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The AnyPlus Navigated Instrument System is indicated for the preparation and placement of the Poly-Axial Screws of the AnyPlus Spinal Fixation System during a navigated thoracolumbar fusion procedure to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. This system is intended to be used in conjunction with the Medtronic StealthStation® System which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The use of the AnyPlus Navigated Instrument system is limited to use only with the AnyPlus Spinal Fixation System.

The subject device, AnyPlus Navigated Instrument System, includes Taps and a Driver that are compatible with the Medtronic StealthStation® S7 Navigation System. The subject, AnyPlus Navigated Instruments (Taps and Driver), is used to place the GS Medical's AnyPlus Spinal Fixation pedicle screws (Poly-Axial Screws) during a navigated thoracolumbar fusion procedure. These instruments include a regular driver for AnyPlus pedicle screws and multiple taps ranging from 4.5mm to 8.5mm in diameter, increasing by increments of 0.5mm.

These Navigated Instruments are supplied non-sterile, reusable, and fabricated from UNS S45500 Precipitation-Hardened Stainless Steel in accordance with ASTM F899.

This 510(k) summary describes the AnyPlus Navigated Instrument System, a device for spinal surgery. The information provided is sufficient to answer the request.

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 Data Provenance

The document does not explicitly state the sample size used for the test set or the specific data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "performance testing" and "recognition and location testing."

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

The document does not provide information regarding the number of experts, their qualifications, or their involvement in establishing ground truth for the test set. The testing appears to be primarily technical and performance-based against a navigation system and a predicate device.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method like 2+1, 3+1, or none. The testing described focuses on device performance and compatibility rather than subjective interpretation by experts.

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

This device is a navigated instrument system for spinal surgery, not an AI-assisted diagnostic or imaging interpretation tool that involves human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device and was not performed according to the provided information.

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

This device is an instrument system used in conjunction with a navigation system (Medtronic StealthStation® System) and operated by a surgeon. It is not an algorithm that performs autonomously or 'standalone' in a diagnostic sense. The testing described is about the standalone performance of the instruments (Taps and Driver) in interacting correctly with the navigation system. The "algorithm" here would be the navigation system's own algorithms, which are not the subject device. The performance data focuses on the navigational instruments' ability to be recognized, located, and successfully used for screw placement.

7. The Type of Ground Truth Used

The ground truth used for this type of device is primarily physical and functional performance metrics. This includes:

• Dimensional Accuracy: Comparing the critical lengths of the subject device to the predicate device within specified tolerances.
• System Recognition and Location: Confirming that the navigation system correctly identifies and tracks the instruments.
• Successful Mechanical Interaction: Verifying that the instruments can successfully prepare and place pedicle screws.
• Material and Technological Identity: Confirming that the subject device matches the primary predicate in these fundamental aspects.

It is not based on expert consensus, pathology, or outcomes data in the traditional sense, as these are instruments, not diagnostic tools.

8. The Sample Size for the Training Set

This document describes a medical instrument, not a machine learning or AI algorithm that requires a "training set" in the context of data. Therefore, the concept of a training set sample size is not applicable to this device.

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

As the concept of a "training set" is not applicable, this question is also not relevant to the information provided for this device.

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The GS Medical AnyPlus II Spinal Fixation System is composed of a non-cervical spinal fixation devices. It is intended for use as posterior pedicle screw fixation system (T1-S2), a posterior hook fixation system (T1-L5), or as an 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 following indications regardless of 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, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, reduction screw, canulated screws, long arm screws, cortical screws, and a set screw). The screws are available with diameters ranging from 4.5 to 10.5mm, and lengths ranging from 20-100mm in 5mm increments. They are available in noncannulated, cannulated, and longarm geometries with both mono and poly types for each geometry option. All AnyPlus II Spinal Fixation System implant components are manufactured from Ti6AI4V ELI according to ASTM F136.

These implants are supplied non-sterile and are not reusable. The instruments in this system are supplied non-sterile, are reusable, and patient contacting materials are fabricated from Precipitation Hardened Stainless Steels (STS630 and STS555) that complies with ASTM F899.

The provided text is a 510(k) summary for a medical device called the "AnyPlus II Spinal Fixation System." This document is focused on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical or AI-driven study.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, training sets, and ground truth establishment for a study proving the device meets acceptance criteria cannot be extracted from this document.

The document details:

• The device's name, regulation, and classification.
• Indications for use.
• Description of the device components and materials.
• A comparison to a predicate device (AnyPlus Spinal Fixation System, K172546), claiming substantial equivalence.
• Performance data consisting of biomechanical testing (static and dynamic axial compression bending, static torsion testing) according to ASTM F1717. This testing aims to show equivalent biomechanical performance to the predicate device (K091717, which seems to be an earlier predicate referenced for biomechanical comparison, rather than the primary equivalence predicate K172546).

In summary, this document does not contain the type of clinical or AI performance study details requested. It is a regulatory submission for a physical medical implant, not a software or AI device requiring such detailed performance evaluation against clinical ground truth.

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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 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.

• Static Axial Compression | Tested according to ASTM F2077-03 and ASTM F2267-04.
  Demonstrated compliance with specific tests including:
• Static and Dynamic Axial Compression
• Static and Dynamic Compression-Shear Testing
• Static and Dynamic Torsion Testing |
  | - Dynamic Axial Compression | |
  | - Static Compression-Shear Testing | |
  | - Dynamic Compression-Shear Testing | |
  | - Static Torsion Testing | |
  | - Dynamic Torsion Testing | |
  | ASTM F2267-04:
• Expulsion Testing | - Expulsion Testing
• Static Subsidence testing under Axial Compression |
  | - Static Subsidence Testing under Axial Compression | |
  | Overall Goal: Substantial equivalence to predicate devices in terms of performance and safety for intended use. | "The information discussed above demonstrates requested changes to the GS Medical PEEK Lumbar Cage device is effective and performs as well as or better than the predicate devices." |

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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