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The GII spinal fixation system when used as a pedicle screw system in the non-cervical posterior spine, the GII spinal fixation system is to be used in skeletally mature patients as an adjunct to fusion using autograft and/or allograft for one or more of the following:

(1) Degenerative or severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar/first sacral (L5-S1) joint with objective evidence of neurologic impairment,

(2) Fracture,

(3) Dislocation,

(4) Scoliosis,

(5) Kyphosis,

(6) Spinal tumor, and/or

(7) Failed previous fusion (pseudoarthrosis).

The GII spinal fixation system when used as a hook and sacral/iliac screw fixation system in the non-cervical posterior spine, the GII spinal fixation system is to be used in skeletally mature patients as an adjunct to fusion using autograft and/or allograft for one or more of the following:

(1) Degenerative spondylolisthesis with objective evidence of neurologic impairment,

(2) Fracture,

(3) Dislocation,

(4) Scoliosis,

(5) Kyphosis,

(7) Spinal tumor, and/or

(8) Failed previous fusion (pseudoarthrosis).

The new GII-Ti-Poly-Axial Screw is intended to be used with the existing components, nuts, washers, cross-links and instrumentation as currently provided with the cleared GII Spinal Fixation System. The previously cleared indications for use of the GII Spinal Fixation System are unchanged.

Acceptance Criteria and Device Performance Study for GII-Ti-Poly-Axial Screw

This document describes the acceptance criteria and the study that proves the GII-Ti-Poly-Axial Screw meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states, "Samples were tested according to accepted engineering and scientific principals." However, it does not provide specific details on:

• The exact sample size used for the mechanical testing of the GII-Ti-Poly-Axial Screw.
• The data provenance (e.g., country of origin, retrospective or prospective nature). Given the nature of a mechanical device test, it is highly likely that the testing was performed in a laboratory setting, likely in Switzerland or at a contract testing facility, and therefore prospective in nature.

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

For a mechanical device like a spinal screw, "ground truth" in the context of clinical outcomes or expert consensus on images is not directly applicable. The "ground truth" here is established by engineering standards and validated testing methodologies to confirm mechanical equivalence. The document does not specify the number or qualifications of experts involved in defining these engineering standards or conducting the tests. It broadly states, "Testing is complete. Samples were tested according to accepted engineering and scientific principals."

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are relevant for studies involving human interpretation (e.g., image reading). Since this study involves mechanical testing of a device's performance against established engineering standards, an adjudication method is not applicable in the traditional sense. The equivalence is demonstrated through objective mechanical measurements and data analysis.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is designed to assess the impact of a device or AI on human reader performance, typically in diagnostic imaging. This type of study was not performed for the GII-Ti-Poly-Axial Screw, as it is a mechanical implant and not an imaging or diagnostic AI device. Therefore, there is no effect size for human reader improvement with or without AI assistance.

6. Standalone Performance Study (Algorithm Only)

A standalone performance study (algorithm only) is relevant for AI/software devices. Since the GII-Ti-Poly-Axial Screw is a physical medical implant, a standalone performance study is not applicable in this context. Its "performance" is demonstrated through physical and mechanical testing, not algorithmic output.

7. Type of Ground Truth Used

The ground truth used for this device is based on established engineering standards and validated mechanical testing protocols. The performance of the new GII-Ti-Poly-Axial Screw is compared directly against the performance characteristics of previously cleared predicate devices (K980852, K032604, K051089) within the GII Spinal Fixation System. This includes characteristics like design, material composition, and mechanical properties determined through testing.

8. Sample Size for the Training Set

For a mechanical device undergoing performance testing for substantial equivalence, a "training set" as understood in machine learning is not applicable. The device is not learning from data; its physical properties are being tested. If "training set" were to broadly refer to the predicate devices and their established performance data that serve as a benchmark, the document references several existing screw components from the GII Spinal Fixation System (K980852, K032604, K051089). The specific number of individual units of these predicate devices used to establish their performance is not provided in this summary.

9. How Ground Truth for the Training Set Was Established

Again, a "training set" in the AI sense does not apply here. However, if we interpret "ground truth for the training set" as the established performance baseline of the predicate devices, this baseline was established through:

• Prior mechanical testing of the predicate devices according to accepted engineering and scientific principles.
• Regulatory clearance (e.g., via previous 510(k) submissions K980852, K032604, and K051089) which confirmed their safety and effectiveness based on their design, materials, and performance data at the time of their clearance.
• Adherence to recognized standards relevant to spinal implants (though specific standards are not cited in this summary).

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The OstaPek® VBR System are vertebral body (partial or total) replacement devices intended for use in the thoracolumbar spine (T1 - L5) to replace and restore height to a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (fracture or disease). The system is to be used in association with bone graft and supplemental spinal fixation. The supplemental fixation system that is intended is the coLigne, AG, GII Spinal Fixation System.

The implants consist of a system of flattened, cuboid, trapezoida & rectangular shaped implants. The OstaPek® VBR System implants offer substantial variation of size and configuration to better approximate the anatomical variation observed in different vertebral levels and patient anatomy. The devices are manufactured with one or more hollowed out central areas to accommodate bone graft material. The superior and inferior surfaces are manufactured in such a way that a series of lands and grooves are formed in the anterior/posterior direction. The purpose of these lands and grooves is to improve stability and bony fixation once the device is inserted. This device is made from the exact same material as the GII Spinal Fixation System, K051089.

The OstaPek® VBR System is a vertebral body (partial or total) replacement device for the thoracolumbar spine (T1 - L5). It is intended to replace and restore height to a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (fracture or disease). The system is to be used in association with bone graft and supplemental spinal fixation (specifically, the coLigne, AG, GII Spinal Fixation System).

This device falls under the classification § 888.3060, Spinal intervertebral body fixation orthosis, Class II, with product code MQP.

Here's an analysis of the provided information regarding the device's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria or detailed performance results in a table format. Instead, it makes a general statement about testing and equivalence to predicate devices.

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

The document does not specify a sample size for any test set or provide information on data provenance (e.g., country of origin, retrospective or prospective). The "Testing Summary" only generally mentions "fatigue, static and biocompatibility testing." These types of tests typically involve material samples and mechanical setups rather than clinical patient data.

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

This information is not provided in the document. Given that the testing mentioned is primarily mechanical (fatigue, static) and biocompatibility, it's unlikely that clinical expert ground truth was established in the traditional sense for these specific tests.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable given the nature of the described testing (mechanical and biocompatibility).

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

A MRMC comparative effectiveness study was not conducted or reported in this document. The device is a physical implant, not an AI-assisted diagnostic or decision-support tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study in the context of an algorithm or AI was not conducted or reported. The device is a physical implant.

7. Type of Ground Truth Used

The ground truth for the "Testing Summary" would likely be based on engineering standards and specifications for fatigue, static load, and biocompatibility, rather than expert consensus, pathology, or outcomes data. The document states "tested according to accepted engineering and scientific principals." This implies that the performance was compared against established benchmarks or the performance of predicate devices under similar test conditions.

8. Sample Size for the Training Set

An AI training set and its sample size are not applicable as this device is a physical implant and not an AI/algorithm-based product.

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

This information is not applicable as there is no AI training set for this device.

Summary of Device Performance Justification:

The coLigne AG. justifies the OstaPek® VBR System's performance and safety by demonstrating its substantial equivalence to existing predicate devices (Lanx VBR, Concord VBR, Theken LPOD, VBR). This equivalence is asserted in terms of design, material composition, surgical technique, and intended use. The document explicitly states that "fatigue, static and biocompatibility testing is completed... Test results demonstrate that the new implants may be expected to perform in a manner equivalent or superior to the referenced comparison systems." This suggests that the device underwent standard mechanical and biological safety testing, and its performance met or exceeded that of its predicates, though the specific quantitative results are not detailed.

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The GII Spinal Fixation System When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the GII@ Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the GII@ Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar/first sacral (L5-S 1) joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

The GII system is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (7) spinal turnor, and/or (8) failed previous fusion (pseudarthrosis).

The new plates are offered in a series of sizes designated by the number of slots or holes within the plates. The I ho w plates are single slot. The new plates are provided precurved to more closely match the natural lordotic curve of the lumbar spine. Two different curves are offered in each size.

The devices are produced of a polyner matrix of Polyetherketonekctone (PEKEKK) Resins and long fiber carbon filaments.

The new plates are intended to be used with the existing pedicle screws, nuts, washers, cross-links and instrumentation as currently provided with the cleared GII Spinal Fixation System. Because the new material is not a metallic material, precautions against mixing dissimilar metals or of a galvanic/corrosive interaction with the existing implants is eliminated.

The previously cleared indications for use are unchanged.

This document is a 510(k) premarket notification for the GII OstaPek® Plate from COLIGNE AG. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain a detailed study report with acceptance criteria and reported device performance in the way typically expected for an AI/ML device.

This submission is for a medical implant (spinal fixation system), not a software/AI device that would involve performance metrics like sensitivity, specificity, or accuracy based on human interpretation or algorithm output. The "acceptance criteria" here refer to compliance with material, mechanical, and biocompatibility standards, which are physical tests rather than clinical study results comparing algorithm performance.

Therefore, many of the requested points are not applicable or cannot be extracted from this type of regulatory document. I will answer the applicable points based on the information provided.

1. Table of acceptance criteria and the reported device performance

For this medical implant, acceptance criteria and performance are related to physical and biological properties.

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

• Test Set Sample Size: Not explicitly stated for mechanical and biocompatibility testing. These tests typically involve a specific number of samples per test type according to the relevant standards (e.g., n=5 or n=10 per test for fatigue).
• Data Provenance (Country of Origin, Retrospective/Prospective): Not applicable in the context of device performance testing. The company is based in Zurich, Switzerland, and the submission is to the US FDA. The testing would have been conducted in a laboratory setting, not on patient data.

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

• Number of Experts & Qualifications: Not applicable. Ground truth for mechanical and biocompatibility testing is established through standardized laboratory methods and measurements, not by human expert consensus or clinical interpretation.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Standardized lab tests have defined pass/fail criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• MRMC Study: No. This is not a diagnostic device or an AI/ML software; it is a physical implant. Therefore, an MRMC study is not relevant.

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

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• Type of Ground Truth: For this device, ground truth is established through:
  • Validated Physical Measurements: Mechanical properties (e.g., strength, fatigue life) are measured using calibrated testing equipment against established engineering standards (e.g., ASTM standards).
  • Biocompatibility Testing: Assessed through in-vitro and in-vivo biological response tests following ISO standards.
  • Material Characterization: Chemical composition and properties verified against material specifications.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device is not an AI/ML model that requires a training set. The "development" would involve engineering design and prototyping, not data training.

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

• Ground Truth for Training Set: Not applicable. See point 8.

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When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the GII Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the GII Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S 1) joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

The GII Spinal system is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).

The GII Spinal Fixation System implants are intended to be used as temporary construct that assists normal healing and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures, attaching longitudinal member to the spine by means of spinal anchors. The GII Spinal System is both a rod-based systems and a plate-based system designed on the same pedicular screw foundation. The longitudinal members consist of spinal rods or plates. The spinal anchors consist of pedicular screws. Transverse connectors are also included in the system to provide rigidity to the construct. Optional construct spacers are available to allow better seating of the plates or connectors onto the pedicular screws as well as poliaxiality.

The provided text describes a medical device, the GII Spinal Fixation System, and its regulatory clearance (510(k)). However, it does not contain information about acceptance criteria or a study demonstrating the device meets such criteria in the context of typical AI/software performance evaluation.

Instead, the document focuses on regulatory equivalence to predicate devices, device description, and indications for use. The "Performance Characteristics" section explicitly states: "Static and Fatigue tests results were supplied to substantiate significant equivalence with previously cleared components." This indicates an engineering-based performance assessment for mechanical equivalence, not a clinical or AI-driven performance study comparing outputs to a ground truth or human readers.

Therefore, I cannot provide the requested information from the provided text for most of the points.

Here's what I can extract and what is missing:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in terms of clinical or AI performance metrics. The underlying acceptance criteria for this type of device (spinal fixation system) would typically relate to mechanical strength, fatigue life, biocompatibility, and sterilization, demonstrating equivalence to predicate devices.
• Reported Device Performance: "Static and Fatigue tests results were supplied to substantiate significant equivalence with previously cleared components." No specific numerical performance values (e.g., accuracy, sensitivity, specificity, or specific mechanical thresholds) are provided in this summary.

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

• Not applicable / Not present. The document describes mechanical tests, not a clinical performance study with a 'test set' of data in the AI sense.

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 / Not present. Ground truth establishment by experts is relevant for clinical or diagnostic AI systems, not for a spinal fixation system's mechanical performance.

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

• Not applicable / Not present.

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 / Not present. This device is a physical implant, not an AI diagnostic tool that would assist human readers.

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

• Not applicable / Not present.

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

• Not applicable / Not present. For mechanical testing, the "ground truth" would be established engineering standards (e.g., ASTM or ISO standards for spinal implants) and direct measurement of mechanical properties, rather than clinical ground truth types.

8. The sample size for the training set

• Not applicable / Not present. This device is not an AI algorithm.

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

• Not applicable / Not present.

In summary, the provided document is a 510(k) summary for a physical medical device (spinal fixation system) and discusses its regulatory clearance based on substantial equivalence to predicate devices, primarily substantiated by mechanical performance tests (Static and Fatigue tests). It does not contain the characteristics of a study for evaluating AI or software performance as requested in your prompt.

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