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The Curiteva Porous PEEK Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Curiteva Porous PEEK Laminoplasty System is used to hold or buttress the allograft or autograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

The Curiteva Porous PEEK Laminoplasty System is an internal fixation device for spinal surgery that consists of various configurations of plates and screws. The implant configurations are available in different types and sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The plates come preformed with holes to receive bone screws. Screws are used to attach the plates to bone. System plate configurations may be used with allograft or autograft material. A hinge plate is provided when additional stabilization is necessary.

All system components are manufactured from Titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136, or PEEK (Polyetheretherketone) as described by ASTM F2026.

The Curiteva Porous PEEK Laminoplasty implants are sterile, single-use devices and available in a variety of different sizes to accommodate the individual pathology and anatomical conditions of the patient. The implants have solid and porous PEEK regions.

The Curiteva Porous PEEK Laminoplasty implants are manufactured from implant-grade PEEK (per ASTM F2026). Each porous PEEK implant has been surface treated with a hydroxyapatite (HA) coating that is approximately 20nm thick.

The provided text is a 510(k) Premarket Notification from the FDA regarding the Curiteva Porous PEEK Laminoplasty System. This document is a clearance letter for a medical device and does not contain information about an AI/ML (Artificial Intelligence/Machine Learning) device or its performance study.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves an AI/ML device meets those criteria, as the input document is not about such a device. The key information points requested (test set sample size, data provenance, expert panels, adjudication, MRMC studies, standalone performance, ground truth establishment, training set details) are specific to the validation of AI/ML models, which is not discussed in this medical device clearance document.

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The Vy Spine™ VyLam™ Laminoplasty System is indicated for use in laminoplasty of the lower cervical and upper thoracic spine (C3 to T3) in skeletally mature patients. The system devices are designed for use with allogenic bone graft in order to prevent the allograft from expulsion or impinging on the spinal cord. One device may be used per vertebra.

The Vy Spine™ VyLam™ Laminoplasty System is comprised of implant and instrument components. The implant components, plates and screws, will hold the decompression after a laminoplasty procedure. The implant components are manufactured from Ti-6Al-4V ELI per ASTM F136 and are available in multiple anatomical sizes to accommodate various vertebral bodies. The instruments are manufactured from stainless steel per ASTM F899, high grade plastic, and silicone rubber.

The provided document is a 510(k) summary for the Vy Spine™ VyLam™ Laminoplasty System. It focuses on demonstrating substantial equivalence to a predicate device, primarily through mechanical testing and a comparison of technological characteristics. It does not describe a study involving human subjects, AI/algorithm performance, or the establishment of ground truth by expert consensus for diagnostic purposes.

Therefore, most of the requested information about acceptance criteria, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and ground truth types cannot be found in this document.

However, I can extract information related to the performance data and the "acceptance criteria" (in this context, demonstrating equivalent mechanical strength).

Here's what can be extracted based on the provided text:

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a Finite Element Analysis (FEA) for the additional implant plates.

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

The document states: "FEA analyses for the additional plates' four-point bending (based on ASTM F2193) were performed to compare the strength of the additional plates to the standard plate in the predicate Vy Spine™ VyLam™ Laminoplasty System (K232471). The performance data verifies that the subject is substantially equivalent to the predicate Vy Spine™ Laminoplasty System (K232471)."

While a specific table is not provided, the "acceptance criteria" implicitly relates to the additional plates demonstrating equivalent or superior mechanical strength to the standard plate of the predicate device, as verified by FEA. The "reported device performance" is the conclusion that the performance data verifies substantial equivalence in strength.

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

• Sample Size: This was a computational study (FEA) rather than a study with a "test set" in the sense of patient data or a large number of physical parts tested. The "sample" would be the computational models of the specific new plates: VyLam™ Double Hook Plate, VyLam™ Inline Double Hook Plate, and VyLam™ Support Plate. The number of models is not explicitly stated beyond "additional plates."
• Data Provenance: Not applicable as this is a computational analysis, not patient data.

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

• Not applicable. This is a mechanical engineering analysis (FEA), not a medical image interpretation study. "Ground truth" in this context would be derived from accepted engineering principles and standards (ASTM F2193).

4. Adjudication method for the test set:

• Not applicable. This is a computational analysis.

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 is not an AI/diagnostic device.

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

• No. This is not an AI device.

7. The type of ground truth used:

• For the mechanical performance, the "ground truth" is based on established engineering standards (ASTM F2193) and the mechanical properties of the predicate device, against which the new designs were compared via FEA.

8. The sample size for the training set:

• Not applicable. This is not an AI device trained on data.

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

• Not applicable. This is not an AI device.

In summary, the document describes a mechanical performance study using Finite Element Analysis (FEA) to demonstrate substantial equivalence of new implant plates to an existing predicate device based on their mechanical strength. It does not involve patient data, expert interpretations, or AI algorithm performance.

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The Vy Spine™ VyLam™ Laminoplasty System is indicated for use in laminoplasty of the lower cervical and upper thoracic spine (C3 to T3) in skeletally mature patients. The system devices are designed for use with allogenic bone graft in order to prevent the allograft from expulsion or impinging on the spinal cord. One device may be used per vertebra.

The Vy Spine™ VyLam™ Laminoplasty System is comprised of implant and instrument components. The implant components, plates and screws, will hold the decompression after a laminoplasty procedure. The implant components are manufactured from Ti-6Al-4V ELI per ASTM F136 and are available in multiple anatomical sizes to accommodate various vertebral bodies. The instruments are manufactured from stainless steel per ASTM F899, high grade plastic, and silicone rubber.

This document is a 510(k) premarket notification for a medical device (Vy Spine™ VyLam™ Laminoplasty System). The information provided focuses on the regulatory aspects and substantial equivalence to predicate devices, rather than a study proving the device meets specific performance acceptance criteria in the way a clinical or diagnostic AI study would.

Therefore, many of the requested categories related to AI/diagnostic study design (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this type of submission.

However, I can extract information related to the mechanical performance data that was conducted to demonstrate substantial equivalence.

Here's the breakdown of the available information:

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: This information is not provided in the document. Mechanical testing typically involves a certain number of specimens per test, but the specific quantity is not reported here.
• Data Provenance: Not applicable for mechanical testing. This is lab-based testing of device components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is mechanical testing to established standards, not a diagnostic study requiring expert ground truth.

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

Not applicable. This is 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 is mechanical testing, not an AI or diagnostic imaging study.

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

Not applicable. This is mechanical testing.

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

The "ground truth" for mechanical performance in this context is the established ASTM standards (ASTM F2193 and ASTM F543). The device's performance must meet the requirements defined within these standards.

8. The sample size for the training set

Not applicable. This is mechanical testing, not a machine learning study with a training set.

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

Not applicable.

Study Proving Device Meets Acceptance Criteria:

The study referenced is the mechanical testing detailed in the "Performance Data and Substantial Equivalence" section.

• Tests Conducted: Static four-point bend testing per ASTM F2193, dynamic four-point bend testing per ASTM F2193, and axial pullout testing per ASTM F543.
• Conclusion: "The performance data indicates that the subject device is substantially equivalent to predicate devices and has met all mechanical test requirements based on worst-case construct testing and the engineering rationale."

This statement confirms that the results of these mechanical tests demonstrated that the Vy Spine™ VyLam™ Laminoplasty System met the acceptance criteria defined by the relevant ASTM standards, thereby supporting its substantial equivalence to predicate devices for regulatory clearance.

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The Curiteva Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Curiteva Laminoplasty System is used to hold or buttress the allograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

The Curiteva Laminoplasty System is an internal fixation device for spinal surgery that consists of various configurations of plates and screws. The implant configurations are available in different types and sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The plates come preformed with holes to receive bone screws. Screws are used to attach the plates to bone. System plate configurations may be used with allograft or autograft material. A hinge plate is provided when additional stabilization is necessary. All system components are manufactured from Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136, or PEEK (Polyetheretherketone) as described by ASTM F2026.

The provided document is a 510(k) summary for a spinal implant device (Curiteva Laminoplasty System), not an AI/ML medical device. Therefore, it does not contain the information requested regarding acceptance criteria and performance studies for an AI/ML device.

Specifically, the document discusses:

• Acceptance Criteria & Performance: The performance data section (page 4, section F) states that "Non-clinical testing performed on the Curiteva Laminoplasty System supports substantial equivalence to predicate devices." The tests performed are:
  • Static four-point bending per ASTM F2193
  • Dynamic four-point bending per ASTM F2193
  • Axial screw pullout per ASTM F543
    It concludes that the strength and performance are sufficient for intended use and substantially equivalent to the primary predicate device (K032534). However, this refers to mechanical testing of a physical implant, not the performance of an AI/ML algorithm.

Therefore, I cannot extract the following information which is relevant to AI/ML device studies:

1. Table of acceptance criteria and reported device performance (for AI/ML): Not applicable.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, ground truth establishment for training set: None of this information is present as the document describes a physical medical device, not an AI/ML algorithm.

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The CENTERPIECE™ Plate Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The CENTERPIECE™ Plate Fixation System is used to hold the graft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

The CENTERPIECE™ Plate Fixation System consists of a variety of sizes of plates and screws. The CENTERPIECE™ Plate Fixation System screws are made of from medical grade titanium or titanium alloy. Screws will be provided sterile and non-sterile and are reusable.

This FDA 510(k) K212428 submission is for a medical device, the CENTERPIECE™ Plate Fixation System, and not a software or AI/ML device. Therefore, the questions regarding acceptance criteria, study details, and ground truth establishment for AI/ML performance are not applicable in this context.

The document describes the device, its intended use, and its substantial equivalence to a predicate device based on performance testing of its mechanical properties and MRI safety, not on AI/ML diagnostic or predictive performance.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of numerical acceptance criteria for each test and reported performance values. Instead, it summarizes the types of performance testing conducted to demonstrate functionality and compatibility, and ultimately, substantial equivalence to the predicate device. The conclusion states that the implants "have shown through comparison and testing to be substantially equivalent to the identified predicate devices." This implies that the performance met the unstated acceptance criteria for demonstrating equivalence.

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML study involving a test dataset of images or other clinical data. The "test set" refers to physical samples of the device undergoing mechanical and safety testing. The specific number of devices tested is not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of device performance, would be established by engineering standards, material properties, and regulatory requirements, not by expert consensus on clinical data.

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 clinical data, which is not relevant here.

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 not an AI/ML product.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This device is not an AI/ML algorithm.

7. The type of ground truth used: For mechanical tests (Static Compression, Pull Out Strength), the "ground truth" would be established by engineering specifications, material science principles, and relevant ISO/ASTM standards for spinal fixation devices. For MRI Safety, the ground truth is based on established guidelines and testing protocols for medical device compatibility within MRI environments.

8. The sample size for the training set: Not applicable. This is not an AI/ML product.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML product.

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The Life Spine Hinged Laminoplasty System is indicated for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Life Spine Hinged Laminoplasty System is used to hold or butresses the allograft or autograft material in place to prevent the graft material from expulsion or impinging the spinal cord.

The Life Spine Hinged Laminoplasty System consists of various plates and screw configurations to address surgeon and patient needs. The plates have screw holes at the ends that allow attachment to bone. The center hole of the plate allows it to be affixed to allograft or autograft material. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine Hinged Laminoplasty System components with components from any other system or manufacturer. The Life Spine Laminoplasty System components should never be reused under any circumstances.

The provided text is a 510(k) summary for the Life Spine Hinged Laminoplasty System. It is a submission to the FDA for market clearance of a medical device, specifically a spinal interlaminal fixation orthosis.

This document describes the device itself (its components, materials, and intended use) and its substantial equivalence to previously cleared predicate devices. It does not describe a study involving an AI/software device that measures or analyzes data, nor does it provide acceptance criteria or performance data for such a device.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving that an AI/software device meets acceptance criteria, as the input document is about the physical Life Spine Hinged Laminoplasty System and not an AI/software device.

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The NuVasive® Camber Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Camber Laminoplasty System is used to hold the allograft or autograft material in place in order to prevent the allograft or autograft material from expulsion, or impinging the spinal cord.

The NuVasive® Camber Laminoplasty System consists of plates and screws of various sizes made from titanium alloy (ASTM F136) to provide reinforcement while expanding the spinal canal and preserving the posterior elements. Instruments required to implant the device are also available.

This document describes the FDA 510(k) clearance for the NuVasive® Camber Laminoplasty System. This is a medical device, not an AI/ML imaging device, so the typical acceptance criteria and study designs for AI/ML devices (e.g., MRMC studies, standalone performance, ground truth establishment for AI training/testing data) are not applicable here.

Therefore, the response below will describe the device-specific acceptance criteria and the methods used to prove the device meets these criteria, based on the provided text, while explicitly stating that AI/ML specific criteria were not relevant for this device.

Acceptance Criteria and Study Proving Device Meets Criteria for NuVasive® Camber Laminoplasty System

The NuVasive® Camber Laminoplasty System is a spinal implant device cleared through the FDA's 510(k) pathway. The core acceptance criterion for this pathway is demonstration of substantial equivalence to legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. For devices like this, performance is primarily assessed through non-clinical, bench-top mechanical testing rather than AI/ML specific performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

• Axial Pullout (per ASTM F2193)
• Static 3-Point Bend
• Dynamic 3-Point Bend
  The results demonstrate that the subject Camber Laminoplasty System meets the same criteria as the predicate devices. |

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

• Sample Size: Not specified as "sample size" in the context of human data or imaging data. For mechanical testing, the number of test specimens (e.g., number of plates/screws tested) would typically be defined by the test standard (e.g., ASTM F2193) and internal protocols. The document does not provide the specific number of units tested.
• Data Provenance: The studies were non-clinical, bench-top tests performed by the manufacturer, NuVasive, Incorporated. The provenance is internal engineering lab testing. These tests are not retrospective or prospective in the sense of clinical studies.

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

• This question is not applicable as the device is a mechanical implant, not an AI/ML imaging device. There were no "experts" establishing ground truth in the sense of image interpretation for AI. Device performance was assessed via engineering specifications and mechanical testing standards.

4. Adjudication Method for the Test Set

• This question is not applicable for the same reasons as #3. Performance was measured objectively through mechanical tests (e.g., force, displacement), not through human interpretation or adjudication.

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

• This question is not applicable. This describes an AI/ML imaging device study. The NuVasive® Camber Laminoplasty System is a physical medical implant. No MRMC study was conducted.

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

• This question is not applicable. This refers to AI/ML algorithm performance. The device is a mechanical implant, not an algorithm.

7. The type of ground truth used

• The "ground truth" for this device's performance is defined by established mechanical engineering standards and criteria relevant to spinal implants (e.g., ASTM F2193, and criteria for static and dynamic bend tests). The device had to demonstrate it met these pre-defined engineering criteria, which are derived from the biomechanical requirements for such implants. There was no clinical outcomes data, pathology, or expert consensus used as "ground truth" in the way it's used for AI/ML diagnostic devices.

8. The Sample Size for the Training Set

• This question is not applicable. There was no "training set" as this is not an AI/ML device.

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

• This question is not applicable. There was no "training set."

Summary of Relevant Information from the Document:

• Device Type: Spinal interlaminal fixation orthosis (mechanical implant).
• Regulatory Pathway: 510(k) Premarket Notification.
• Primary Evidence for Clearance: Demonstration of substantial equivalence through comparison of intended use, technological characteristics, and non-clinical performance data (mechanical testing) against legally marketed predicate devices.
• Key Tests Conducted: Axial Pullout (per ASTM F2193), Static 3-Point Bend, Dynamic 3-Point Bend.
• Conclusion: The device was found to be substantially equivalent to the predicate devices, meeting the necessary mechanical performance criteria. No clinical studies were required or conducted.

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The Life Spine Laminoplasty System is indicated for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Life Spine Laminoplasty System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.

The Life Spine Laminoplasty System consists of plates screws in various diameters and lengths to support a laminoplasty procedure. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine Laminoplasty System components with components from any other system or manufacturer. The Life Spine Laminoplasty System components should never be reused under any circumstances.

The provided text describes the 510(k) premarket notification for the Life Spine Laminoplasty System. It focuses on demonstrating substantial equivalence to predicate devices, primarily through material composition and mechanical performance testing.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text details mechanical performance testing to demonstrate substantial equivalence, not a clinical study on human subjects. Therefore, the concepts of "test set" in the context of clinical data provenance (country of origin, retrospective/prospective) are not applicable here.

• Sample Size for Mechanical Testing: Not explicitly stated. For mechanical testing, the "sample size" would refer to the number of devices or components tested to achieve statistical significance according to the ASTM standards.
• Data Provenance: Not applicable as this is engineering performance data.

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

This information is not applicable. The "ground truth" here is mechanical performance according to established ASTM standards, which are engineering metrics, not interpretations by medical experts.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing results are objective measurements against a standard, not subject to adjudication by experts.

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

No, an MRMC comparative effectiveness study was not done. The submission is for a medical device (spinal fixation system), and the testing described is mechanical performance testing to ensure the device itself meets structural and material requirements for its intended use, demonstrating equivalence to already cleared devices. It is not an AI-enabled diagnostic tool requiring human reader performance analysis.

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

The "ground truth" for this submission is based on engineering standards and established performance of predicate devices. The device's material properties and mechanical performance (e.g., strength, durability) are compared against the requirements of ASTM F2193-02 (Four Point Bending) and ASTM F543 (Screw Pull-Out) and the known performance characteristics of the predicate devices (Medtronic Centerpiece, Stryker Escalate, Synthes Arch).

8. The Sample Size for the Training Set

Not applicable. This submission does not involve machine learning or AI, and therefore, there is no "training set."

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

Not applicable. There is no training set mentioned or implied in this submission.

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The Choice Spine Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Choice Spine Laminoplasty Fixation System is used to hold or buttress the allograft or autograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

The proposed Choice Spine Laminoplasty Fixation System is an implant system that consists of various plates and screw configurations. The proposed plates are available in various configurations to address surgeon and patient needs as necessary. The proposed plate devices come preformed with holes for bone screws. The plate offered can be affixed to allograft or autograft material and secured with a bone screw from the system. A hinge plate is provided when additional stabilization is necessary. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy. The system components are made from medical grade Titanium Alloy Ti-6AI-4V ELI (ASTM F136), 17-4 SS (ASTM F899), 465 SS (ASTM A564), and 6061 T6 Aluminum (ASTM B221 and B209).

The provided document is a 510(k) premarket notification for the Choice Spine Laminoplasty™ Fixation System. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria or the study that proves the device meets those criteria in the typical sense of a diagnostic or AI-driven device.

Instead, for a medical device like a spinal fixation system, "acceptance criteria" are generally met through a combination of:

• Design Specifications and Material Compliance: Ensuring the device is manufactured from medical-grade materials to specific dimensions and tolerances.
• Biocompatibility Testing: Ensuring the materials are safe for implantation in the human body.
• Mechanical Performance Testing: Evaluating the device's strength, durability, and resistance to various forces it might experience in vivo.
• Sterilization Validation: Ensuring the device can be sterilized effectively without compromising its integrity.
• Clinical Performance (often through substantial equivalence): Demonstrating that the device performs as intended and is as safe and effective as legally marketed predicate devices.

The document primarily focuses on the Substantial Equivalence claim, which is the cornerstone for 510(k) clearance.

Here's an analysis based on the provided text, addressing your points where information is available or inferable:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are derived from recognized standards and comparative performance to predicates, rather than a specific set of diagnostic metrics.

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

For a spinal fixation system seeking 510(k) clearance, the "test set" primarily refers to the physical devices (prototypes or production samples) subjected to mechanical and material testing, not a dataset of patient images or outcomes.

• Sample Size for Mechanical Testing: Not explicitly stated in the document. These tests (ASTM F2193, ASTM F543) typically require a specific number of samples (e.g., n=5 or n=6) to establish statistical significance for material properties and device performance.
• Data Provenance: The mechanical test data would be generated in a lab setting, typically by the manufacturer or a contract testing facility, specifically for this device design. It's not "retrospective or prospective" in the sense of clinical trials.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This concept is not applicable to this type of medical device submission. "Ground truth" established by experts is relevant for diagnostic devices or AI algorithms where subjective human interpretation is being evaluated or augmented. For a spinal implant, mechanical tests use objective physical measurements against established standards, and "ground truth" for clinical safety and effectiveness is largely inferred from substantial equivalence to devices with a known clinical history.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used in clinical studies or when interpreting diagnostic images to resolve discrepancies among expert readers and establish a reference standard. For mechanical testing, the results are quantitative measures from instruments.

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

No, an MRMC comparative effectiveness study was not conducted or is not detailed in this 510(k) summary. MRMC studies are typically performed for diagnostic imaging devices or AI tools to assess reader performance with and without AI assistance. This device is a physical implant, not a diagnostic tool.

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 or AI product. Its performance is evaluated through mechanical testing and comparison to predicate devices, not algorithm-only performance.

7. The Type of Ground Truth Used

For this device, the "ground truth" is primarily established through:

• Recognized Standards: Specific ASTM standards (F2193, F543) define the methodologies and expected performance characteristics for spinal fixation devices. Compliance with these standards forms a "physical ground truth."
• Predicate Device Performance: The established safety and effectiveness of the identified predicate devices (DePuy Mountaineer, Synthes Arch Fixation System, Medtronic CENTERPIECE Plate Fixation System, Spectrum Spine Laminoplasty Plating System) serve as a de-facto "clinical ground truth" for substantial equivalence. The new device is accepted if it performs similarly or better in mechanical tests and has similar indications and materials.

8. The Sample Size for the Training Set

Not Applicable. This device is hardware, not an AI algorithm. Therefore, there is no "training set."

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

Not Applicable. As there is no training set for a hardware device, no ground truth needed to be established for it.

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The HAVEN™ Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The HAVEN™ Laminoplasty System is used to hold bone allograft material in place in order to prevent the graft from expulsion or impinging the spinal cord.

The CANOPY® Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The CANOPY® Laminoplasty Fixation System is used to hold bone allograft or autograft material in place in order to prevent the graft from expulsion or impinging the spinal cord.

The HAVEN™ Laminoplasty System consists of spinal fixation plates for use in Laminoplasty. These implants are composed of titanium or titanium alloy (per ASTM F67, F136, F1295, and F1472). HAVEN™ implants may be used with previously cleared CANOPY®, RELIEVE®, QUARTEX™, ELLIPSE®, PROTEX CT® screws and CANOPY® Spacer.

The CANOPY® Laminoplasty Fixation System consists of spinal fixation plates and screws for use in laminoplasty procedures. CANOPY® implants are inserted through a posterior cervical or thoracic approach, and are available in various sizes and geometric options to fit individual patient anatomy. Fixation plates may be used with bone graft material. Hinge plates may be used to stabilize a weakened or displaced lamina. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy.

CANOPY® plates and screws are manufactured from titanium or titanium alloy, as specified in ASTM F67, F136, F1295 and F1472. Optional graft chambers are manufactured from radiolucent PEEK as specified in ASTM F2026 and contain tantalum or titanium alloy markers to permit radiographic visualization, per ASTM F67, F136, F560, F1295 or F1472.

This document describes the FDA's clearance of the HAVEN™ Laminoplasty System and CANOPY® Laminoplasty Fixation System. It is a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria based on patient outcomes.

Therefore, the requested information about acceptance criteria and specific study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for test and training sets, and training set sample size) is largely not applicable in the context of this 510(k) submission.

Explanation:

• 510(k) Premarket Notification: This type of submission aims to demonstrate that a new device is "substantially equivalent" to a device already on the market (a predicate device). This often relies on comparing technical characteristics, materials, and mechanical or non-clinical performance, rather than clinical efficacy against pre-defined acceptance criteria for patient outcomes.
• Mechanical Testing vs. Clinical Studies: The performance data section explicitly states, "Compression, cantilever bending and expulsion testing performed on the HAVEN™ plates demonstrates substantial equivalence to the predicate devices. No additional testing for CANOPY® plates was performed." This indicates that the primary basis for clearance was a comparison of mechanical properties, not clinical performance against specific metrics.
• Absence of Clinical Study Details: The document does not mention any clinical studies, patient data, ground truth establishment by experts, or statistical analyses of human reader performance (MRMC) or standalone algorithm performance that would be typical for AI/ML device clearances requiring such details.

However, based on the provided document, I can extract the following relevant information regarding performance and its basis for substantial equivalence:

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

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

• Not Applicable in the traditional sense for clinical data. The performance claims are based on mechanical testing of the devices themselves, not on a test set of patient data.
• Data Provenance: The mechanical testing was performed by the manufacturer, Globus Medical Inc.

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

• Not Applicable. No expert-established ground truth for patient data is mentioned as part of this 510(k) clearance.

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

• Not Applicable. No adjudication method for expert review of patient data is mentioned.

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 a physical medical device (spinal fixation system), not an AI/ML algorithm for image interpretation or diagnosis. Therefore, no MRMC study or AI assistance evaluation was performed.

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.):

• Not Applicable for clinical ground truth. For the mechanical testing, the "ground truth" would be the engineering specifications and performance benchmarks derived from the predicate device's established mechanical properties.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device relying on a training set of data.

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

• Not Applicable. As above, no training set for an algorithm is involved.

In summary: The provided document is a 510(k) clearance for a spinal implant system. The "study" referenced is mechanical performance testing to demonstrate substantial equivalence to predicate devices, not a clinical study involving patient data, expert review, or AI performance metrics.

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