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The GUARDIAN-SG Inflatable Bone Expander System is intended to the reduction and fixation of fractures and/or creation of a void in cancellous bone in this includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

The GUARDIAN-SG Inflatable Bone Expander System (IBES) is designed to reduce spinal compression fracture and restore sagittal alignment. By creating a space in the vertebral body to facilitate the insertion of bone cement and using cement dispensing plunger, the major benefits of GUARDIAN-SG IBES are the significant reduction in back pain and increase patient`s functional abilities, allow a return to the previous level of activity.

The GUARDIAN-SG IBES components are Inflatable Bone Tamp (balloon catheter, compressor) and accessory kit. And balloon catheter' main components are the shaft, Yhub and the inflatable balloon located at the distal tip and inflatable balloon is covered maximum 0.03g of silicone fluid to enhance lubricity when the balloon catheter is inserted in the cannula. Radiopaque markers located at the distal and proximal end of deflated working surface allow fluoroscopic visualization of the deflated balloon catheter during positioning.

The Balloon catheter, compressor and the accessory kit are supplied sterile and disposable use.

This document is related to a 510(k) premarket notification for the GUARDIAN-SG Inflatable Bone Expander System. It does not contain information about acceptance criteria, device performance, a study proving acceptance criteria, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC comparative effectiveness studies, standalone algorithm performance, or training set details.

The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, materials, design, and use concept. It mentions that "The GUARDIAN-SG Inflatable Bone Expander System met the specifications and performance characteristics" and that "testing included functional, such as balloon compliance, deflation time, insertion / withdraw force and fatigue testing as well as mechanical testing, such as tensile strength." However, it does not provide the specific acceptance criteria for these tests or the detailed results of the tests themselves.

Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, or details about a study proving the device meets acceptance criteria. The provided text does not contain that level of detail.

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The SYNSTER® CERVICAL CAGE are indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The SYNSTER® (ALIF, PLIF, PTLIF and TLIF) CAGE, RHEA® PLIF CAGE and TALON® TLIF CAGE are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The devices are intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE, RHEA® PLIF CAGE and TALON® TLIF CAGE will be offered in various device configurations based on surgical approach and patient anatomy, and consist of:

1. Cervical Interbody Fusion Device (SYNSTER® CERVICAL CAGE), which may be implanted as a single device via an anterior approach.
2. Lumbar Interbody Fusion Device [SYNSTER® (ALIF, PLIF, PTLIF, and TLIF) CAGE, RHEA® PLIF CAGE and TALON® TLIF CAGE], which may be implanted
   As a single device via an Anterior or Anterolateral or Lateral (ALIF) approach;
   Bi-laterally via a posterior (PLIF) approach;
   As a single device via a posterior transforaminal (PTLIF) approach;
   As a single device via a transforaminal (TLIF) approach.

The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE, RHEA® PLIF CAGE and TALON® TLIF CAGE components are made of polyether ether ketone (PEEK OPTIMA® LT1) that conforms to ASTM F2026, and is supplied as nonsterile and/or gamma sterile. Additionally, the devices contain titanium makers (ASTM F136) to assist the surgeon with proper placement of the device. The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF, RHEA® PLIF CAGE and TALON® TLIF CAGE are implanted by using the instruments specially designed and manufactured from stainless steel materials that conform to ASTM F899.

The provided text describes a 510(k) submission for an intervertebral body fusion device, focusing on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against specific metrics for diagnostic accuracy.

Therefore, most of the requested information regarding diagnostic device performance, such as sample size, provenance, expert qualifications, and ground truth, is not available in the provided document. This submission primarily focuses on the mechanical and physical properties, sterility, and shelf life of the intervertebral cages, aiming to show they are equally safe and effective as pre-existing devices.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable / Not provided. The tests mentioned (sterility, shelf life, mechanical) are typically performed on product samples in a laboratory setting, not on a "test set" of patients or data in the context of diagnostic accuracy.

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

• Not applicable / Not provided. This information is relevant for diagnostic devices that interpret images or other patient data, which is not the primary focus of this submission.

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

• Not applicable / Not provided. Similar to point 3, this is for diagnostic accuracy studies.

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:

• No. This is not an AI-assisted diagnostic device, so an MRMC study is irrelevant here.

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

• No. This is a physical intervertebral fusion device, not an algorithm.

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

• For mechanical and material tests: The "ground truth" is defined by the relevant ASTM and ISO standards' specifications and test methodologies.
• For sterility: The "ground truth" is defined by the ISO 11737-1 standard for demonstrating sterility assurance.
• For shelf life: The "ground truth" is determined by the stability of the device over time under specified conditions.

8. The sample size for the training set:

• Not applicable / Not provided. This concept applies to machine learning models, which are not part of this device submission.

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

• Not applicable / Not provided. This concept applies to machine learning models.

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The SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw System are non-cervical, pedicle screw systems indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S 1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw System are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis)

The SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw . System are posterior, noncervical, pedicle screw spinal system which consists of a variety of shapes and sizes of rods, screws, and cross links which can be rigidly locked into a variety of configurations, made for the individual case. Please note that certain components are specifically designed to connect to ø 5.5mm or ø 6.0mm rods. Care should be taken so that the correct components are used in the spinal construct. The Pedicle Screw Spinal Fixation System was made out of medical grade titanium alloy described by standard such as ASTM F136. Never use stainless steel and titanium implant components in the same construct.

To achieve best results, do not use any of the Pedicle Screw Spinal Fixation System with components from any other system or manufacturer unless specifically allowed to do so in this. The Pedicle Screw Spinal Fixation System implant will be provided non-sterile.

The provided text is a 510(k) Summary for a medical device called the SYNSTER® Pedicle Screw System and SYNSTER® PLUS Pedicle Screw System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical or standalone study.

Therefore, many of the requested items (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and even detailed training set information) are not applicable or not explicitly detailed in this type of regulatory submission.

Here's an breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present acceptance criteria in the typical sense of a target performance metric (e.g., sensitivity, specificity, accuracy) for a diagnostic or AI device. Instead, it demonstrates compliance with mechanical testing standards to prove the physical properties and safety of the pedicle screw system are substantially equivalent to existing, legally marketed devices.

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

• Sample size for test set: Not applicable/not stated. The non-clinical tests relate to the physical device components, not a "test set" of patient data.
• Data provenance: Not applicable/not stated, as this is a mechanical engineering study, not a clinical data study.

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

Not applicable. Ground truth, in the context of this 510(k), would refer to the validated mechanical properties and stress tolerances according to engineering standards (ASTM F1717). This is established by engineering principles and testing protocols, not human experts evaluating patient data.

4. Adjudication method for the test set:

Not applicable. There is no "test set" in the sense of a dataset requiring adjudication. Mechanical tests follow predefined procedures.

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 device is a pedicle screw system, a physical implant for spinal fixation, not an AI or diagnostic imaging device. Therefore, MRMC studies are not relevant.

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

Not applicable. As noted, this is a physical medical device, not an algorithm.

7. The type of ground truth used:

The ground truth for this submission is based on adherence to recognized mechanical engineering standards (ASTM F1717) for spinal implant devices and comparison to the performance of legally marketed predicate devices. The "truth" is that the device's mechanical properties meet the established benchmarks for safety and performance in its intended use.

8. The sample size for the training set:

Not applicable. There is no concept of a "training set" for this type of device submission. The device is manufactured and tested based on established engineering designs and materials.

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

Not applicable. (No training set in the AI sense). The "ground truth" for the device's design and manufacturing is established through adherence to medical device design principles, material science, and performance specifications derived from relevant ASTM standards and predicate device characteristics.

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The SYNSTER CERVICAL CAGE is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The SYNSTER (ALIF, PLIF, PTLIF and TLIF) CAGE is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE will be offered in various device configurations based on surgical approach and patient anatomy, and consist of:

• 1. Cervical Interbody Fusion Device (SYNSTER® CERVICAL CAGE), which may be implanted as a single device via an anterior approach.
• 2. Lumbar Interbody Fusion Device [SYNSTER® (ALIF, PLIF, PTLIF and TLIF) CAGE], which may be implanted
  • As a single device via an Anterior or Anterolateral or Lateral (ALIF) approach; ।
  • Bi-laterally via a posterior (PLIF) approach; ।
  • As a single device via a posterior transforaminal (PTLIF) approach; -
  • As a single device via a transforaminal (TLIF) approach. -

The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain titanium makers (ASTM F136) to assist the surgeon with proper placement of the device.

The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE is implanted by using the (SCCI, SACI, SPCI, SPTCI and STCI) instruments manufactured from stainless steel materials that conform to ASTM F899.

This submission describes the SYNSTER® CERVICAL CAGE and SYNSTER® (ALIF, PLIF, PTLIF and TLIF) CAGE, intervertebral body fusion devices. The devices are made of PEEK Optima LT1 with titanium markers and are intended for intervertebral body fusion in skeletally mature patients with degenerative disc disease. The testing described for these devices primarily focuses on mechanical performance rather than AI/software performance. Therefore, many of the typical AI/ML-related questions are not applicable to this submission.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in terms of number of devices tested, but the testing refers to "non-clinical tests" conducted in accordance with specific ASTM standards. These standards typically involve a defined number of samples for each test type. The document does not specify the exact number of units tested.
• Data Provenance: Not applicable in the context of clinical data. The data originates from benchtop mechanical testing performed according to ASTM standards. There is no information regarding country of origin or retrospective/prospective nature as it's not clinical data.

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

Not applicable. The ground truth for this type of device (mechanical performance) is established by adherence to recognized national/international standards (ASTM F2077-03, ASTM F2267-04, and ASTM Draft Standard F 04.25.02.02) and engineering principles, not by expert consensus on clinical interpretation. The "experts" would be materials scientists and mechanical engineers performing and interpreting the tests according to the standards.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of human interpretations. Mechanical test results are objective measurements compared against specified criteria from standards.

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 submission is for a physical medical device (intervertebral cage), not an AI/ML software device.

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

Not applicable. This submission is for a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for demonstrating the device's acceptable performance is defined by the mechanical properties and criteria stipulated in the referenced ASTM standards. These standards provide objective measures and acceptance thresholds for static and dynamic compression, shear, torsion, subsidence, and expulsion.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; therefore, there is no training set in the conventional sense.

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

Not applicable. There is no training set for this physical medical device.

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The GUARDIAN Inflatable Bone Expander System is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebralaugmentation, such as kyphoplasty.

The GUARDIAN, Inflatable Bone Expander System (IBES), is designed to reduce spinal compression fracture and restore sagittal alignment. By creating a space in the vertebral body to facilitate the insertion of bone cement and using cement dispensing plunger, the major benefits of GUARDIAN are the significant reduction in back pain and increase patient's functional abilities, allow a return to the previous level of activity. The GUARDIAN, Inflatable Bone Expander System components are Inflatable Bone Tamp (balloon catheter, inflation syringe) and accessories kit. And balloon catheter' main components are the shaft, hub and the inflatable balloon located at the distal tip and inflatable balloon is covered maximum 0.03g of silicone fluid to enhance lubricity when the balloon catheter is inserted in the cannula. Radiopaque markers located at the distal and proximal end of deflated working surface allow fluoroscopic visualization of the deflated balloon catheter during positioning. Accessories kit consists of GUARDIAN Bone Access Needle (starting needle cannula, starting needle trocar), GUARDIAN Osteo Introducer System (guide wire, cannula, trocar-R, trocar-S, drill), GUARDIAN Bone Filler Device (cement bar, cement infusion) and guide impactor.

The provided text describes a 510(k) summary for the GUARDIAN Inflatable Bone Expander System (IBES). This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting a full clinical study with specific acceptance criteria in the same way a novel device might. Therefore, many of the typical clinical study elements like expert ground truth, adjudication methods, or MRMC studies are not applicable or detailed in this document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are typically related to meeting established performance standards for similar predicate devices, and demonstrating that the new device performs at least as well as the predicate device or meets defined engineering specifications.

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

The document does not specify a sample size for a clinical "test set" in the traditional sense. The testing mentioned (functional and mechanical) was likely bench testing of the device itself, not human subjects.

• Test Set Sample Size: Not applicable/not specified in the context of a clinical test set. The tests mentioned are likely bench tests performed on device prototypes or production samples.
• Data Provenance: The tests are described as being performed to show that the device "met the specifications and performance characteristics." This implies in-house engineering and laboratory testing by the manufacturer (BM Korea Co., Ltd.). There is no indication of clinical data from human subjects or country of origin for such data.

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

• Number of Experts: Not applicable. The "ground truth" for this type of submission is the established performance and safety profile of the predicate devices and the engineering specifications for the new device. There is no mention of external experts establishing ground truth for a clinical dataset.
• Qualifications of Experts: Not applicable in this context. The "experts" involved would be the engineers and quality assurance personnel at BM KOREA Co., Ltd. who conducted the functional and mechanical testing.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Given that this involves bench testing for mechanical and functional properties, there would be no need for clinical adjudication methods like 2+1 or 3+1. Performance is measured against predefined engineering specifications.

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

• MRMC Study: No. The document does not describe any clinical study, let alone an MRMC comparative effectiveness study involving human readers or AI assistance. The submission is based on demonstrating substantial equivalence through non-clinical (bench) testing.

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

• Standalone Performance: Not applicable. This device is a physical medical device (an inflatable bone expander system), not an AI algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this submission.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this 510(k) submission relies on:
  • Engineering Specifications: The device's functional and mechanical properties were tested against predefined engineering specifications.
  • Predicate Device Performance: The underlying assumption and "truth" for substantial equivalence is that the predicate devices are safe and effective, and the new device performs comparably in terms of its characteristics and intended use.
  • Material Compatibility/Safety Standards: Implied, but not explicitly detailed as "ground truth." The use of silicone fluid for lubricity would be evaluated against established material safety standards.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is a physical medical device, not an AI model that requires a training set of data.

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

• Training Set Ground Truth: Not applicable, as there is no training set for a physical medical device.

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