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When used as an interbody fusion device, the TruLift® Lateral Expandable Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the TruLift® Lateral Expandable Spacer can also be connected to the Lateral Plate System by a set screw.

The Lateral Plate System is intended to be used as a non-pedicle lateral fixation system in skeletally mature patients and is intended to provide immobilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels T1-L5 with the following indications:

• Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

• -Spondylolisthesis

• -Spinal stenosis

• -Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis)

• -Tumor

• -Pseudoarthrosis

• -Failed previous fusion

• -Trauma (i.e., fracture or dislocation)

The Lateral Plate System, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The 1-hole plate is not intended for use in load-bearing applications. The Lateral Plate System can also be connected to the TruLift® Lateral Spacer System by a set screw.

The TruLift® Lateral Expandable Spacer System is available in a range of sizes and footprints and can expand to the desired height (8mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the TruLift® Lateral Expandable Spacer System components with components from any other system or manufacturer. The TruLift® Lateral Expandable Spacer System components should never be reused under any circumstances.

The Lateral Plate System consists of a variety of plates and screws to suit the individual pathology and anatomical conditions of the patient. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.The plates are manufactured in a variety of configurations with options including different lengths and curvature. The screws are manufactured in variable and fixed configurations with diameters and lengths. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the Lumbar spine using an anterior approach. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient.

The Lateral Plate System also utilizes a variety of standard orthopedic instruments to assist in the placement of the devices.

Do not use any of the Lateral Plate System components from any other system or manufacturer. The Lateral Plate System components should never be reused under any circumstances.

This document is an FDA 510(k) summary for a medical device (TruLift® Lateral Expandable Spacer System & Lateral Plate System). It describes the device, its intended use, and its equivalence to predicate devices, focusing on design, materials, and mechanical performance. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to AI/software performance.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, ground truth establishment, or AI-specific study details (such as MRMC studies or standalone algorithm performance), as these types of studies are not relevant to the content provided in this 510(k) summary. This document is focused on demonstrating the physical and mechanical equivalence of the spinal implant system to existing predicate devices, not on the performance of a software or AI component.

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The GX Navigation Instruments are intended to be used during the preparation and placement of Life Spine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The GX Navigation Instruments are compatible with the following Life Spine implant systems: ARx Spinal System, Avatar Extended Tab MIS System, Nautilus Thoracolumbar Spinal System, Centerline Thoracolumbar Spinal System and Centric-T System.

The GX Navigation instruments are manufactured from Stainless Steel as specified in ASTM F899, non-sterile, reusable instruments designed to function with the Medtronic® StealthStation® System. Refer to the appropriate navigation system Instructions for Use and/or Surgical Technique Guide for details regarding navigation system use.

The provided FDA 510(k) summary for the GX Navigation Instrument System does not contain detailed information regarding acceptance criteria and a specific study proving the device meets those criteria in the context of AI/machine learning performance. The document focuses on establishing substantial equivalence to predicate devices, primarily through design, materials, and mechanical performance testing.

However, based on the information provided, we can extract details related to the performance testing that was submitted:

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

The document mentions "Testing according to Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems testing to ASTM F2554-18 was presented to demonstrate substantial equivalency."

While specific numerical acceptance criteria and reported values are not provided in this summary, the standard ASTM F2554-18 focuses on positional accuracy. For a stereotaxic instrument, the key performance metric would be the accuracy with which it guides the surgeon to the intended anatomical location.

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

The document does not specify a "test set" in the context of an AI/ML algorithm or a dataset for performance evaluation. The testing performed is described as "Testing according to Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems testing to ASTM F2554-18," which typically involves physical measurements on a phantom or test setup rather than a patient dataset. Therefore, information about data provenance (country of origin, retrospective/prospective) and sample size for a "test set" in the context of data-driven AI/ML is not applicable here.

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

This information is not provided as the submission relates to a surgical navigation instrument system, not an AI/ML diagnostic or predictive device requiring ground truth from human experts on a dataset.

4. Adjudication method for the test set:

Not applicable, as the testing described does not involve human interpretation of a test set that would require an adjudication method.

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 navigation instrument, not an AI assistance tool for human readers/clinicians in diagnostic interpretation.

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

Not applicable. The device is an instrument system designed to be used with a navigation system (Medtronic StealthStation) and a surgeon. It is not a standalone algorithm.

7. The type of ground truth used:

For the positional accuracy testing (ASTM F2554-18), the ground truth would typically be established by precise metrology instruments or a known, highly accurate reference within the test setup, adhering to the specifications of the standard. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense for AI/ML.

8. The sample size for the training set:

Not applicable. This device does not appear to be an AI/ML device that requires a training set. The performance testing is based on physical and mechanical evaluations.

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

Not applicable, as there is no mention of a training set for an AI/ML component.

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The Life Spine SIMPACT Sacroiliac Joint Fixation System is intended for sacroiliac fusion for the following conditions: · Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months. · To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. · Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

The Life Spine SIMPACT Sacroiliac Joint Fixation System consists of fully threaded screws and partially threaded cannulated screws in various diameters and lengths to enhance sacroiliac joint fusion. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136. All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine Simpact Sacroiliac Joint Fixation System components with components from any other system or manufacturer. The Life Spine Simpact Sacroiliac Joint Fixation System components should never be reused under any circumstances.

Here's a breakdown of the acceptance criteria and study information for the Life Spine SIMPACT Sacroiliac Joint Fixation System, based on the provided FDA 510(k) summary:

This device is not an AI/ML powered device, therefore no AI-specific information is available. The submission is for a traditional medical device (sacroiliac joint fixation system) and focuses on demonstrating substantial equivalence to existing predicate devices through material and mechanical performance testing, rather than clinical performance or AI algorithm validation.

However, I can extract the information relevant to a traditional medical device submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size (e.g., number of screws tested) for the ASTM F543 tests. These are typically benchtop mechanical tests performed on a sufficient number of samples to ensure statistical validity and representativeness. The data provenance is laboratory testing rather than patient data.

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

Not applicable. This device is not AI-powered, and ground truth in the context of clinical expert consensus is not relevant for this type of mechanical testing. The "ground truth" here is adherence to mechanical standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical consensus in diagnostic studies, not for mechanical bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is not an AI-assisted diagnostic tool, so no MRMC study or AI-related comparative effectiveness was performed.

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

Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established through adherence to recognized international standards for medical device materials and mechanical testing (ASTM F543). The performance is compared to that of legally marketed predicate devices, implying that the predicate devices' performance against these standards sets the benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

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

Not applicable. This device does not involve a training set.

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When used as an interbody fusion device, the TRULIFT® Expandable Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The TRULIFT® Expandable Spacer System is available in a range of sizes and footprints and can expand to the desired height (8mm to 16mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6AI-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the TRULIFT® Expandable Spacer System components with components from any other system or manufacturer. The TRULIFT® Expandable Spacer System components should never be reused under any circumstances.

I apologize, but the provided text from the FDA 510(k) clearance letter for the "TruLift Expandable Spacer System" deals with a spinal implant (intervertebral body fusion device), not an AI/ML-enabled medical device for which the requested information regarding acceptance criteria, study findings, sample sizes, expert ground truth, and human-in-the-loop performance would be relevant.

The document discusses the mechanical and material equivalence of the TruLift system to predicate spinal implants, based on ASTM performance standards for devices of its type (e.g., static axial compression, dynamic compressive shear). It does not involve any form of AI, image analysis, or diagnostic/prognostic capabilities that would require the kind of clinical validation study you've described.

Therefore, I cannot extract the information you've requested about acceptance criteria and a study proving an AI device meets them, because this document pertains to a traditional, mechanical Class II medical device.

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The PLATEAU-A Ti Anterior Lumbar Spacer is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of nonoperative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The Plateau-X Ti Lateral Lumbar Spacer is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolistthesis at the involved level(s). It is to be used in patients who have had at least six months of nonoperative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The PLATEAU-A Ti Anterior Lumbar Spacer implants are intervertebral body fusion devices comprised of a variety of spacer implants manufactured from Titanium Alloy (Ti-6A1-4V ELI per ASTM F136). The spacers are hollow to permit packing autograft bone graft and/or allogeneic bone composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to help prevent rotation and/or migration. The implants are available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient.

The Plateau-X Ti Lateral Lumbar Spacer is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

The provided document is a 510(k) summary for the Life Spine Plateau®-A Ti Anterior Lumbar Spacer & Plateau®-X Ti Lateral Lumbar Spacer. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study for a new device with novel performance claims.

Therefore, the information typically requested regarding acceptance criteria, study design, expert involvement, and ground truth for demonstrating device performance as understood in the context of AI/ML or diagnostic devices is not directly applicable or available in this document.

However, I can extract information related to the device's substantial equivalence demonstration for mechanical performance.

Here's an analysis based on the provided text, addressing the points where possible:

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

• Acceptance Criteria: The document does not specify quantified acceptance criteria (e.g., specific load values or displacement limits) for the mechanical tests. Instead, it relies on demonstrating that the new device performs acceptably compared to its predicate devices. The implicit acceptance criterion is that the new device's mechanical performance is equivalent to or better than the predicate devices, as demonstrated by meeting relevant ASTM standards.
• Reported Device Performance: The document states: "Testing according to ASTM F2077 & F2267 included Static axial compression, static expulsion, static subsidence, and dynamic axial compression tests was presented to demonstrate the substantial equivalency of the Life Spine Plateau (K080411/K111569)." It does not provide numerical results of these tests, only that the tests were performed and were sufficient to demonstrate substantial equivalency to the predicate.

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 explicitly provided. For mechanical testing, the "sample size" would refer to the number of device units tested. The document does not specify the number of units or the specific test specimens.
• Data provenance (country of origin, retrospective/prospective) is not relevant to this type of mechanical testing. The testing would be conducted in a laboratory setting.

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 device is an implanted medical device (spinal spacer), and its evaluation for 510(k) clearance primarily involves mechanical and material testing, not subjective assessment by medical experts for ground truth establishment.

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

• Not applicable. Adjudication methods are typically used in clinical studies involving interpretation (e.g., by radiologists) to establish ground truth or resolve discrepancies. This document describes mechanical testing.

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

• Not applicable. This is not an AI/ML device or a diagnostic device that would involve human readers or AI assistance.

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

• Not applicable. This is an implanted medical device, not an algorithm.

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

• For mechanical testing, the "ground truth" is defined by the objective measurements obtained from standardized tests (e.g., load-displacement curves, failure loads). Compliance with relevant ASTM standards (F2077 & F2267) serves as the benchmark against which performance is measured.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable.

In summary: The provided document is a 510(k) summary demonstrating substantial equivalence for an orthopedic implant through mechanical testing. It does not contain information typically found in submissions for diagnostic or AI/ML devices regarding clinical study design, expert ground truth, or performance metrics against specific acceptance thresholds in a clinical context. The "study" mentioned is the series of mechanical tests to ASTM standards, and the "acceptance criteria" are implicitly met by demonstrating equivalency to the predicate devices through these tests.

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Solstice CCI is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical/thoracic 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 Solstice CCI is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, The Solstice CCI may be connected to the titanium Life Spine NAUTILUS Spine System using the 3.5mm/5.5mm titanium parallel connectors.

The Solstice CCI is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), multiple component system comprised of a variety of non-sterile, single use implantable components. The system consists of an assortment of occipital plates, occipital bone screws, hooks, connectors, rods, and locking caps.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Solstice CCI components with components from any other system or manufacturer. The components should never be reused under any circumstances.

The provided FDA 510(k) clearance letter and summary for the Solstice CCI device primarily focus on mechanical and material equivalency to predicate devices, rather than an AI/ML-driven diagnostic or assistive technology. Therefore, the typical acceptance criteria and study designs associated with AI performance (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by expert consensus) are not applicable to this device submission.

The "Performance Data" section explicitly states:

"The Solstice CCI was tested according to ASTM F2706 which included Static & Dynamic Axial Compression Bending and Torsion."

This indicates that the performance evaluation was primarily mechanical testing to ensure the device's structural integrity and ability to function as intended, rather than its diagnostic accuracy or impact on human reading performance.

Given this, I cannot extract the information requested in your prompt regarding acceptance criteria and study design for an AI/ML medical device.

If this were an AI/ML device submission, the requested information would typically look like this (illustrative example based on common AI/ML diagnostic device submissions):

Hypothetical Example for an AI/ML Device (NOT based on the provided document)

Let's imagine, for the sake of demonstrating the requested output, that the Solstice CCI was an AI-driven system designed to detect spinal fractures from medical images.

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

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

• Test Set Sample Size: 1500 medical images (e.g., CT scans of the spine).
• Data Provenance: Retrospective data collected from multiple institutions across the United States (e.g., university hospitals, large medical centers). Data diversity included varying scanner types, patient demographics, and image acquisition protocols.

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

• Number of Experts: 3 board-certified radiologists.
• Qualifications: Each radiologist had at least 10 years of experience specializing in musculoskeletal or neuroradiology and had previously participated in consensus reading studies.

4. Adjudication method for the test set

• Adjudication Method: 2+1; All cases were independently reviewed by two primary radiologists. In cases of disagreement between the two primary readers, a third, senior radiologist acted as an arbiter to establish the final ground truth.

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

• MRMC Study: Yes, an observer performance study was conducted.
• Effect Size: Human readers demonstrated a statistically significant improvement in fracture detection accuracy (measured by AUROC) when assisted by the AI algorithm compared to reading without AI assistance. The average AUROC for human readers increased from 0.85 (without AI) to 0.91 (with AI assistance), representing an improvement of 0.06 AUROC points (p < 0.001). This translated to a 15% reduction in missed fractures and a 10% reduction in false positives.

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

• Standalone Performance: Yes, the standalone performance of the AI algorithm was evaluated independently against the established ground truth on the test set. (See table in section 1 for metrics).

7. The type of ground truth used

• Type of Ground Truth: Expert Consensus (Radiologist Consensus). In some challenging cases, correlation with pathology reports (e.g., for surgical samples from confirmed fractures) or follow-up clinical outcomes (e.g., imaging at later time points) was used to support consensus.

8. The sample size for the training set

• Training Set Sample Size: 50,000 medical images (CT scans).

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

• Ground Truth for Training Set: Ground truth for the training set was primarily established through a combination of radiological reports and labels provided by a team of experienced radiologists (different from the test set readers). A subset of these images (e.g., 5-10%) underwent a more rigorous internal consensus review process (e.g., by 2-3 radiologists) to ensure high-quality labeling for critical cases or ambiguous findings. Automated methods, where clinically robust (e.g., based on structured reports or PACS annotations), might also be used to augment initial labeling.

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The ARx Spinal System, is intended for posterior pedicle screw fixation of the non-cervical posterior spine (T1 to S2/ ilium) in skeletally mature patients and for pediatric patients to treat adolescent idiopathic scoliosis . It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. When used as a posterior spine thoracic/lumbar system, the ARx Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures and spinal deformity (scoliosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (pseudarthrosis), (6) spinal stenosis, (7) spondylolisthesis.

In order to achieve additional levels of fixation in skeletally mature patients, the ARx Spinal System 5.5/6.0 rod system may be connected to the Solstice OccipitoCervicoThoracic Fixation System's 3.5mm rod.

The ARx Spinal System consists of screws and longitudinal rods intended to provide temporary stabilization and immobilization following surgery to fuse a portion of the thoracic, lumbar, and/or sacral spine. The ARX Spinal System consists of an assortment of rods and screws. The bone screw, head, and taper lock are assembled together during manufacturing to create the ARX Spinal System screw assembly component. The ARX Spinal System implant components are made from titanium alloy (Ti-6A1-4V ELI) as described by ASTM F136 and Cobalt Chrome (Co-28Cr-6Mo) as described by ASTM F1537. Do not use any of the ARX Spinal System components with the components from any other system or manufacturer.

The provided text is a 510(k) premarket notification summary for a medical device, the ARx Spinal System. This type of FDA submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance criteria through a clinical study or AI/software analysis.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, especially in the context of an AI/machine learning enabled device. The "Performance Data" section specifically mentions mechanical testing (ASTM F1717 & F1798) to demonstrate substantial equivalence to a predicate device, which is typical for implantable orthopedic devices, not diagnostic or AI-powered tools.

To directly answer your request based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document refers to mechanical performance testing against ASTM standards to show equivalence, not clinical performance metrics or AI algorithm performance. No acceptance criteria table or reported performance for an AI/software device is present.

2. Sample sizes used for the test set and the data provenance: Not applicable. The "performance data" refers to mechanical testing of the device itself, not a test set of data for an AI algorithm. No information on data provenance (country, retrospective/prospective) is provided as it's not relevant to this type of device submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for an AI algorithm test set is mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set for an AI algorithm is mentioned.

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 pertains to an implantable spinal system, not an AI-assisted diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There is no AI algorithm in scope for this submission.

8. The sample size for the training set: Not applicable. There is no AI algorithm described.

9. How the ground truth for the training set was established: Not applicable. There is no AI algorithm described.

In summary, the provided FDA 510(k) clearance letter and summary are for an orthopedic implant (ARx Spinal System) and detail the process of demonstrating substantial equivalence primarily through design, materials, indications for use, and mechanical testing, not through clinical trials or performance assessments of AI/software for diagnostic purposes.

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The ProLift® Lateral Fixated is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ProLift® Lateral Fixated is to be filled with autograft and/ or allogenic bone graft comprised of cancellous and/or corticocancellous bone, may be used with two bone screws, and is to be used with supplemental fixation.

The ProLift® Lateral Fixated is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6AI-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration. The screws are manufactured in variable and fixed configurations with diameters of 5.5mm and 6.5mm and lengths of 25mm-60mm. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient.

This document (K200338) is a 510(k) premarket notification for a medical device called ProLift® Lateral Fixated, which is an intervertebral body fusion device. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it is at least as safe and effective.

The provided document does not contain information about software, artificial intelligence (AI),
or a study involving human readers and AI assistance. This submission focuses on the mechanical and material performance of an implantable intervertebral fusion device, not on diagnostic or AI-powered image analysis.

Therefore, I cannot fulfill the request for information regarding AI acceptance criteria, human reader studies, or ground truth establishment in the context of an AI device, as the content is irrelevant to those topics.

The document describes the following acceptance criteria and the study that proves the device meets them for this specific type of medical device (intervertebral fusion device):

Here's the relevant information from the document regarding the device's performance validation:

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

   • The document primarily refers to standard ASTM testing for intervertebral body fusion devices. It implies that the acceptance criteria are adherence to these standards.
   • Acceptance Criteria (Implied by standard testing): Meets the performance requirements for static compression, dynamic compression, static shear, and dynamic shear as specified by ASTM F2077.
   • Reported Device Performance: "Static compression, dynamic compression, static shear and dynamic shear testing according to ASTM F2077, was presented to demonstrate the substantial equivalency of the Pro-Lift Expandable System (K191005)." (This suggests the ProLift® Lateral Fixated met these criteria as it's being compared to a predicate that already demonstrated this).
   • The document states: "The ProLift® Lateral Fixated was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance."

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

   • The document does not specify sample sizes for mechanical testing. This information would typically be in a detailed test report, which is not included in this summary.
   • Data provenance is not applicable here as it's lab-based mechanical testing of the physical device, not patient data.

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

   • Not applicable. This is mechanical engineering testing, not expert interpretation of diagnostic data. The "ground truth" is established by the physical properties and performance measured against ASTM standards.

4. Adjudication method for the test set:

   • Not applicable. This is not a study involving human adjudication of data; it's 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, an MRMC comparative effectiveness study was not done. This device is an implantable medical device, not an AI or diagnostic software.

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

   • No, this is not relevant to an implantable device.

7. The type of ground truth used:

   • The "ground truth" for the mechanical performance of this device is established by compliance with recognized consensus standards (ASTM F2077) for intervertebral body fusion devices and direct measurement of mechanical properties (e.g., strength, durability) under load.

8. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of mechanical testing for an implantable device, as there is no machine learning or AI involved.

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

   • Not applicable. See point 8.

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When used as an interbody fusion device, the ProLift® Expandable System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The ProLift Expandable System is available in a range of sizes and footprints and can expand to the desired height (8mm to 16mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

This document describes the ProLift® Expandable System, an intervertebral body fusion device. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it is a 510(k) Pre-market Notification for a medical device submitted to the FDA, demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information. The document explicitly states: "No additional testing was performed, see comparison analysis." This indicates that the approval was based on demonstrating the new device's substantial equivalence to a previously approved device (the predicate device) through a comparison analysis of design, materials, indications for use, and mechanical performance, rather than through new performance studies with specific acceptance criteria.

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The Stand-Alone ALIF Tianium System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of nonoperative treatment. This device is intended to allow packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion.

The Stand-Alone ALIF Titanium System is intended for use with three titanium alloy screws which are provided with the system. If the physician chooses to use fewer than three of the provided screws, then a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine must be used. When used with Barbs (Anchors), these devices are intended for use with supplemental fixation (e.g. Pedicle screws or posterior fixation).

The Stand-Alone ALIF Titanium System implants are intervertebral body fusion devices comprised of a variety of spacer implants manufactured from Titanium Alloy (Ti-6Al-4V ELI per ASTM F136). The spacers are hollow to permit packing autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to help prevent rotation and/ or migration. The anterior face of the spacer has integrated screw holes to allow for placement of three titanium alloy screws that anchor the implant to the adjacent vertebrae. Additionally, the barbs may be inserted through the screw holes in place of screws. The barbs are intended to provide additional stability to the cage but require supplementary fixation, such as pedicle screws. The implants are available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Stand-Alone ALIF Titanium System components with components from any other system or manufacturer. The components should never be reused under any circumstances.

This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Stand-Alone ALIF Titanium System." It primarily describes the device's intended use, materials, and substantial equivalence to previously cleared devices. It does not present information about an AI/ML-driven device, nor does it contain a study proving the device meets acceptance criteria related to AI/ML performance.

Therefore, I cannot extract the information required to answer your prompt, as the prompt's questions pertain specifically to the acceptance criteria and study proving performance for an AI/ML-based medical device.

This document is about a spinal implant (an intervertebral body fusion device), not an artificial intelligence or machine learning product. It discusses mechanical performance testing (ASTM F2077-14 for static and dynamic compression/shear) to demonstrate substantial equivalency to predicate devices, which is a different type of performance evaluation than what would be done for an AI/ML device.

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