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The GS Medical AnyPlus® PEEK Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. GS Medical AnyPlus® PEEK Cage System are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. GS Medical AnyPlus® PEEK Cage System are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

The GS Medical AnyPlus® PEEK Cage System device is designed for restoring the height of the intervertebral space after resection of the disc. AnyPlus® PEEK Cage System device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The intervertebral body fusion devices are made of poly-ether-ether- ketone (PEEK Optima LT1) body with the X-ray (radio-opaque) markers made of Tantalum. The AnyPlus® PEEK Cage System devices are radiolucent allowing X-ray visualization to verify device placement. AnyPlus® PEEK Cage System device is supplied sterile and non-sterile and is intended for single use only. AnyPlus® PEEK Cage System is designed for interbody stabilization of the cervical spine.

The provided text describes a medical device, the GS Medical AnyPlus® PEEK Cage System, for which FDA 510(k) clearance was sought. It details the device's intended use, technological characteristics, and non-clinical testing.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

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

The document mentions non-clinical testing according to ASTM standards. It does not provide specific sample sizes for these tests, nor does it detail the provenance of any data beyond indicating "worst-case" models for pyrogen testing. There is no human patient data or a "test set" in the traditional sense for evaluating diagnostic or predictive performance.

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

This information is not applicable (N/A) as the device is a spinal fusion cage and underwent non-clinical performance testing, not a study requiring expert-established ground truth for diagnostic accuracy.

4. Adjudication method for the test set

This information is not applicable (N/A) for the same reason as point 3.

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 explicitly states: "No clinical testing was performed." The device did not involve human readers or AI assistance.

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

No, this device is a physical medical implant (spinal cage), not an algorithm or AI system. Therefore, standalone algorithm performance testing is not applicable (N/A).

7. The type of ground truth used

The "ground truth" for this device's performance was established through engineering and material science standards (ASTM 2077-11 and ASTM F2267-04). These standards define the acceptable mechanical and material properties for intervertebral body fusion devices.

8. The sample size for the training set

This information is not applicable (N/A). This product is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable (N/A) for the same reason as point 8.

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The TRACKER Kyphoplasty System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine, tibia, radius, and calcaneus. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

The TRACKER Kyphoplasty System (KS) comprises the TRACKER-X, P (GSK System) and the TRACKER-I (GCD System). The TRACKER-X, P and the TRACKER-I System are packaged in their own containers and are then packaged together in a TRACKER Kyphoplasty System container. The TRACKER-I System is sold only as a System. The individual System Accessories are not sold separately. The GSK System consists of the TRACKER-P balloon expander and the TRACKER-X balloon catheter. The TRACKER-I is a cement dispenser kit intended for percutaneous access to bone and delivery of bone cement.

The provided document is an FDA 510(k) summary for a medical device called the "TRACKER Kyphoplasty System." This document is focused on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study where the device meets specific acceptance criteria in the context of diagnostic performance or clinical outcomes.

Therefore, the requested information regarding acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for an AI/diagnostic device is not applicable to this document.

This document describes a kyphoplasty system, which is a surgical tool used for reducing fractures and creating voids in bone, typically in kyphoplasty procedures. The "acceptance criteria" and "study" described here pertain to the engineering and material performance of the device, establishing its safety and effectiveness by demonstrating its equivalence to a predicate device.

Here's an breakdown of the device performance presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:
The document does not specify general "sample sizes" in terms of patient data. The tests performed are engineering and material tests on the device itself.

• Data provenance: Not applicable in the context of patient data for a diagnostic study. The tests are laboratory-based and performed on the device components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. The "ground truth" for these tests relates to engineering specifications and international standards (e.g., ISO for sterilization and biocompatibility, ASTM for shelf life). Experts would be engineers and scientists overseeing and conducting these specific types of technical tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for ambiguous diagnostic cases, not for objective engineering or material performance tests.

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 not an AI/diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" is defined by established engineering standards and specifications (e.g., ISO standards for sterilization and biocompatibility, ASTM for shelf life). The device's performance is measured against these pre-defined technical criteria.

8. The sample size for the training set:
Not applicable. This is not an AI/diagnostic device, and therefore no "training set" in that context exists.

9. How the ground truth for the training set was established:
Not applicable.

Summary of the Study:

The "study" presented here is a series of non-clinical performance tests conducted on the TRACKER Kyphoplasty System to demonstrate its safety and effectiveness through substantial equivalence to a predicate device (MEDINAUT Kyphoplasty System K153296).

The tests covered:

• Functional performance: Balloon Deflation, Burst Pressure, Fatigue Strength, Unconstrained Burst Strength, Inflated Dimension, Insertions and Withdrawal Force, Tensile Bond. For these, the document states "In all instances the device functioned as intended and all results were satisfactory and met all performance specifications."
• Sterilization validation: Performed according to ISO 11138-2, ISO 11135-1, and ISO 1422.
• Shelf life validation: Conducted per ASTM F 1980, validating a 3-year shelf life.
• Biocompatibility testing: Performed according to ISO 10993-1, 5, 7, 10, 11, including tests for cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity, and pyrogenicity. All tests met required endpoints.

The conclusion is that the TRACKER Kyphoplasty System is as safe and effective as the predicate device because it shares the same intended uses, indications, technological characteristics, principles of operation, and its performance data are satisfactory against relevant engineering and biocompatibility standards.

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The MVP Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications:

• Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

• · Spondylolisthesis
• · Trauma (including fracture or dislocation)
• · Spinal Stenosis
• Deformities or curvatures (kyphosis, lordosis, or scoliosis)
• Tumors
• · Pseudoarthrosis
• Failed Previous Fusion

The MVP Cervical Plate System is a multiple component system that comprises several sizes of plates and screws and associated manual surgical instruments. The MVP Cervical Plate System implants are supplied non-sterile, are single use, and are fabricated from medical grade titanium alloy (Ti6Al4V ELI, ASTM F 136). The Instruments in the MVP Cervical Plate System are supplied non-sterile, are reusable, and are fabricated from titanium alloy Ti-6Al-4V or stainless steel.

The provided text describes a medical device, the MVP Cervical Plate System, and its clearance process with the FDA. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance, human reader improvement with AI assistance, or standalone algorithm performance.

Instead, the document details a traditional 510(k) submission for a physical medical device (cervical plate system) and focuses on demonstrating substantial equivalence to predicate devices through mechanical performance testing.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document as they are specific to studies evaluating AI/ML-driven devices.

Here's the relevant information that can be extracted:

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

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

• Sample Size: Not explicitly stated as a "test set" in the context of clinical data. The performance testing refers to mechanical testing of the device components.
• Data Provenance: Not applicable in the context of clinical data. The performance details refer to mechanical tests of the physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This document describes mechanical testing of a physical device, not an AI/ML algorithm requiring expert-established ground truth for image interpretation or diagnosis.

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

• Not Applicable. This document describes mechanical testing of a physical device.

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 document describes mechanical testing of a physical device. There is no mention of AI assistance or human readers.

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

• Not Applicable. This document describes a physical medical device (cervical plate system), not an algorithm.

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

• The "ground truth" for this device's performance was established by comparison to the mechanical performance of predicate devices as measured by standardized engineering tests (ASTM F1717-15).

8. The sample size for the training set

• Not Applicable. This document describes mechanical testing of a physical device, not an AI/ML algorithm.

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

• Not Applicable. This document describes mechanical testing of a physical device, not an AI/ML algorithm.

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The AnyPlus Spinal Fixation System are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1 – S2), a posterior hook fixation system (T1 – L5),or as an anterolateral fixation system (T8 – L5). All components are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

AnyPlus Spinal Fixation System is made of devices for fixation of the noncervical spine. They include smooth rods, plates, screws, hooks, nut, screws, and transverse links. The purpose of this submission was to add components to the Anyplus Spinal Fixation System.

This document does not describe an AI/ML powered medical device. It pertains to a Spinal Fixation System, which is a physical implant used in spinal surgery.

Therefore, the requested information about acceptance criteria, study design for AI/ML performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this device.

The "Performance Data" section in the document indicates that the device underwent mechanical testing according to ASTM F1717 standards (static compression bending, static torsion, and dynamic compression bending) to demonstrate its safety and effectiveness. This is typical for physical orthopedic implants, not software algorithms.

The "Substantial Equivalence" section confirms that the device was deemed substantially equivalent to predicate physical devices based on intended use, indications, technological characteristics, principles of operation, and mechanical testing results.

In summary, this document describes the FDA clearance of a medical device (spinal fixation system) that is a physical product, not an AI/ML algorithm.

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The AnyPlus® Cervical PEEK Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. AnyPlus® Cervical PEEK cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. AnyPlus® Cervical PEEK cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The AnyPlus® Cervical PEEK Cage System is designed for restoring the height of the intervertebral space after resection of the disc. AnyPlus® Cervical PEEK Cage System consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The intervertebral body fusion devices are made of poly-ether-ether-ketone (PEEK Optima LT1) body with the X-ray (radio-opaque) markers made of Tantalum. The AnyPlus® Cervical PEEK Cage System are radiolucent allowing X-ray visualization to verify device placement. AnyPlus® Cervical PEEK Cage System is supplied non-sterile and is intended for single use only. AnyPlus® Cervical PEEK Cage System is designed for interbody stabilization of the cervical spine.

The provided text describes the 510(k) summary for the "AnyPlus® Cervical PEEK Cage System," which is a medical device for spinal fusion. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device.

However, I can extract the relevant information from the provided text as if the non-clinical testing served as the "study" for this type of medical device's performance acceptance.

Here's the breakdown based on your request, interpreting "acceptance criteria" as meeting performance standards and "study" as the non-clinical testing performed:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "sample size" in terms of patient data or clinical cases for a test set. This is a non-clinical study. The "test set" refers to the physical devices tested according to the ASTM standards. The specific number of devices tested for each standard is not provided in this summary.

• Data Provenance: The testing was non-clinical, involving physical devices in a laboratory setting. Therefore, there's no country of origin for "data" in the sense of patient data, nor is it retrospective or prospective. It's a laboratory-based evaluation of device mechanics.

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

Not applicable. For non-clinical, mechanical testing of a medical implant, "ground truth" is established by the specified ASTM test method and engineering principles, not by expert consensus on clinical findings. The results are objective measurements of physical properties.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "test set" involves objective mechanical testing against engineering standards, not subjective interpretations requiring adjudication.

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 document pertains to a physical medical implant (a cervical PEEK cage system), not an AI/ML device for diagnostic imaging or similar applications where human readers' performance would be evaluated. No such study was conducted or is relevant to this submission.

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

Not applicable. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is derived from the established ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices. These standards define the mechanical performance requirements and test methodologies. The device's performance measured against these objective, standardized tests serves as the ground truth for its mechanical properties.

8. The Sample Size for the Training Set

Not applicable. This is a non-clinical submission for a physical device, not an AI/ML algorithm that requires a training set.

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

Not applicable for the same reasons as #8.

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AnyPlus® PEEK Lumbar Fusion Cage device is intended for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The AnyPlus PEEK Lumbar Cage is to be combined with internal supplemental fixation cleared for use in the lumbar spine.

The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The implants are made of polyether-ether-ketone (PEEK OPTIMA LTI) (Manufacturer - INVIBIO) body (PEEK conforming to ASTM F2026) with the x-ray markers made of Tantulum (conforming to ASTM F560). This submission includes the addition of sizes to the model PLIF devices, a revision of the shapes of the ALIF, PLIF and TLIF model and the addition of the TPLIF model based on the PLIF design to accommodate surgeons using a Transforaminal Posterior Lateral Interbody Fusion (TPLIF) surgical approach.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not explicitly stated in the document. The testing was non-clinical (mechanical bench testing), so it would involve a certain number of devices tested for each parameter. The document indicates "All performance test results" suggests that a sufficient number was tested to make a comparative claim, but the exact count isn't provided.
• Data Provenance: Non-clinical (bench testing) performed by the manufacturer, GS Medical Co., Ltd. The country of origin for the device manufacturing is Korea.

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

• Number of Experts: Not applicable. This was non-clinical mechanical testing, not a study involving human experts establishing ground truth for diagnostic or clinical outcomes.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. As non-clinical mechanical testing, there is no "adjudication method" in the traditional sense. The performance was measured directly against established standards (ASTM F2077, ASTM F2267) and compared to a predicate device.

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

• Was an MRMC study done? No. The document explicitly states: "No clinical testing was performed."

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

• Was a standalone study done? This is a medical device (implantable cage) and not an AI algorithm. Therefore, the concept of a "standalone algorithm" study does not apply. The performance evaluated was the standalone mechanical integrity of the device itself.

7. Type of Ground Truth Used:

• Type of Ground Truth: The "ground truth" for this non-clinical testing was defined by the performance specifications outlined in the ASTM standards (ASTM F2077, ASTM F2267) and the measured performance of a legally marketed predicate device. The device was deemed "substantially equivalent" if its performance met or exceeded these established benchmarks.

8. Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This refers to the training of an AI algorithm. This device is a physical medical implant, not a software algorithm, and therefore does not have a "training set."

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

• How Ground Truth Was Established: Not applicable, as this is not an AI algorithm.

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AnyPlus® PEEK Lumbar Fusion Cage device is intended for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The implants are made of polyether-ether-ketone (PEEK OPTIMA LT1) (Manufacturer - INVIBIO) body with the x-ray markers made of Titanium alloy (Ti-6Al-4V). This submission includes the addition of sizes to the model ALIF devices and a revision of the shapes of the TLIF model and the PLIF model to accommodate surgeons using a Direct Lateral Interbody Fusion (DLIF) surgical approach.

The provided text describes the 510(k) summary for the GS Medical AnyPlus PEEK Lumbar Fusion Cage. It details the device's characteristics, intended use, and the non-clinical testing conducted to demonstrate substantial equivalence to predicate devices. However, the document does not describe a study involving a test set, human readers, or an AI algorithm.

Instead, the submission focuses on non-clinical performance standards for an intervertebral body fusion device. Therefore, many of the requested points regarding acceptance criteria and studies are not applicable in this context.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are based on demonstrating mechanical performance and safety, primarily through non-clinical testing in accordance with established ASTM (American Society for Testing and Materials) standards. The "device performance" reported is that the device met these standards.

Study Details (Applicable points from the Request)

Since this is a non-clinical, mechanical performance study of an implantable device, most of the requested points related to AI, human readers, and ground truth establishment in a diagnostic context are not relevant or present in this document.

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

   • This document describes non-clinical laboratory testing of the device itself (e.g., mechanical strength, durability), not a "test set" of patient data. The "sample size" would refer to the number of devices tested in the lab for each specific test, which is not detailed in this summary.
   • Data provenance: Not applicable in the sense of patient data. The "data" comes from mechanical testing performed on the fabricated devices.

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

   • Not applicable. There is no "ground truth" in the diagnostic sense for this type of non-clinical device testing. Performance is evaluated against engineering standards (ASTM F2077, ASTM F2267).

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

   • Not applicable. This is not a study involving human adjudication of clinical data.

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:

   • Not applicable. This document is for a physical medical implant, not an AI-powered diagnostic device.

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

   • Not applicable. This is not an algorithmic device. The "standalone performance" is the mechanical performance of the implant itself under specified test conditions.

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

   • Not applicable in the clinical sense. The "ground truth" for this device's performance is compliance with the specified ASTM mechanical testing standards and comparison to the predicate device's known performance.

7. The sample size for the training set:

   • Not applicable. This is not an AI/algorithm-based device requiring a training set.

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

   • Not applicable.

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The AnyPlus PEEK Lumbar Cage is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of nonoperative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The implants are made of polyether-ether-ketone (PEEK) body with the x-ray markers made of Titanium alloy (Ti-6Al-4V).

The manufacturer conducted non-clinical testing of the GS Medical AnyPlus PEEK Lumbar Cage to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

No specific "test set" in the context of clinical data (e.g., patient data, images) was used or reported in this 510(k) summary. The testing was non-clinical, focusing on the mechanical performance of the device itself. Therefore, concepts like country of origin or retrospective/prospective do not apply.

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

Not applicable. This was a non-clinical, mechanical performance study based on established ASTM standards, not clinical ground truth established by experts.

4. Adjudication Method for the Test Set:

Not applicable. There was no clinical ground truth requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

No. This was a non-clinical evaluation of a medical implant's mechanical properties, not an AI-assisted diagnostic device requiring an MRMC study.

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

Not applicable. This device is an intervertebral body fusion cage and does not involve any algorithm or AI for standalone performance evaluation in this context.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance was defined by the ASTM (American Society for Testing and Materials) standards: ASTM F2077-03 and ASTM F2267-04. These standards specify methodologies and acceptance criteria for mechanical testing of intervertebral body fusion devices.

8. The Sample Size for the Training Set:

Not applicable. There was no "training set" as this was a non-clinical evaluation, not a machine learning or AI study.

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

Not applicable. There was no "training set" or need for establishing ground truth for such a set in this non-clinical testing.

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AnyPlus Spinal Fixation System are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2), a posterior hook fixation system (T1-L5), or as a anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

The AnyPlus Spinal Fixation System consists of various hooks, screws, rods and connectors and is intended to create a rigid spinal construct. A table of components can be found in Section 11. The AnyPlus Spinal Fixation System includes components from GSS Pedicle Screw System previously cleared in K053573. These components will keep their original cleared trade name. A table of components can be found in Section 11 identified as GSS Pedicle Screw System 510(k): K053573. The components are manufactured from Ti6Al4V ELI according to ISO 5832-3 and ASTM F-136. The screws are available from 4.0 to 10.5mm diameters with lengths ranging from 20 to 100mm (Length does not include the screw head). Specialized instruments are available for the application and removal of the Anypluss Spinal Fixation System. A table of components can be found in Section 11.

The provided text describes a 510(k) summary for the "AnyPlus Spinal Fixation System," a medical device. This document does not describe a study involving "acceptance criteria" and "device performance" in the way one would typically expect for an AI/ML or diagnostic device. Instead, it focuses on demonstrating "substantial equivalence" of a spinal fixation system to predicate devices through technical characteristics and intended use.

Therefore, many of the requested elements are not applicable to the provided document. I will extract and describe the information that is present.

1. Table of Acceptance Criteria and Reported Device Performance

This section is Not Applicable in the context of the provided document. The document describes a spinal fixation system, not an AI/ML or diagnostic device with performance metrics like accuracy, sensitivity, or specificity. The submission aims to demonstrate "substantial equivalence" to predicate devices based on material, design, and intended use, rather than meeting specific performance acceptance criteria from a clinical study.

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

This section is Not Applicable. The document is a 510(k) summary for a physical spinal fixation system. It does not involve a "test set" of data or data provenance in the context of device performance evaluation as would be relevant for an AI/ML device. The evaluation is based on technical specifications, material properties, and comparison to legally marketed predicate devices.

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

This section is Not Applicable. There is no "ground truth" derived from experts in this context, as it is not a diagnostic or AI/ML device being evaluated. The evaluation relies on engineering principles, material science, and regulatory comparison.

4. Adjudication Method for the Test Set

This section is Not Applicable. There is no "test set" or adjudication process described for this type of medical device submission.

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 section is Not Applicable. MRMC studies are relevant for diagnostic devices (often involving human readers and AI assistance). The "AnyPlus Spinal Fixation System" is a physical implant, not a diagnostic tool or an AI-assisted interpretation system.

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

This section is Not Applicable. This concept applies to AI/ML software. The device is a physical spinal fixation system, not an algorithm.

7. The Type of Ground Truth Used

This section is Not Applicable. As stated, there is no "ground truth" in the context of a diagnostic or AI/ML evaluation for this device. The regulatory approval is based on demonstrating substantial equivalence to predicate devices, material testing, and design specifications.

8. The Sample Size for the Training Set

This section is Not Applicable. There is no "training set" as this is not an AI/ML device.

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

This section is Not Applicable. As there is no training set mentioned, establishing ground truth for it is not relevant to this document.

Summary of Relevant Information from the Provided Text:

The document is a 510(k) summary for the AnyPlus Spinal Fixation System. The primary goal of this submission is to demonstrate substantial equivalence to predicate devices already on the market, rather than meeting specific performance acceptance criteria through a clinical study or AI/ML evaluation.

• Device Description: The AnyPlus Spinal Fixation System consists of various hooks, screws, rods, and connectors made from Ti6Al4V ELI (Titanium Alloy) according to ISO 5832-3 and ASTM F-136. It is intended to create a rigid spinal construct.
• Intended Use: Non-cervical spinal fixation for posterior pedicle screw fixation (T1-S2), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5) in skeletally mature patients as an adjunct to fusion. Indications include degenerative disc disease, spondylolisthesis, trauma, deformities/curvatures, tumor, stenosis, pseudoarthrosis, and failed previous fusion.
• Predicate Devices:
  • GSS Pedicle Screw System (K053573) - Also from GS Medical Co., Ltd.
  • Synthes Pangea System (K052123)
  • INCOMPASS SPINAL FIXATION SYSTEM (K021564)
• Demonstration of Equivalence: The submission argues that the AnyPlus Spinal Fixation System is "as effective, and performs as well as or better than the predicate devices" based on comparing technical characteristics (materials, components, intended use, and classification) to these predicate devices. The materials used (Titanium Alloy Ti-6Al-4V ELI) and compliance with standards (ASTM F1717-04, ASTM F1798-97, ASTM F136-98, ISO 5832-3:1996, ANSI/AAMI/ISO 17665-1) are highlighted as part of this demonstration.

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The GSS Pedicle Screw System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 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 GSS Pedicle Screw System is 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 GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, locking spacer, and a transverse (cross) linking mechanism.

The GSS Pedicle Screw System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The GSS Pedicle Screw System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the GSS Pedicle Screw System.

The provided text describes the "GSS Pedicle Screw System" and its 510(k) submission. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a diagnostic AI device submission would.

Instead, this document focuses on demonstrating substantial equivalence to previously approved predicate devices based on mechanical testing, as is typical for implantable medical devices like pedicle screw systems.

Therefore, many of the requested points are not applicable or cannot be answered based on the provided text.

Here is a breakdown based on the given information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable for this type of device submission. The study described is mechanical testing, not a clinical study with a "test set" of patients or data.

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

• Not applicable. Ground truth, in the context described (expert consensus for diagnostic AI), is not relevant for this device's submission. Mechanical testing relies on standardized methodologies, not expert interpretation of patient data.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" of cases/data that would require adjudication in the context of this submission.

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

• No. This type of study is for evaluating diagnostic performance (e.g., how human readers perform with vs. without AI assistance). The "GSS Pedicle Screw System" is an implantable medical device, and its submission relies on mechanical testing, not diagnostic performance studies.

6. Standalone (Algorithm Only) Performance Study

• No. This device is not an algorithm or AI. It is a physical implantable device.

7. Type of Ground Truth Used

• Mechanical Test Standards (ASTM F1717): For this device, the "ground truth" for proving performance is adherence to and successful completion of standardized mechanical tests, showing the device is robust and performs as expected under simulated physiological loads. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense applied to diagnostic tools, but rather a demonstration of structural integrity and functional capability relative to established standards and predicate devices.

8. Sample Size for the Training Set

• Not applicable. There is no "training set" as this device is not an AI/algorithm that learns from data.

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

• Not applicable. There is no "training set" or corresponding ground truth establishment process for this type of device.

Summary of the Device's Approval Approach:

The GSS Pedicle Screw System gained clearance via the 510(k) pathway by demonstrating substantial equivalence to existing legally marketed devices (Global Spinal Fixation System (K001668) and OPTIMA™, Spinal System (K031585)). This equivalence was primarily proven through mechanical testing in accordance with ASTM F1717, which showed that the subject device performs comparably to the predicate devices in terms of its physical and mechanical properties. The focus of this type of submission is on the device's design, materials, and functional performance under simulated conditions, rather than clinical diagnostic accuracy or reader performance.

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