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The Aesculap Ennovate Cervical Spinal and Occiput System is intended to provide immobilization of spinal segments as an adjunct to following acute and chronic instabilities of the craniocervical junction, the cervical spine (Cl to C7) and the thoracic spine (Tl-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radior myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Aesculap Ennovate Cervical Spinal and Occiput System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Aesculap Ennovate Lumbar System may be connected to the Aesculap Ennovate Cervical Spinal and Occiput System using connectors and rods.

The Aesculap ENNOVATE Cervical Spinal and Occiput System is implant systems used to facilitate the biological process of spinal fusion. This system is intended to promote fusion of the cervical and thoracic spine (C1-T3) and occipito-cervico-thoracic junction (occiput-T3). The Aesculap ENNOVATE Cervical Spinal and Occiput System consist of various plates, screws, rods, hooks, and connectors.

The provided text is a 510(k) Summary for the Aesculap ENNOVATE Cervical Spinal and Occiput System, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through bench testing (performance data).

The request asks for information about the acceptance criteria and the study that proves the device meets the acceptance criteria, specifically in the context of an AI/algorithm-based device. The original document does not describe an AI/algorithm-based device. It describes a physical implant system (screws, rods, plates, etc.) for spinal stabilization. Therefore, the questions related to AI/algorithm performance studies (such as MRMC studies, standalone algorithm performance, ground truth establishment for training/test sets, training set sample size, expert consensus, etc.) are not applicable to this submission.

The "Performance Data" section solely lists ASTM standards that the physical device was tested against. These standards evaluate the mechanical properties of the implant system (e.g., strength, fatigue, static properties) to ensure it performs as safely and effectively as the predicate device.

Given that the request is for an AI/algorithm device study and the provided document is for a physical orthopedic implant, I can only address the "acceptance criteria" and "device performance" in the context of the mechanical and material testing described for this specific physical device.

Acceptance Criteria and Device Performance (Based on the provided document for a physical implant):

The acceptance criteria for this physical device are implicitly tied to the successful completion of the listed ASTM standard tests, demonstrating equivalence in mechanical performance to the predicate device. The performance is stated to be "as safely and effectively" as the predicate device based on these tests.

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

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

• Sample Size: Not specified in the document. For physical device testing, this typically refers to the number of implants or components tested according to the ASTM standards.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, since it's bench testing, the "data" originates from the physical tests performed on the device samples in a laboratory setting.

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

• Not Applicable. This is a physical device, and its performance is evaluated against engineering standards, not by expert interpretation of images or data. Ground truth here is based on the objective measurements from the mechanical testing.

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

• Not Applicable. Adjudication methods are relevant for human interpretation or complex data analysis, not for direct physical property measurements against engineering standards.

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

• Not Applicable. This is not an AI/algorithm-based device. An MRMC study would not be performed for a physical implant.

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

• Not Applicable. This is not an AI/algorithm-based device.

7. The type of ground truth used:

• Mechanical Performance Standards: The ground truth for this physical device is the set of mechanical and material properties defined by the ASTM standards (e.g., tensile strength, fatigue life, torque limits) which are universally accepted engineering benchmarks for such implants. Compliance with these quantitative standards serves as the "ground truth."

8. The sample size for the training set:

• Not Applicable. This is a physical device, not an algorithm that requires a training set.

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

• Not Applicable. As above, no training set for an algorithm is involved.

In summary, the provided document describes a 510(k) submission for a physical medical device. The "acceptance criteria" and "study proving device meets criteria" are based on a series of bench tests against pre-defined ASTM engineering standards to demonstrate substantial equivalence to an existing predicate device, primarily in terms of mechanical and material performance. The questions related to AI/algorithm studies are not relevant to this specific premarket notification.

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The ENNOVATE® Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and nonpedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). The device is indicated for treatment of the following acute and chronic instabilities or deformities:

1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
2. Spondylolisthesis,
3. Trauma (i.e., fracture or dislocation)
4. Spinal Stenosis,
5. Deformities or Curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6. Tumor.
7. Pseudoarthrosis, and
8. Failed previous fusion

The ENNOVATE Spinal System is an implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. This system includes screws of varying types, diameters and lengths, hooks, rods, rod-to-rod connectors, lateral offset and cross connectors of various styles and lengths. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3 as well as CoCr alloy conforming to ISO 5832-12.
The ENNOVATE Spinal System is a spinal rod and screw system. This system's screws can be rigidly locked into a wide range of configurations, therefore allowing each construct to be formed to the needs of an individual patient. All screws within this system are not intended for use with bone cement. Rods of this system may be shaped intraoperatively to correct or maintain proper spinal curvature. The hooks have curved blades underneath the head portion of the implant that wrap around posterior anatomy of the spine to provide an alternative method of anchoring the rod to the spine.

The provided text does not contain information about an AI/ML-powered medical device or its performance criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary for the ENNOVATE® Spinal System, which is a physical medical device (a thoracolumbosacral pedicle screw system) used for spinal fusion.

Therefore, I cannot answer the questions related to acceptance criteria for an AI device, sample sizes for test sets, expert ground truth establishment, MRMC studies, or training set details, as this information is not present in the provided context for this specific device.

The "Performance Data" section in the document refers to biomechanical testing of the physical spinal implant system (e.g., dynamic/static compression, torsion tests per ASTM standards, endotoxin testing), not the performance of a software algorithm.

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The ENNOVATE Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograff or allograft. The ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). The device is indicated for treatment of the following acute and chronic instabilities or deformities.

1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
2. Spondylolisthesis,
3. Trauma (i.e., fracture or dislocation)
4. Spinal Stenosis.
5. Deformities or Curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6. Tumor.
7. Pseudoarthrosis, and
8. Failed previous fusion

The ENNOVATE Spinal System is an implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. This submission includes modified polyaxial screws, additional multiaxial-cross-connectors, offset connectors and additional components in sterile version. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V), conforming to ISO 5832-3.
The ENNOVATE Spinal System is a spinal rod and screw system. This system's polyaxial screws can be locked into a wide range of configurations, therefore allowing each construct to be formed to the needs of an individual patient. Rods of this system are shaped intraoperatively to correct or maintain proper spinal curvature.

This document is a 510(k) premarket notification for a medical device (ENNOVATE® Spinal System) and as such, it describes the equivalence of the device to existing predicate devices, rather than establishing acceptance criteria and proving the device meets them through a performance study against a defined ground truth.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert consensus, adjudication methods, MRMC studies, and standalone algorithm performance, is not present in this document.

The document focuses on demonstrating substantial equivalence through:

• Indications for Use: Listing the conditions the device is intended to treat, which are the same as the predicate devices.
• Technological Characteristics: Stating that the components, materials (titanium alloy, medical grade silicone, stainless steel, titanium alloy, PEEK), and configurations are similar to predicate and reference devices.
• Performance Data: Citing various ASTM standards (F1717-15, F2193-14, F1798-13, F543-13/17) for mechanical testing (dynamic/static compression, torsion, flexion bending, pull-out strength, driving torque). These tests confirm the physical properties and mechanical performance are comparable to the predicate, not that the device meets clinical acceptance criteria.

In summary, this document does not contain the information required to populate the requested table or answer the specific questions about clinical performance studies, AI algorithms, or human-in-the-loop improvements, because it is a 510(k) submission focused on substantial equivalence, not a clinical trial report proving a device meets specific clinical performance acceptance criteria.

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The ENNOVATE Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). The device is indicated for treatment of the following acute and chronic instabilities or deformities.

1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
2. Spondylolisthesis,
3. Trauma (i.e., fracture or dislocation)
4. Spinal Stenosis.
5. Deformities or Curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6. Tumor.
7. Pseudoarthrosis, and
8. Failed previous fusion

The ENNOVATE Spinal System is an implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. This system includes polyaxial screws of varying diameters and lengths, rod-to-rod and cross connectors of various styles and lengths. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V), conforming to ISO 5832-3.
The ENNOVATE Spinal System is a spinal rod and screw system. This system's polyaxial screws can be rigidly locked into a wide range of configurations, therefore allowing each construct to be formed to the needs of an individual patient. Rods of this system may be shaped intraoperatively to correct or maintain proper spinal curvature.

This document describes a spinal system, not a device that would typically have acceptance criteria and performance metrics in the way an AI/ML or diagnostic device would. This is a 510(k) premarket notification for a medical device called the "ENNOVATE Spinal System," which is a metallic implant system for spinal fusion.

The document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing novelty or specific performance criteria like sensitivity, specificity, or accuracy for a diagnostic tool.

Therefore, many of the requested categories are not applicable to this type of device and regulatory submission. I will explain why each category is not applicable and what information is provided in the document.

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

• Not Applicable. For a spinal implant system like the ENNOVATE Spinal System, "acceptance criteria" are typically related to mechanical and material performance standards, not diagnostic accuracy or clinical outcomes in the same way as an AI/ML device. The "performance" reported is compliance with these standards through mechanical testing.

Note: The document states that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable. In addition, testing per the guidance 'Spinal System 510(k)s May 3, 2004' was completed where applicable." This indicates that the device met the performance requirements outlined in these guidance documents, primarily through mechanical testing to demonstrate substantial equivalence.

The following sections are NOT APPLICABLE because this document describes a physical spinal implant system, not a diagnostic AI/ML device requiring clinical performance evaluation with ground truth.

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

• Not Applicable. This is a mechanical device, not an AI/ML diagnostic. No 'test set' of clinical data for diagnostic performance is described. The 'test set' here refers to physical devices tested in a lab.

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. Ground truth, in the context of expert review, is for diagnostic devices or AI, not for mechanical spinal implants.

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

• Not Applicable. Adjudication methods are relevant for clinical endpoints or diagnostic interpretations, not for mechanical testing of an implant.

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 specific to AI/ML diagnostic tools, not an orthopedic implant.

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

• Not Applicable. This is specific to AI/ML diagnostic tools.

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

• Not Applicable. Ground truth refers to the definitive determination of a condition for diagnostic purposes. For a spinal implant, the "truth" is whether it meets engineering specifications and functions mechanically as intended.

8. The sample size for the training set

• Not Applicable. This is for AI/ML models. No training set is involved for this mechanical device.

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

• Not Applicable. As above, no training set or ground truth in this context.

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The AIS S4 Navigation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. They are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion during the navigation of polyaxial screws (T1-T3).

The AIS S4 Navigation Instruments are manual surgical instruments which are designed to interface with BrainLAB's already cleared surgical navigation systems. Instruments in this system may be pre-calibrated or manually calibrated to already cleared systems using manufacturers' instructions. These instruments are intended to be used in spine applications to perform general or manual functions within the orthopedic surgical environment.

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "The AIS S4 Navigation Instruments met the performance requirements. No safety or effectiveness issues were raised by the performance testing." However, specific numerical acceptance criteria (e.g., accuracy thresholds, precision values) are not provided in this submission. The nature of the device (surgical navigation instruments designed to interface with other cleared systems) suggests that the performance requirements likely relate to the accuracy and reliability of tracking and spatial localization when used with the BrainLAB navigation systems.

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

The document states "BrainLAB conducted validation activities including usability testing with the AIS S4 Navigation Instruments." However, no information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) is provided.

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

The document does not describe the specific ground truth establishment process for the performance data. Therefore, the number of experts and their qualifications are not mentioned. Given that the performance data appears to be from "validation activities including usability testing," it's plausible that healthcare professionals were involved in assessing the usability and functionality, but their specific roles in establishing a quantifiable ground truth are not detailed.

4. Adjudication Method:

No adjudication method is described in the provided text.

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

No MRMC comparative effectiveness study is mentioned. The submission focuses on the standalone performance and equivalence of the AIS S4 Navigation Instruments when used with existing BrainLAB navigation systems, rather than comparing human readers with and without AI assistance.

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

This submission is about surgical navigation instruments, which are physical tools that assist a surgeon; they are not an AI algorithm in the typical sense that would have "algorithm-only" performance without human interaction. The "performance data" described refers to "validation activities including usability testing" of the instruments themselves. Therefore, while technically these instruments are used "standalone" in the sense that they are physical tools, their performance is inherently tied to human use and their interface with the BrainLAB navigation system. The study described focuses on their functional performance in this context, rather than a quantifiable, algorithm-only output.

7. Type of Ground Truth Used:

The document mentions "validation activities including usability testing," and states that the instruments "met the performance requirements." This suggests the ground truth was likely based on functional assessment and verification against predefined specifications for accuracy, precision, and usability when integrated with the BrainLAB navigation systems. It is not explicitly stated to be based on expert consensus, pathology, or outcomes data in the traditional sense, but rather on the technical performance and usability of the instruments.

8. Sample Size for the Training Set:

This device is a set of physical surgical instruments, not an AI or machine learning algorithm that requires a "training set" of data. Therefore, this concept is not applicable, and no training set sample size is provided.

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

As the device is a set of physical surgical instruments and not an AI algorithm, there is no training set and therefore no ground truth establishment for a training set.

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The OrthoPilot® Next Generation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to position endoprosthesis in athroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for endoprosthesis replacement surgery (such as total knee, unicondylar knee, and total hip systems) and provides intraoperative measurement. It indicates angles and positions for implant placement.

Aesculap's OrthoPilot® Next Generation is a computer assisted surgical navigation system that uses proprietary software to provide anatomical information to a surgeon. The hardware in the system consists of the following primary components: stereotaxic camera, computer (w/ monitors), rigid bodies (transmitters), passive markers, power supply, various tagged instruments, transport cart and stand. The computer accepts input from the transmitters on the rigid bodies either mounted to the patients bones or mobile to palpate anatomical landmarks in conjunction with a camera to monitor the spatial location of the transmitters in relation to each other and/or instruments. The software modules for the OrthoPilot® Next Generation consist of modules for both a knee suite and a hip suite.

The provided text is a 510(k) premarket notification for a medical device called "OrthoPilot® Next Generation." This type of document is a submission to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) submission primarily focuses on demonstrating substantial equivalence, not on providing detailed clinical trial or performance study data with acceptance criteria in the way a PMA (Premarket Approval) application would. The document states:

"There is no change to previous performance data for the OrthoPilot® Next Generation navigation system."

"The intended use and fundamental scientific technology of the OrthoPilot® Next Generation Navigation system remain unchanged including the integration of passive marker spheres cleared as part of K141694. The only difference is an update to the knee software modules (TKA, TKR and UKA) for the integration of passive marker spheres cleared as part of K141694 and the other minor improvements."

This indicates that the current submission (K153396) is for minor software updates and relies on prior clearances (K080547 and K141694) for performance data. Therefore, the detailed information requested regarding acceptance criteria, specific study designs, sample sizes, ground truth establishment, and MRMC studies for this specific submission is not present in the provided text, as this type of information would have been part of the original submissions that established the performance of the core device.

The document refers to compliance with software development standards (IEC 62304) and FDA guidance for software in medical devices, which are process-oriented rather than providing specific performance metrics.

Based only on the provided text, I cannot furnish the detailed information requested in your prompt. The document does not describe a new comprehensive study to prove the device meets specific acceptance criteria for a new clinical performance claim. It is an "update" submission for minor changes building on previously cleared devices.

If this were a PMA application or a de novo submission, or if the original 510(k) for K080547 or K141694 were provided, that information might be available. However, for K153396, the performance is essentially tied to the previous clearances.

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The Aesculap S4 Cervical Spinal and Occiput Systems are intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (Cl to C7) and the thoracic spine (T-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Aesculap S4 Cervical Spinal and Occiput Systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Aesculap S4 Lumbar System may be connected to the Aesculap S4 Cervical Spinal and Occiput Systems using connectors and rods.

The Aesculap S4 Cervical Spinal and Occiput Systems are implant systems used to facilitate the biological process of spinal fusion. This system is intended to promote fusion of the cervical and thoracic spine (C1-T3) and occipito-cervico-thoracic junction (occiput-T3). The Aesculap S4 Cervical Spinal and Occiput Systems consist of plates, bone screws, rods, hooks, and connectors. This consists of 3.5mm rod, thin and thick lamina hooks, 3.5 and 4.0mm polyaxial screws of various lengths and cross connectors. The occipital plate is fixed to the occiput with bone screws and the transition by a locking mechanism. The end of the construct is stabilized with polyaxial screws to the upper thoracic spine, as required. The components are available in a variety of lengths in order to accommodate patient anatomy. The Aesculap S4 Cervical Spinal and Occiput Systems are manufactured from Titanium alloy and will be provided non-sterile.

The provided document is a 510(k) summary for the Aesculap S4 Cervical Spinal and Occiput Systems. It describes the device, its indications for use, and a comparison to predicate devices. It also details the performance testing conducted. However, this document does not contain information typically found in a study proving a device meets acceptance criteria for an AI/ML powered device, as the Aesculap S4 Cervical Spinal and Occiput Systems are physical medical implants, not an AI/ML software device.

Therefore, I cannot extract the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because this submission pertains to a physical orthopedic implant system, not a digital health or AI/ML device.

The "Performance Data" section solely refers to non-clinical mechanical testing of the implant system against established ASTM standards to demonstrate substantial equivalence to predicate devices, not clinical performance data or AI/ML specific metrics.

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When used as an Intervertebral Body Fusion System:

The T-Space Spinal Implant System are indicated for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 Spondylolisthesis at involved levels. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The AIS T-Space Spinal Implant System is intended for use with supplemental spinal fixation systems that have been cleared for use in the lumbrosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems). The AIS T-Space Spinal Implant System implants can be used individually or in pairs. The AIS T-Space Spinal Implant System is also intended for use with autogenous bone graft.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Aesculap device.

The T-Space Spinal Implant System is an intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The implants are offered in a coated and uncoated version and a variety of shapes and sizes to meet the requirements of the individual patient anatomy. The uncoated PEEK version is manufactured from PEEK - Optima (per ASTM F2026). The coated version will be the same in design as the uncoated PEEK implant with a titanium layer and a vacuum plasma spray coating (Plasmapore® - per ISO 5832-3). The device will have tantalum radiographic markers per ASTM F-560.

I'm sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, including details like sample sizes, data provenance, expert qualifications, and MRMC study information.

Here's why:

• The document is a 510(k) Premarket Notification from the FDA. This type of document primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device, rather than proving a device meets specific, novel acceptance criteria through a full clinical trial or detailed performance study.
• The "Performance Data" section (page 5) describes non-clinical (mechanical) testing, not a clinical study. It lists various ASTM standards for static and dynamic mechanical properties, as well as coating-related tests. These tests are designed to show that the new device performs at least as well as, or exceeds the performance of, the predicate devices in these physical characteristics.
• Missing Information: The document does not contain the following information you requested, as it is generally not part of a 510(k) summary for devices demonstrating substantial equivalence through non-clinical testing:
  • Specific acceptance criteria beyond "meets or exceeds the performance of the predicate devices" in mechanical tests.
  • Sample sizes for test sets in a clinical context.
  • Data provenance (country of origin, retrospective/prospective for clinical data).
  • Number and qualifications of experts for ground truth.
  • Adjudication methods.
  • MRMC comparative effectiveness study details.
  • Standalone algorithm performance (as this is a physical implant, not an algorithm).
  • Type of ground truth used (pathology, outcomes data, etc.).
  • Training set sample size (for an AI/algorithm).
  • How ground truth for a training set was established (for an AI/algorithm).

In summary, the provided text describes mechanical performance testing to demonstrate substantial equivalence of a spinal implant to predicate devices, not a clinical study with acceptance criteria related to patient outcomes or a study involving AI/algorithms or human readers.

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Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.

Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.

Hinge Knee Systems are designed for use in patients in primary or revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments are absent or insufficient. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.

The Columbus Total Knee System, Columbus Revision Knee System are designed for use with bone cement.

The VEGA patella is manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE) that incorporates a wrought stainless steel radiographic marker. The VEGA patella is intended to articulate with the femoral and tibial components of the Columbus Total Knee System, Columbus Revision Knee Svstem or EnduRo Knee System.

The VEGA patella is sterile and intended for single use only.

The provided text describes a 510(k) premarket notification for a medical device (Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System) and a line extension (VEGA patella). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and performance metrics in the way a diagnostic AI/ML device would.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable or cannot be extracted from this type of regulatory submission. The document primarily details the device, its intended use, and its substantial equivalence to a previously cleared device.

However, I can provide information relevant to your request based on the type of data presented in this regulatory document.

Here's a breakdown of the information that can be extracted, along with explanations for categories that are not applicable:

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

The document does not present acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or a quantitative study with reported results in the typical sense of a diagnostic device. Instead, the acceptance criteria implicitly relate to demonstrating substantial equivalence to a predicate device, and the "performance" data refers to assessments supporting this equivalence.

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

• Sample Size: Not applicable. This document refers to engineering analyses (geometrical comparison, lateral stability evaluation) rather than a clinical study with a "test set" of patients or cases. The "sample" would be the device designs themselves.
• Data Provenance: Not applicable for the reasons above. This is an engineering and design-based assessment.

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

• Number of experts: Not applicable. This type of submission relies on engineering principles and regulatory assessment, not expert consensus on ground truth in a clinical context.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set

• Adjudication method: Not applicable. There is no clinical test set requiring adjudication in this context.

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

• MRMC study: Not applicable. This document is for a knee implant system, not a diagnostic AI/ML device.

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

• Standalone performance: Not applicable. This document is for a medical implant, not an algorithm or AI system.

7. The type of ground truth used

• Ground truth: The "ground truth" implicitly used here is that the predicate device (Aesculap VEGA Knee System with the VEGA patella) is safe and effective when marketed. The current submission aims to demonstrate that incorporating the VEGA patella into the Columbus and EnduRo systems maintains substantial equivalence to this established "ground truth" represented by the predicate device's clearance. The assessments mentioned (geometrical comparison, lateral stability) are engineering approaches to confirm this equivalence.

8. The sample size for the training set

• Sample size for training set: Not applicable. This is not an AI/ML device and therefore does not have a "training set" in that sense. The "development" would involve engineering design and possibly bench testing, not machine learning training.

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

• Ground truth for training set: Not applicable (not an AI/ML device).

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The OrthoPilot® Next Generation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to position endoprosthesis in arthroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for endacement surgery (such as total knee, revision knee, unicondylar knee, and total hip systems) and provides intraoperative measurement. It indicates angles and positions for implant placement.

Aesculap's OrthoPilot® Next Generation is a computer assisted surgical navigation system that uses proprietary software to provide anatomical information to a surgeon. The hardware in the system consists of the following primary components: stereotaxic camera, computer (w/ monitors), rigid bodies (transmitters), passive markers, power supply, various tagged instruments, an ultrasound module, transport cart and stand. The computer accepts input from the transmitters on the rigid bodies either mounted to the patients bones or mobile to palpate anatomical landmarks in conjunction with a camera to monitor the spatial location of the transmitters in relation to each other and/or instruments. The computer can also accept spatial input for anatomical landmarks from an ultrasound unit. The software modules for the OrthoPilot Next Generation consist of modules for both a knee suite and a hip suite.

The provided text is a 510(k) summary for the "Aesculap OrthoPilot Next Generation" surgical navigation system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of diagnostic or interpretive performance.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy, human reader improvement with AI) cannot be extracted from this document, as it describes a computer-assisted surgical navigation system and not an AI-driven diagnostic device.

However, I can extract information related to the device's performance data based on the context of a surgical navigation system, which focuses on verification and validation of changes to the device.

Here's what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific quantitative acceptance criteria (e.g., error margins in millimeters or degrees for navigation) and corresponding reported device performance. Instead, it mentions that the device was verified and validated for certain aspects.

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

The document does not detail specific "test sets" in the diagnostic sense, nor does it provide sample sizes (e.g., number of procedures, patients, or data points) for the verification and validation activities mentioned. Data provenance (country of origin, retrospective/prospective) is also not discussed. The performance data refers to testing conducted on the device components and software.

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 and not provided. The device is a surgical navigation system, and "ground truth" for its performance would likely be related to precision and accuracy measurements in a lab or cadaveric setting, not expert consensus on diagnostic images.

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

Not applicable and not provided.

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 and not provided. This device is not an AI-driven diagnostic tool to assist human readers. It is a computer-assisted surgical navigation system.

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

This concept doesn't directly apply here in the context of a diagnostic algorithm. The device, being a surgical navigation system, works with human surgeons in the loop. Its "standalone performance" would be its inherent accuracy and precision in guiding instruments, which is what "navigation performance" verification and validation would cover. However, specific details of this testing are not given.

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

The document does not specify the type of "ground truth" for the verification and validation of the navigation system's performance. For a surgical navigation system, "ground truth" would typically involve highly precise measurements of physical placement, angles, or trajectories compared to ideal or calibrated values. This might be established through metrology equipment or other highly accurate measurement systems in a controlled environment.

8. The sample size for the training set

Not applicable and not provided. This document does not describe an AI/machine learning model that requires a training set. The software is proprietary and provides anatomical information to the surgeon.

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

Not applicable and not provided, as there is no mention of a training set for an AI/ML model.

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