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The F3D Lateral Lumbar Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). F3D Lateral Lumbar implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Hyperlordotic interbody devices (≥20° lordosis) must be used in conjunction with the Oro Lateral plate for fixation. If using the 1-hole CoreLink Oro Lateral Plate System, additional supplemental fixation is required (e.g. posterior fixation).

The CL5 Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). CL5 Lumbar implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The CoreLink Oro Lateral Plate System (LPS), in two and four-hole configurations, is intended for use as a laterally placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The CoreLink Oro Lateral Plate System is designed to provide temporary stability until fusion is achieved. It is intended for lateral or anterolateral lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion.

Alternatively, the CoreLink Oro Lateral Plate System may remain attached to CoreLink Lateral lumbar interbody devices after implantation. In this configuration the CoreLink Oro LPS must only be used to treat patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.

The CoreLink Oro LPS, one-hole configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The one-hole plate is not intended for use in load-bearing applications.

Hyperlordotic interbody devices (≥20° lordosis) must be used in conjunction with the CoreLink Oro Lateral Plate System (LPS) for fixation.

The F3D Lateral Lumbar Interbody System, additively manufactured Ti-6A1-4V ELI per ASTM F3001 implants, and the CL5 Lateral Lumbar Interbody System, PEEK implants per ASTM F2026 with Tantalum per ASTM F560, are lumbar interbody spacers designed to provide mechanical support to the lumbar spine while arthrodesis occurs. The lateral lumbar spacers with hollow footprints for placement of graft material feature a wide variety of footprint, height, and lordosis options to accommodate patient anatomical needs. The F3D spacers are designed with a porous surface to optimize bone in-growth. The CL5 spacers are designed with ridges on the superior and inferior surfaces to improve grip against the end-plates and prevent expulsion. The Oro Lateral Plate System consists of plates and screws intended for use as a laterally placed supplemental fixation device via the lateral or anterior lateral surgical approach above the great vessels or via the anterior surgical approach below the bifurcation of the great vessels. The Oro Plate System implants are manufactured from Ti-6AI-4V ELI per ASTM F136 with Nitinol springs per ASTM F2063 in the plate's screw anti-backout plates. The plates are offered in 1-Screw, or 4-Screw configurations and in multiple lengths for single level fixation. The 1-Screw plate configuration is designed to maintain the relative position of interbody spacers during spinal fusion and is non-load bearing. The 2-Screw and 4-Screw plate configurations are designed as supplemental fixation for lumbar fusion. The plate screws are available in a variety of size options.

All Oro plates may be permanently attached to the F3D or CL5 spacers and assume the indications for use of the spacers.

The spacer and plate systems have been previously cleared (K183239, K150847, and K190016). This 510(K) submission offers additional implants to the previously cleared sets.

The provided text describes medical devices (spinal implants) and their indications for use, characteristics, and comparison to predicate devices for FDA clearance. However, it does not include information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding sample sizes for test/training sets, expert involvement, or MRMC studies.

The document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to already legally marketed devices, rather than presenting a detailed clinical study with performance metrics against pre-defined acceptance criteria for diagnostic AI/software.

Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets them because this type of information is not present in the provided text. The document primarily discusses mechanical testing results to demonstrate that the strength of the devices is "sufficient for their intended use and are substantially equivalent to legally marketed predicate devices."

The requested information points cannot be extracted from the given text as it pertains to AI/software performance validation, while the document describes physical medical devices and their mechanical testing.

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CoreLink Robotic Navigation Instruments are indicated to be used during the preparation screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures for skeletally mature patients, where reference to a rigid anatomical structure such as vertebra can be identified. These instruments are designed for use with the Globus ExcelsiusGPS system, which is indicated 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 system is indicated for the placement of spinal and orthopedic bone screws.

CoreLink Robotic Navigation Instruments are non-sterile, reusable instruments including taps and drivers that can be operated manually. These instruments are intended to be used with the Globus Medical Excelsius GPS® Robotic Navigation Platform to aid in implantation of CoreLink Pedicle Screw System implants (NextGen Pedicle Screw System, CoreLink Midline Fixation System (CentraFix), and Tiger Spine System). The instruments are manufactured from stainless steel.

The provided document is a 510(k) summary for the CoreLink Robotic Navigation Instruments. This type of submission is for medical devices that are substantially equivalent to a predicate device already on the market. As such, the focus of the submission is primarily on demonstrating this substantial equivalence through engineering analysis and comparison to existing cleared devices, rather than on extensive clinical performance data or a standalone performance study as would be seen for novel AI/ML-enabled devices.

Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving device performance (beyond engineering analysis for equivalence), sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The document states:

• "The CoreLink Robotic Navigation Instruments have been evaluated through an engineering analysis and geometric comparison to predicate devices to establish the safety and efficacy for accuracy performance."
• "The results of this engineering analysis show that the subject is substantially equivalent to the cleared predicate."

This means the device's acceptable performance is demonstrated by its similarity to already cleared devices, and it's not being assessed as a novel AI/ML device requiring the robust performance study details typical for such submissions.

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CoreLink Navigation Instruments is indicated for use during the preparation and placement of Siber Ti Sacroiliac Joint Fusion System implants and Entasis Dual-Lead Sacroiliac Implant System implants 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 S8 System (V1.2.0), 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel for use with CoreLink pedicle screw and sacroiliac screw systems. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures.

The purpose of this submission is to offer compatibility of the previously cleared CoreLink Navigation Instruments for sacroiliac fusion implants with additional CoreLink Sacroiliac Screws and to update the sacroiliac navigation instrument set.

The provided text describes a 510(k) premarket notification for the CoreLink Navigation Instruments. However, it does not contain the detailed information required to answer your specific questions regarding acceptance criteria and the study that proves the device meets those criteria, especially in the context of an AI/ML-driven device.

This document is a regulatory submission for a manual surgical instrument (CoreLink Navigation Instruments) designed to assist in locating anatomical structures during spinal surgery, used in conjunction with a separate navigation system (Medtronic StealthStation S8 System). It's not a submission for an AI/ML-driven device that would typically involve acceptance criteria related to algorithmic performance (e.g., sensitivity, specificity, F1-score), ground truth establishment by experts, or MRMC studies.

Therefore, I cannot extract the information asked for in your prompt (e.g., acceptance criteria table, sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC study details, standalone performance, type of ground truth, etc.) from the given text.

The closest information provided is:

• Device Type: Non-sterile, re-usable manual surgical instruments.
• Purpose: To assist surgeons in precisely locating anatomical structures.
• Performance Data: "Performance testing per ASTM F2554 has been conducted to evaluate positional accuracy of the CoreLink Navigation Instruments as submitted under previous submissions of the CoreLink Navigation Instruments (K212825). An engineering analysis has been performed to show that the subject instruments present no new worst case for positional accuracy and that the previous testing is representative of the subject instruments."

This indicates that the "performance" here refers to the physical and mechanical accuracy of the manual instruments, not the diagnostic or predictive performance of an AI model.

To answer your questions, I would need a different type of document, specifically one that describes a clinical or technical validation study for an AI/ML medical device.

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The F3D-C2 Cervical Stand-Alone System is a Stand-Alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels depending on the assembly. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The F3D-C2 Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) depending on the assembly. The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment. The F3D-C2 Cervical Stand-Alone System is an interbody fusion device intended to be used with two titanium alloy screws and/or anchors which accompany the implants. When used with screws, the F3D-C2 Cervical Stand-Alone System is intended for use at one or two levels of the cervical spine (C2-T1) and requires no additional fixation. When used with one or more anchors, the F3D-C2 Cervical Stand-Alone System is intended for use at one level of the cervical spine (C2-T1) and requires additional supplemental fixation such as posterior cervical screw fixation.

The F3D Corpectomy devices are vertebral body replacement devices intended for use in the cervical (C2-T1) and thoracolumbar spine (T1-L5). When used in the cervical spine (C2-T1), F3D Corpectomy devices are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These spacers are 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, with bone graft used at the surgeon's discretion. When used in the thoracolumbar spine (T1-L5). F3D Corpectomy devices are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

The F3D Cervical Stand-Alone System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The F3D Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of non-operative treatment prior to treatment. The F3D Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation.

The F3D™ Lateral System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non- operative treatment prior to treatment with an intervertebral cage.

The CoreLink® M3™ Stand-Alone ALIF System is a standalone interbody fusion system indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The device may be used with supplemental fixation. Hyperlordotic implants (≥20° lordosis) are intended for use with supplemental fixation (e.g. posterior fixation) that are cleared for use in the lumbar spine. The system is indicated to be used with autograft bone. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The implants are intended to be used with the bone screws and lock provided. The system is designed to be a 3-screw implant, and all three (3) screws must be used. The accompanying lock must be used anytime the device is used with any number of screws. If the physician chooses to use less than the recommended number, or none of the provided screws, then the additional supplemental fixation in the lumbar spine must be used to augment fixation.

Foundation 3D cervical implants are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as disco genic pain with degeneration of the disc confirmed by patient history and radiographic studies. Foundation cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Foundation 3D Interbody implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. Foundation 3D lumbar implants are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

The Foundation™ 3D Interbody Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Foundation™ Cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Foundation™ 3D Interbody implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. The Foundation™ 3D Interbody Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation™ implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The CoreLink, F3D Interbody System is a collection of additively manufactured, machined implants and associated instruments for surgical site preparation and implantation to provide mechanical support to the cervical and lumbar spine while arthrodesis occurs. The subject cages are additively manufactured from Ti-6Al-4V per ASTM F3001. Integration consists of additive Ti-6Al-4V (ASTM F3001) anchors (also referred to as nails) or machined Ti- 6A1-4V (ASTM F136 and ISO 5832-3) screws. The spacer and screw components are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient. The basic shape of the spacer is a trapezoidal column to provide surgical stabilization of the spine. The inferior/superior aspects of the spacer incorporate a vertical cavity which can be packed with bone graft. The F3D Interbody System has open macroscopic 3D pores with a microscopic, roughened surface and nano scale features.

This is a 510(k) summary for the F3D Interbody System, which is a collection of spinal implants. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner one might find for a novel AI/software device.

Therefore, many of the requested points regarding acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies (especially MRMC, standalone AI performance) are not applicable or not provided in this type of regulatory submission for a physical medical device.

However, I can extract information related to the device's performance evaluation as described.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" for a study in the sense of predefined thresholds for clinical performance. Instead, it describes performance testing conducted to characterize the material and its biological interactions, with the implicit acceptance criterion being that the device performs at least as well as or better than the predicate devices for comparable properties, and demonstrates favorable osteoblast functions.

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

• Sample Size: Not specified in terms of number of human subjects or distinct physical devices for each test. The performance data section describes types of tests performed (e.g., Scanning Electron Microscopy, Osteoblast Adhesion and Proliferation) but does not provide details on the number of samples or replicates for these tests. This is typical for pre-market submissions focusing on material characterization and in vitro biological response rather than clinical trials.
• Data Provenance: Not specified. It's an in vitro and material characterization study, so concepts like "country of origin" or "retrospective/prospective" in a clinical sense are not directly applicable.

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 is not a study involving expert review of medical images or clinical data to establish a ground truth. The "ground truth" for the material characterization and in vitro biological studies would be the results obtained from the analytical techniques themselves (e.g., SEM images, quantitative assays for collagen, ALP, calcium).

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

Not applicable. There was no expert adjudication process for this type of performance 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

Not applicable. This document describes a physical medical device (spinal implants) and material science/biological response testing, not an AI/software device that would involve human readers or an MRMC study.

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

Not applicable. This is not an AI/software device.

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

The "ground truth" for the reported performance data is derived from direct measurements and analytical results from laboratory studies quantifying material characteristics and cellular responses. Examples include:

• Microscopic imagery (SEM, AFM) for nano-scale features.
• Spectroscopic analysis (EDS) for chemical composition.
• Quantitative assays for osteoblast adhesion, proliferation, collagen content, alkaline phosphatase activity, and extracellular calcium deposition.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device. The studies are for characterizing the material and its biological interactions.

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

Not applicable. This is not an AI/machine learning device.

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CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink 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 S8 (V1.2.0), 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.

CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel for use with CoreLink pedicle screw and sacroiliac screw systems. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures.

The purpose of this submission is to add instruments to the previously cleared CoreLink Navigation Instruments set to offer navigation compatibility with additional CoreLink pedicle screws.

The provided text describes a 510(k) summary for CoreLink Navigation Instruments. This document does not contain information about an AI/ML powered device, but rather a set of non-sterile, reusable manual surgical instruments designed to interface with a navigation system. As such, the specific criteria requested for AI/ML powered devices, such as performance metrics like ROC curves, sensitivity, specificity, and detailed study designs involving AI performance, are not applicable here.

However, I can extract information related to the performance evaluation of the CoreLink Navigation Instruments based on the provided text.

Here's an analysis of the available information regarding acceptance criteria and performance:

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

The document mentions "Performance testing per ASTM F2554 has been conducted to evaluate positional accuracy of the CoreLink Navigation Instruments". It also states that "An engineering analysis has been performed to show that the subject instruments present no new worst case for positional accuracy and that the previous testing is representative of the subject instruments."

However, the specific acceptance criteria (e.g., a defined threshold for positional accuracy) and the quantitative reported device performance values are not explicitly stated in this summary. It only indicates that testing per a standard was conducted and an engineering analysis confirmed representativeness.

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

The document refers to "Performance testing per ASTM F2554". ASTM F2554 is a standard for "Standard Test Method for Positional Accuracy of Computer-Assisted Surgical Systems." This standard outlines methods for testing, but the specific sample size (e.g., number of tests, number of instruments tested) used in the CoreLink study is not provided in this summary.

Similarly, the data provenance (e.g., country of origin, retrospective/prospective) related to this performance testing is not mentioned.

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

This question is geared towards AI/ML device evaluations where expert consensus often establishes ground truth for image interpretation or diagnosis. For a surgical instrument like the CoreLink Navigation Instruments, "ground truth" would typically relate to physical measurements of accuracy. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense is not directly applicable. The ground truth would be established by the measurement methods defined in ASTM F2554, likely involving precision measurement instruments and qualified test operators, but specifics are not provided.

4. Adjudication method for the test set

Similarly, adjudication methods (like 2+1 or 3+1) are common in studies where multiple human readers assess medical data for diagnostic agreement. For performance testing of a physical instrument's accuracy, a formal adjudication method among experts is not typically used. The "ground truth" is based on the precision of the measurement system itself. Details of any such process are not provided.

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

An MRMC study is relevant for evaluating the impact of an AI system on human diagnosticians. Since the CoreLink Navigation Instruments are physical surgical tools and not an AI diagnostic system, an MRMC comparative effectiveness study in the context of "human readers improve with AI" is not applicable. The device aids surgeons in locating anatomical structures in spinal surgery with the Medtronic StealthStation® System, not in diagnostic interpretation.

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

This question is also specific to AI/ML software. The CoreLink Navigation Instruments are physical instruments. Therefore, a standalone performance evaluation of an "algorithm only" is not applicable.

7. The type of ground truth used

As mentioned in point 3, for physical surgical instruments, ground truth for performance testing (e.g., positional accuracy) would typically be established through highly accurate physical measurement systems and methodologies, often prescribed by standards like ASTM F2554. This is distinct from "expert consensus, pathology, or outcomes data" which are common for diagnostic AI/ML systems. The specific type of ground truth measurement system used is not detailed beyond reference to ASTM F2554.

8. The sample size for the training set

This question refers to the training of an AI/ML model. Since the CoreLink Navigation Instruments are physical surgical tools and not an AI system, there is no training set in the context of machine learning.

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

As there is no training set for this device, how its ground truth was established is not applicable.

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The Entasis 3D Dual-Lead Sacroiliac Implant System is intended for sacroiliac joint fusion for conditions including degenerative sacrollitis and sacroiliac joint disruptions, to augment immobilization of the sacropelvic fixation as part of a lumbar or thoracolumbar fusion and acute, nonacute, and non-traumatic fractures involving the sacroiliac joint. This includes those whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

The Entasis 3D Dual-Lead Sacroiliac Implant System consists of additive and machined dual-lead sacroiliac screws and optional washers to aid in load bearing and conformity to patient anatomy. The Entasis 3D Dual-Lead Sacroiliac Implant System is manufactured from additive titanium alloy (Ti-6Al-4V) per ASTM F3001 or machined from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. These screws are available in lengths from 30 mm to 110 mm and diameters of Ø7 mm to Ø14.5 mm.

The provided text describes a 510(k) premarket notification for a medical device called the "Entasis 3D Dual-Lead Sacroiliac Implant System." This document is a regulatory submission to the FDA, demonstrating substantial equivalence to previously cleared predicate devices.

Crucially, the provided text does not contain any information about the acceptance criteria, study methodologies, or performance results related to an AI/ML algorithm or software as a medical device (SaMD). It describes a physical implant system and its mechanical testing for structural integrity.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving an AI/ML device meets them, as the input material is irrelevant to such a request.

This document focuses on:

• Device Description: A sacroiliac implant system made of titanium alloy for joint fusion.
• Intended Use: Sacroiliac joint fusion for various conditions including degenerative sacroiliitis, joint disruptions, sacropelvic fixation augmentation, and fractures.
• Technological Characteristics: Comparison to predicate devices, highlighting similarities in indications, materials, structural support, surgical approach, sizes, and design features.
• Performance Data: Non-clinical (mechanical) testing of the implant system itself (Static Torsion, Driving Torsion, Pullout, Static & Dynamic Cantilever Bending).
• Conclusion: The device is substantially equivalent to predicate devices based on technological characteristics and mechanical performance.

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

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The CoreLink NextGen Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1 - S1/Ilium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used for posterior non-cervical screw fixation in pediatric patients, the CoreLink NextGen Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CoreLink NextGen Pedicle Screw System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

The NextGen Pedicle Screw System is a thoracolumbosacral pedicle screw system containing metallic implants intended to provide immobilization and stabilization of spinal segments. The system consists of traditional pedicle screw assemblies or modular tulip heads with modular screw shanks with extended tab reduction tulip or closed head tulip options, cross-link connectors, set screws, and spinal rods. Components are offered in various shapes and sizes to meet the requirements of the individual patient anatomy. Implants in the NextGen Pedicle Screw System are manufactured from titanium alloy Ti-6Al-4V per ASTM F136 and cobalt chromium alloy Co-28Cr-6Mo per ASTM F1537.

The provided text does not contain information about acceptance criteria or a study proving that an AI-powered device meets such criteria.

The document is a 510(k) premarket notification for a medical device called the "NextGen Pedicle Screw System." This system is described as a Thoracolumbosacral Pedicle Screw System, which provides immobilization and stabilization of spinal segments. The document focuses on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technological characteristics, materials, component selection, component sizes, biocompatibility, and non-clinical mechanical performance data.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets them, as the provided text is about a physical medical implant device and its mechanical testing, not an AI or software device.

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CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink 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 S8 (V1.2.0), 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.

CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures. The purpose of this submission is to add instruments to the previously cleared CoreLink Navigation Instruments set to offer navigation compatibility with more CoreLink pedicle screws.

The FDA document K220973 concerns the "CoreLink Navigation Instruments" and includes a brief summary of performance data. However, it does not contain the detailed information necessary to fully address all the points in your request regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" for an AI/device performance evaluation.

This 510(k) submission is for navigation instruments, which are described as non-sterile, re-usable manual surgical instruments designed to interface with a navigation system (Medtronic StealthStation® System S8). The performance data section states: "CoreLink, LLC has conducted an engineering analysis to demonstrate that the system modifications provide adequate and substantially equivalent accuracy for their intended use."

This implies a mechanical/engineering performance evaluation, not a study involving AI assistance for human readers, nor detailed clinical outcome data in the context of an AI-driven diagnostic or prognostic device. Therefore, many of the requested fields are not applicable or cannot be extracted from the provided text.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance (Based on provided text)

The document primarily focuses on demonstrating substantial equivalence to predicate devices through an engineering analysis, rather than setting specific quantitative acceptance criteria for a new AI application.

Study Details (Based on provided text)

Most of the requested study details are not applicable or not provided in this 510(k) summary, as it describes an engineering analysis for mechanical instruments, not an AI performance study.

1. Sample size used for the test set and the data provenance: Not explicitly stated for performance testing; the "engineering analysis" suggests bench testing or simulations rather than a clinical dataset in the context of AI.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; ground truth establishment as typically understood in AI studies (e.g., for image interpretation) is not relevant for this device's type of performance evaluation.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted diagnostic or prognostic device.
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 intended to be used by a surgeon in conjunction with a navigation system.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical accuracy, ground truth would typically refer to known physical measurements or engineering specifications against which the instrument's performance is compared. Details are not provided in this summary.
7. The sample size for the training set: Not applicable for this type of device and performance evaluation.
8. How the ground truth for the training set was established: Not applicable.

In summary:

The provided FDA letter and 510(k) summary pertain to a Class II surgical instrument (CoreLink Navigation Instruments) used with a separate navigation system. The "performance data" mentioned refers to an "engineering analysis" to demonstrate mechanical accuracy and substantial equivalence to existing devices, not the performance of an AI algorithm based on clinical data. Therefore, the detailed questions about AI study design, ground truth establishment, reader studies, and training/test sets are outside the scope of the information provided in this regulatory document.

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The F3D-C2 Cervical Stand-Alone System is a Stand-Alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels depending on the assembly. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The F3D-C2 Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) depending on the assembly. The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone marrow aspirate as an adjunct to fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment.

The F3D-C2 Cervical Stand-Alone System is an interbody fusion device intended to be used with two titanium alloy screws and/or anchors which accompany the implants. When used with screws, the F3D-C2 Cervical Stand-Alone System is intended for use at one or two levels of the cervical spine (C2-T1) and requires no additional fixation. When used with one or more anchors, the F3D-C2 Cervical Stand-Alone System is intended for use at one level of the cervical spine (C2-T1) and requires additional supplemental fixation such as posterior cervical screw fixation.

The CoreLink F3D Cervical Stand-Alone Interbody Fusion System is a collection of additively manufactured and machined implants and associated instruments for surgical site preparation and implantation to provide mechanical support to the cervical spine while arthrodesis occurs. The subject cages are additively manufactured from Ti-6Al-4V per ASTM F3001. Integration consists of additive Ti-6Al-4V (ASTM F3001) anchors (also referred to as nails) or machined Ti-6A-4V (ASTM F136 and ISO 5832-3) screws. The spacer and screw components are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient. The basic shape of the spacer is a trapezoidal column to provide surgical stabilization of the spine. The inferior/superior aspects of the spacer incorporate a vertical cavity which can be packed with bone graft.

The provided text describes a medical device, the F3D-C2 Cervical Stand-Alone System, and its FDA 510(k) clearance. However, it does not include information about acceptance criteria, device performance in terms of metrics like sensitivity, specificity, or accuracy, or any study involving human readers or AI.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them because such details are not present in the provided document.

The document discusses the regulatory clearance process for a spinal implant and focuses on:

• Device Description: What the F3D-C2 Cervical Stand-Alone System is made of and its components.
• Indications for Use: The medical conditions and patient population for which the device is intended.
• Technological Characteristics: How it compares to predicate devices.
• Non-Clinical Performance Data: A list of mechanical tests performed to demonstrate its safety and effectiveness compared to predicate devices. These tests are physical and mechanical, not related to AI or diagnostic accuracy.

The performance data mentioned are for mechanical tests such as static axial compression, dynamic axial compression, subsidence, and pullout, all referencing ASTM standards. These are physical properties of the implant, not performance metrics for a diagnostic or AI-driven medical device.

To directly answer your numbered points based only on the provided text, I would have to state that the information is not present for most of them:

1. A table of acceptance criteria and the reported device performance: Not provided. The text lists types of mechanical tests (e.g., Static axial compression per ASTM F2077) but does not provide specific acceptance criteria values or reported performance values for these tests.
2. Sample sized used for the test set and the data provenance: Not provided. The mechanical tests typically involve testing multiple units of the device but the sample size is not stated. Data provenance refers to the origin of clinical data, which is not applicable here as these are non-clinical mechanical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are mechanical tests, not clinical studies involving expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is about a physical medical implant, not an AI or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context you're asking. For mechanical tests, the "ground truth" would be the engineering specifications and established test methods, but not expert consensus or pathology in a clinical sense.
8. The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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CoreLink Navigation Instruments are intended to be used in the preparation and placement of Tiger OCT screw implants 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 S8 (V1.2.20), 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.

CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures.

The purpose of this submission is to add instruments to the previously cleared CoreLink Navigation Instruments set to offer compatibility with CoreLink OCT pedicle screws.

The provided text describes a 510(k) premarket notification for "CoreLink Navigation Instruments." This submission does not relate to an AI/ML powered device, but rather to traditional surgical navigation instruments. Therefore, the information requested in the prompt regarding acceptance criteria and studies for an AI/ML device cannot be extracted from the provided text.

The text focuses on demonstrating substantial equivalence to a predicate device for the purpose of adding new instruments to an existing navigation system. The performance data mentioned specifically refers to "confirmatory positional accuracy testing per ASTM F2554" and "engineering analysis including tolerance stack analysis," which are standard for mechanical medical devices, not AI/ML algorithms.

Therefore, I cannot fulfill the request as the provided document does not contain information about an AI/ML powered device or its associated acceptance criteria and validation studies.

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