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The Instinct Java spinal fixation system is designed for spinal fixation procedures in skeletally mature patients performed through a posterior approach.

The Instinct Java spinal fixation system is indicated for the temporary realignment and stabilization of one or more intervertebral segments from the thoracic spine to the sacrum until bony fusion is obtained.

The Instinct Java spinal fixation system is indicated to achieve bony fusion via osteosynthesis at thoracic. Iumbar and/or lumbosacral levels of the spine in documented cases of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondvlolisthesis, fracture, spinal stenosis, kyphotic or lordotic spinal deformities, scoliosis, tumor and pseudoarthrosis, or for revision of a failed previous fusion.

The Instinct Java System is a temporary implant system used to correct spinal deformity in skeletally mature patients and facilitate the biological process of spinal fusion. This system is intended for non-cervical posterior use in the thoracic, lumbar and sacral areas of the spine. The Instinct Java spinal fixation system is indicated to achieve bony fusion via osteosynthesis at thoracic, lumbar and/or lumbosacral levels of the spine in documented cases of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, spinal stenosis, kyphotic or lordotic spinal deformities, scoliosis, tumor and pseudoarthrosis or for revision of a failed previous fusion.

The system consists of implants and instruments. The implants consist of monoaxial and polvaxial pedicle screws of varying diameters and lengths, blockers, pre-contoured and straight Titanium alloy rods, transverse connectors of varying lengths, hooks, autostable hooks and axial and side-by-side connectors. All implants are made of titanium alloy and one commercially pure titanium component within the transverse connectors.

Re-usable surgical instruments are provided to facilitate placement of the implants.

In addition, the Instinct Java System is compatible with the transverse connectors currently cleared for the market as part of the Sequoia Spinal System, identified in K082032. Furthermore, the Instinct Java titanium alloy rods may be connected to the NexLink Band & In-Line Rod Connector, identified in K062505, K060634, K052566, K052247, K031985. The system may also be used in combination with the Zimmer Spine Universal Clamp 5.5mm Ti implants. Axial and side-by-side connectors may be used with Nexlink 4.0 rods and Optima 6.0 rods.

The implants and instruments are provided non-sterile. Instructions for Use are provided that contain validated cleaning and sterilization instructions for the user.

This system is intended to provide stabilization until a solid spinal fusion develops. The system may then be removed, per the surgeon's discretion. This decision should be made based on the risk/benefit evaluation for each patient.

This document is a 510(k) summary for the Zimmer Spine Instinct™ Java® System, a spinal fixation system. It describes the device, its intended use, and its comparison to predicate devices for demonstrating substantial equivalence. The information provided heavily focuses on the mechanical and material equivalence of the device components rather than software-driven performance or AI.

Therefore, the requested information regarding acceptance criteria and studies related to an AI device's performance cannot be extracted from this document. The document describes a traditional medical device (spinal implant) and its regulatory clearance process based on substantial equivalence to existing devices, which typically involves mechanical testing and material compatibility, not studies of AI performance metrics like sensitivity, specificity, or reader studies.

No information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI device is present in the provided text.

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The Instinct Java spinal fixation system is designed for spinal fixation procedures in skeletally mature patients performed through a posterior approach. The Instinct Java spinal fixation system is indicated for the temporary realignment and stabilization of one or more intervertebral segments from the thoracic spine to the sacrum until bony fusion is obtained.

The Instinct Java spinal fixation system is indicated to achieve bony fusion via osteosynthesis at thoracic, lumbar and/or lumbosacral levels of the spine in documented cases of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, spinal stenosis, kyphotic or lordotic spinal deformities, scoliosis, tumor and pseudoarthrosis, or for revision of a failed previous fusion.

The Instinct Java System is a temporary implant system used to correct spinal deformity in skeletally mature patients and facilitate the biological process of spinal fusion. This system is intended for non-cervical posterior use in the thoracic, lumbar and sacral areas of the spine. The system consists of implants and instruments. The implants consist of monoaxial and polyaxial pedicle screws of varying diameters and lengths, iliac screws, reduction screws, open and closed offset connectors, blockers, pre-contoured and straight Titanium alloy and straight cobalt chromium rods, and transverse connectors of varying lengths. All implants are made of titanium alloy except for the addition of CoCrMo Alloy rods and one commercially pure titanium component within the transverse connectors. Re-usable surgical instruments are provided to facilitate placement of the implants.

The provided document is a 510(k) summary for the Zimmer Spine Instinct™ Java® System. It focuses on the substantial equivalence to predicate devices and does not describe a study involving patient data, clinical outcomes, or human readers for diagnostic purposes with AI assistance. Instead, it relies on engineering testing to demonstrate equivalence. Therefore, some of the requested information, such as expert ground truth, adjudication methods, MRMC studies, standalone performance with patient data, and training set information, is not applicable or available in this document.

Here's the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

This document does not describe a test set involving patient data. The evaluation was based on engineering bench testing of the device components. Therefore, the concept of data provenance (e.g., country of origin, retrospective/prospective) is not applicable in this context. The "sample size" would refer to the number of device components tested, which is not specified but would be in line with the requirements of the ASTM standards.

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 device performance was established through compliance with recognized engineering standards (ASTM F1717-11a and ASTM F1798-97 (2008)) and demonstrated physical characteristics, not expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable, as no human readers or diagnostic interpretations of patient data were involved in establishing the performance of the device.

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

No. This document does not describe a clinical study (MRMC or otherwise) involving human readers or AI assistance. The evaluation focuses on the mechanical and material equivalence of the device to predicate devices through engineering testing.

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

Not applicable. This is not an AI/algorithm-based device in the sense of image analysis or diagnostic decision-making. Its performance is based on mechanical properties and material composition.

7. The Type of Ground Truth Used

The ground truth used was based on engineering standards and physical measurements of the device's mechanical properties, such as axial compression bending, static torsion, gripping capacity, flexion-extension moment, and AP(x) static pullout, as defined by ASTM F1717-11a and ASTM F1798-97 (2008).

8. The Sample Size for the Training Set

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

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

Not applicable, as there is no training set for this type of device evaluation.

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The Instinct Java spinal fixation system is designed for spinal fixation procedures in skeletally mature patients performed through a posterior approach. The Instinct Java spinal fixation system is indicated for the temporary realignment and stabilization of one or more intervertebral segments from the thoracic spine to the sacrum until bony fusion is obtained.

The Instinct Java spinal fixation system is indicated to achieve bony fusion via osteosynthesis at thoracic, lumbar and/or lumbosacral levels of the spine in documented cases of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, spinal stenosis, kyphotic or lordotic spinal deformities, scoliosis, tumor and pseudoarthrosis, or for revision of a failed previous fusion.

The Instinct Java System is a temporary implant system used to correct spinal deformity in skeletally mature patients and facilitate the biological process of spinal fusion. This system is intended for non-cervical posterior use in the thoracic, lumbar and sacral areas of the spine. The Instinct Java spinal fixation system is indicated to achieve bony fusion via osteosynthesis at thoracic, lumbar and/or lumbosacral levels of the spine in documented cases of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, spinal stenosis, kyphotic or lordotic spinal deformities, scoliosis, tumor and pseudoarthrosis or for revision of a failed previous fusion.

The system consists of implants and instruments. The implants consist of monoaxial and polvaxial pedicle screws of varying diameters and lengths, blockers, pre-contoured and straight rods, and transverse connectors of varying lengths. All implants are made of titanium alloy, with the exception of one commercially pure titanium component within the transverse connectors.

Re-usable surgical instruments are provided to facilitate placement of the implants.

In addition, the Instinct Java System is compatible with the transverse connectors currently cleared for the market as part of the Sequoia Spinal System, identified in K082032. Furthermore, the Instinct Java may be connected to the NexLink Band & In-Line Rod Connector, identified in K062505, K060634, K052566, K052247, K031985.

The implants and instruments are provided non-sterile. Instructions for Use are provided that contain validated cleaning and sterilization instructions for the user.

This system is intended to provide stabilization until a solid spinal fusion develops. The system may then be removed, per the surgeon's discretion. This decision should be made based on the risk/benefit ratio for each patient.

The subject of this 510(k) is the addition of screw and rod lengths, an alternative thread design on the pedicle screw head, a new driver, and new instrument containers and implant caddies.

The provided text describes a 510(k) premarket notification for a medical device, specifically the Zimmer Spine Instinct™ Java® System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a study in the context of an AI/ML device.

Therefore, the following information cannot be extracted from the provided text:

• Acceptance Criteria and Reported Device Performance (Table): The document does not define specific performance metrics or acceptance criteria for a new device's function, nor does it report the device's performance against such criteria. It focuses on the equivalence of mechanical properties to existing devices.
• Sample size for the test set and data provenance: No test set information is provided.
• Number of experts and qualifications for ground truth: No ground truth establishment is described.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

What the document does provide in relation to "acceptance criteria" and "study":

The document states that substantial equivalence was confirmed through mechanical testing, which served as the "study" to demonstrate that the new device meets the performance characteristics of its predicates.

Acceptance Criteria (Implicit) and Reported "Device Performance":

Explanation:

The "acceptance criteria" in this context are the standards and requirements set forth by the specified ASTM standards and the need for validated cleaning/sterilization. The "reported device performance" is simply that the device conforms to these standards and that the instructions were validated. This is not a quantitative reporting of performance metrics but rather a qualitative statement of compliance.

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The Instinct Java spinal fixation system is designed for spinal fixation procedures in skeletally mature patients performed through a posterior approach. The Instinct Java spinal fixation system is indicated for the temporary realignment and stabilization of one or more intervertebral segments from the thoracic spine to the sacrum until bony fusion is obtained.

The Instinct Java spinal fixation system is indicated to achieve bony fusion via osteosynthesis at thoracic, lumbar and/or lumbosacral levels of the spine in documented cases of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, spinal stenosis, kyphotic or lordotic spinal deformities, scoliosis, tumor and pseudoarthrosis, or for revision of a failed previous fusion.

The Instinct Java System is a temporary implant system used to correct spinal deformity in skeletally mature patients and facilitate the biological process of spinal fusion. This system is intended for non-cervical posterior use in the thoracic, lumbar and sacral areas of the spine. The Instinct Java spinal fixation system is indicated to achieve bony fusion via osteosynthesis at thoracic, lumbar and/or lumbosacral levels of the spine in documented cases of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, spinal stenosis, kyphotic or lordotic spinal deformities, scoliosis, tumor and pseudoarthrosis or for revision of a failed previous fusion.

The system consists of implants and instruments. The implants consist of monoaxial and polyaxial screws of varying diameters and lengths, blockers, pre-contoured and straight rods, and transverse connectors of varying lengths. All implants are made of titanium alloy, with the exception of one commercially pure titanium component within the transverse connectors.

Re-usable surgical instruments are provided to facilitate placement of the implants.

In addition, the Instinct Java System is compatible with the transverse connectors currently in the market as part of the Sequoia Spinal System, identified in K082032. Furthermore, the Instinct Java may be connected to the NexLink Band & In-Line Rod Connector, identified in K062505, K060634, K052566, K052247, K031985.

The implants and instruments are provided non-sterile. Instructions for Use are provided that contain validated cleaning and sterilization instructions for the user.

This system is intended to provide stabilization until a solid spinal fusion develops. The system may then be removed, per the surgeon's discretion.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes bench testing for the Instinct Java System, not a clinical study involving a "test set" in the context of diagnostic AI or clinical trials. Therefore, information about a test set sample size, country of origin, or retrospective/prospective data is not applicable. The testing was performed on the device components themselves.

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

This information is not applicable as the study involves bench testing of a physical medical device (spinal fixation system), not an AI algorithm requiring expert-established ground truth from clinical data.

4. Adjudication Method for the Test Set

This is not applicable for a bench testing study of a physical medical device.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes bench testing of a physical medical device, not an AI system.

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

No, a standalone algorithm performance study was not done. The device is a physical spinal fixation system, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance was established through adherence to specified ASTM standards (ASTM F-1717:2004) for mechanical performance (static, dynamic compression bending, static torsion) and validated cleaning and sterilization protocols for the non-sterile components.

8. The Sample Size for the Training Set

This information is not applicable. The document describes bench testing of a physical medical device, not an AI system requiring a training set.

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

This information is not applicable for a physical medical device. The "ground truth" for the device's design and manufacturing is adherence to engineering specifications and regulatory standards.

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The LEXUS Cervical Fixation System is indicated for the following:

• DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and . radiographic studies)
• . Spondylolisthesis
• . Spinal stenosis
• . Fracture/dislocation
• . Failed previous fusion
• . ' Tumors

The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.

Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1 -T3) spine.

The pedicle screws are limited to placement in T1 -T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

The LEXUS Cervical Spinal Fixation System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of polyaxial screws, rods, set screws, and hooks.

Materials: All products are made of titanium alloy (Ti-6Al-4V ELI/ in conformance with ASTM F136) approved for medical use.

The LEXUS Cervical Fixation System's performance was evaluated through mechanical testing according to ASTM F1717 standards, which outlines methods for static and dynamic tests of spinal implant constructs in a vertebral body model.

1. Acceptance Criteria and Reported Device Performance:

Note: The provided document states that the device was "tested according to the ASTM F1717", and that it is "considered substantially equivalent to other legally marketed devices" and "expected to be equivalent in safety and effectiveness." This implies that the device met the performance requirements specified in the ASTM F1717 standard, which serve as the acceptance criteria for mechanical performance for such spinal fixation systems. Specific numerical acceptance criteria and actual reported performance values are not detailed in this summary.

2. Sample Size and Data Provenance for Test Set:

• Sample Size: Not specified in the provided document. As this is mechanical testing, the "sample size" would refer to the number of physical devices or constructs tested for each mechanical test.
• Data Provenance: The testing was conducted by or for L&K BIOMED Co., Ltd., based in the Republic of Korea. The document does not specify the location of the testing laboratory (e.g., in-house, third-party, country). This is a technical performance study, not a clinical study involving human patients.

3. Number of Experts and Qualifications for Ground Truth of Test Set:

• Not applicable. This study focuses on the mechanical performance of the device, not a diagnostic or prognostic assessment requiring expert medical opinion for ground truth.

4. Adjudication Method for Test Set:

• Not applicable. This is a mechanical engineering test, not a clinical study requiring adjudication of expert opinions.

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

• Not applicable. This is a submission for a physical medical device (spinal fixation system) and its mechanical performance, not an AI or imaging-based diagnostic device. Therefore, no MRMC study was performed.

6. Standalone Performance Study:

• Yes, a standalone study was performed in the sense that the device's mechanical performance was tested independently of its clinical implantation or interaction with human readers. The tests (Static/Dynamic Axial Compression, Static Tension, Static Torsion) evaluated the device itself.

7. Type of Ground Truth Used:

• The "ground truth" for this study is defined by the objective physical and mechanical properties and behaviors of the device as measured against the industry standard (ASTM F1717). This includes parameters like strength, stiffness, and fatigue life under specified loading conditions.

8. Sample Size for Training Set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

9. How Ground Truth for Training Set was Established:

• Not applicable. As this is not a machine learning or AI device, there is no training set and therefore no ground truth establishment for a training set.

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When intended to promote fusion of the cervical spine and the thoracic spine (C1 - T3), the S4 Spinal System is intended for the following;

• DDD (Neck pain pf discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Spinal stenosis
• Fracture/dislocation
• Failed previous fusion
• Tumors

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1 -- T3) spine.

The use of the polyaxial screws is limited to placement in T1 - T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

The S4 Spinal System consists of 3.5mm rods in 6 lengths, thin and thick lamina hooks, 3.5 The 64 Opinal System of various lengths and a cross connector. The S4 Spinal System is manufactured from Titanium forged alloy Ti6Al4V.

The S4 Spinal System is a medical device for spinal fusion. The 510(k) summary provided does not contain explicit acceptance criteria or the details of a study proving the device meets said criteria in the format requested. Instead, it indicates that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices - The Basic Elements' was completed where applicable."

Therefore, I cannot provide a direct answer to your request in the specified format from the provided text excerpt. The document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a detailed performance study with acceptance criteria.

However, I can extract information related to what aspects were considered for the 510(k) clearance, which implicitly implies that the device is expected to meet the performance standards set by the predicate devices.

Here's an analysis based on the provided text:

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

This information is not explicitly provided in the given text. The document states that "All required testing per [guidance document] was completed where applicable." This implies that standard tests relevant to orthopedic devices were performed, but the specific acceptance criteria for each test and the numerical performance results are not detailed.

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

This information is not provided in the given text. The document refers to "testing" but does not specify the sample sizes or the nature of the data (e.g., in vitro, in vivo, clinical trial, retrospective, prospective, country of origin).

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

This information is not provided in the given text. Since the document does not describe a clinical study with a "test set" requiring ground truth established by experts, this detail is absent.

4. Adjudication method for the test set:

This information is not provided in the given text. As there is no described clinical study, an adjudication method for a test set is not 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:

This information is not provided in the given text. The S4 Spinal System is a mechanical implant, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant to this device and is not mentioned.

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

This information is not provided in the given text. As the device is a spinal implant, the concept of an "algorithm only" or "human-in-the-loop" performance study does not apply.

7. The type of ground truth used:

This information is not explicitly provided in the given text. Given that the clearance is based on substantial equivalence to predicate devices and adherence to general guidance for orthopedic devices, the "ground truth" would likely be derived from established biomechanical testing standards, material property tests, and the clinical history and performance of the predicate devices.

8. The sample size for the training set:

This information is not provided in the given text. The concept of a "training set" is typically associated with machine learning or AI algorithm development, which is not applicable to this device as described.

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

This information is not provided in the given text, for the same reason as point 8.

Summary of available information regarding performance:

• Performance Data: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices - The Basic Elements' were done where applicable." This indicates that the device underwent mechanical and material testing to demonstrate its safety and effectiveness, consistent with regulatory requirements for similar orthopedic implants.
• Substantial Equivalence: The S4 Spinal System is deemed substantially equivalent in design to the following predicate devices:
  • Nex-Link Spinal System (K031985)
  • Vertex Spinal System (K042789, 042524)
  • Summit Spinal System (K013222, K030103, K041203)

This means that the S4 Spinal System's performance characteristics are considered comparable to these cleared devices, implying that it meets similar performance expectations and safety profiles. The specific "acceptance criteria" for the S4 Spinal System would therefore align with those established for its predicate devices and the relevant FDA guidance.

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