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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 PYXIS 3D Titanium Cervical Cages 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 PYXIS 3D Titanium Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. GS Medical PYXIS 3D Titanium Cervical 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 GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the height of the intervertebral space after resection of the disc. The intervertebral body fusion devices are made of 3D printed titanium alloy (Ti-6Al-4V) in accordance with and manufactured as per ASTM F3001. The material and manufacturing process of the subject device, PYXIS 3D Titanium Cervical Cage is identical to the additional predicate (PYXIS 3D Titanium Cage System, K223868). The PYXIS 3D Titanium Cervical Cage System implants are available in various heights, footprints, and lordotic angles to suit the individual patient's pathology and anatomical conditions. The subject device cages ranging in height from 5mm-10mm in 1 mm increments with 0°, 4°, and 8° options. Also in 4.5mm hight for the 0° angle. The cages are provided in three distinct footprints.

This FDA document is a 510(k) premarket notification for a medical device called the PYXIS 3D Titanium Cervical Cage System. It describes the device and claims substantial equivalence to previously cleared predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets such criteria in the context of an AI/ML powered device, or any kind of AI/ML component at all.

The "PERFORMANCE DATA" section (page 5) simply states that "The worst-case cage of the PYXIS 3D Titanium Cage System underwent testing according to ASTM 2077, specifically static and dynamic axial compression testing, static and dynamic compression shear testing, static and dynamic Torsion testing; expulsion testing, and subsidence testing according to ASTM F2267." These are standard mechanical and structural tests for intervertebral body fusion devices, not performance metrics related to an AI/ML algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study details for an AI/ML device based on the provided text. The device in question is a purely mechanical implant.

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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 QUASAR Stand-alone ACIF 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. The GS Medical QUASAR Stand-alone ACIF System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. When the GS Medical QUASAR Standalone ACIF System is used with all the titanium alloy screws for which the implant is designed it does not require supplemental fixation. When used with fewer screws the implant should be used in conjunction with supplemental fixation that has been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

The subject device, the QUASAR Standalone ACIF System cages are designed for restoring the height of the intervertebral space after resection of the disc while also providing biomechanical stability with the addition on an integrated plate. This integrated plate allows for the user to bypass using an additional plate as seen with traditional ACIF spacers. The QUASAR Standalone ACIF System devices consist of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The supplementary fixation screws are used along with the subject device cage and plate.

The intervertebral body fusion devices are made of hydroxyapatite polyether-ether-ketone (HA PEEK OPTIMA LT1) body with Titanium alloy plates (Ti-6Al-4V) and supplementary screws made up of Titanium alloy (Ti-6Al-4V).

The provided text describes a medical device, the "QUASAR Standalone ACIF System," and its clearance by the FDA. However, it does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.

The document is a 510(k) clearance letter for an intervertebral body fusion device, which is a physical implant used in spinal surgery, not an AI/ML diagnostic or therapeutic system. The "Performance Data" section (F) describes mechanical testing of the implant (e.g., static and dynamic axial compression, shear, torsion, expulsion, and subsidence testing) against ASTM standards, which are physical engineering standards for device performance, not clinical performance metrics for AI.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device based on the given input because the input describes a non-AI/ML medical device.

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The PYXIS 3D Titanium Cage System 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-S 1. 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 PYXIS 3D Titanium Cage System is to be combined with supplemental fixation cleared for use in the lumbar spine.

The GS Medical PYXIS 3D Titanium Cage System devices are designed for restoring the height of the intervertebral space after resection of he disc. They system consists of various cages for intervertebral body fusion ranging in height from 5mm-21mm with multiple lordotic options depending on the approach.

The components are manufactured from 3D printed Titanium Alloy (Ti-6Al-4V ELI) meeting the specifications of ASTM F3001 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion.

The PYXIS 3D Titanium Cage System implants are available in various heights, footprints, and lordotic angles to suit the individual patient's pathology and anatomical conditions.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria for a medical device that involves artificial intelligence or software performance.

The document is a 510(k) premarket notification for the PYXIS 3D Titanium Cage System, which is an intervertebral body fusion device made of titanium alloy for spinal surgery. The performance data mentioned (Section VI) relates to biomechanical testing of the physical implant (e.g., static and dynamic axial compression, shear, expulsion, and subsidence testing), not to the performance of an AI/software device.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance for an AI/software device.
2. Sample size and data provenance for a test set for an AI/software device.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone (algorithm only) performance.
7. Type of ground truth (expert consensus, pathology, outcomes data).
8. Training set sample size.
9. Ground truth establishment for the training set.

The document discusses the substantial equivalence of a physical medical implant (cage) to predicate devices based on its intended use, technological characteristics (material, design, dimensions), and biomechanical performance. It does not describe any AI/software component or related performance studies.

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The GS Medical CYGNUS-C Standalone ACIF 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. The GS Medical CYGNUS-C Standalone ACIF System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. The GS Medical CYGNUS-C Standalone ACIF System is to be used with two titanium alloy screws which accompany the implant and does not require supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The CYGNUS-C Standalone ACIF System cages are designed for restoring the height of the intervertebral space after resection of the disc while also providing biomechanical stability with the addition on an integrated plate. This integrated plate allows for the user to bypass using an additional plate as seen with traditional ACIF spacers. The CYGNUS-C Standalone ACIF System devices consist of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The Subject device also contains supplementary fixation screw. The intervertebral body fusion devices are made of hydroxyapatite polyether-ether-ketone (HA PEEK OPTIMA LT1) body with a titanium alloy (Ti-6Al-4V) plate and X-ray (radioopaque) markers made of tantalum. The supplementary screws are made up of titanium alloy (Ti-6Al-4V).

The provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) premarket notification summary for a medical device (CYGNUS-C Standalone ACIF system), which focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a clinical or performance study with detailed acceptance criteria.

Therefore, I cannot provide the requested information. The document primarily discusses:

• Device Description and Intended Use: For cervical spinal fusion.
• Predicate Devices: Used for comparison to establish substantial equivalence.
• Technological Characteristics: Materials and design.
• Performance Data (Mechanical Testing): States that the device underwent testing according to ASTM standards (ASTM 2077, ASTM F2267) and "the results met all acceptance criteria." However, it does not specify what those acceptance criteria were nor the detailed results of the tests.
• Biocompatibility: Based on predicate devices.
• Conclusion: Substantial equivalence.

There is no mention of a human-in-the-loop study, MRMC study, expert ground truth establishment, or training/test set details related to AI/algorithm performance, as the device described is a physical implant, not an AI-powered diagnostic tool.

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GS Medical's Pegasus-X Expandable PLIF System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). The Pegasus-X Expandable PLIF Cage is to be combined with internal supplemental fixation cleared for use in the lumbar spine.

The Pegasus-X Expandable PLIF Cage devices are designed for restoring the height of the intervertebral space after resection of the disc. The Pegasus-X Expandable PLIF Cage devices consist of implants in various heights, footprints, and lordotic configurations with architecture designed to accept pre and post packing of bone graft material. The intervertebral body devices are made of titanium alloy (Ti-6AL-4V ELI). The Pegasus-X Expandable PLIF Cage devices are not radio lucent but have large windows through the sides that will allow visualization of the placement and subsequent bone fusion. The Expandable PLIF Cage (Posterior Lumbar Interbody Fusion Cage) are designed for segments L2 to S1.

The provided text is a 510(k) summary for the Pegasus-X Expandable PLIF System, a medical device for spinal fusion. It focuses on demonstrating substantial equivalence to already cleared predicate devices.

Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-based medical device performance study.

The "Performance Data" section solely refers to mechanical and biomechanical testing of the physical implant itself (e.g., static and dynamic compression, expulsion, subsidence testing) against ASTM standards, not clinical performance or AI/ML algorithm performance.

Therefore, I cannot provide the requested information based on the given text.

To address your query regarding acceptance criteria and a study proving an AI/ML device meets them, the document would need to describe:

• Clinical performance metrics: Such as sensitivity, specificity, accuracy, F1-score, AUC for a diagnostic AI, or an effect size for an MRMC study if it's an AI-assisted tool.
• A clinical study design: Whether prospective or retrospective, the patient population, image acquisition protocols, and how ground truth was established for AI model evaluation.
• Details about the dataset: Sample size, data provenance (e.g., types of medical images, where they came from), and how it was split into training and test sets.
• Expert ground truth establishment: Number and qualifications of experts, and their adjudication methods.

Without such information, any attempt to answer your questions would be speculative and incorrect based only on the provided text.

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The TRACKER Plus 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, and calcaneus. This includes 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 TRACKER Plus Kyphoplasty System consists of the balloon catheter, cement dispenser kit, and cement mixing system. The cement dispenser kit and the cement mixing system are intended to be used with the balloon catheter, but are sold separately.

The provided text does not contain information about an AI/ML device or a study involving such a device. The document is a 510(k) premarket notification for a medical device called the "TRACKER Plus Kyphoplasty System," which is a system used for the reduction of fractures and/or creation of a void in cancellous bone.

Therefore, I cannot provide a response to your request, as it pertains to AI/ML device acceptance criteria and studies, and this document describes a traditional medical device (kyphoplasty system) that does not incorporate AI/ML capabilities.

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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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