for sterility and pyrogenicity. These are objective engineering and biological safety criteria.

8. The sample size for the training set:

Not applicable. There is no training set for a non-AI mechanical device.

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

Not applicable. There is no training set for a non-AI mechanical device.

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CORUS Spinal System is a set of instruments to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease.

The CORUS™ Spinal System is a set of surgical instruments indicated for performing posterior cervical fusion. The instruments will be supplied sterile and single use only. The system consists of Access Chisel, Access Chisel Handle, Decortication Trephine, Guide Tube, Decortication Rasp, Decortication Burr, Bone Graft Tamp and a Fork Mallet. In combination, these instruments allow the user to access the posterior cervical spine to perform posterior cervical fusion by decortication of bone surfaces, including the posterior lateral mass and facet joints, combined with application of autograft or allograft.

The provided text is related to an FDA 510(k) premarket notification for a medical device called the CORUS Spinal System. This document does not describe an AI medical device or a study involving AI.

The 510(k) submission states specifically:

• "The purpose of this Special 510(k) submission is to modify the device trade name and device Instructions for Use. The intended use, indications for use, and contraindications of the modified device, as described in the Instructions for Use, have not changed as a result of this modification."
• "Furthermore, there have been no changes in design, intended use, indications for use statement, contraindications, operating principle, component materials, manufacturing processes, packaging, or sterilization method since FDA's clearance of K180876."
• "Therefore, no verification or validation activities were required."

This means the submission is for a minor administrative change (trade name and IFU modifications) to an existing, already cleared device (K180876). It is not for a new device, a device with modified technology, or an AI/software as a medical device (SaMD). Therefore, there are no acceptance criteria, performance studies, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance data to report based on this document, as these elements are typically required for the initial clearance of a device, especially one involving AI or novel technology.

In summary, the request for information regarding acceptance criteria and study proving device meets criteria is not applicable to this specific FDA document, as it describes a special 510(k) for minor non-technological changes to an already cleared device, not the initial clearance or an AI-enabled device.

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DTRAX Spinal System is a set of instruments indicated to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease.

The DTRAX® Spinal System is a set of surgical instruments indicated for performing posterior cervical fusion. The instruments will be supplied sterile and single use only. The system consists of a facet joint access tool, lateral mass decortication trephine, mallet, cannula, decortication rasp, decortication burr, and tamp. In combination, these instruments allow the user to access the posterior cervical spine to perform posterior cervical fusion by decortication of bone surfaces, including the posterior lateral mass and facet joints, combined with application of autograft or allograft.

The provided text describes the 510(k) submission for the DTRAX® Spinal System, a set of surgical instruments. The information focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and adherence to consensus standards. It does not contain the kind of detailed information about acceptance criteria and clinical study results (like MRMC studies, human reader improvement with AI assistance, ground truth establishment for training and test sets, etc.) that would be present for an AI/ML medical device.

Therefore, many of the requested details cannot be extracted from this document, as it pertains to a mechanical surgical instrument system, not an AI/ML medical device.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

Acceptance Criteria and Device Performance

The document does not explicitly present acceptance criteria in a table format with reported performance against specific metrics in the way one would see for an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, it states that "Non-clinical testing has demonstrated the DTRAX® Spinal System meets the performance requirements to safely distribute and use in accordance with the Indication for Use."

The performance assessment is described as:

Study Details (as inferable from a non-AI/ML device submission)

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated as a numerical 'sample size' for a test set in the context of clinical images or patient data. The testing involved "simulated use cadaveric testing" and "bench testing." The number of cadavers or test repetitions is not specified.
   • Data Provenance: The cadaveric testing implies a source of human cadavers (country of origin not specified). Bench testing is in-laboratory. The studies were non-clinical.

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

   • Not applicable / Not present. This type of ground truth establishment is typically for AI/ML devices analyzing medical images. For a surgical instrument, performance is assessed through mechanical testing and cadaveric simulations, not through expert reading of results in the same way.

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

   • Not applicable / Not present. Adjudication methods are relevant for interpretation of medical images or clinical outcomes, not for the mechanical performance of surgical tools.

4. 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. An MRMC study is relevant for AI-assisted diagnostic devices. This document describes a surgical instrument, not an AI device, so no such study was conducted or reported.

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

   • Not applicable. This device is a manual surgical instrument and does not involve an algorithm.

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

   • For the cadaveric testing, the "ground truth" was likely the successful completion of the surgical procedure and assessment of bone decortication/fusion preparation.
   • For bench testing, the "ground truth" was meeting engineering specifications for strength, integrity, and compliance with recognized standards.

7. The sample size for the training set:

   • Not applicable / Not present. This document describes a non-AI/ML medical device. "Training set" is a concept for machine learning algorithm development, which is not relevant here.

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

   • Not applicable / Not present. As there is no AI/ML component, there is no training set or associated ground truth establishment process in the context of machine learning.

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The PMT Posterior Fixation System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1 to T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The PMT Posterior Fixation 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.

The PMT Posterior Fixation System is a bone screw and rod construct that will be supplied sterile and single use only. It consists of polyaxial screws, fixation rods, and locking set screws. The polyaxial screws are designed to be utilized for pedicle fixation or anchored to the posterior lateral mass of the cervical (C1 to C7) and thoracic (T1 to T3) vertebra. A set screw is used to connect and anchor the rod to each screw head while locking the orientation of the polyaxial screw.

The PMT Posterior Fixation System is manufactured from 6Al-4V Titanium Alloy, conforming to ASTM F136. The polyaxial screw, available in diameters of 3.5mm and 4.0mm, is self-tapping with a range of screw lengths between 8mm to 24mm. The rod is offered in two diameters, 3.5mm and 3.8mm, with a range in lengths of 15mm to 240mm. The screw head that is assembled to the polyaxial screw accepts the 3.5mm or 3.8mm rod. The set screw comes in one size and has a matching thread profile to the screw head.

The provided text describes a 510(k) premarket notification for a medical device called the "PMT Posterior Fixation System." This document is a regulatory submission to the FDA, demonstrating that the new device is "substantially equivalent" to an existing legally marketed predicate device.

Crucially, this document focuses on demonstrating substantial equivalence of a physical medical implant, not an AI/software device that requires performance metrics against acceptance criteria related to accuracy, sensitivity, specificity, etc.

Therefore, most of the requested information regarding acceptance criteria for AI performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies is not applicable to this document. The "performance testing" referenced is for the physical properties of the implant (e.g., static compression bending, static torsion, dynamic compression bending) as per ASTM F1717, to demonstrate its mechanical equivalence to the predicate device.

Here's an attempt to answer the questions based on the provided text, while highlighting what is not applicable:

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

   • Not Applicable in the AI/Software context: This document does not describe acceptance criteria for an AI algorithm's performance (e.g., sensitivity, specificity, AUC).
   • Applicable in the medical device context (physical attributes): The acceptance criteria are implicitly that the PMT Posterior Fixation System performs equivalently or better than the predicate device in biomechanical tests as per ASTM F1717.
     | Acceptance Criteria (Implied) | Reported Device Performance |
     | :---------------------------- | :-------------------------- |
     | Substantial equivalence to predicate device in mechanical performance (static compression bending, static torsion, dynamic compression bending) as per ASTM F1717. | "Non-clinical testing conducted per ASTM F1717 (static compression bending, static torsion, and dynamic compression bending) has demonstrated that the PMT Posterior Fixation System is substantially equivalent to the predicate device." |

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

   • Not Applicable in the AI/Software context: There is no "test set" of patient data for AI performance evaluation.
   • Applicable in the medical device context (physical attributes): This refers to the number of physical devices or components tested. The document does not specify the sample size for the mechanical testing, only that testing was conducted per ASTM F1717. Data provenance (country of origin, retrospective/prospective) is not relevant for this type of mechanical testing.

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

   • Not Applicable: This pertains to establishing ground truth for AI model evaluation. The document describes a physical medical device; no "ground truth" based on expert interpretation of medical images or data is established here. Mechanical performance is measured through standardized ASTM tests.

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

   • Not Applicable: Adjudication is relevant for resolving discrepancies in expert interpretations for establishing ground truth in AI studies. This is not a study of AI 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

   • Not Applicable: This is a study design for evaluating AI assistance to human readers. The document is for a physical medical implant, not an AI diagnostic or assistive tool.

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

   • Not Applicable: There is no algorithm being evaluated in this submission.

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

   • Not Applicable for AI/Software ground truth: The concept of "ground truth" as used in AI performance evaluation (e.g., for disease detection in images) does not apply here.
   • Ground truth (for mechanical testing): The "ground truth" for the mechanical performance of this physical device is established by the specifications and standardized testing methods defined in ASTM F1717. The predicate device's performance also serves as a benchmark for "equivalence."

8. The sample size for the training set

   • Not Applicable: This is relevant for AI model development. There is no training set mentioned for this physical device.

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

   • Not Applicable: As there is no training set for an AI model, this question is not relevant.

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ALLY™ Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

The ALL Y™ Bone Screws are fully threaded cortical screws offered in various diameters and lengths. All screws are manufactured from titanium alloy. The implants are single use only.

The provided text describes the 510(k) submission for the ALLY™ Bone Screws, a Class II medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its performance in a clinical setting against specific acceptance criteria in the way an AI/ML device would.

Therefore, many of the requested categories are not applicable to this submission. This device is a bone screw, not an AI/ML algorithm or software device.

Here's a breakdown of the available information based on your request:

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

For a traditional medical device like a bone screw, acceptance criteria typically refer to engineering specifications and performance testing results against established industry standards.

2. Sample size 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. For engineering tests of a medical device, the sample size would typically refer to the number of screws tested for each mechanical property. The data provenance would be that the tests were conducted in a lab setting, not from clinical data.

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. For a bone screw, "ground truth" is established through standardized mechanical testing and engineering analysis rather than expert consensus on clinical data.

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

Not applicable. Adjudication methods are relevant for studies involving human interpretation (e.g., image reading) to establish ground truth, not for mechanical testing of a device.

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

Not applicable. This device is a bone screw, not an AI/ML diagnostic tool requiring MRMC studies.

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

Not applicable. This device is a bone screw, not an AI/ML algorithm.

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

The "ground truth" for this device's performance is established by objective mechanical testing against ASTM F543 standards and engineering analysis. It is not based on expert consensus, pathology, or outcomes data in the traditional sense.

8. The sample size for the training set

Not applicable. This device is a bone screw, not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is a bone screw, not an AI/ML algorithm.

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