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The CODA Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2-C7) as an adjunct to fusion is skeletally mature patients. Specific indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The CODA™ Anterior Cervical Plate (ACP) System is intended for anterior fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. The system consists of non-sterile plates and screws that are manufactured from titanium alloy (Ti-6Al-4V ELI). The plates have an integrated active locking mechanism, are offered in various lengths, and accommodate constrained and variable screws. The system includes nonsterile, reusable instruments and sterile, single use instruments designed to facilitate proper implantation of the plate and screws.

This document is a 510(k) summary for the CODA™ Anterior Cervical Plate System. It describes the device, its intended use, and provides a conclusion of substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, I cannot provide the requested information based on the text provided. The document primarily focuses on regulatory approval based on demonstrating equivalence to an already marketed device, rather than detailed performance study results.

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The CervAlign Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion.

The CervAlign Anterior Cervical Plate System is designed to promote cervical fusion by providing temporary resistance to flexion, extension, lateral bending, and axial rotation with strength and stiffness in the cervical spine (C2-C7). The system includes implants of various sizes of screws and plates to accommodate varying patient anatomies. The plates have integrated cover-style locking mechanisms that actuate to cover each screw. Implants are manufactured from titanium alloy, Ti-6Al-4V ELI (ASTM F136). The implants are supplied with instrumentation necessary to facilitate the insertion and removal. The implants and instruments are provided non-sterile and must be sterilized before use. Sterilization cases and trays are provided to facilitate proper sterilization and storage.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The summary specifically states for the mechanical tests (ASTM F1717-18 series) and MR safety evaluations that there was "no impact to the following non-clinical performance data that was included in cleared submission K183060. This testing is not included in the subject submission." This indicates that these tests were previously conducted for the predicate device and were considered still valid for the current submission due to the device's similarity. The "Locking Mechanism Retention" test is explicitly mentioned as being part of the current submission.

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

The provided document does not mention a "test set" in the context of clinical studies for this device. The submission is based entirely on non-clinical performance data and demonstration of substantial equivalence to a predicate device. Therefore:

• Sample Size for Test Set: Not applicable, as no human clinical test set was used.
• Data Provenance: Not applicable for clinical data. For non-clinical data, the provenance would be from laboratory testing. The country of origin for such testing is not specified. The testing described is likely prospective in a laboratory setting.

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

Not applicable, as no human clinical test set or ground truth established by experts for such a set was used for this submission. The device equivalence is based on engineering and materials testing, not diagnostic performance.

4. Adjudication Method for the Test Set

Not applicable, as no human clinical test set necessitating adjudication was used.

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

No. An MRMC comparative effectiveness study was not done, as this is a physical implant device and not a diagnostic AI/CAD system. The submission relies on non-clinical performance testing and substantial equivalence to a predicate.

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

Not applicable, as this is a physical medical device (spinal implant) and not an algorithm or AI system.

7. Type of Ground Truth Used

The concept of "ground truth" (e.g., pathology, outcomes data) as typically understood for diagnostic or AI devices is not directly applicable here. For this device, the "truth" is established by:

• Engineering Standards: Adherence to established ASTM (American Society for Testing and Materials) standards for mechanical properties and MR compatibility.
• Biological Safety Standards: Compliance with ISO 10993-1 for biocompatibility.
• Predicate Device Performance: The primary "ground truth" for substantial equivalence is the known safe and effective performance of the predicate device (CervAlign Anterior Cervical Plate System K183060). The new submission aims to demonstrate that its characteristics and performance are equivalent or better than this established device.

8. Sample Size for the Training Set

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

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

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

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The EVOS Cabling System is intended to be used in general orthopaedic repair procedures including patellar fractures, general cerclage, trochanteric reattachment, femoral and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nail and screw fixation techniques.

The EVOS Cabling System is used in orthopedic trauma and reconstructive surgeries to reduce and stabilize fractures and osteotomies. The EVOS Cabling System may be used for supplementary fracture fixation when used with bone plates or screws. The EVOS Cabling System includes a sterile, stainless-steel cable implant (ASTM F1314) packaged together with a stainless-steel crimp (ASTM F138). Non-sterile, reusable instruments are also provided to facilitate proper implantation of the cable-crimp implant.

This is a 510(k) summary for a medical device (EVOS Cabling System), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and sample sizes for AI/ML evaluation is not applicable and not present in the provided text.

The document discusses the substantial equivalence of the EVOS Cabling System to predicate devices based on non-clinical evidence. It outlines mechanical performance testing, MR safety evaluation, packaging and sterilization testing, biological safety evaluation, and pyrogenicity evaluation. However, these are standard device evaluation methods and not related to AI/ML performance.

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The DAC plate system with proprietary compression technology is indicated for use in skeletally mature patients for stabilization and fixation of fractures, revisions, arthrodeses and reconstruction of small bones of the foot such as:

• Midfoot and hindfoot arthrodeses or osteotomies
• Tarsometatarsal arthrodeses (metatarsocuneiform, metatarsocuboid, Lapidus)
• Intercuneiform arthrodeses
• Naviculocuneiform arthrodeses
• Talonavicular arthrodeses
• Calcaneocuboid arthrodeses
• Linsfranc arthrodeses
• Mono-or-bi-cortical osteotomies in the forefoot, midfoot and hindfoot
• First metatarsophalangeal arthrodeses

The DAC Dynamic Active Compression Plate (DAC plate) System is a zero-step locking plate that provides stability and active compression. The system includes screws and plates of varying sizes and configurations to accommodate various patient anatomies. The plates contain nitinol wires housed under tension in sliders kept in place with release pins. When the built-in release pins are removed, the nitinol wires return to their straight condition, creating compression. The implant components of the system are manufactured from titanium alloy (ASTM F136) and nitinol (ASTM F2063). The components of this system should not be used with components of any other system. The implants are provided non-sterile and are supplied with instrumentation to facilitate use of the device components.

This document describes the DAC Dynamic Active Compression Plate (DAC plate) System, for which Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. sought FDA clearance (K200513).

Based on the provided information, the device is a bone fixation system, and the clearance was based on non-clinical evidence demonstrating substantial equivalence to predicate devices, rather than a clinical study involving human patients. Therefore, information related to clinical study design, patient samples, expert reads, MRMC studies, or standalone algorithm performance is not applicable in this context.

Here's a breakdown of the requested information based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a non-clinical evaluation based on direct comparisons to standards and predicates, the "acceptance criteria" are the established standards, and "reported device performance" refers to the device's ability to meet those standards or demonstrate equivalent mechanical properties to the predicate.

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

Not Applicable. No human-based "test set" or clinical data was used. The evaluation relied on non-clinical, in-vitro mechanical testing, engineering analysis, and MR safety testing performed on device samples.

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

Not Applicable. No human experts were used to establish "ground truth" for a test set in the context of this non-clinical submission. Ground truth was established by adherence to recognized ASTM and ISO standards for mechanical, biological, and MR safety performance.

4. Adjudication method for the test set

Not Applicable. As no human-based test set was used, no adjudication method was required.

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 submission does not involve an AI device or a MRMC comparative effectiveness study.

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

Not Applicable. This is a hardware medical device (bone plate system), not a software or AI algorithm.

7. The type of ground truth used

The "ground truth" for this device's substantial equivalence determination was:

• Adherence to recognized international standards: ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards for mechanical properties, biological safety, and MR safety.
• Comparison to predicate devices: Demonstration that the subject device's technological characteristics and performance were equivalent to legally marketed predicate devices, with no new safety or effectiveness issues.

8. The sample size for the training set

Not Applicable. There was no "training set" in the context of an algorithm or AI. This was a physical device subjected to standard engineering and materials testing.

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

Not Applicable. Please refer to point 8.

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Streamline Navigated Instruments are intended to be used during the preparation and placement of screws from the Streamline TL and MIS Systems and preparation of screws from the Streamline OCT System 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 Streamline Navigated Instruments are non-sterile, reusable instruments for use with the Medtronic StealthStation Navigation System to assist surgeons in precisely locating anatomical structures in either open or minimally invasive (MIS) procedures for preparation and placement of screws from the Streamline TL Spinal Fixation System and Streamline MIS Spinal Fixation System and preparation of screws from the Streamline OCT Occipito-Cervico-Thoracic System. The Streamline Navigated Instruments include pedicle finders, modular handle, taps, drills, and screw inserters designed for use with Streamline TL, Streamline MIS, and Streamline OCT Systems. The instruments are manufactured from stainless steel (ASTM F899).

Here's a breakdown of the acceptance criteria and the study details for the Streamline Navigated Instruments, as extracted from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The document doesn't provide specific numerical thresholds for acceptance, only that the device was tested against the standard and deemed sufficient.)

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

The document does not specify a distinct "test set" in the traditional sense of a clinical or observational study with human participants. The performance evaluation was based on non-clinical testing.

• Sample Size: Not applicable in the context of a clinical test set. The evaluation involved testing the instruments themselves according to a standard.
• Data Provenance: Not applicable. The "data" comes from engineering and laboratory testing.

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

This is not applicable as the evaluation was based on non-clinical testing of device accuracy and compatibility with a navigation system, not on medical image interpretation or clinical outcomes requiring human expert ground truth.

4. Adjudication Method for the Test Set

None. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where discrepancies might arise. This non-clinical performance evaluation does not involve such a process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The study described is a non-clinical performance evaluation of device accuracy and compatibility, not a comparative effectiveness study involving human readers or AI assistance.

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

This question is not applicable as the device (Streamline Navigated Instruments) is a physical surgical instrument designed to be used with a navigation system and by a human surgeon. It is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation was defined by:

• ASTM F2554-18 "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems": This standard serves as the benchmark for evaluating positional accuracy.
• Dimensional comparison and tolerance analysis: This establishes whether the instruments meet the required specifications for functionality and compatibility with the Medtronic StealthStation System.

8. The Sample Size for the Training Set

Not applicable. The Streamline Navigated Instruments are physical instruments, not an AI or machine learning model that requires a training set.

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

Not applicable. As the device is not an AI model, there is no training set or associated ground truth for it.

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The Tritium® Sternal Cable Plate System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

The Tritium® Sternal Cable Plate System includes implants of various sizes; plates and cable plugs comprised of commercially pure titanium, Grade IV (ASTM F67), and cables and screws comprised of Titanium 6AI 4V Alloy (ASTM F136). The system also includes needles comprised of Custom 470 stainless steel, 420 stainless steel (ASTM F899, Custom 470 SST) and leader comprised of Titanium 3AI/ 2.5V Alloy (ASTM F2146).

The system is designed to enhance the stability and strength of traditional sternal closure techniques. Utilizing a unique load sharing concept, the device can be implanted to distribute lateral force across the osteotomy. The system can be used with traditional monofilament wire or Pioneer Sternal Cable. The device system should be implanted using only the manual surgical instruments designed specifically for this system of implants, which may be implanted via an open or minimally invasive approach.

The provided document is an FDA 510(k) clearance letter for the Tritium® Sternal Cable Plate System. It is a premarket notification for a medical device and not for a digital health/AI device. Therefore, the content does not describe acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML-based medical device.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K161876 Tritium® Sternal Cable Plate System), primarily based on:

• Same indications for use.
• Same materials, manufacturing processes, and biocompatibility.
• Same principles of operation and fundamental technology.
• Same instrumentation and general surgical technique.
• Same sterility, shelf life, packaging, and bacterial endotoxin evaluation.
• Same mechanical performance.

The "Purpose of submission" states: "Obtain clearance for the following modification to the predicate K161876 Tritium® Sternal Cable Plate System: add magnetic resonance (MR) conditional safety labeling based on completed non-clinical testing." This indicates the primary study performed was related to MR compatibility.

Therefore, it is not possible to extract the requested information (acceptance criteria for AI/ML performance, study details for an AI/ML device, ground truth establishment, etc.) from this document.

The document describes non-clinical testing for MR safety. Below is a summary of the MR safety testing mentioned, which is not related to AI/ML device performance or clinical outcomes:

Acceptance Criteria and Study for MR Safety (Non-Clinical)

Study Details (for MR Safety - Non-Clinical):

1. Sample size used for the test set and the data provenance: Not applicable in the context of a typical clinical test set for AI. The "test set" here refers to the physical device components tested in an MR environment. The document does not specify the number of devices tested, but implied it was sufficient to meet the ASTM standards. Data provenance is not described as it is a non-clinical, in-vitro test.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for MR safety is established by adherence to international standards (ASTM) and measurable physical phenomena. No human experts are involved in establishing ground truth for these physical tests.
3. Adjudication method: Not applicable for non-clinical physical testing.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this was a non-clinical MR safety study, not a clinical effectiveness study.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
6. The type of ground truth used: Ground truth for MR safety is defined by the physical principles of magnetic resonance and the quantitative limits set by ASTM standards (e.g., displacement force, torque, temperature rise, artifact size).
7. The sample size for the training set: Not applicable. This is not an AI/ML device requiring training data.
8. How the ground truth for the training set was established: Not applicable.

Summary of why the requested information cannot be provided:

The provided FDA document is for a physical medical device (Tritium® Sternal Cable Plate System) used for bone fixation, and the clearance is based on substantial equivalence and non-clinical MR safety testing. It is not for a digital health product, an AI/ML device, or any software as a medical device. Therefore, the questions related to AI/ML device performance, human reader studies, ground truth establishment for AI, and training/test set sizes for AI algorithms are not relevant to this document.

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The Streamline TL Spinal Fixation System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw (T1-S2), posterior hook (T1-L5) or sacral/iliac screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudarthrosis, and failed previous fusion.

The Streamline TL Spinal System consists of a variety of rods, screws (poly-axial, fixed, and reduction), rod connectors, crosslinks, set screws, hooks and other connecting components used to build a spinal construct. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The Streamline TL Spinal System includes Class I manual instrumentation to facilitate implantation of the device components.

The provided document is a 510(k) premarket notification letter from the FDA regarding a spinal fixation system. It details the device's indications for use, its description, and a summary of performance testing.

However, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled medical device. The device in question is a physical spinal fixation system, not a software or AI/ML product.

Therefore, I cannot provide the requested information for the acceptance criteria and the study that proves the device meets them, as the provided text pertains to a mechanical medical device and not an AI/ML system.

To answer your request, I would need a document describing the validation activities for an AI/ML-enabled medical device.

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When the Fortlink-A is used as a lumbar interbody fusion (IBF) implant, it is indicated for intervertebral body fusion of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This IBF device is used to facilitate interbody fusion in the lumbar spine from L1-L2 to L5-S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF device is intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) months of non-operative treatment with an interbody fusion device. Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

When Fortilink-C is used as cervical interbody fusion (IBF) implants, these devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the cervical spine and are placed via an anterior approach from C2-C3 to C7-T1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) weeks of non-operative treatment with an interbody fusion device.

When Fortilink-TS and Fortilink-L are used as lumbar interbody fusion (IBF) implants, these devices are indicated for intervertebral body fusion of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L1-L2 to L5-S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an interbody fusion device.

The Fortilink® interbody fusion (IBF) devices are designed to be inserted into the intervertebral body space of the spine and are intended for intervertebral body fusion. These implants are manufactured from a radiolucent polymer (PolyEtherKetone (PEKK)) (ASTM F2820) which should support radiographic imaging inside the implant to evaluate fusion status and are assembled with radiographic markers composed of tantalum (ASTM F560) to facilitate proper implant position. The implant is provided sterile by gamma irradiation and is intended to be used with supplemental fixation cleared for the implanted level. The implant is supplied with instrumentation necessary to facilitate the insertion and removal of the implant, as well as qeneral manual surqical instruments.

The implant is provided in different footpring heights to provide implant options best suited to an individual's pathology and anatomical condition.

This document is a 510(k) Pre-market Notification for the Fortilink® Interbody Fusion Device (IBF) with TETRAfuse® 3D Technology. It seeks clearance for an additional design, the Fortilink-A, and MR Conditional labeling for the entire Fortilink family. The document establishes substantial equivalence to predicate devices based on technological characteristics and performance testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Study Providing Evidence of Meeting Acceptance Criteria:

The study described in this document is a non-clinical performance testing study, primarily focusing on mechanical testing and MR Safety testing for the Fortilink® Interbody Fusion Device (IBF) with TETRAfuse® 3D Technology, specifically focusing on the addition of the Fortilink-A design and MR Conditional labeling.

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

• Sample Size for Mechanical Testing: The document states that the "worst-case construct for the predicate family of Fortilink devices" was assessed. It does not provide a specific numerical sample size (e.g., number of devices tested for each mechanical test).
• Data Provenance: The data is generated from non-clinical (bench) testing performed by the manufacturer, Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. The country of origin of the data is not explicitly stated beyond the manufacturer's location in Marquette, Michigan, USA. This is a prospective test in the sense that the testing was conducted specifically to support this 510(k) submission.

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

This information is not applicable to this type of submission. For mechanical and MR safety testing, "ground truth" is established by adherence to recognized ASTM standards and FDA guidance documents. The expertise lies in the engineers and technicians performing the tests and interpreting the results according to these standardized methodologies, rather than clinical experts establishing a ground truth based on patient data.

4. Adjudication Method for the Test Set

This information is not applicable to the non-clinical testing performed. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or image interpretation studies where multiple human readers assess a case.

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

This information is not applicable. This submission concerns an interbody fusion device, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or reported.

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

This information is not applicable. This device is an implanted medical device, not a software algorithm.

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

For the mechanical testing and MR Safety testing, the "ground truth" is defined by:

• Recognized consensus standards: Specifically, the ASTM standards (F2077-18, F2267-04 (2018), F2052-15, F2213-17, F2182-11a, F2119-07 (Reapproved 2013)) and the DRAFT Z8423Z standard for expulsion testing.
• FDA Guidance: "Guidance for Industry and Food and Drug Administration Staff, Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices."

The device's performance is compared against the requirements and specifications outlined in these documents to demonstrate compliance.

8. The Sample Size for the Training Set

This information is not applicable. This is a hardware medical device submission, not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable for the same reason as point 8.

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The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2 or sacral/iliac screw fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (DDD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Streamline MIS Instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

Streamline MIS Spinal Fixation System is a temporary, multiple component cannulated pedicle screw system comprised of a variety of components that allow the surgeon to build a spinal implant construct through an open or percutaneous approach. The implant components include rods, extended tab cannulated polyaxial pedicle screws, crosslinks, and locking set screws that are fabricated from titanium alloy (ASTM F136) and provided nonsterile. The components are available in various sizes to accommodate differing patient anatomy. The system is attached to the pedicles by means of screws to the posterior, noncervical spine. The spinal construct is completed by connecting the screws with titanium alloy rods. Crosslinks can be used if additional stabilization is necessary.

The Streamline MIS Spinal Fixation System includes instrumentation to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

Class I manual instruments are also included.

I am sorry, but based on the provided text, there is no information regarding the acceptance criteria, device performance, sample sizes for test and training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC comparative effectiveness studies, standalone algorithm performance, or the specific type of ground truth used for the Streamline MIS Spinal Fixation System.

The document is a 510(k) premarket notification for a medical device (spinal fixation system) and primarily focuses on demonstrating substantial equivalence to a predicate device. It highlights:

• Device Description and Indications for Use: What the device is and what it's used for.
• Comparison to Predicate: Stating that the new device has the same intended use, technological characteristics, operating principle, design features, performance, base materials, and shelf life as the predicate device(s).
• Summary of Mechanical Performance Data: Mentions "non-standard testing" for specific characteristics like torque to failure for instrumentation drivers, but does not provide acceptance criteria or specific performance results. It concludes that this testing "supports that Streamline MIS Spinal Fixation System is substantially equivalent to the predicate device for safety and efficacy."
• Summary of Magnetic Resonance (MR) Safety Evaluation: Mentions standard testing (ASTM F2503-13, ASTM F2502-15, ASTM F2213-17 and ASTM F2182-11a) to determine MR labeling as 'MR Conditional', but again, no specific acceptance criteria or performance metrics are listed.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the study setup for evaluating an AI/algorithm-based device from this document. The document describes a mechanical spinal fixation system, not an AI or software-as-a-medical-device that would typically involve the kind of performance studies you are asking about (e.g., using experts, ground truth, training/test sets for an algorithm).

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When Fortilink®-C is used as cervical interbody fusion (IBF) implants, these devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the cervical spine and are placed via an anterior approach from C2-C3 to C7-T1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) weeks of non-operative treatment with an interbody fusion device.

When Fortilink®-TS and Fortilink®-L are used as lumbar interbody fusion (IBF) implants, these devices are indicated for intervertebral body fusion of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L1-L2 to L5-S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) months of non-operative treatment prior to treatment with an interbody fusion device.

The Fortilink® interbody fusion (IBF) devices are designed to be inserted into the intervertebral body space of the spine, and are intended for intervertebral body fusion. The purpose of this 510(k) is to seek marketing clearance for modifications to the straight and angled inserter tools for the Fortilink®-L device. The modifications include the following:

Straight Inserter: Improve opening mechanism and disassembly prevention features

Angled Inserter:

• Apply an offset and angle to the inserter handle to align it with the Fortilink®-L . implant
• Apply the same design changes (improved opening mechanism and disassembly ● features) as applied for the straight inserter

This document describes a 510(k) premarket notification for the Fortilink® IBF System with TETRAfuse®3D Technology, specifically focusing on modifications to inserter tools. It does not contain information about a study proving the device meets acceptance criteria related to clinical performance, nor does it involve an AI/ML component.

Therefore, I cannot provide the requested information as the document *does not contain details about acceptance criteria or a study related to device performance in the context of clinical outcomes or AI/ML. *

The information present in the document pertains to:

• Device cleared: Fortilink® IBF System with TETRAfuse®3D Technology, with modified straight and angled inserter tools.
• Purpose of 510(k): Seeking marketing clearance for modifications to inserter tools, not for the underlying interbody fusion device's clinical efficacy or safety, which would have been established in previous clearances (referenced by K172343).
• Assessment of modifications: The substantial equivalence is based on engineering analysis and testing, including:
  • Risk analysis
  • Simulated insertion/removal testing
  • Tissue blocking opening testing
  • Reuse testing
  • Stack-up of design drawings
• Acceptance Criteria for the Modifeid Inserter Tools: "All completed tests met the pre-determined acceptance criteria." However, the specific quantitative acceptance criteria for these engineering tests are not detailed in this summary.
• Type of Ground Truth: For the mechanical/engineering tests, the "ground truth" would be the successful completion of the tests according to design specifications and pre-determined mechanical/functional requirements. This is not clinical ground truth.

In summary, the provided document is a regulatory clearance letter and 510(k) summary for a device modification (inserter tools), not a clinical study report or performance evaluation of a device (especially not an AI/ML device) that would typically involve the detailed acceptance criteria and study information you've requested.

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