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This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of: 1. Endoscopic marking. - 2. Hemostasis for - · Mucosal/submucosal defects less than 3 cm, - · Bleeding ulcers, - · Arteries less than 2 mm. - · Polyps less than 1.5 cm in diameter, - · Diverticula in the colon, and - · Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection, - 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel, 4. As a supplementary method for closure of GI tract luminal perforations less than 20 mm that can be treated conservatively. 5. Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus in patients with fistulas, leaks, perforations, or disunion.

The Instinct Plus Endoscopic Clipping Device is a sterile, single use metallic clip used for tissue approximation and hemostasis in the gastrointestinal tract. The metallic clip is 14.4 mm long and has an opening span of 16 mm. The clip is preloaded on a 230 cm long introducer comprised of a coated coil spring, drive wire and deployment handle. The clip may be deployed to the site of interest using a straight viewing flexible endoscope with a minimum accessory channel of 2.8 mm, or side viewing flexible endoscope with a minimum accessory channel of 4.2 mm. The clip can be rotated for positioning by rotating the handle of the introducer and may be reopened and closed up to five times prior to deployment. The Instinct Plus Endoscopic Clipping Device is supplied sterilized by ethylene oxide gas in a peel-open package and intended for one-time use. The product is packaged with three-year shelf life.

The provided text describes a 510(k) premarket notification for the "Instinct Plus Endoscopic Clipping Device." This is a regulatory submission for a medical device, where the manufacturer demonstrates that their new device is substantially equivalent to a legally marketed predicate device. The information presented is primarily focused on demonstrating this equivalence rather than a full clinical study report on diagnostic accuracy or comparative effectiveness of an AI product.

Therefore, many of the requested items (e.g., sample sizes for training/test sets, number of experts for ground truth, MRMC study results, standalone performance of an AI algorithm, etc.) are not applicable to this type of document, as it concerns a physical medical device (an endoscopic clipping device) and not an AI-based diagnostic tool. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance specifications of the physical device and bench testing results, not a clinical study to establish diagnostic performance.

However, I can extract the relevant information regarding the device's technical specifications and the non-clinical testing performed.

1. Table of Acceptance Criteria and Reported Device Performance

The document focuses on demonstrating substantial equivalence to a predicate device (K192697) by tightening dimensional specifications and performing non-clinical bench testing. The "acceptance criteria" here relate to the device's functional performance during these tests.

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

• Test set sample size: Not explicitly stated as a number of devices or clinical cases. The "test set" here refers to devices used in bench testing.
• Data provenance: The testing was "non-clinical bench testing" and "validation testing" performed by the manufacturer, Cook Medical Inc. This is not clinical data (e.g., country of origin, retrospective/prospective) in the context of human subjects.

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

• Not applicable. This pertains to an AI/diagnostic product that requires expert-annotated ground truth. This document describes a physical medical device and its engineering performance.

4. Adjudication method for the test set

• Not applicable. This pertains to expert review and consensus for AI/diagnostic product ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a physical medical device, not an AI product or a diagnostic tool. No MRMC study was performed.

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

• Not applicable. This is a physical medical device, not an AI algorithm.

7. The type of ground truth used

• Engineering specifications and functional performance criteria. The "ground truth" for this device's performance is whether it meets its design requirements and functional specifications (e.g., consistent clip deployment, strength of components). This is established through engineering and quality control procedures, not expert consensus on medical images or pathology.

8. The sample size for the training set

• Not applicable. This document describes a physical medical device and its engineering performance, not an AI model requiring a training set.

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

• Not applicable. This document describes a physical medical device and its engineering performance.

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This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of

• 1. Endoscopic marking,
• 2. Hemostasis for
  • · Mucosal/submucosal defects less than 3 cm
  • · Bleeding ulcers,
  • · Arteries less than 2 mm,
  • · Polyps less than 1.5 cm in diameter,
  • · Diverticula in the colon, and
  • · Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection,
• 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel,

4. As a supplementary method for closure of GI tract luminal perforations less than 20mm that can be treated conservatively
5. Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus in patients with fistulas, leaks, perforations, or disunion.

The Instinct Plus Endoscopic Clipping Device is a sterile, single use metallic clip used for tissue approximation and hemostasis in the gastrointestinal tract. The metallic clip is 14.4 mm long and has an opening span of 16 mm. The clip is preloaded on a 230 cm long introducer comprised of a coated coil spring, drive wire and deployment handle. The clip may be deployed to the site of interest using a straight viewing flexible endoscope with a minimum accessory channel of 2.8 mm, or side viewing flexible endoscope with a minimum accessory channel of 4.2 mm. The clip can be rotated for positioning by rotating the handle of the introducer and may be reopened and closed up to five times prior to deployment.

The Instinct Plus Endoscopic Clipping Device is supplied sterilized by ethylene oxide gas in a peel-open package and intended for one-time use. The product is packaged with one-year shelf life.

This is a 510(k) premarket notification for the Instinct Plus Endoscopic Clipping Device. The document claims substantial equivalence to two predicate devices: the K151802 Resolution™ 360 Clip and the K132809 Instinct Endoscopic Hemoclip.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists "design input requirements" that performance testing was conducted to meet. These essentially serve as acceptance criteria. However, explicit numerical or categorical acceptance values for each criterion are not provided in the summary. Instead, it generally states that the device "met the design input requirements."

Table: Acceptance Criteria and Reported Device Performance

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

The document is a 510(k) summary and does not provide specific details on the sample sizes used for each performance test. It mentions "performance testing was conducted," but no numbers of devices tested, number of simulated cases, or specific patient data are given. As this filing is for a mechanical device and discusses performance data but does not explicitly mention clinical studies using patient data, it is highly likely that the testing involved lab-based, benchtop, or simulated use testing of the device's physical and functional characteristics. Therefore, there is no mention of retrospective or prospective data or country of origin for a clinical test set.

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

Since the testing described is primarily focused on mechanical and functional performance (e.g., strength, deployment, retention), the concept of "ground truth" established by human experts for diagnostic accuracy studies (like radiologists) is not applicable here. The "ground truth" for these performance tests would be defined by engineering specifications, material properties, and functional benchmarks derived from predicate devices or established standards.

4. Adjudication Method for the Test Set:

Not applicable, as this is primarily a performance and mechanical testing summary, not a study involving human interpretation or diagnostic accuracy where adjudication would be necessary.

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

No, an MRMC study was not done. The document describes performance testing of the device itself, not a comparative effectiveness study involving human readers with and without AI assistance (which is typical for AI/CAD devices).

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

Not applicable. This is not an AI/CAD device.

7. The Type of Ground Truth Used:

For the performance data, the "ground truth" would be established by:

• Engineering Specifications: Pre-defined design limits and tolerances for force, dimensions, durability, etc.
• Material Standards: Compliance with known material properties.
• Predicate Device Performance: Benchmarking against the known performance characteristics of the legally marketed predicate devices.
• Established Test Methods: Adherence to validated laboratory testing protocols.

8. The Sample Size for the Training Set:

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

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

Not applicable. This is not a machine learning or AI device.

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Instinct brand condoms ( Instinct Plain, Instinct Dotted, Instinct Ultrathin) are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Not Found

This document is a 510(k) clearance letter from the FDA for INSTINCT BRAND CONDOMS. It does not contain information about a study with acceptance criteria and device performance metrics in the context of an AI/ML medical device. Therefore, I cannot extract the requested information from the provided text.

Specifically, the document pertains to a traditional medical device (condoms) and its substantial equivalence to previously marketed devices, not an AI/ML-driven device that would involve performance metrics like sensitivity, specificity, or the use of training/test sets, expert adjudication, or MRMC studies.

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This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3 cm in the upper GI tract, bleeding ulcers, arteries less than 2 mm, and polyps less than 1.5 cm in diameter in the GI tract. This device is not intended for the repair of GI tract lumenal perforations.

The Instinct Endoscopic Hemoclip is a sterile, single use device that consists of metal clip that detaches from the introducer to maintain approximation of tissue to achieve hemostasis in the gastrointestinal tract. The device is compatible with endoscopes with a minimum accessory channel of 2.8 mm. The Instinct Endoscopic Hemoclip is 230 cm long. The deployed clip portion of the Instinct Endoscopic Hemoclip is stainless steel and nitinol while the introducer is nylon, stainless steel and nitinol.

The provided text describes a 510(k) summary for the Instinct Endoscopic Hemoclip. This document assesses the substantial equivalence of a new medical device to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not directly available in this document.

However, I can extract information related to the device's performance assessment as presented in the submission.

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

Based on the provided text, specific numerical acceptance criteria are not detailed. The performance assessment focused on demonstrating that the device met "performance requirements" through non-clinical bench testing.

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

The document mentions "non-clinical bench testing." This typically refers to laboratory-based evaluations.

• Sample Size: Not specified.
• Data Provenance: Non-clinical bench testing data. Country of origin not specified (implied to be within the company's testing facilities, likely in the USA where the company is based). The data is generated prospectively during the device development and testing phase.

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)

This information is not applicable to non-clinical bench testing. Ground truth for mechanical performance tests is typically established by engineering specifications and objective measurements, not by expert consensus.

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

This information is not applicable to non-clinical bench testing. Mechanical test results are objective and measured against predefined specifications.

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

An MRMC study is not mentioned. This type of study is typically for evaluating diagnostic imaging devices with human interpretation, not for mechanical devices like a hemostasis clip.

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

This concept is not applicable to a mechanical medical device like a hemoclip. There is no "algorithm only" performance for such a device; its function is mechanical and directly applied by a clinician.

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

The "ground truth" for the non-clinical bench testing would be the pre-defined engineering specifications and measurable performance standards for visual verification and tensile strength.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of mechanical bench testing for a device like this. Machine learning algorithms, which require training sets, are not mentioned.

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

Not applicable, as there is no training set mentioned.

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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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