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The VEOS Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine (from T1 to S1).

The VEOS Spinal Fixation System is intended for noncervical pedicle 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 VEOS Spinal Fixation System is intended for noncervical pedicle 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 VEOS Spinal Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. Pediatric pedicle screw fixation is limited to a posterior approach.

This system is intended to be used with autograft and/or allograft.

The Spineway VEOS Spinal Fixation System is composed of implant devices made from a titanium alloy Ti6Al4V-ELI per ISO 5832-3 and Cobalt-Chrome per ISO 5832-12. All implants are provided sterile or non-sterile. The implants are to be implanted from the posterior approach. The screws are available as monoaxial reduction screws in multiple diameters and length. Titanium rods are available in two diameters and multiple lengths. CoCr rods are available in one diameter and two length. CoCr rods are only available non-sterile. Transverse connectors are available in various sizes to attach to the two parallel rods. Associated instrumentation to complete the procedure is provided. Screws for MS applications are available as polyaxial cannulated screws in multiple diameters and lengths. Rods for MS applications are available as pre-bent rods and straight rods. Associated instrumentation to complete the procedure is provided.

The provided text is an FDA 510(k) clearance letter for a medical device called the "VEOS Spinal Fixation System." This document primarily focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, and intended use, rather than presenting a performance study of an AI/ML powered medical device against specific acceptance criteria.

Therefore, the requested information about acceptance criteria and a study proving a device meets acceptance criteria (especially in the context of AI/ML performance) is not present in the provided text. The document clearly states:

• "Clinical testing was not performed." (Page 5)

The tests summarized are non-clinical, mechanical tests (ASTM F1717 and ASTM F1798) to evaluate the structural competence of the spinal fixation system, which are physical properties of the implant, not performance metrics of an AI/ML algorithm.

Therefore, I cannot provide the requested table and details because the provided document does not contain information about:

1. A table of acceptance criteria and reported device performance (in the context of AI/ML).
2. Sample sizes for a test set or data provenance for AI/ML.
3. Number of experts, their qualifications, or adjudication methods for ground truth establishment.
4. MRMC studies or standalone AI performance.
5. Type of ground truth (expert consensus, pathology, outcomes data).
6. Sample size for a training set or how its ground truth was established.

This document describes the clearance of a physical medical implant, not an AI/ML-driven diagnostic or treatment device.

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The mont blanc 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 or deformities of the thoracic, lumbar and sacral/iliac spine.

This mont blanc system is intended for posterior noncervical pedicle fixation and non-pedicle fixation (from T1 to S1) for the following indications in skeletally mature patients:

· 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;
• · deformities (i.e., scoliosis, kyphosis, and/or lordosis);
• · spinal tumor,
• · pseudoarthrosis; and
• · failed previous fusion.

The mont blanc system is intended to be used with autograft and/or allograft.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Mont Blanc and Mont Blanc MIS Spinal Systems metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Mont Blanc and Mont Blanc MIS Spinal Systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The mont blanc MIS 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 or deformities of the thoracic, lumbar and sacral spine.

This mont blanc MIS system is intended for posterior noncervical pedicle fixation and non-pedicle fixation (from T1 to S1) utilizing a percutaneous minimally approach for the following indications in skeletally mature patients:

· 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;
• · deformities (i.e., scoliosis, kyphosis, and/or lordosis);
• · spinal tumor,
• · pseudoarthrosis; and
• · failed previous fusion.

The mont blanc MIS system is intended to be used with autograft and/or allograft.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Mont Blanc MIS Spinal Systems metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The Mont Blanc and Mont Blanc MIS Spinal Systems are intended to be used with autograft and/or allograff. Pediatric pedicle screw fixation is limited to a posterior approach.

The Spineway mont blanc & mont blanc MIS Spinal Systems are implant device systems comprised of a titanium alloy Ti 6Al-4V ELI per ISO 5832-3 and Cobalt-Chrome per ISO 5832-12. The fenestrated screws are polyaxial screws in diameters from 5.0 – 8.0 mm and in lengths from 30 – 55 mm. 6 fenestration holes are present in screws of length 35 mm or longer, 3 fenestration holes are present in screws of length 30 mm.

Dual connectors and domino connectors are available to connect 2 parallel rods together, lliac lateral connectors are available to create an Iliac fixation, and Axial connectors are available to connect 2 coaxial rods together.

Associated instrumentation to complete the procedure is provided reusable and non-sterile.

The provided FDA 510(k) summary (K191726) for the mont blanc & mont blanc MIS Spinal Systems does not contain information typically associated with acceptance criteria and study designs for AI-powered medical devices. Instead, it focuses on demonstrating substantial equivalence for a traditional implantable medical device (spinal fixation system) through mechanical testing.

Therefore, many of the requested categories (such as AI performance metrics, sample size for test/training sets, expert qualifications, adjudication methods, or MRMC studies) are not applicable to this document. The study described is a performance testing study for physical implants, not an AI efficacy study.

Here's a breakdown of the information that is available or not applicable/provided based on the document:

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in terms of numerical quantity but refers to "worst-case constructs comprised of Screws, Rods, Locking Screws, & Connectors." This implies a set of physical prototypes or manufactured units selected to represent the most challenging mechanical scenarios.
• Data Provenance: Not applicable in the context of clinical data. This refers to in-vitro mechanical testing conducted by the manufacturer.

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

• Not applicable. Ground truth for mechanical testing is established by engineering specifications and objective measurements against ASTM standards, not by expert interpretation of clinical data.

4. Adjudication Method for the Test Set

• Not applicable. This relates to clinical expert review, which is not part of mechanical performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study is for evaluating the impact of AI assistance on human reader performance, which is not relevant for a spinal implant device.

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

• No. This device is a physical spinal implant, not an algorithm.

7. The Type of Ground Truth Used

• Not explicitly stated as "ground truth" but based on: Objective measurements from mechanical testing (Static Compression Bending, Static Torsion, Torque to Failure, Dynamic Compression Bending) against established engineering standards (ASTM F1717-15) and comparison to predicate device performance.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical implant, not a machine learning model.

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

• Not applicable. No training set for an AI model is described.

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The Ayers Rock Cervical interbody fusion system is indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. These patients should have had 6 weeks of non-operative treatment. The Ayers Rock Cervical interbody fusion devices are to be used with autogenous bone graft and implanted via an open, anterior approach. The Ayers Rock Cervical interbody fusion system is to be used with supplemental fixation.

The Avers Rock Cervical interbody fusion system consists of cervical spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Ayers Rock Cervical interbody fusion system is manufactured from PEEK-OPTIMA® LT1 polymer and contains tantalum radiopaque markers. The Ayers Rock Cervical interbody fusion system is for single level anterior spinal use from the C2-C3 to C7-T1 disc levels.

This document is a 510(k) Premarket Notification from the FDA for the "Ayers Rock Cervical interbody fusion system." It describes the device, its indications for use, and the testing performed to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to predicate devices through mechanical testing. The specific performance requirements are derived from established ASTM standards and an industry norm.

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

The document does not explicitly state the sample size for each specific mechanical test (e.g., number of devices tested for static compression). It also does not mention the data provenance in terms of country of origin or whether the study was retrospective or prospective, as this is a materials/mechanical performance study, not a clinical study involving human subjects or medical data.

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

Not applicable. The ground truth for this type of device (interbody fusion system) in a 510(k) submission based on mechanical testing is established by adherence to recognized industry standards (ASTM) and a "recognized industry norm" for expulsion testing. Expert consensus on medical imaging or clinical outcomes is not relevant for this type of testing.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human interpretation of data where adjudication methods like 2+1 or 3+1 would be used. The acceptance is determined by meeting the specified mechanical and material performance criteria defined by the standards.

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

Not applicable. This is not a study involving human readers or AI. It is a mechanical performance study of an intervertebral body fusion 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-driven device. It is a physical medical implant.

7. The Type of Ground Truth Used

The ground truth used for this study is based on established engineering and material science standards and recognized industry norms. Specifically:

• ASTM F2077-14: Standard Test Methods for Intervertebral Body Fusion Devices.
• ASTM F2267-04 (reapproved 2011): Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression.
• USP34 and NF 29: United States Pharmacopeia and National Formulary standards for bacterial endotoxin testing.
• Recognized industry norm: For expulsion testing.

These standards define the expected performance characteristics for interbody fusion devices.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its performance is evaluated through direct mechanical and material testing.

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

Not applicable, as there is no "training set" for this type of device and study. The "ground truth" (i.e., acceptable performance levels) for the mechanical testing is established by the specified ASTM standards and industry norms.

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The Mont Blanc and Mont Blanc MIS Spinal Systems are intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine and sacral/iliac screw fixation.

The Mont Blanc and Mont Blanc MIS Spinal Systems are intended for noncervical 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 Mont Blanc MIS System is intended for noncervical 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 Mont Blanc MIS Spinal Systems metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Mont Blanc and Mont Blanc MIS Spinal Systems are intended to be used with autograft. Pediatric pediale screw fixation is limited to a posterior approach.

The Spineway Mont Blanc and Mont Blanc MIS Spinal Systems are composed of implant device made from a titanium alloy Ti6Al4V-ELI per ISO 5832-3 and Cobalt-Chrome per ISO 5832-12. All implant components are provided sterile. It is to be implanted from the posterior approach. The screws are available as monobloc and monobloc reduction (traction) screws and polyaxial reduction (traction) screws in diameters from 4.0-8.0 mm and in lengths from 25-55 mm and polyaxial iliac screws of 7 and 8mm diameters with lengths from 55mm to 110mm. Rods are available in 5.5mm diameter in lengths from 40-500 mm. Hooks are available in various sizes to attach to the thoracic and lumbar spine. Transverse connectors are available in various sizes to attach to the two parallel rods. Associated instrumentation to complete the procedure is provided.

Screws for MIS applications are available as polyaxial cannulated screws in diameter from 4.5-8mm and in lengths from 25-60mm. Rods for MIS applications are available as 5.5mm pre-bent rods from 50-140mm and straight rods from 50-500mm.

This document is a 510(k) Pre-Market Notification from the FDA regarding the Spineway Mont Blanc and Mont Blanc MIS Spinal Systems. It focuses on establishing substantial equivalence to previously cleared predicate devices, primarily through mechanical performance testing.

Here's an analysis of the provided text in relation to your request about acceptance criteria and studies that prove the device meets them:

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

The document does not explicitly state numerical acceptance criteria in a table format, nor does it provide specific reported device performance values in a table. Instead, it relies on comparison to predicate devices and established ASTM standards. The "Conclusion" states that the device is substantially equivalent to predicate devices in terms of "mechanical test results." This implies that the device's performance in the listed tests was comparable to or better than the predicate devices, thereby meeting an implicit acceptance criterion tied to the predicate's performance and the ASTM standards.

The performance standards listed are the tests performed, not the numerical acceptance criteria or the specific device performance outcomes.

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

The document does not specify the sample sizes used for the mechanical tests (e.g., number of implants tested). It refers to "pre-clinical testing performed per ASTM F1717-14" and "pre-clinical testing performed per ASTM F1798-98 (2003)." These ASTM standards typically outline the methodologies and requirements for testing, which would include sample size recommendations, but the specific sample sizes used in this particular study are not detailed in the provided text.

The data provenance is implied to be from Spineway S.A., a company located in Ecully, France. The testing is pre-clinical bench testing, not human clinical trial data, so the terms retrospective or prospective don't directly apply in the same way.

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 question is not applicable to the provided document. The document describes pre-clinical mechanical testing of a spinal implant system. "Ground truth" in this context would refer to the physical properties and performance of the device under specific test conditions, which are measured directly by engineering methods, not established by expert consensus or interpretations in the way medical images or diagnostic outcomes are.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for resolving discrepancies in expert interpretations (e.g., of medical images). The studies described here are mechanical bench tests, where measurements are objective and do not require expert adjudication in this manner.

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 question is not applicable. The device described is a spinal implant system (pedicle screws, rods). It is not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.

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

This question is not applicable. The device is a physical spinal implant system, not a software algorithm.

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

As mentioned in point 3, the concept of "ground truth" for a mechanical device largely pertains to its physical and mechanical properties. The "ground truth" for the test set would be the objective measurements obtained from the mechanical tests (e.g., force at failure, stiffness) as defined by the ASTM standards. There is no expert consensus, pathology, or outcomes data used to establish "ground truth" for these pre-clinical tests. The acceptable "truth" is whether the device meets or exceeds the mechanical properties of the predicate device and the standard requirements.

8. The sample size for the training set

This question is not applicable. There is no machine learning or AI component to this device that would require a "training set." The testing described is traditional mechanical engineering testing.

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

This question is not applicable, as there is no training set for this type of device.

In summary, the provided document focuses on demonstrating substantial equivalence for a physical spinal implant system through pre-clinical mechanical testing, rather than studies involving AI, human readers, or clinical outcomes data.

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The Twin Peaks Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Twin Peaks System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Twin Peaks System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

The Twin Peaks Lumbar Interbody Fusion System consist of 3 designs, PLIF & PLIF BS, TLIF and OLIF. The PLIF and TLIF implants are available as a lordotic form, while the OLIF implants are provided with no lordosis. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile, and a set of instrument for implantation is provided to facilitate implantation. Two radiographic markers made of tantalum per ASTM F560 are included in the PLIF and OLIF PEEK implants, and three radiographic markers made of tantalum per ASTM F560 are included in the TLIF PEEK implant to allow radiographic visualization.

This document is a 510(k) premarket notification for the Twin Peaks Lumbar Interbody Fusion System. It describes the device, its indications for use, and the performance testing conducted to demonstrate substantial equivalence to predicate devices. However, the document does not contain information about an AI/ML device or its acceptance criteria and a study to prove it meets them. This notification is for a traditional medical device (intervertebral body fusion system) and the performance testing refers to mechanical and material tests, not AI/ML algorithm performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device based on the provided text.

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The Mout Blanc Spinal System is intended for noncervical pedicle fixation from the T1 to S1 vertebrae and sacral/iliac screw fixation in skeletally mature patients as an adjunct to fission for the following indications: degenerative disc disease (defined as back pain of discogence 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.

The Spineway Mont Blanc Spinal System is an implant device made from a titanium alloy TI 6Al 4V-ELI. It is to be implanted from the posterior approach. The screws are available as monobloc and monobloc reduction (traction) screws and polyaxial reduction (traction) screws in diameters from 4.0-8.0 mm and in lengths from 25-55 mm and polyaxial iliac screws of 7 and 8mm diameters with lengths from 55mm to 110mm. Rods are available in 5.5mm diameter in lengths from 40-500 mm. Hooks are available in various sizes to attach to the thoracic and lumbar spine. Transverse connectors are available in various sizes to attach to the two parallel rods. Associated instrumentation to complete the procedure is provided.

This document is a 510(k) premarket notification for a medical device and, as such, does not contain the detailed study information typically found in a scientific publication or clinical trial report. The provided text outlines the regulatory submission for the Mont Blanc Spinal System but does not describe a study that proves the device meets specific acceptance criteria in terms of a clinical or AI-based performance evaluation.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device based on pre-clinical mechanical testing and similarities in design, materials, and intended use.

Here's an breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

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)

• Sample Size for Test Set: Not applicable in the context of this regulatory submission. The "test set" here refers to the actual physical devices undergoing mechanical testing, not a data set for an AI model. The number of samples for mechanical testing is not specified.
• Data Provenance: The device is manufactured by Spineway S.A. in Ecully, France. The pre-clinical testing was performed according to ASTM F1717-10, an international standard for spinal implant fatigue testing.

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 document describes mechanical component testing, not a clinical study involving expert interpretation or ground truth establishment in a medical imaging or diagnostic context.

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

• Not applicable. This pertains to clinical data interpretation, 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 document is about a spinal implant system, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness is discussed.

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

• Not applicable. This device is a physical spinal implant, not an algorithm.

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

• The "ground truth" for the mechanical testing is based on established engineering principles and the specifications within the ASTM F1717-10 standard. The "truth" is whether the device meets the mechanical performance requirements defined by this standard for similar predicate devices.

8. The sample size for the training set

• Not applicable. This document does not describe an AI/machine learning model, so there is no training set.

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

• Not applicable. As above, no AI/machine learning model is described.

In summary: The provided FDA 510(k) submission describes a spinal implant system and its regulatory clearance based on substantial equivalence to a predicate device. The "study" referenced is a set of pre-clinical mechanical tests (static compression bend, static torsion, dynamic compression bend) performed according to the ASTM F1717-10 standard. The document does not provide quantitative performance results for these tests, but concludes that they were sufficient to demonstrate equivalence. It does not involve a clinical study, human readers, AI, or any methodologies related to establishing ground truth from expert consensus or patient outcomes.

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The Spineway Blue Mountain Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The Spineway Blue Mountain Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions. This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.

The Spineway Blue Mountain Cervical Plate System that includes titanium alloy (per ASTM F136 and ISO 5832-3) plates and screws that are intended to stabilize the spine during the fusion process. The plates and screws are available in various sizes to accommodate patients' anatomy. The plates are contoured to follow the curves of the cervical spine.

Based on the provided text, the document is a 510(k) summary for the Spineway Blue Mountain Cervical Plate System. A 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance data like one would expect for an AI/ML medical device.

Therefore, the information required to populate the requested table and answer the study-related questions is not present in this document. The document explicitly states:

• "Spineway determined that the changes made to the device did not present a new worst case, and therefore, no new testing was conducted." (Page 4)

This indicates that no new performance data or studies were performed for this particular 510(k) submission to demonstrate the device meets specific acceptance criteria. Instead, the submission relies on the substantial equivalence to a predicate device, which would have had its own performance data and acceptance criteria established during its clearance process.

Here's a breakdown of why the requested information cannot be extracted from this document, followed by what could be inferred about the predicate device if it were an AI/ML device (which it is not in this case):

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

• Not Available: The document states "no new testing was conducted." Thus, there are no reported device performance metrics against specific acceptance criteria for this K150036 submission.

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

• Not Available: No new test sets were used as no new testing was conducted.

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

• Not Available: No new test sets or ground truth establishment processes are described.

4. Adjudication method for the test set:

• Not Available: No new test sets are described.

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 (Cervical Plate System) is a physical implant, not an AI/ML diagnostic or assistive device, so MRMC studies are not relevant.

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

• Not Applicable: This is a physical device, not an algorithm.

7. The type of ground truth used:

• Not Applicable: For an implantable device like a cervical plate, "ground truth" as typically discussed for AI/ML devices is not relevant. Its performance is assessed through biomechanical testing, material properties, and clinical outcomes.

8. The sample size for the training set:

• Not Applicable: This is a physical device, not an AI/ML model, so there is no "training set."

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

• Not Applicable: This is a physical device, not an AI/ML model.

Summary based on the provided text:

The document focuses on demonstrating that the "Blue Mountain Cervical Plate System" is substantially equivalent to a previously cleared predicate device (Qualgenix Blue Mountain Cervical Plate System, K112809). The equivalence is based on materials, screw type, screw diameters, screw locking mechanism, and the fact that new plate sizes and instruments for the current device did not introduce new worst-case scenarios, negating the need for new performance testing.

Therefore, this document does not contain the information requested about acceptance criteria and study data for the device's performance, as no such new studies were part of this 510(k) submission.

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