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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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When intended to promote fusion of the cervical spine and the thoracic spine, (CI-T3), the NexLink Spinal Fixation System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

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

The Nex-Link Spinal Fixation System is intended for fixation to, and stabilization of, the cervicothoracic spine (C1-T3). The system consists of a series of longitudinal members, anchors, transverse connectors, and instruments for inserting and securing the implants.

The subject devices are the result of design modifications made to previously existing Abbott Spine implants intended for use in the posterior spine. The subject devices share the same intended use and fundamental scientific technology as the predicates.

Here's an analysis of the provided text regarding the Koro634 device, focusing on acceptance criteria and supporting studies:

Based on the provided document (KORO634, Nex-Link Spinal Fixation System), it appears this submission is for a 510(k) premarket notification of intent to market, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical effectiveness data.

Therefore, the typical structure for reporting acceptance criteria and a study proving device performance (especially for AI/standalone device cases) is not fully applicable here. However, I can extract the relevant information regarding performance and the type of evidence provided.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the format one might expect for a new performance study. Instead, the "acceptance" for this 510(k) relies on demonstrating substantial equivalence to a predicate device. The performance data presented is focused on non-clinical (bench) testing to support this substantial equivalence.

Study Details (Based on the provided text)

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

   • Sample Size: Not applicable. The document refers to "Laboratory and bench testing results" but does not specify sample sizes for these tests (e.g., number of implants tested for fatigue, static bending, etc.).
   • Data Provenance: Not specified. It's safe to assume these were conducted in a laboratory setting, likely in the US where the submitter is located. This would be retrospective in the sense that the tests are performed on manufactured parts, not in vivo clinical data.

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

   • Not applicable. For mechanical bench testing, "ground truth" is typically established by engineering standards (e.g., ASTM, ISO) or internal specifications, not by expert consensus on diagnostic images or clinical outcomes.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods (like 2+1 or 3+1) are relevant for clinical endpoint determination or expert consensus on image interpretation, which are not part of the non-clinical performance data described here.

4. 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 document is for a spinal fixation system (physical implant), not an AI device or imaging software. Therefore, an MRMC study is not relevant.

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

   • No. This is a physical medical device. "Standalone" performance as an algorithm is not applicable.

6. The type of ground truth used:

   • The "ground truth" for the non-clinical performance data would be engineering specifications and established mechanical testing standards (e.g., strength, stiffness, fatigue life). The results of these bench tests are compared against the predicate device's known performance or established industry standards to demonstrate equivalence.

7. The sample size for the training set:

   • Not applicable. This device is a physical implant, not an AI algorithm requiring a training set.

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

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

Summary of Clinical Data (or lack thereof):

The document explicitly states: "Clinical data and conclusions were not needed for this submission." This further emphasizes that the basis for approval (substantial equivalence) rests solely on the non-clinical, laboratory, and bench testing, rather than human clinical trials or performance data.

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