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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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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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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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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 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.

The provided text describes a medical device, the CervAlign™ Anterior Cervical Plate System, and its regulatory clearance. However, it does not contain the specific information requested regarding AI/CADe device acceptance criteria or related studies. The document is a 510(k) summary for a physical orthopedic implant, not an AI-powered diagnostic or assistive device. Therefore, I cannot provide the details about acceptance criteria, clinical study specifics, ground truth establishment, or sample sizes in the context of AI/CADe devices based on this input.

The document discusses non-clinical mechanical testing and MR safety evaluations to demonstrate substantial equivalence to predicate devices, which is typical for physical implants.

If you have a document related to an AI/CADe device, please provide that, and I will be happy to extract the requested information.

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The Streamline OCT Occipito-Cervico-Thoracic System is intended to provide immobilization of spinal segments as an adjunct to fusion when using autograft for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/ or traumatic dislocations; instabilitity of deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Streamline OCT System may be connected to the Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System using connectors and/or transition rods.

The Streamline OCT System consists of a variety of rods, hooks, polyaxial screws, high-angle screws, locking caps, occipital plates, occipital screws, and connecting components used to build an occipito-cervico-thoracic spinal construct. System components are manufactured from ASTM F136 medical grade titanium alloy and ASTM F1537 medical grade cobalt chromium molybdenum alloy. Medical grade titanium alloy and medical grade cobalt chromium molybdenum alloy may be used together. The system should be implanted using only the surgical instruments designed for the system. Cases and caddies are supplied for sterilization and transport of the implants and instruments. The purpose of this submission is to modify and add components to the system.

This document is a 510(k) premarket notification for a medical device called the "Streamline OCT Occipito-Cervico-Thoracic System." This kind of document focuses on demonstrating that a new device is "substantially equivalent" to existing legally marketed devices, rather than establishing acceptance criteria and proving performance against them in the same way one might for a novel device or software.

Therefore, the requested information, particularly regarding acceptance criteria, specific performance metrics, sample sizes for training/test sets, ground truth establishment by experts, and MRMC studies, is not typically found or required in a 510(k) submission for this type of device (spinal fixation system). The demonstration of substantial equivalence relies more on comparing the new device's design, materials, indications for use, and mechanical performance to existing predicate devices.

However, I can extract the information that is available in the document that somewhat aligns with your request:

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

There isn't a table of "acceptance criteria" and reported device performance in the sense of accuracy, sensitivity, or specificity for an AI/software device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence through non-clinical mechanical testing. The "reported device performance" refers to the results of these mechanical tests compared to predicate devices.

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 for Test Set: Not applicable in the context of this 510(k) for a spinal fixation system. There isn't a "test set" of clinical data or images as typically understood for AI/software. The testing involved mechanical tests of the devices themselves.
• Data Provenance: Not applicable. The "data" comes from mechanical testing conducted in a laboratory setting, not clinical patient data.

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

Not applicable. Ground truth as established by clinical experts for a test set is not relevant for this type of device's 510(k) submission. Mechanical testing relies on engineering standards and measurements.

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

Not applicable. This concept is for clinical data review, not mechanical testing.

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

Not applicable. This device is a physical spinal fixation system, not an AI or software device that assists human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For the mechanical testing, the "ground truth" is established by validated engineering test standards (ASTM F1798, ASTM F1717, and ASTM F2706) and the results derived from those specified testing protocols.

8. The sample size for the training set

Not applicable. There is no "training set" for a physical medical device. Device design and refinement are based on engineering principles, materials science, and testing, not machine learning training.

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

Not applicable (as there's no training set). The design and development of the device components are informed by established engineering practices and biomechanical understanding of spinal anatomy and mechanics.

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The Unison-C Anterior Cervical Fixation System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2 to T1. Degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is intended to be used with autograft bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion, and is implanted via an anterior approach. Implants must be used with two of the provided bone screws. This system is to be used in patients who have had six weeks of non-operative treatment.

The Unison-C Anterior Cervical Fixation system is intended for stand-alone cervical interbody fusion procedures to provide structural stability in skeletally mature individuals following discectomy. The system includes intervertebral body implants (with an integrated locking mechanism and radiographic pins) and screws, and does not require the use of supplemental fixation.

These implants are manufactured from a radiolucent polymer (PEEK-OPTIMA® LT1 polymer from INVIBIO® Biomaterial Solutions (polyether ether ketone) (ASTM F2026)), to allow radiographic imaging inside the implant to evaluate fusion status. The implants are assembled with radiographic markers composed of tantalum (ASTM F560) to facilitate proper implant positioning. The screws and locking mechanism are manufactured from of titanium alloy (ASTM F136). Sterile implants are provided sterile by gamma irradiation.

Implants are supplied with instrumentation necessary to facilitate the insertion and removal of the implants, as well as general manual surgical instruments. Cases and caddies are supplied for sterilization and transport of the non-sterile implants and instruments.

The purpose of this submission is to obtain clearance of modifications to the predicate system (K152793).

The provided text describes a medical device, the "Unison®-C Anterior Cervical Fixation System," and its clearance by the FDA. However, it does not detail a study proving the device meets specific acceptance criteria in the context of AI/ML performance.

The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance (mechanical testing) rather than clinical studies or performance against specific AI/ML criteria. Therefore, most of the requested information regarding AI/ML device performance and ground truth establishment cannot be extracted from this document.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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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 6Al 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 3Al/ 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.

I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) premarket notification for a medical device (Tritium® Sternal Cable Plate System) and primarily focuses on establishing substantial equivalence to a predicate device.

Here's why I cannot fulfill your request:

• No acceptance criteria or device performance data: The document states, "Engineering analysis was completed for the subject line extension product and demonstrated no new performance data was required for a determination of substantial equivalence." It also explicitly mentions, "No clinical performance data was required for a determination of substantial equivalence." This means there are no specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) or reported device performance values available in this document.
• No details on clinical studies: Since no clinical performance data was required, there are no details about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
• No ground truth establishment for a study: As no studies are described with performance outcomes, there's no information on how ground truth would have been established for a test or training set.
• No training set information: The document discusses a device (implants, plates, cables, screws) used in surgical procedures, not an AI/ML algorithm that would require a training set.

The document mainly covers:

• The device's intended use and indications.
• Its components and materials.
• Its classification and product codes.
• Its substantial equivalence to a predicate device based on design, materials, and mechanical strength (without providing specific test results in this summary).

Therefore, I cannot extract the information requested as it is not present in the provided text.

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