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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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The Arthrex Spine Compression FT Screws are intended to stabilize the spine as an aid to fusion through immobilization of the facet joints, either through bilateral transfacet fixation, or unilateral transfacet fixation when used contralateral to pedicle screw fixation. The Arthrex Spine Compression FT Screws are intended to be used with or without bone graft, at a single or multiple levels, from C2 to S1, for treatment of any or all of the following: pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; spondylolisthesis; spondylolysis; degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; degeneration of the facets with instability and trauma including spinal fractures and/or dislocations. The Arthrex Spine Compression FT Screw is also indicated for fracture fixation of small bones and bone fragments including pars interarticularis and odontoid. The fracture fixation of pars interarticularis is indicated for the adult and adolescent population (12 to 21 years of age).

The Arthrex Spine Compression FT Screws are headless, threaded, cannulated titanium implants that are available in a variety of sizes. The screws have a fully threaded screw shaft with a tapering head and a variable-stepped thread pitch that allows the screw the ability to provide compression and stability between bony fragments or joints.

The provided FDA approval letter heavily focuses on the regulatory and administrative aspects of the device, primarily confirming its substantial equivalence to predicate devices based on non-clinical performance data. It does not contain information about a study proving specific acceptance criteria related to AI/algorithm performance, human reader improvement with AI assistance (MRMC), or detailed clinical trial information.

The document discusses the mechanical performance of the Arthrex Spine Compression FT Screw, which is a physical medical device (a screw for spinal fixation), not a software or AI-driven diagnostic tool. Therefore, many of the requested points (e.g., sample size for test set, ground truth for test set, number of experts, MRMC study, standalone algorithm performance, training set details) are not applicable to the type of device described in this FDA letter.

However, based on the information provided, I can infer and state what is available regarding the device's performance demonstration:

Device: Arthrex Spine Compression FT Screw

Purpose of Submission: To obtain clearance for the Arthrex Spine Compression FT Screws for spine indications, demonstrating substantial equivalence to predicate devices.

Type of Device: A physical, implantable medical device (a screw for spinal fixation), not an AI/software diagnostic tool.

Acceptance Criteria and Device Performance (Non-Clinical)

Since this is a physical device, the "acceptance criteria" discussed are related to its mechanical performance and safety for implantation and MR compatibility, not diagnostic accuracy or AI performance.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated for mechanical or MR compatibility testing. These are typically bench tests following established standards, not patient-based test sets.
• Data Provenance: The studies are described as "non-clinical testing" conducted by Arthrex. This implies in-house laboratory testing. Not applicable to country of origin, retrospective/prospective data as these are not clinical trials.

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

• Not applicable. The "ground truth" for mechanical and MR compatibility tests is defined by the test standards (e.g., ASTM F2193, F2182-19, F2119-13) and physical measurements, not by expert interpretation.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical image interpretation, not for bench testing of mechanical properties.

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

• No. An MRMC study is designed to assess human reader performance, typically with and without AI assistance, for diagnostic tasks. This device is a surgical implant, not a diagnostic AI tool.

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

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

7. The Type of Ground Truth Used:

• For mechanical testing: Engineering specifications and direct physical measurements according to validated test methods (ASTM standards).
• For MR compatibility: Measurements against established safety limits and comparisons to predicate devices, verified through standardized test methods (ASTM standards) and in-vivo electromagnetic simulation.

8. The Sample Size for the Training Set:

• Not applicable. This device does not use a training set as it is not an AI/machine learning product.

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

• Not applicable.

Important Note:

The letter does mention, "A clinical literature summary was provided to support the expansion of indications." This indicates that existing clinical data from published literature was used to support the broadened indications for use of the device, rather than a new, dedicated clinical trial being conducted for this 510(k) submission. However, details of this literature review are not provided in the letter.

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The Karma® Fixation System is intended for bilateral facet stabilization for fusion as an adjunct to a 1-level interbody lumbar fusion from L1 to L5 with autogenous and/or allogenic bone graft. The Karma Fixation System must be accompanied by an FDA cleared intervertebral body fusion device implanted at the same spinal level. The Karma Fixation System is indicated for the treatment of patients with lumbar degenerative disc disease at a single level from L1 to L5 in skeletally mature patients who have failed conservative care.

The Karma® Fixation System is a system that provides adjunctive fixation. The system consists of a PEEK band. The Karma band consists of a strap manufactured from PEEK compounded with 7.5% barium sulphate for radiopacity. The leading tip of the device is comprised of a spherical feature followed by a tapered neck to allow for an instrument to assist in advancing the strap around the bony structures to be secured. The spherical tip of the device contains a tantalum insert for visualization when fluoroscopic imaging is used. The device has teeth along its length that interact with a latching mechanism at the opposite end of the strap. The latch allows a loop created by feeding the strap through the latch to be made consecutively shorter or taut by continuing to pull the strap through the latch. Prior to creating the loop, the spherical tip of the device is cut off and discarded to allow for the strap to pass through the latch. The latch resists the lengthening of the loop due to forces that would pull the strap in the opposite direction, thereby securing the bony structures. Once the desired loop length is reached, the unneeded portion of the strap may be cut off and discarded. An instrument, Tensioner, is provided and can be used fully tension the implant.

The provided FDA 510(k) clearance letter and summary for the Karma® Fixation System is for a medical device (spinal fixation system), not a software device or AI-powered system that would typically have acceptance criteria focused on algorithm performance metrics like sensitivity, specificity, or AUC. Therefore, the questions related to AI performance, such as sample size for test sets, expert adjudication, MRMC studies, standalone performance, and training set details, are not applicable to this submission.

The "acceptance criteria" for a medical device like the Karma® Fixation System are typically related to:

• Mechanical and Biomechanical Performance: Ensuring the device can withstand expected physiological loads and perform its intended structural function.
• Biocompatibility: Verifying that the materials used are safe for implantation in the human body.
• Sterilization: Confirming the device can be effectively sterilized.
• Labeling and Packaging: Ensuring proper information is provided.
• Substantial Equivalence: Demonstrating that the device is as safe and effective as a legally marketed predicate device.

The study that proves the device meets its acceptance criteria (i.e., its safety and effectiveness compared to a predicate) is discussed under "Performance Data" and "Clinical Data."

Here's an interpretation based on the information provided, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a spinal fixation system, the "acceptance criteria" are implied by the need to demonstrate substantial equivalence to a predicate device in terms of safety and effectiveness. The "reported device performance" refers to the studies conducted to support this equivalence. Specific numerical acceptance criteria (e.g., minimum load-bearing capacity, fatigue life) are often part of the detailed testing protocols submitted to the FDA but are not explicitly listed in this summary.

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

• Sample Size for Test Set:
  • Biomechanical studies: Not specified, but typically involves a small number of cadaveric spines.
  • Clinical Data: Not specified, but includes CT evaluations, adverse event data, and patient-reported outcomes at 12 and 24 months. The specific number of patients is not mentioned.
• Data Provenance: Not explicitly stated (e.g., country of origin). The nature of the clinical data (CT evaluations, adverse events, patient-reported outcomes at specific follow-up points) suggests a prospective or retrospective clinical study, but this is not definitively stated.

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 this type of device submission. The "ground truth" for a spinal fixation system is typically established through objective measurements in mechanical/biomechanical testing and clinical outcomes, rather than expert consensus on image interpretation. Clinical assessments would be performed by qualified medical professionals (e.g., surgeons, radiologists), but their specific number or qualifications for "ground truth establishment" are not relevant in the context of AI model evaluation.

4. Adjudication Method for the Test Set

This question is not applicable as it pertains to expert disagreement resolution in AI model evaluation, which is not relevant for musculoskeletal implants.

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 question is not applicable. MRMC studies are specific to evaluating AI-assisted diagnostic or interpretative devices, not spinal fixation systems.

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

This question is not applicable. The Karma® Fixation System is a physical implant, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance assessment relies on a combination of:

• Biomechanical Data: Objective measurements from cadaveric testing (e.g., stability, stiffness).
• Computational Modeling: Results from Finite Element Analysis (FEA) predicting stress distribution and fatigue.
• Clinical Outcomes Data:
  • Imaging: CT evaluations at 12 and 24 months.
  • Adverse Event Data: Reported complications.
  • Patient-Reported Outcomes (PROs): Oswestry Disability Index (ODI) and visual analog scale (VAS) for back and leg pain.

8. The Sample Size for the Training Set

This question is not applicable. The Karma® Fixation System is a physical medical device, not an AI model that requires a "training set."

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

This question is not applicable. There is no "training set" for this type of device.

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The AERO MIS Facet Fusion System is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following:

• Spondylolisthesis,
• Spondylolysis,
• Pseudoarthrosis or failed previous fusions which are symptomatic, or
• Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability.

The system is intended for use with bone graft material.

The AERO MIS Facet Fusion System contains various sized facet screws for bilateral stabilization of the facet joints from levels C2 through S1, inclusive. The system is supplied with various orthopedic instruments. There are various facet screw sizes available for implanting to accommodate a range of facet joint sizes and geometries.

I am sorry, but the provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "AERO MIS Facet Fusion System." This document discusses the regulatory approval process and states that the device is "substantially equivalent" to a previously cleared predicate device based on its indications for use, design, function, materials, and performance.

However, the text does not contain any information about acceptance criteria, a study proving device performance against those criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria, as the necessary information is not present in the provided document.

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The Ion 3D Facet Screw may be used in conjunction with the Ion 3D GraftRasp to perform posterior spinal fusion. The Ion 3D GraftRasp may be used to rasp or decorticate bone from the facets and/or transverse processes and for the delivery of hydrated allograft or autograft. The Ion 3D Facet Screw is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following:

• · Spondylolisthesis
• · Spondvlolysis
• · Pseudoarthrosis or failed previous fusions which are symptomatic
  · Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability
  The Ion 3D Facet Screw is intended for use with bone graft material (allograft, or autograft).

The Ion 3D contains various sized facet screws with and without graft windows for bilateral stabilization of the facets from C2-S1. The Ion 3D is provided in various configurations, including single-use, and reusable. The Instruments are offered in sterile and non-sterile configurations. All implants are manufactured from Ti6Al4V per ASTM F136.
The purpose of this 510(k) is to add new Ion 3D Facet Screws and new instruments to the system.

The provided text is a 510(k) Pre-market Notification summary for a medical device (Ion 3D Facet Screw) and does not describe a clinical study with an AI component or detailed performance criteria in the way a diagnostic AI device would. Instead, it focuses on demonstrating substantial equivalence to predicate devices through engineering justifications and non-clinical performance testing.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable or available within this document.

Here's a breakdown of the information that can be extracted and a clear indication of what is not present:

1. Table of acceptance criteria and reported device performance:

The document doesn't provide specific numerical acceptance criteria or performance metrics in a table format as would be seen for a diagnostic AI device. Instead, it relies on demonstrating that the device's mechanical performance is not "worst-case" compared to predicates and that it meets standards for biocompatibility and sterilization.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission, as it focuses on non-clinical testing (mechanical, biocompatibility, sterilization, cleaning) rather than a clinical performance study with test data. The "test set" here refers to the physical devices and materials tested.
• Data Provenance: Not applicable. The testing is primarily laboratory-based and simulated.

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

• Not applicable. Ground truth as typically understood for AI or diagnostic devices (e.g., expert consensus on pathology images) is not relevant to this type of mechanical and material testing. The "ground truth" for these tests would be the established scientific and engineering principles and standards (e.g., ISO 10993).

4. Adjudication method for the test set:

• Not applicable. There is no mention of adjudication, as this type of testing does not involve subjective expert review for establishing ground truth from clinical data.

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. An MRMC study was not conducted. This device is a surgical implant (facet screw) and associated instruments, not an AI-powered diagnostic or assistive tool for human readers.

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

• No. This device is a physical implant and surgical tools; there is no standalone algorithm to evaluate.

7. The type of ground truth used:

• For mechanical performance: Engineering principles and simulation models (Finite Element Analysis) as surrogate for clinical performance under defined loads.
• For biocompatibility: International standard ISO 10993.
• For sterilization and cleaning: Industry-accepted validation protocols and standards.

8. The sample size for the training set:

• Not applicable. This document refers to a physical medical device, not an AI algorithm that requires a training set.

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

• Not applicable. No training set is involved for this type of device submission.

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The zLOCK Lumbar Facet Fixation System is an integrated construct comprised of a modular spacer and a single facet screw. The system is intended for temporary stabilization of the spine as an adjunct to fusion through bilateral immobilization of the facet joints in skeletally mature patients.

The zLOCK Lumbar Facet Fixation System is intended for use as an adjunct to a 1-level interbody lumbar fusion from L3 to L5 with autogenous and/or allogenic bone graft and must be accompanied by an FDA cleared intervertebral body fusion device implanted at the same spinal level. The zLOCK Lumbar Facet Fixation System is indicated for the treatment of patients with lumbar degenerative disease at a single level from L3 to L5 in skeletally mature patients who have failed conservative care.

The zLOCK Lumbar Facet Fixation System is composed of a modular spacer and facet screws as an integrated construct to achieve posterior lumbar facet fixation as an adjunct to fusion. All implants are supplied sterile for single use only. The modular spacers are available in one footprint with a variety of heights to accommodate varying anatomical conditions of the patient, contain a screw hole, and are bendable with toothed surfaces to firmly anchor into the joint space and contain bone graft. The facet screw is cannulated, self-tapping, with a preassembled polyaxial washer; it is provided in one size. The modular spacer and facet screw are manufactured from Titanium Grade 1 and Titanium 6Al 4V alloy, respectively.

The system is supplied with a set of non-sterile, reusable instruments to access the site, prepare it for implantation, and perform device implantation.

The purpose of this 510(k) was to add a new screw size to the previously cleared zLOCK Lumbar Facet Fixation System (K240085) and to modify the length of the spacer component.

The provided text describes a 510(k) premarket notification for a medical device called the zLOCK Lumbar Facet Fixation System. However, it does not contain the information required to answer your specific questions regarding acceptance criteria and the study that proves the device meets those criteria.

This document focuses on regulatory approval, particularly demonstrating substantial equivalence to a previously cleared device (K240085). It mentions "Performance Testing" including "Axial Pullout per ASTM F543" and "Driving Torque per ASTM F543," but it does not provide the acceptance criteria or reported performance data for these tests. It also does not involve any AI or software components, meaning there would be no ground truth, expert review, or MRMC studies involved.

Therefore, I cannot populate the table or provide details for the study as requested. The information is simply not present in the provided text.

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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 Ion 3D Facet Screw may be used in conjunction with the Ion 3D GraftRasp to perform posterior spinal fusion. The Ion 3D GraftRasp may be used to rasp or decorticate bone from the facets and/or transverse and for the delivery of hydrated allograft or autograft.

The Ion 3D Facet Screw is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following:

• · Spondylolisthesis
• · Spondylolysis
• · Pseudoarthrosis or failed previous fusions which are symptomatic

· Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability

The Ion 3D Facet Screw is intended for use with bone graft material (allograft, or autograft).

The Ion 3D contains various sized facet screws with and without graft windows, for bilateral stabilization of the facets from C2-S1. The Ion 3D is provided in various configurations, including single-use, and reusable. The Instruments are offered in sterile and non-sterile configurations. All implants are manufactured from Ti6Al4V per ASTM F136.

The provided document does not contain information related to software or AI-driven medical devices. The focus of this 510(k) submission is on a physical medical device, the "Ion 3D Facet Screw," and its accessories. The performance testing described is mechanical (e.g., axial pushout, static and dynamic three-point bend testing) to demonstrate the structural integrity and functionality of the physical screw and graft rasp.

Therefore, the requested information regarding acceptance criteria for device performance related to a study, the sample size for a test set, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for training sets is not applicable to this document. These details are typically required for the validation of diagnostic or AI-based devices, not for the mechanical testing of an orthopedic implant.

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SC Medica FFX is a lumbar facet device that is placed bilaterally through a posterior surgical approach and spans the facet interspace. SC Medica FFX must be used with an FDA-cleared transfacet screw cleared for use in the lumbar spine. SC Medica FFX is intended to provide temporary fixation to the spine as an aid to lumbar fusion through bilateral immobilization of the facet joints at one or two levels with autogenous and/or allogenic bone graft. SC Medica FFX must be accompanied with an FDA-cleared intervertebral body fusion device and/or with an FDA-cleared posterior lumbar pedicle screw and rod system implanted at the same spinal level(s) as an adjunct to a single or two-level intervertebral body or posterolateral fusion, respectively. SC Medica FFX is indicated for the treatment of patients with lumbar degenerative disc disease (DDD) from L3 to S1 in skeletally mature patients who have failed conservative care.

FFX implants are intended to provide temporary fixation and stabilization to the spine as an aid to lumbar fusion through bilateral immobilization of the facet joints. The FFX implant is a sterile, single patient use, long-term implantable device made of titanium.

The provided document is a 510(k) premarket notification for the SC Medica FFX device. It does not contain any information related to acceptance criteria, a study proving the device meets acceptance criteria, or any of the detailed aspects of a clinical or analytical performance study (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details, etc.).

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing (sterilization, biocompatibility, shelf-life, and mechanical testing) and states that "clinical data demonstrated a substantially equivalent safety and effectiveness profile". However, it does not provide any specifics about this "clinical data" (e.g., patient numbers, study design, endpoints, statistical analysis, or any of the ground truth or reader study details requested).

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study that proves the device meets those criteria based on the provided text. The document primarily confirms the FDA's clearance of the device based on substantial equivalence, rather than detailing a specific performance study against defined acceptance criteria.

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The zLOCK Lumbar Facet Fixation System is an integrated construct comprised of a modular spacer and a single facet screw. The system is intended for temporary stabilization of the spine as an adjunct to fusion through bilateral immobilization of the facet joints in skeletally mature patients.

The zLOCK Lumbar Facet Fixation System is intended for use as an adjunct to a 1-level interbody lumbar fusion from L3 to L5 with autogenous and/or allogenic bone graft and must be accompanied by an FDA cleared intervertebral body fusion device implanted at the same spinal level. The zLOCK Lumbar Facet Fixation System is indicated for the treatment of patients with lumbar degenerative disc disease at a single level from L3 to L5 in skeletally mature patients who have failed conservative care.

The zLOCK Lumbar Facet Fixation System is composed of a modular spacer and facet screws as an integrated construct to achieve posterior lumbar facet fixation as an adjunct to fusion. All implants are supplied sterile for single use only. The modular spacers are available in one footprint with a variety of heights to accommodate varying anatomical conditions of the patient, contain a screw hole, and are bendable with toothed surfaces to firmly anchor into the joint space and contain bone graft. The facet screw is cannulated, self-tapping, with a preassembled polyaxial washer; it is provided in one size. The modular spacer and facet screw are manufactured from Titanium Grade 1 and Titanium 6Al 4V alloy, respectively.

The system is supplied with a set of non-sterile, reusable instruments to access the site, prepare it for implantation, and perform device implantation.

This document describes the zLOCK Lumbar Facet Fixation System, a medical device, and its acceptance criteria as demonstrated through non-clinical and clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details the non-clinical and clinical studies conducted but does not explicitly state numerical acceptance criteria with corresponding device performance metrics in a readily extractable table format. Instead, it describes the types of tests performed and concludes that the device "supports substantial equivalence to predicate devices" and that clinical data "supports there are no increased safety or effectiveness concerns compared to predicates."

To present this in a structured table, we'll infer the acceptance criteria from the nature of the tests and the general goal of demonstrating substantial equivalence. The reported performance is qualitative, indicating the device met the implied benchmarks for substantial equivalence.

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

• Sample Size for Test Set: The document does not explicitly state the specific number of patients included in the clinical study. It refers to a "prospective, multi-center single arm interventional study."
• Data Provenance: The clinical study was conducted "outside the United States." It was a "prospective" study, meaning data was collected forward in time specifically for this research.

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

The document does not provide information on the number or qualifications of experts used to establish a ground truth for the clinical test set. It mentions "radiographic and CT evaluations" were used, but not who interpreted them or how consensus was reached.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1) used for the clinical test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The clinical study was described as a "single arm interventional study," meaning there was no direct comparison between AI assistance and unassisted human readers, or between human readers with and without the device's specific outputs. The device itself is a surgical implant, not an AI or imaging diagnostic tool that would typically involve a MRMC study for assessing reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The zLOCK Lumbar Facet Fixation System is a physical implant, not a software algorithm or diagnostic tool. Therefore, a "standalone algorithm-only" performance study is not relevant to this device.

7. Type of Ground Truth Used

For the non-clinical tests, the "ground truth" would be the engineering specifications, material properties, and biomechanical parameters established by the ASTM standards and finite element analysis models.

For the clinical data, the ground truth for safety and effectiveness was established through:

• Radiographic and CT evaluations: These provided objective imaging evidence of fusion and device placement/stability.
• Safety data: Collection of adverse events.
• Patient Reported Outcomes (PROs): Subjective measures like Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) for back and leg pain.

These measures collectively served as the basis for evaluating the device's performance against the implicit "ground truth" of no increased safety or effectiveness concerns compared to predicate devices.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical implant, not a machine learning or AI algorithm that requires a training set in the typical sense.

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

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

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