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The golden gate™ anterior plate system is intended to provide stabilization during the development of a spinal fusion. The golden gate™ System is indicated for use in the anterior/anterolateral thoracolumbar spine (T1-L5) for the treatment of: DDD (back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), Spondylolisthesis, Spondylolysis, Fracture (including dislocation or subluxation), Spinal stenosis, Deformities (i.e., scoliosis, kyphosis, lordosis), Tumor, Pseudarthrosis, Revision of previous surgery.

The golden gate™ anterior plate system is used for the surgical stabilization and fixation of the thoracolumbar spine to provide a suitable environment for fusion to occur. The fixation components of the system include plates, screws and connectors (hex nuts and inlays). These are available in a variety of sizes and lengths to accommodate differing patient anatomy.

The provided text describes a 510(k) premarket notification for a medical device called the "golden gate™ System," a spinal intervertebral body fixation orthosis. The notification focuses on establishing substantial equivalence to previously cleared predicate devices through performance data, specifically mechanical testing.

Here's an analysis of the acceptance criteria and study information based on your request:

1. Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance criteria (e.g., minimum load bearing capacity in Newtons, or maximum displacement in millimeters). Instead, it relies on a comparative standard: performing as well as or better than the predicate devices when tested against the ASTM F1717 standard. This is a common approach for 510(k) submissions demonstrating substantial equivalence.

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

• Sample Size: The document does not specify a numerical sample size for the "worst case golden gate™ construct" tested. It refers to a "worst case" construct, implying that representative configurations of the device were tested. For mechanical testing, this typically involves a limited number of samples for each configuration to demonstrate compliance with a standard.
• Data Provenance: The study was a prospective mechanical laboratory study. The document does not provide details on the country of origin of the data beyond the sponsor being a German company (ulrich GmbH & Co. KG) with a US subsidiary (ulrich medical USA, Inc.). The testing was performed in accordance with ASTM F1717, an international standard.

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

This section is not applicable to this submission. The device is a mechanical implant, and its performance is evaluated through objective mechanical testing against a recognized standard (ASTM F1717), not through subjective interpretation by human experts or clinical ground truth.

4. Adjudication Method for the Test Set

This section is not applicable. The "test set" in this context refers to the physical devices undergoing mechanical stress tests. There is no human adjudication involved in interpreting these objective mechanical measurements.

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

This section is not applicable. An MRMC study is relevant for diagnostic devices or AI systems where human reader performance is being evaluated or compared. This submission pertains to a surgical implant, and its effectiveness is determined by mechanical stability and successful fusion, not diagnostic accuracy.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This section is not applicable. The "golden gate™ System" is a physical medical device (spinal implant), not a software algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective mechanical test results directly measured during the tests (e.g., load-to-failure, displacement, fatigue cycles) compared against the benchmark performance of predicate devices as per the ASTM F1717 standard.

8. Sample Size for the Training Set

This section is not applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set."

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

This section is not applicable, as there is no training set for this device.

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This anterolateral / anterior system consists of several vertebral screws, locking nuts, spine plates and rods. The points of attachment are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T1-L5). This system is intended to provide stabilization during the development of a solid spinal fusion. When used as an anterolateral / anterior spine plate and rod system, the MACST Modular Anterior Construct System is indicated for patients with:

• Degenerative disk disease defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies
• Spondylolisthesis ●
• Spondylolysis .
• Fracture .
• Spinal stenosis .
• Deformities (i.e., scoliosis, kyphosis, whether neuromuscular or related . to deficient posterior elements)
• Tumors (neoplastic disease) .
• Pseudarthrosis .
• Revision of previous surgery .

The MACST Polyaxial Screw and Thoracic Line is an extension of the existing MACSTL implant system, cleared through 510(k) K002824 on May 8, 2001. The extension consists of a larger Polyaxial screw, as well as, a shorter Polyaxial screw for the Thoracic spine. The MACST Polyaxial screw with the larger diameter (10mm) is also designed to work as a rescue screw in poor bone quality.

The provided text is a 510(k) summary for a medical device called the MACST Modular Anterior Construct System, a spinal stabilization system. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than robust clinical or performance studies with acceptance criteria for a new device.

Therefore, many of the requested details about acceptance criteria, specific studies, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory document.

However, I can extract the available information and indicate where data is not provided or not applicable.

Here's the breakdown 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

• Sample Size (Test Set): Not applicable. No specific test set for performance evaluation is described as this is a substantial equivalence submission relying on prior device data and standard compliance.
• Data Provenance: Not applicable. No clinical or comparative performance data from human or lab studies of the new device is presented. The submission focuses on design equivalence and material compliance.

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

• Not applicable. No ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set

• Not applicable. No adjudication method for a test set is described.

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

• No. An MRMC study was not done, as this is a spinal implant, not an imaging or diagnostic device typically requiring reader studies.

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

• Not applicable. This is a physical medical device (spinal implant), not a software algorithm.

7. The Type of Ground Truth Used

• Not applicable. The submission does not describe a study involving "ground truth" as would be relevant for diagnostic or AI-based devices. The "truth" here is the device's adherence to design specifications and material properties, which are generally demonstrated through bench testing or material certifications, not clinical "ground truth" derived from patient outcomes or expert consensus for diagnosis.

8. The Sample Size for the Training Set

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

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

• Not applicable. As above, this is a physical medical device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

Based on the provided 510(k) summary, the "study" demonstrating the device meets acceptance criteria is a declaration of substantial equivalence to predicate devices and conformance to applicable ASTM and ISO standards.

The key points are:

• Reliance on Predicate Devices: The MACST Polyaxial Screw and Thoracic Line is presented as an extension of the existing MACST implant system (K002824) and is deemed substantially equivalent to it and other predicate devices (K011556, K990959, K002371). This implies that if the predicate devices meet performance and safety criteria, the new device with similar design and materials also meets them.
• Standards Conformance: The document states, "The new MACST System conforms to applicable ASTM and ISO standards." This indicates that the device has undergone testing (or its materials/design are known to comply) with recognized industry standards related to spinal implants, likely covering aspects like mechanical strength, fatigue, material biocompatibility, and sterilization. However, specific results from these tests are not included in this summary document. These standards themselves define the acceptance criteria for various physical and mechanical properties.

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This anterolateral/anterior system consists of several vertebral screws, locking nuts, spine plates and rods. The points of attachment are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T3-L5). This system is intended to provide stabilization during the development of a solid spinal fusion. When used as an anterolateral/anterior spine plate and rod system, the macs " HMA Anterior Spinal Stabilization System is indicated for patients with:

• . Degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
• Spondylolisthesis ●
• Spondylolysis
• . Fracture
• . Spinal stenosis
• Deformities (i.e., scoliosis, kyphosis, lordosis, whether . neuromuscular or related to deficient posterior elements)
• . Tumors (neoplastic disease)
• Pseudarthrosis
• Failed previous fusion surgery ●

The MACS 1 HMA Anterior Spinal Stabilization System includes implantable metallic plates, rods, clamps, locking nuts and screws. The components are used in various combinations to form a construct for use during anterior spinal fusion surgery. The MACS" modular anterior construct system (K002824), which was cleared on May 8, 2001, consists of the twin screws, where as the MAC™ HMA Anterior Spinal Stabilization System consists of the HMA Polyaxial and Monoaxial Screws. Both of these systems are considered a part of each other. The stabilization plates, connection rods, fixation nut, locking screw, bone graft clamp and screw have been cleared under the MACS" modular anterior construct system (K002824).

Here's an analysis of the provided text regarding the acceptance criteria and study for the MACS™ HMA Anterior Spinal Stabilization System:

This device is an anterior spinal stabilization system, a physical implant. The evaluation process for such devices differs significantly from software-based medical devices (like AI algorithms for image analysis) where performance metrics like sensitivity, specificity, and AUC are common. For implantable mechanical devices, the "acceptance criteria" and "study" revolve around mechanical integrity and biocompatibility, often demonstrated through laboratory testing and comparison to predicate devices, rather than clinical trials with human subjects focused on diagnostic accuracy.

Therefore, many of the requested points are not applicable to this type of device and the information provided in the 510(k) summary.

Acceptance Criteria and Study for MACS™ HMA Anterior Spinal Stabilization System

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document mentions "samples of constructs made of titanium" for fatigue testing. It does not specify the exact number of samples used.
• Data Provenance: The testing was laboratory-based mechanical testing, not human clinical data. Thus, "country of origin of the data" and "retrospective or prospective" do not apply in the typical sense. The testing was prospective in the sense that it was performed specifically for this submission.

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

• This question is not applicable as the "test set" involves mechanical components (spinal implants) and not diagnostic data requiring expert interpretation. The "ground truth" for mechanical testing is established by engineering standards and measurements, not by human experts.

4. Adjudication Method for the Test Set

• This question is not applicable. Mechanical testing does not involve adjudication by experts in the way clinical diagnostic studies do. The results are objective measurements from laboratory equipment.

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. This is a physical medical device (implant), not an AI diagnostic algorithm. Therefore, no MRMC study, AI assistance, or human reader improvement metrics are relevant.

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

• This question is not applicable. This is a physical medical device (implant), not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on engineering standards and direct physical measurements (e.g., of load cycles for fatigue, stiffness, and strength) in a laboratory setting, as per applicable ASTM and ISO standards (e.g., ASTM F-1717-96 for the predicate device).

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" in the context of mechanical device testing for a 510(k) submission.

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

• This question is not applicable. There is no "training set" or corresponding "ground truth" in the context of mechanical device testing for a 510(k) submission.

Summary of the Study:
The study performed was a laboratory-based mechanical fatigue test on "worst case" configurations of the MACS™ HMA Anterior Spinal Stabilization System constructs made of titanium. The purpose was to demonstrate the mechanical integrity and fatigue life of the device. The specific results of this testing are referenced as being available in Section IV and Appendix I of the full submission, but not summarized numerically in the provided text. The device's conformance to applicable ASTM and ISO standards is also stated, implying that its mechanical properties (stiffness, strength, fatigue life) meet recognized industry benchmarks that were likely used as performance acceptance criteria. The claim of "substantial equivalence" to predicate devices (like the K-Centrum Anterior Spinal Fixation System, which also underwent ASTM F-1717-96 testing) further supports that similar mechanical performance criteria and testing methodologies were applied.

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