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The VERTICALE® Triangular Fixation System, when used in combination with the VERTICALE® Posterior Spinal Fixation System, is intended for immobilization of the spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine. The VERTICALE® Triangular Fixation System is intended to treat the following conditions: trauma (i.e., fracture or dislocation); tumor, pseudoarthrosis; and failed previous fusion.

The VERTICALE® Triangular Fixation System is intended for iliac fixation and must be attached to the VERTICALE® Posterior Spinal Fixation System to treat the conditions listed above.

Refer to the labeling for the VERTICALE® Posterior Spinal Fixation System for limitations and instructions for use.

The VERTICALE® Triangular Fixation System consists of iliac screws with a UHMWPE lined slot, a polyaxial head as well as related instruments. The VERTICALE® Triangular Fixation System is intended to be used with VERTICALE® Posterior Spinal Fixation System (K171421).

The implants of the VERTICALE Triangular Fixation System are manufactured from titanium alloy conforming to ASTM F136 / ISO 5832-3 and Ultra-High-Molecular-Weight Polyethylene according to ASTM F648 / ISO 5834-1 and -2.

The provided text describes a 510(k) premarket notification for a medical device called the "VERTICALE® Triangular Fixation System." However, the document focuses on regulatory approval based on substantial equivalence to predicate devices through non-clinical testing and engineering rationales, rather than a clinical study evaluating AI software or diagnostic performance against specific acceptance criteria for an AI/ML device.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML product.

The listed aspects in your prompt (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, ground truth types) are typically associated with the rigorous validation of AI/ML-driven medical devices. This document describes a more traditional mechanical device approval process based on non-clinical performance testing (e.g., strength, durability).

To directly answer your prompt, I would need a different type of document, specifically one detailing the clinical or technical validation of an AI/ML medical device.

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Silony Medical Navigation Instruments are intended to be used during the preparation and placement of VERTICALE® pedicle screws during spinal surgery to assist the surgeon in precise locating anatomical structures. These instruments are designed for use with stereotactic navigation system Medtronic StealthStation®, 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.

Silony Medical's VERTICALE® navigation instruments are reusable surgical instruments for use with the Medtronic® StealthStation® Navigation System is designed to assist surgeons in the precise localization of anatomical structures, preparation and placement of pedicle screw implants during spinal procedures.

The VERTICALE® Navigation Instruments include awls, probes, taps, drivers and inserts. The VERTICALE® Navigation Instruments are to be used with the VERTICALE® Posterior Spinal Fixation System cleared under K171421.

All instruments are made of stainless steel per ASTM F899. The VERTICALE Navigation Instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic StealthStation Navigation System hardware and software.

The provided text does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The submission (K223649) is for VERTICALE® Navigation Instruments, which are physical surgical instruments used with a stereotactic navigation system, not an AI or algorithm-based device.

Therefore, the information requested in the prompt, such as acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not applicable to this medical device submission.

The "Performance Data" section (page 5) refers to testing performed per ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems." This standard is for evaluating the accuracy of surgical navigation systems, and the submitter states that these data are applicable because the new instruments complement existing ones and a technical evaluation confirmed compatibility and functionality. The relevant performance for this device is its navigational accuracy and compatibility with the Medtronic StealthStation®, not an AI-driven diagnostic or prognostic capability.

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Silony Medical Navigation Instruments are intended to be used during the preparation and placement of VERTICALE® pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. These instruments are designed for use with stereotactic navigation system Medtronic StealthStation®, 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.

The Silony Medical VERTICALE® Navigation Instruments are reusable surgical instruments for use with the Medtronic® StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in open procedures for preparation and placement of pedicle screw system implants.

The VERTICALE® Navigation Instruments include awls, probes, taps, and drivers. The VERTICALE® Navigation Instruments are to be used with the VERTICALE® Posterior Spinal Fixation System.

All instruments are made of stainless steel per ASTM F899. Taps range in size from Ø4.5mm to Ø10.2mm. The VERTICALE® Navigation Instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic StealthStation Navigation System hardware and software.

The provided document is a 510(k) premarket notification for the VERTICALE® Navigation Instruments, which are reusable surgical instruments used with a navigation system for spinal surgery. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in terms of accuracy or clinical outcomes.

Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in this document. The document primarily addresses the safety and effectiveness of the instruments themselves through non-clinical testing for positional accuracy in conjunction with a computer-assisted surgical system.

Here's an attempt to answer the questions based only on the provided text, with clear indications where the information is absent:

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

The document mentions that the instruments were tested per ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems." However, it does not explicitly state specific numerical acceptance criteria (e.g., maximum allowed positional deviation) for this test, nor does it provide the reported numerical performance data for the VERTICALE® Navigation Instruments. It only states: "The results of this non-clinical testing show that performance of the VERTICALE® Navigation Instruments is sufficient for its intended use and is substantially equivalent to legally marketed 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 specified in the document. As this is a non-clinical instrument test, the concept of a "test set" in the context of patient data is not applicable here.
• Data provenance: Not applicable in the context of this non-clinical instrument performance test. The testing was conducted to assess the physical instruments' performance in a controlled setting, not on patient data.

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 was a non-clinical instrument performance test, not a study involving human interpretation of medical data where expert ground truth would be established.

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

Not applicable. This was a non-clinical instrument performance test.

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

No. This document does not mention any MRMC study or AI assistance. The device is a set of physical surgical navigation instruments, not an AI-powered diagnostic or assistive tool for human readers.

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

Yes, in a sense, the ASTM F2554-18 testing would represent a "standalone" performance evaluation of the instruments when used with the navigation system, without direct human clinical "in-the-loop" performance evaluation in a patient setting. The test assessed the physical accuracy of the instruments themselves.

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

For the ASTM F2554-18 test, the "ground truth" would be the known, precisely measured physical dimensions and positions established by the testing methodology according to the standard. This would involve calibrated measurement systems to determine the positional accuracy of the navigated instruments against reference points.

8. The sample size for the training set

Not applicable. This document describes the testing of physical surgical instruments, not a machine learning algorithm that requires a training set.

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

Not applicable. (See answer to #8).

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The VERTICALE Cervical System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction (occiput-C2), the cervical spine (C1 to C7) and the thoracic spine (T1-T3):

• traumatic spinal fractures and /or traumatic dislocations
• instability or deformity
• failed previous fusions (e.g. pseudoarthrosis)
• tumors involving the cervical/thoracic spine
• 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 VERTICALE Cervical System is a posterior double rod fixation system for immobilization and stabilization of the spinal seqments of the craniocervical junction (occiput-C2), cervical spine (C1-C7), and thoracic spine (T1-T3).
The system may only be used in the field of human medicine and consists of polyaxial screws, favored anqle polyaxial (FA) screws, rods, occiput plates, connectors and the related instrumentation.
The VERTICALE Cervical System will be used in patients with occiput cervical and upper cervical spine instabilities.
The implants of the VERTICALE Cervical System are manufactured from titanium alloy conforming to ASTM F136 / ISO 5832-3. They are delivered in a sterile condition and can be used without any further preparations. The implants are packaged in accordance with EN ISO 11607 Part 1+2 and sterilized with gamma irradiation at a minimum dose of 25 kGy.
Implants delivered by the manufacturer in a sterile condition may not be sterilized. They are intended for single use.

I am sorry, but based on the provided text, I cannot find the specific information regarding the acceptance criteria, reported device performance, sample sizes, data provenance, expert details, adjudication methods, MRMC study, standalone performance, or ground truth details for a device that relies on AI.

The document you provided is an FDA 510(k) clearance letter for the VERTICALE® Cervical System, which is a posterior double rod fixation system for spinal immobilization. This device is a traditional medical implant, not an AI/ML-driven device. The document primarily discusses:

• Substantial Equivalence: Comparing the device to a predicate device (Mountaineer OCT Spinal System) based on indications for use, principles of operation, technological characteristics, materials, and performance testing.
• Non-Clinical Performance Data: It lists mechanical performance tests (e.g., ASTM F1717-18, ASTM F2706-18, ASTM F1798-13), biocompatibility (ISO 10993-1), cleaning and sterilization (ISO 11137), and shelf-life testing. These are standard tests for medical implants.
• Clinical Performance Data: States explicitly, "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

Therefore, the requested information about acceptance criteria, study details, expert qualifications, and ground truth for an AI/ML device is not present in this document.

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The FAVO S-TLIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The device is to be used in patients who have had at least six months of non-operative treatment.

The FAVO S-TLIF Cage is intended for use in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).

The FAVO S-TLIF Cage is intended for use at one or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The FAVO S-TLIF Cage can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

The FAVO S-TLIF (straight transforaminal lumbar interbody fusion) Cage is an implant for primary stabilization and restoration of physiological lordosis in the lumbar and thoracic spine. The cage is designed for transforaminal approaches.

The aim is to eliminate discogenic back pain, correct deformities, remedy instabilities, restore intervertebral height, restore physiological lordosis, and provide biomechanical support for bone fusion in the disc space.

The system is designed for use with autogenous bone graft to facilitate fusion and must be used with additional stabilization. For posterior lumbar stabilization, Silony Medical recommends the use of a posterior spinal fixator (e.g., the VERTICALE system). The devices are to be used in patients who have had at least six months of non-operative treatment. The FAVO S-TLIF is manufactured from titanium alloy conforming to ASTM F136 / ISO 5832-3 and ASTM F3001.

The FAVO S-TLIF implant is delivered in a sterile condition and can be used without any further preparations. The cages are packaged in accordance with EN ISO 11607 Party 1+2 and sterilized with gamma irradiation at a minimum dose of 25 kGy.

Implants delivered by the manufacturer in a sterile condition may not be sterilized.

This document is a 510(k) Premarket Notification for a medical device called FAVO® S-TLIF, which is an intervertebral body fusion device. The document does not describe a study that uses AI or machine learning technology, so the request for acceptance criteria and study details related to an AI device cannot be fulfilled from this document.

The provided text describes the regulatory clearance of a physical medical device (intervertebral body fusion cage) and outlines its indications for use, device description, and non-clinical performance data (mechanical testing, biocompatibility, sterilization, shelf life, and transport testing). It explicitly states that no human clinical testing was required because the indications for use are equivalent to a predicate device and non-clinical testing supports substantial equivalence.

Therefore, since the request pertains to an AI device and this document is about a physical spinal implant with no mention of AI or machine learning, I cannot extract the requested information.

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The Oyster ACIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Oyster ACIF Cage is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 to T1. The System is intended to be used with supplemental fixation; the Oyster ACIF Cage device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

The Oyster cages are Cervical Interbody Fusion cages and have been developed for at up to two contiguous levels from C2 to T1. It is intended for insertion between two adjacent cervical vertebrae. The implants are offered in heights from 4 to 10mm, and 3 footprints (14mm x 15mm, 16mmx17mm, 14mmx17mm). The implants are manufactured by SLM and standard milling process.

This document is a 510(k) summary for the Oyster ACIF Cage, an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to predicate devices through material and mechanical testing, rather than an AI/ML-driven device that would involve a test set, ground truth, and human reader performance studies.

Therefore, many of the requested criteria for an AI/ML device, such as acceptance criteria based on metrics like sensitivity/specificity, sample size for AI test sets, expert adjudication methods, MRMC studies, and training set information, are not applicable to this submission.

Here's an analysis based on the provided document:

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

The document does not provide a table of acceptance criteria in the traditional sense for an AI/ML device (e.g., performance metrics like sensitivity, specificity, AUC). Instead, it focuses on mechanical performance data comparing the device's strength to predicate devices. The acceptance criteria are implicitly that the mechanical test results are "sufficient for its intended use and is substantially equivalent to legally marketed 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)

This information is not applicable as the device is a spinal implant, not an AI/ML diagnostic tool. The "testing" refers to mechanical and material property tests on the device itself, not a clinical test set of patient data.

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)

This is not applicable. Ground truth, in the context of an AI/ML device, refers to verified labels for medical data, typically established by clinical experts. For a spinal implant, "ground truth" relates to the physical and biological performance of the material and design, established through engineering standards and biological compatibility assessments.

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

This is not applicable. Adjudication methods are used in clinical studies involving interpretation of medical images or data by human experts for ground truth establishment.

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 is not applicable. MRMC studies are used to evaluate the impact of AI on human reader performance in diagnostic tasks. This device is a physical implant.

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

This is not applicable. Standalone performance is a concept for AI algorithms.

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

For this device, the "ground truth" to which its performance is compared is based on established engineering standards (ASTM F2077, ASTM F2267) and the performance characteristics of legally marketed predicate devices. It's a "truth" derived from physical and mechanical testing, not clinical diagnosis.

8. The sample size for the training set

This is not applicable. This refers to AI/ML model training, which is not relevant for this medical device.

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

This is not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device (spinal implant). The acceptance criteria and performance data discussed are related to the device's mechanical and material properties, rather than its performance as an AI/ML diagnostic tool. Therefore, many of the questions asked, which are specific to AI/ML device evaluation, are not relevant to this submission.

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The ROCCIA PLIF System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the ROCCIA PLIF System is indicated in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis. These implants may be implanted via an open posterior approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The ROCCIA PLIF cage is manufactured from polyetheretherketone (PEEK) according ASTM F2026. The cage is equipped with a chamber system that can be filled with autogenous bone graft. The integrated x-ray markers which are made of tantalum according ASTM F560 enable a presentation of the implant during insertion and postoperative control examinations.

The ROCCIA PLIF cage is available in different sizes and angles. The implants are single use devices. The ROCCIA instrumentation is ergonomically appropriate and designed as modular components. The ROCCIA insertion device enables the user to perform various instrumentation steps with just a single instrument. The instruments are designed to be used with the ROCCIA PLIF, and are made of materials common for medical devices used in implantable device instrumentation tools. The instruments are intended to be cleaned, sterilized, and reused for the purposes of the multiple implantation procedure. The ROCCIA instrumentation is manufactured from stainless steels conforming to ISO 16061 and ASTM F899.

This document is a 510(k) premarket notification for the ROCCIA® PLIF intervertebral body fusion device. The focus of the document is to demonstrate "substantial equivalence" to legally marketed predicate devices, rather than establishing acceptance criteria or proving device performance through specific studies with reported metrics in the way a clinical trial for an AI/ML device would.

Therefore, many of the requested categories related to acceptance criteria, study design, and performance metrics are not applicable in this context. The document relies on non-clinical performance data and the established safety and efficacy of the predicate devices.

Here's a breakdown of the information as it relates to your request:

1. Table of Acceptance Criteria and Reported Device Performance

This type of information (specific performance metrics with acceptance criteria) is not present in the provided document. The submission is focused on demonstrating that the new device is "substantially equivalent" to existing predicate devices based on non-clinical testing and shared characteristics, rather than meeting novel performance thresholds in a clinical study.

The closest to "acceptance criteria" are the standards the device passed:

The document does not provide specific numerical performance values for these tests (e.g., specific load resistance in Newtons, or subsidence displacement in mm), only that the device "passed all the testing in accordance with internal requirements, national and international standards."

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

• Test Set Sample Size: Not applicable. This submission relies on non-clinical ( benchtop/laboratory) testing, not a clinical test set of patient data.
• Data Provenance: Not applicable. The "data" are from mechanical, material, and sterilization tests performed on the device itself, not patient data.

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

• Number of Experts: Not applicable. Ground truth, in the sense of clinical annotations by experts, is not established for this type of submission.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No. This device is a physical intervertebral body fusion device, not an AI/ML-driven diagnostic or assistive tool. Therefore, an MRMC study and effects on human reader improvement are not relevant.

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

• Standalone Performance: No. This is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the non-clinical performance data, the "ground truth" is defined by the specifications within the relevant ASTM and ISO standards (e.g., ASTM F2077, ASTM F2267, ISO 10993-1, ISO 11137). The device components and materials are also specified to conform to relevant ASTM standards (e.g., PEEK according to ASTM F2026, tantalum according to ASTM F560, stainless steels conforming to ISO 16061 and ASTM F899).

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/ML device that requires training data.

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

• Ground Truth for Training Set: Not applicable. This is not an AI/ML device.

Summary of the K181899 Submission:

The K181899 submission for the ROCCIA® PLIF device is a traditional 510(k) pathway to market. It demonstrates substantial equivalence by:

• Comparing the device's indications for use, principles of operation, technological characteristics, and materials to legally marketed predicate devices.
• Providing non-clinical performance data (mechanical, biocompatibility, sterilization, shelf life, storage, transport testing) showing that the ROCCIA PLIF meets established design input specifications and relevant national and international standards (e.g., ASTM F2077, ASTM F2267, ISO 10993-1, ISO 11137).
• Stating that no human clinical testing was required due to the equivalence to predicate devices with proven safety and efficacy.

This regulatory pathway does not involve the types of clinical studies, expert-based ground truth, or AI/ML performance metrics that your request primarily focuses on.

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The ROCCIA TLIF and ROCCIA ALIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The device is to be used in patients who have had at least six months of non-operative treatment.

The ROCCIA TLIF Cage implants are intended for use in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12- L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).

The ROCCIA TLIF and ROCCIA ALIF Cage implants are intended for use at one or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ROCCIA TLIF Cage implants can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

The ROCCIA® Transforaminal Lumbar Interbody Fusion (ROCCIA® TLIF) and ROCCIA® Anterior Lumbar Interbody Fusion (ROCCIA® ALIF) cages are implants for the primary stabilization and restoration of the physiologic lordosis of the lumbar and thoracic spine. Subject device implants are manufactured from Titanium Alloy Ti6Al4V ELI per ASTM F136. The ROCCIA® TLIF and ROCCIA® ALIF cages are offered in a variety of sizes to facilitate a variety of patient anatomies.

The ROCCIA® instrumentation is ergonomically appropriate and designed as modular components. The instruments are designed to be used with the ROCCIA® Transforaminal Lumbar Interbody Fusion (TLIF) and ROCCIA® Anterior Lumbar Interbody Fusion (ALIF), and are made of materials commonly used to manufacture medical device instruments. The instruments are intended to be cleaned, sterilized, and reused for the purposes of future implantation procedures.

This document is a 510(k) summary for the ROCCIA® TLIF and ROCCIA® ALIF intervertebral body fusion devices. It's a regulatory submission to the FDA, demonstrating substantial equivalence to previously approved devices. Therefore, it does not include information on acceptance criteria for device performance in a clinical study to assess its diagnostic accuracy or effectiveness against a clinical outcome, as would be typical for AI/ML-driven diagnostic devices.

Instead, the "acceptance criteria" here refer to the mechanical performance of the implantable device, which is evaluated against recognized ASTM standards for intervertebral body fusion devices. The "study" proving this is a series of non-clinical, laboratory-based mechanical tests.

Here's the breakdown of the information you requested, based on the provided document:

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

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

This document discusses non-clinical mechanical testing, not clinical studies with patient data. Therefore, the concept of a "test set" and "data provenance" as applied to clinical data does not directly apply. The "sample size" would refer to the number of devices tested in the lab for each mechanical test. This specific number is not explicitly stated in the provided text. The tests are conducted in a laboratory setting, not a clinical one.

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)

This is a non-clinical mechanical performance evaluation. There were no experts establishing ground truth in terms of clinical diagnoses or outcomes, as no human-based diagnostic performance is being evaluated. The "ground truth" for these tests are the established physical properties and behaviors defined by the ASTM standards themselves.

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

Not applicable, as this is non-clinical mechanical testing, not a clinical study requiring human expert adjudication of results.

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 for an implantable medical device (intervertebral body fusion cage), not an AI/ML diagnostic or assistive device.

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

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

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

The ground truth used for these tests are the established mechanical testing standards (ASTM F2077-11, ASTM F2267-04, and S-01:2013) for intervertebral body fusion devices. These standards define the parameters and acceptable ranges for static and dynamic loading, subsidence, and expulsion.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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The VERTICALE® System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine. The VERTICALE® System is intended for non-cervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the VERTICALE® MIS System is intended for non-cervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the VERTICALE® MIS metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The subject device is intended to be used with autograft and/or allograft. Pedicle screw fixation is limited to a posterior approach.

The VERTICALE® System is a posterior fixation system for stabilizing the thoracic, lumbar and sacral spine. The VERTICALE® System is a modular, versatile fixation system consisting of pedicle screws, iliac screws, revision screws, hooks and rods for the fusion of treated spinal segments.

The pedicle screws are available in a range of sizes, and in solid, cannulated and fenestrated designs, which when used in combination with the rods, can be used for a range of indications. The pedicle screws and hooks are manufactured from titanium alloy and the rods, from titanium alloy or cobalt chrome alloy.

The VERTICALE® System comprises modular ergonomically designed, bi-functional two-in-one (2 in 1) instruments with modular handle options. The VERTICALE® System also offers a set of minimal invasive instrumentation (MIS) to facilitate minimally invasive implantation of the components.

The VERTICALE® System is color coded by diameter for ease of identification.

The VERTICALE® implants are manufactured from Ti6Al4V ELI conforming to ASTM F136 and CoCrMo conforming to ASTM F1537. The VERTICALE® System specific instruments are manufactured from materials conforming to ISO 16061 and ASTM F899.

The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.q., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.

I am sorry, but the provided text is a 510(k) summary for a medical device (spinal fixation system) and does not contain information about acceptance criteria or a study proving that an AI/ML powered device meets those criteria.

The document focuses on demonstrating substantial equivalence of the VERTICALE® Posterior Spinal Fixation System to legally marketed predicate devices through:

• Indications for Use: Matching the predicate devices.
• Technological Characteristics: Similar materials, design, and function.
• Non-Clinical Performance Data: Mechanical testing (ASTM F1717-15, ASTM F1798-13), biocompatibility (ISO 10993-1), and validation activities for cleaning, sterilization, packaging, shelf life, and transport.
• Absence of Clinical Data Requirement: Stating that due to established safety and efficacy of similar predicate devices, clinical testing was not required.

Therefore, I cannot provide the requested table or answer the specific questions about an AI/ML powered device's acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the given text.

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The ROCCIA® MultiLIF is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The ROCCIA® MultiLIF implants are intended for use in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).

The ROCCIA® MultiLIF implants are intended for use at one or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ROCCIA® MultiLIF implants can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

The ROCCIA MultiLIF cage is manufactured from Ti6Al4V ELI alloy. The cage has a large cylindrical hollow in the middle which can be filled with bone material. The cage has numerous threaded holes that allow for correct placement of the cage.

The ROCCIA MultiLIF cage is available in a range of sizes to accommodate individual patient pathology and anatomical conditions.

The ROCCIA instrumentation is ergonomically appropriate and designed as modular components. The ROCCIA insertion device enables the user to perform various instrumentation steps with just a single instrument. The instruments are designed to be used with the ROCCIA MultiLlF, and are made of materials common for medical devices used in implantable device instrumentation tools. The instruments are intended to be cleaned, sterilized, and reused for the purposes of future implantation procedures.

The ROCCIA MultiLIF cage is manufactured from Ti6Al4V ELI alloy conforming to ASTM F136. The ROCCIA instrumentation is manufactured from stainless steels conforming to ISO 16061 and ASTM F899.

The provided text describes a 510(k) premarket notification for the ROCCIA® MultiLIF intervertebral body fusion device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials for effectiveness in the same way a PMA would require. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of substantial equivalence to a predicate device, primarily through non-clinical performance testing.

Here's the information extracted and organized based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are typically met by demonstrating that the device performs equivalently to the predicate device in relevant non-clinical tests. The reported device performance is that it met these equivalence standards.

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

• Sample Size: Not applicable in the context of clinical trials with human subjects for this specific submission. The "test set" for performance evaluation involved in vitro mechanical testing of the device and a predicate. The specific number of physical device samples tested for each non-clinical test (mechanical load, subsidence, static expulsion) is not specified in the provided document.
• Data Provenance: The data comes from non-clinical performance tests conducted by Silony Medical GmbH, presumably in a laboratory setting. There is no mention of country of origin for this testing, nor is it a retrospective or prospective human clinical data set.

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

• Number of Experts: Not applicable. The "ground truth" for the non-clinical tests is established by adherence to recognized international and national standards (e.g., ASTM F2077, ASTM F2267) and internal requirements. There isn't a human expert "ground truthing" process for these engineering performance tests in the same way there would be for an AI diagnostic device.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert interpretations of cases in clinical studies or for AI ground truth labeling. The "test set" here refers to physical device testing against engineering standards, not human-interpreted data.

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

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is a physical intervertebral body fusion device, not a diagnostic AI or imaging device that would typically involve human readers.

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

• No standalone (algorithm only) performance study was done. This device is a physical medical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

• For non-clinical performance evaluation, the "ground truth" is defined by established engineering standards and pre-defined acceptable performance ranges for the physical device, typically benchmarked against the predicate device's performance in the same tests. For the overall submission, the primary ground truth is the substantial equivalence of the device to its predicate, as determined by the FDA based on the provided non-clinical data and comparison of intended use, technological characteristics, and materials.

8. The Sample Size for the Training Set

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

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

• Not applicable. No training set was used.

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