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The NextAR Spine platform is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. It is indical for any medical condition in which the use of stereotaxtic surgery may be appropriate, when reference to a rigid anatomical structure, such as vertebrae or pelvis, can be identified relative to images of the anatomy. This can include the following spinal implant procedures, such as:

• · Pedicle Screw Placement (Thoracic and Lumbosacral spine)
• Iliosacral Screw Placement
  The NextAR Spine platform is intended to be used in combination with NextAR™M Stereotaxic instruments and / or Medacta preoperative planning. In the case of pre-operative planning software is used preoperatively to plan the surgical placement of pedicle screws based upon radiological images of the patient. As an optional display, the NextAR Smart Glasses can be used auxiliary to the NextAR Spine Platform to view stereotaxic information as presented by the NextAR Spine Platform. The NextAR Smart Glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.

The NextARTM Spine Platform is a CT based computer-assisted surgical navigation platform used in either open/mini open or percutaneous spine surgery procedure and includes the following components:

• Navigation software which displays information to the surgeon; ●
• Augmented Reality glasses; ●
• Optical tracking system; ●
• PC based hardware platform; ●
• Fiducial Block: ●
• Adaptor for sensor:
• Spine attachment instruments ●
• Reusable surgical instruments for spine surgery procedures. ●
  The system operates on the common principle of stereotaxic technology in which markers are mounted on the bones and an infrared camera is used to monitor the spatial location of the instruments. Tracking sensors attached to the bones enable the surgeon to view the position and orientation of the instrumentation relative to the intra-operative data in real-time while performing the surgical procedure. The tracking sensors, the fiducial block, and a group of pins and drills are provided sterile.
  The NextAR™ Spine Platform aids the surgeon in executing the surgical plan by visualizing all the information in real time on a screen monitor.
  The NextAR Spine system is a surgical navigation platform which uses the information of either an intra-operative scan or pre-operative CT in combination with an intra-operative 3D-CArm scan in order to register the spine to navigation elements.
  The registration can be performed with one of the following approaches:
• Direct 3D: based on the use of an intra-operative 3D-CArm scan ●
• . 3D-3D: based on the use of a pre-operative CT scan and an intra-operative 3D-CArm scan
  The system's navigation technology is based on an active infrared camera coupled with an active tracker (Target). These elements allow, by means of the different registration approaches and use of compatible instruments, to accurately prepare trajectories in the vertebrae and/or to implant screws while visualizing information in real time on a screen monitor.

Here's a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating numerical acceptance criteria for clinical performance. However, based on the performance data section, the device's accuracy was a key performance metric evaluated. The acceptance criteria for accuracy are not explicitly stated in numerical terms in this document, but the study described aimed to confirm its performance comparable to the predicate.

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

The document mentions a "Cadaver study" as part of the performance testing.

• Sample Size: The exact number of cadavers used is not specified in the provided text.
• Data Provenance: The study was a "Cadaver study," indicating it was conducted on human cadavers. This is a form of retrospective data in terms of patient-specific outcomes, as the cadavers represent once-living individuals, but the experimental setup is controlled like a prospective study. The country of origin is not specified.

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

The document does not provide details on the number of experts or their specific qualifications (e.g., radiologists with X years of experience) used to establish ground truth within the cadaver study. It states the system is intended to aid surgical placement, implying the ground truth would typically be related to the accuracy of instrument placement or trajectory relative to anatomical landmarks, ideally verified by expert assessment or post-procedure imaging analysis.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1) for the test set (cadaver study).

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size regarding human readers improving with AI vs. without AI assistance. The device is a navigation platform for surgeons, implying human-in-the-loop assistance, but a formal MRMC study as typically performed for diagnostic AI is not described.

6. Standalone (Algorithm Only) Performance:

The document does not explicitly describe a standalone (algorithm only without human-in-the-loop performance) study. The device is designed as a "surgical navigation platform" to "aid the surgeon" and display information "in real-time on a screen monitor," indicating an inherent human-in-the-loop design.

7. Type of Ground Truth Used:

For the "Accuracy test" and "Cadaver study" related to placement, the ground truth would likely involve:

• Precise measurements of instrument tip position or trajectory relative to anatomical landmarks.
• Verification using high-resolution imaging (e.g., CT scan) of the cadaver after "screw placement" to assess deviation from planned trajectories or ideal anatomical placement.
  The document does not explicitly state the method for establishing ground truth, but for a navigation system, it would generally be based on anatomic truth verified by imaging or detailed measurements.

8. Sample Size for the Training Set:

The document does not provide any information regarding the sample size for a training set. As a substantial equivalence determination, the focus is on performance testing and comparison to predicates, not on the details of algorithmic training. The "Dedicated algorithm" is mentioned as a technological characteristic, implying machine learning components, but its training details are not disclosed here.

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

Since there is no information on a training set, the document does not provide details on how its ground truth was established.

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The PAO cortical screws are intended to refixate the acetabular fragment to the ilium, after Periacetabular osteotomy.

The PAO cortical screws are implantable devices for acetabular refixation after a Periacetabular osteotomy. They are provided sterile and single-packaged, for single use only. The PAO cortical screws are designed in two different sizes (Ø3.5mm and Ø4.5mm), both available in different working lengths (from 20mm to 140mm and from 50mm to 140mm respectively) to be suitable to treat all the desired population. The PAO Cortical Screws are made of Stainless Steel AISI 316 LVM according to ISO 5832-1.

This document pertains to the Medacta International SA PAO Cortical Screw, a medical device intended for refixating the acetabular fragment to the ilium after a Periacetabular osteotomy. As such, the information provided does not describe an AI/ML powered device, but rather a physical implantable device. Therefore, many of the requested categories related to AI/ML device studies are not applicable.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a physical medical device (cortical screw) and not an AI/ML powered device, the "acceptance criteria" and "device performance" are related to mechanical and material properties, not diagnostic or predictive performance metrics. The document references performance testing according to ASTM standards.

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

• Sample Size for Test Set: Not explicitly stated in the document. The performance tests (e.g., ASTM F543-17) would have involved a certain number of screws, but the specific quantity is not reported.
• Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. There is no patient data involved in these non-clinical studies.

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

• Not applicable as this is a physical device and not an AI/ML device requiring expert ground truth for classification or diagnosis. The "ground truth" for mechanical properties is established by the specifications of the ASTM standard.

4. Adjudication Method for the Test Set:

• Not applicable for a physical device.

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

• Not applicable. This is not an AI/ML system being compared to human readers.

6. Standalone Performance Study (Algorithm only without Human-in-the-Loop):

• Not applicable. This is a physical medical device.

7. Type of Ground Truth Used:

• For the non-clinical performance and material tests, the "ground truth" is defined by the specifications and methodologies outlined in the referenced international standards (e.g., ASTM F543-17, ISO 5832-1, European Pharmacopoeia §2.6.14, USP chapter , USP chapter ).

8. Sample Size for the Training Set:

• Not applicable. There is no AI/ML algorithm involved, therefore no "training set."

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

• Not applicable. There is no AI/ML algorithm involved, therefore no "training set" or corresponding ground truth establishment.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The device's substantial equivalence to predicate devices and its safety and effectiveness are supported by non-clinical studies focused on its mechanical performance and material properties. These studies include:

• Design Validation: A specific design validation for the PAO Cortical Screws was conducted.
• Performance Testing: This involved static tests on the PAO Cortical Screws according to ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws. The evaluation specifically included torsional properties, driving torque, axial pull-out strength, and self-tapping performance.
• Pyrogenicity Testing: Bacterial endotoxin tests were conducted according to European Pharmacopoeia §2.6.14 (equivalent to USP chapter ), and pyrogen tests were performed according to USP chapter .

The document also states that the material used (Stainless Steel AISI 316 LVM according to ISO 5832-1) is shared with reference devices, addressing potential new safety and effectiveness questions related to material differences.

No clinical studies were conducted as part of this submission for substantial equivalence. The conclusion is that "the PAO cortical screws implants are substantially equivalent to the predicate devices" based on the provided non-clinical data, comparison of technological characteristics, and risk analysis.

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The iFuse-TORQ™ Implant System is indicated for:
· Fusion of the sacroiliac joint for sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis.
· Fracture fixation of small and large bones of the pelvis

The iFuse-TORO Implant System consists of the iFuse-TORO Implants and associated Instruments which are included in two Instrument Sets: iFuse-TORQ Instrument Set and iFuse-TORQ Revision Instrument Set. The iFuse-TORQ Implant System is designed to provide a non-impacted, threaded solution for sacroiliac joint fusion, as well as compression across the SI joint, and for fracture fixation of small and large bones of the pelvis.
The iFuse-TORQ Implants are sterile, single use 3D-printed implants that are provided in various lengths and diameters, and feature flutes and multiple fenestrations along the shaft length (Table 1). The iFuse-TORO Implants are provided in two primary configurations – fully threaded and lag implant designs with optional washers. The cannulated implants include a tapered distal tip and dualsingle-dual lead threads that are compatible with off-the-shelf 3.2 mm guidewires. The iFuse-TORQ Implant designs allow for packing of autograft and allograft materials.
The iFuse-TORO Instruments are provided in two sets: iFuse-TORO Instrument Set (with Primary and Navigation Instruments) and the iFuse TORO Revision Instrument Set. The iFuse-TORO Instruments Sets consist of single use, disposable and reusable instruments. The instruments are provided non-sterile and are intended for cleaning and steam sterilization by the user prior to each use. The iFuse-TORQ Instruments consist of both Class II and Class I medical devices which facilitate the introduction, adjustment / positioning, final placement, and removal (if required) of the implants in the target anatomy.

The provided text describes the regulatory clearance of a medical device, the iFuse-TORQ™ Implant System. It details its purpose, technical specifications, and the testing performed to demonstrate its substantial equivalence to previously cleared predicate devices.

However, the document focuses on the mechanical and material-based acceptance criteria and testing for the implant system itself, rather than the performance of an AI/algorithm-based device.

Specifically, the "Study that proves the device meets the acceptance criteria" in this document refers to bench testing of physical properties, sterilization validation, biocompatibility, and packaging, as listed in Table 2. It does not describe a study involving an algorithm's performance, human readers, or image analysis.

Therefore, many of the requested criteria for an AI/algorithm-based device cannot be answered from the provided text.

Here's a breakdown of what can and cannot be extracted from the document:

Cannot be extracted from the provided document (related to AI/Algorithm performance):

• Table of acceptance criteria and reported device performance for an AI/Algorithm: The document lists standards for physical properties, sterilization, etc., not for AI performance metrics (e.g., sensitivity, specificity, AUC).
• Sample size used for the test set (for an AI/Algorithm): No test set of medical cases/images for AI evaluation is mentioned.
• Data provenance (e.g., country of origin, retrospective/prospective): Not applicable to the presented physical/material testing.
• Number of experts and their qualifications for ground truth: No expert review of cases/images is described.
• Adjudication method for the test set: Not applicable.
• MRMC comparative effectiveness study: No such study involving human readers and AI assistance is mentioned.
• Stand-alone (algorithm only) performance: No algorithm is described.
• Type of ground truth used (expert consensus, pathology, outcomes data): Not applicable to the physical device testing.
• Sample size for the training set (for an AI/Algorithm): Not applicable, as there's no AI/algorithm.
• How ground truth for the training set was established: Not applicable.

What can be extracted, interpreting "device" as the iFuse-TORQ™ Implant System:

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

   The document lists various standards (acceptance criteria) that the device was tested against. The "reported device performance" is implicitly stated as meeting these standards, leading to the "substantially equivalent" determination. However, the specific quantitative results of each test (e.g., exact fatigue life, specific shear strength values) are not provided in this summary.

   Acceptance Criteria (Standards Met/Evaluated against)	Type of Test/Performance Demonstrated (Reported)
   SS EN ISO 11137-1, 2, 3	Sterilization Validation (Implants)
   ANSI / AAMI / ISO 11737-1, 2	Sterilization Validation (Implants)
   ANSI/AAMI/ISO 17665-1, AAMI TIR12, ANSI/AAMI ST79, ST77	Sterilization Validation (Instruments)
   EN ISO 19227, ISO 10993-5	Cleaning Validation (Implants)
   AAMI TIR30	Cleaning Validation (Instruments)
   AAMI TIR12, TIR17	Repeat Cleaning & Steam Sterilization (Instruments)
   EN ISO 11607-1, ASTM D4332-14, D4169-16, F2096-11, F88-15	Packaging Validation (Implants & Instruments)
   ASTM F1980-16	Shelf Life Rationale (Implants)
   ISO 10993-1	Biocompatibility Assessments (Implants & Instruments)
   ASTM F543-17, F2193-20	Bench Testing (Implants & Instruments), Torsion Testing (Implants)
   ASTM F3001-14	Elemental Analysis (Implants)
   ASTM F2193-20	Fatigue Testing (Implants)
   ASTM F1854-15	Stereological Evaluation of Porous Layer
   ASTM F1044-05	Static Shear Testing
   ASTM F1160-14	Shear Fatigue Testing
   ISO 13179-1, ASTM F1147-05	Static Tensile Testing
   ASTM F1978-18	Abrasion Properties
   ASTM F2052-15, F2119-13, F2182-19e2, F2213-06, F2503-13	MR Compatibility Assessment
   ASTM F2554-2018	Positional Error (Navigational Instruments)
   ANSI/AAMI HE75, EN 62366, IEC 62366-1	Simulated Use Testing (System Validation)

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

   • Sample Size: The document does not specify exact sample sizes for each bench test (e.g., number of implants tested for fatigue). It generally states "comprehensive Design Verification and Validation Testing."
   • Data Provenance: Not applicable in the context of human data. The testing was laboratory-based, performed by SI-BONE.

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

   • Not applicable to the type of testing performed. Ground truth for material and mechanical properties is established through standardized testing methods, not expert consensus on cases.

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

   • Not applicable.

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

   • No. This document does not pertain to an AI-assisted diagnostic device, but rather a physical implant system.

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

   • No. This is not an algorithm.

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

   • For the physical device, the ground truth is established by the specifications defined in the relevant ASTM, ISO, and AAMI standards for materials, manufacturing, sterility, biocompatibility, and mechanical performance.

8. The sample size for the training set:

   • Not applicable, as this is not an AI/ML device.

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

   • Not applicable, as this is not an AI/ML device.

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The M.U.S.T. Sacral Illac Screw and Pelvic Trauma System is intended for use in skeletally mature patients for fracture fixation of small and long bones of the pelvis, and for sacroiliac joint fusion for patients suffering from sacroiliac joint disruptions and degenerative sacroiliitis.

The M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System is designed for sacroiliac joint fusion in degenerative sacroiliitis, as well as for the fixation of small and long bone fractures in trauma cases.

The M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System consists of various sized screws, manufactured from Ti6A14V ELI and coated with rough Hydroxyapatite (HA). The HA coating allows for biological fixation and potentially leads to arthrodesis.

The sacroiliac (SI) joint screws are hollow-body threaded fusion devices with a multiplefenestrated pattern shaft to promote arthrodesis, a self-tapping design to facilitate screw insertion, and a tapered tip to aid in guidance through pilot hole. Radial windowed slots along the shaft facilitate bone ingrowth after implantation and "bone filling" after insertion.

The SI joint screws are provided in standard and headless designs. The standard screw can be coupled to modular washers of different diameters to optimize and stabilize the contact between the screw head and the cortical bone and to improve the compression activity of the screw. The standard screws are provided sterile in three diameters (8, 9, and 10 mm) and multiple lengths (25 – 80 mm).

The headless screw has an anatomical shape which allows for full insertion into the bone. The headless screws are provided sterile in three diameters (7.5, 9, and 11 mm) and multiple lengths (30 - 75 mm). The M.U.S.T. Sacral Iliac Screws Extension introduces new sizes of these screws keeping the same diameters (7.5, 9, and 11 mm) with new lengths from 80 mm (5 mm increment).

The provided FDA 510(k) document does not describe acceptance criteria for a device, nor does it present the results of a study designed to prove the device meets specific acceptance criteria in the context of device performance as one might expect for AI/ML or diagnostic devices.

Instead, this document is a 510(k) submission for a medical device (M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System), seeking to demonstrate substantial equivalence to a previously cleared predicate device. Substantial equivalence is a regulatory pathway for medical devices in the US, where a new device is compared to a legally marketed predicate device, and it's shown that the new device is as safe and effective as the predicate.

The "performance data" section in this document refers to design verification and validation testing related to the physical characteristics and safety of the bone screws, not diagnostic accuracy or clinical effectiveness in the way an AI/ML device would be evaluated.

Therefore, many of the questions in your prompt are not applicable to the information contained in this 510(k) submission.

Here's an attempt to answer the applicable parts based on the provided text, while clearly indicating where information is not present:

1. Table of acceptance criteria and the reported device performance

This document does not define specific "acceptance criteria" in terms of performance metrics like sensitivity or specificity. Instead, the "acceptance" for this device is based on demonstrating substantial equivalence to a predicate device through engineering and material testing.

The document states that the introduction of new sizes for the M.U.S.T. SI-Joint Headless screws does not create a new worst case compared to the predicate device. Therefore, a comparative analysis was performed to determine if the line extension created a new worst-case product size, and it was determined that the subject devices are substantially equivalent to the previously cleared predicate device.

The "performance data" section lists the following tests that were leveraged from the predicate device:

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 for each test. These are typically engineering tests performed on a limited number of physical samples (e.g., screws) according to the respective ASTM/ISO standards.
• Data provenance: Not specified, but likely from internal Medacta International SA testing (Switzerland). These are not clinical studies with patient data.

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

This is not applicable. This device is a bone fixation fastener, not a diagnostic or AI/ML device requiring expert ground truth for performance evaluation in the clinical sense. The "ground truth" here is compliance with engineering standards and demonstration of substantial equivalence.

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

Not applicable. This is not a study involving human reader consensus for "ground truth."

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

Not applicable. This is not an AI/ML or 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/ML device.

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

The "ground truth" in this context is adherence to established engineering standards (ASTM, ISO) for material properties, mechanical performance, sterilization, and biocompatibility, as well as the device's physical and mechanical comparability to the predicate device. It does not involve clinical outcomes data or expert consensus in a diagnostic sense.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. As above, no training set.

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