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For fracture fixation of small bones and small bone fragments including odontoid fractures.

The AIS Odontoid Fracture Fracture Fixation System is comprised of screws and instruments. The 4.0mm cortical screws are either a fully-threaded or partially threaded. They are offered in various lengths and will be non-sterile. The screws are manufactured from titanium alloy (Ti6Al4V) per ISO 5832/3.

This document is a 510(k) premarket notification summary for the AIS Odontoid Fracture Fixation System. It describes a new medical device and its equivalence to previously cleared devices. However, this type of document focuses on establishing substantial equivalence through non-clinical performance data (mechanical testing) rather than clinical studies of a device's performance in humans, especially for AI/algorithm-based devices.

Therefore, most of the requested information regarding acceptance criteria, device performance from clinical studies, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies, is not applicable or available within this provided text.

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

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

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

• Not applicable/Available. This document describes mechanical testing of a physical implant, not an AI/algorithm. Sample sizes would refer to the number of implants tested in a lab, not 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)

• Not applicable/Available. Ground truth in this context would relate to the physical properties measured in mechanical tests, not expert interpretation of medical images or patient outcomes.

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

• Not applicable/Available. Adjudication methods are relevant for human interpretation tasks, not mechanical testing.

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/Available. This document is for a physical orthopedic implant, not an AI/algorithm-based diagnostic aid.

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

• Not applicable/Available. This is not an AI/algorithm device.

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

• Ground Truth for Mechanical Testing: The "ground truth" for the mechanical tests (Static Testing per ASTM F543 and Static and Dynamic Cantilever Testing per ASTM F2193) would be defined by the standard specifications and performance requirements outlined in those ASTM standards and the performance of the predicate devices. These are engineering standards measuring physical properties.

8. The sample size for the training set

• Not applicable/Available. This device does not involve a "training set" in the context of machine learning.

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

• Not applicable/Available. This device does not involve a machine learning training set or ground truth establishment in that sense.

Summary of what the document does describe:

The document focuses on establishing substantial equivalence for the AIS Odontoid Fracture Fixation System to predicate devices through non-clinical performance testing (mechanical testing). The acceptance criteria for these tests were that the subject device "meets or exceeds the performance of the predicate devices" when evaluated according to ASTM F543 (Static Testing) and ASTM F2193 (Static and Dynamic Cantilever Testing). The results showed that this criterion was met. This approach is standard for demonstrating the safety and effectiveness of a physical implant by ensuring it performs mechanically at least as well as existing, cleared devices.

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The AIS Modulift VBR System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The AIS Modulift VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The Aesculap Modulift VBR System may be used with bone graft.

The AIS Modulift VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the system is comprised of spacers and foot plates of various heights and sizes to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. Once it is adjusted to the desired height the column is mechanically locked in place by means of locking screws (grub screws). Each spacer has an axial hole to allow grafting material to be packed inside the device. Spikes on the end of the foot plates improve the anchoring of the implant to the vertebral body. The foot plates of the device are available in various lordotic and kyphotic angles. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136, and cobalt chrome (CoCr) per ASTM F1537.

The provided document is a 510(k) premarket notification for the AIS Modulift VBR System. This type of FDA submission is for medical devices seeking substantial equivalence to already legally marketed predicate devices, not typically for AI/ML-driven devices. Therefore, the information requested in the prompt, which is tailored for AI/ML device studies (e.g., acceptance criteria for algorithm performance, sample sizes for test sets, ground truth establishment by experts, adjudication methods, MRMC studies), is not relevant or applicable to this document.

The document primarily focuses on demonstrating the substantial equivalence of an adjustable vertebral body replacement system to existing predicate devices, focusing on design, intended use, material composition, function, and size.

However, I can extract information regarding the performance data mentioned in the document in the context of device safety and efficacy, which is a different type of performance than what is typically associated with AI/ML systems.

Based on the provided text, here's what can be extracted, acknowledging the mismatch with AI/ML specific questions:

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

Note: The document implies the acceptance criterion is performing at least as well as the predicate devices in the described tests. The specific quantitative acceptance thresholds are not provided in this summary.

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

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified in the provided text. The testing seems to be laboratory-based ("non-clinical testing").

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 is a mechanical device, and ground truth is typically established through engineering specifications and test protocols, not human expert consensus on medical images/data.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. This refers to consensus among human readers for AI/ML ground truth, which is not relevant here.

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 type of study is for evaluating AI impact on human performance, which is not relevant for this mechanical device.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This refers to AI algorithm performance, not relevant for this device.

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

• Type of Ground Truth: For this mechanical device, the "ground truth" or standard for evaluation would be established engineering principles, material science standards (e.g., ASTM F-136, ASTM F1537), and the performance characteristics of predicate devices in specific mechanical tests (like expulsion). This is distinct from clinical 'ground truth' defined by pathology or expert consensus for AI/ML systems.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This device does not involve a "training set" in the context of machine learning.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set in the AI/ML sense.

Summary of Relevant Performance Data from the document:

The study referenced is "non-clinical testing" as recommended by the FDA Guidance for Spinal System 510(k)'s.

• Test Performed: Expulsion per ASTM Draft Standard F-04.25.02.02.
• Purpose: To demonstrate that the AIS Modulift VBR System is substantially equivalent to other predicate devices.
• Results: The device "meets or exceeds the performance of the predicate devices."

This information confirms that the performance evaluation was based on mechanical testing relevant to physical device function and safety, not on AI/ML diagnostic or prognostic capabilities.

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The AIS Modulift VBR System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The AIS Modulift VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The AIS Modulift VBR System may be used with bone graft.

The AIS Modulift VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the system is comprised of spacers and foot plates of various heights and sizes to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. Once it is adjusted to the desired height the column is mechanically locked in place by means of locking screws (grub screws). Each spacer has an axial hole to allow grafting material to be packed inside the device. Spikes on the end of the foot plates improve the anchoring of the implant to the vertebral body. The foot plates of the device are available in various lordotic and kyphotic angles. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136, and cobalt chrome (CoCr) per ASTM F1537.

The document describes the AIS Modulift VBR System, an adjustable vertebral body replacement device. This device is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). It is intended for use with supplemental spinal fixation systems and may be used with bone graft.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes non-clinical performance testing of the device. It does not provide details on specific sample sizes for each test beyond stating that "non-clinical testing was performed." The data provenance is from laboratory testing performed on the device itself, not from human data or clinical studies.

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

Not applicable. The "ground truth" for this device's performance is established by a set of ASTM and draft standards for orthopedic implants, which define the testing methodology and acceptance criteria. There is no mention of human experts establishing ground truth for the performance tests, as these are engineering and material science tests.

4. Adjudication method for the test set:

Not applicable. The tests are based on engineering standards, and the results are objective measurements against specified criteria, not subjective interpretations requiring adjudication.

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

Not applicable. This is a physical medical device (vertebral body replacement system), not an AI/software device that requires human readers or clinical image interpretation.

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

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

7. The type of ground truth used:

The ground truth used for demonstrating device performance is based on established engineering standards and safety/performance benchmarks for spinal implants, specifically various ASTM standards (F2077, F2267, F1877) and a draft ASTM standard (F-04.25.02.02). The device's performance is compared against these standards and against predicate devices.

8. The sample size for the training set:

Not applicable. This refers to a physical medical device, not a machine learning model.

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

Not applicable. This refers to a physical medical device, not a machine learning model.

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The Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended for use with existing Aesculap femoral heads and femoral stems to replace the hip joint.

The devices are intended for:

• Patients suffering from severe hip pain and disability due to rheumatoid arthritis, . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur
• Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital . femoral ephiphysis
• Patients suffering from disability due to previous fusion .
• Patients with acute femoral neck fractures ♥

Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended for cementless applications.

Aesculap Plasmafit Pro Acetabular Cup System and Vitelene Insert is a modular hip prostheses system intended to be used in conjunction with a prosthetic femoral head and hip stem in total hip arthroplasty.

Aesculap Plasmafit Pro consists of a cementless titanium acetabular cup, a highly crosslinked (B-75 kGv) ultra-high molecular weight polyethylene (UHMW-PE) vitamin E insert, 40mm Biolox® delta, 40mm ISODUR® heads and optional titanium screws.

The hemispherical titanium cup with a slightly flattened dome is coated with a titanium plasma spray on the outer surface which aims to provide a high level of primary stability with its rough finish. Plasmafit Pro cups are available in three (3) similar designs only varying in the number of holes (0, 3, 5/7) around the apex. The number of holes are adapted for optional anchoring 6.5mm diameter titanium alloy screws that may be used to ensure primary stability. Plasmafit Pro anchoring screws are an option available separately in sizes 16mm to 68mm lengths.

Vitelene is designed with a taper-fit to the interior surface of Plasmfit Pro cups. The vitamin E insert has been shown to be more resistant to oxidation than conventional UHMWPE. Characterization of the oxidation indices of aged (ASTM F2003) and un-aged Vitelene measured according to ISO 5834-4 did not decrease . Further, Vitelene remains resistant to oxidation after 5 million cycles of wear as demonstrated in testing performed in accordance to ISO 14242.

Plasmafit Pro cups are available in sizes ranging from 40mm - 70mm.

Plasmafit Pro Acetabular Cup System and Vitelene insert may be used with Aesculap Biolox® delta and ISODUR® (CoCrMo) 40mm ball heads along with the following cleared compatible components: Aesculap Hip Implant Systems Excia, Metha, Prevision, and Unisyn and cleared Aesculap femoral heads: Biolox® Option, Biolox® Forte, Biolox® Delta, and CoCrMo to offer several interoperative implant options taking into consideration different patient bone conditions.

The provided text is related to a 510(k) Premarket Notification for a medical device (Plasmafit Pro Acetabular Cup and Vitelene Insert), not an AI/ML medical device. Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., sensitivity, specificity) is not applicable here.

Instead, this document describes the device's characteristics, its intended use, and argues for its substantial equivalence to previously cleared predicate devices based on non-clinical performance data.

Here's an analysis based on the provided text, reinterpreting "acceptance criteria" as the basis for substantial equivalence:

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

The document does not present a formal table of quantitative acceptance criteria as would be seen for AI/ML performance. Instead, the "acceptance criteria" for this traditional medical device submission revolve around demonstrating substantial equivalence to existing predicate devices.

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

This information is not provided in the document. The "tests" performed are non-clinical (mechanical, material characterization) on the device components, not diagnostic tests on patient data. Therefore, concepts like "test set," "data provenance," "country of origin," "retrospective/prospective," and "sample size for test set" in the context of an AI/ML device do not apply. The tests mentioned (e.g., ASTM F2003, ISO 5834-4, ISO 14242) are standardized laboratory tests for device materials and wear.

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

Not applicable. This is not an AI/ML device, and there is no "ground truth" derived from expert review of patient data. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles and standards against which the device performance is measured (e.g., the specified oxidation resistance limits in ISO 5834-4).

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

Not applicable, as there is no "test set" in the diagnostic sense, nor human expert adjudication. The "adjudication" for non-clinical tests typically involves adherence to standardized testing protocols and interpretation of results by qualified engineers/scientists.

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 device, so no MRMC study, human readers, or AI assistance is involved.

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

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

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

Not applicable. For non-clinical performance, the "ground truth" is defined by established engineering and materials science standards and specifications (e.g., ISO and ASTM standards for material properties, wear, and oxidation resistance).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model that requires a training set. The device itself is manufactured to specifications derived from design and engineering principles.

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

Not applicable, for the same reasons as above.

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The AIS S4 Cervical 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 pedicle screws (T1-T3).

The AIS S4 Cervical 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.

The provided text describes the Aesculap S4 Cervical Navigation Instrumentation, which is a set of manual surgical instruments designed to interface with BrainLAB's surgical navigation systems. The submission is a Traditional 510(k) Premarket Notification.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list specific quantitative acceptance criteria for the device's performance (e.g., a certain level of accuracy in millimeters). Instead, it describes a more qualitative assessment.

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

• Sample Size: The document states that "BrainLAB conducted validation activities including usability testing with the AIS Navigation Instruments." However, it does not specify the sample size (e.g., number of users, number of cases tested) for this usability testing or any other performance testing.
• Data Provenance: The document does not specify the country of origin of the data. The testing appears to be conducted by BrainLAB, a company with international operations, but the specific location of the testing is not mentioned. It is also not explicitly stated whether the data was retrospective or prospective, though usability testing typically involves prospective data collection.

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

• The document mentions "usability testing with the AIS Navigation Instruments." Usability testing typically involves end-users (surgeons) but does not specify the number or qualifications of these experts for establishing ground truth related to navigational accuracy or effectiveness. The study relies on the outcome of the usability testing and performance testing rather than expert-established ground truth in a clinical or imaging sense.

4. Adjudication Method for the Test Set

• The document does not mention any adjudication method for the test set. Given the nature of the testing described (usability and performance requirements), it's unlikely a formal adjudication process (like 2+1 or 3+1 consensus) would be used as it would be in an imaging diagnostic study. The assessment would likely be based on whether the instruments appropriately facilitated the surgical steps and met performance specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No MRMC comparative effectiveness study was done. The document states, "Clinical data was not needed for the AIS Navigation Instruments." The submission focuses on substantial equivalence based on technological characteristics and performance testing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• This question is not applicable as the device (AIS S4 Cervical Navigation Instruments) is a set of manual surgical instruments designed to interface with surgical navigation systems. It is not an AI algorithm or a standalone software. The performance testing would inherently involve human interaction with the instruments and the navigation system.

7. The Type of Ground Truth Used

• The document implies that the ground truth for "performance requirements" would be established by the functional specifications and design requirements of the instruments when used with the BrainLAB navigation systems. For usability testing, the "ground truth" would be whether the instruments are usable and meet the functional needs of the surgeons. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this submission, as clinical data was not required.

8. The Sample Size for the Training Set

• This question is not applicable. The device is a set of manual surgical instruments; it is not an AI algorithm that requires a training set.

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

• This question is not applicable as there is no AI algorithm or training set involved.

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When used as a Vertebral Body Replacement Device: The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebrail body due to tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with bone graft.

When used as an Intervertebral Body Fusion System: The Aesculap PEEK Spinal Implant System consists of CeSpace PEEK Implants that are circular in shape with flattened sides. The CeSpace implants are indicated for spinal fusion erodial in Shape Min Hattoned elessed telefally 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. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System is also intended for use with autogenous bone graft.

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

The Aesculap CeSpace XP Intervertebral Body Fusion System is a cervical intervertebral I no fusiondevice that is implanted into the vertebral body space to improve stability of bour fusional hile supporting fusion. Components are offered in a variety of sizes to meet the requirements of the individual patient anatomy. Components are manufactured from the requirements of the Inalifical P026) with a titanium layer and a vacuum plasma spray coating (Plasmapore® - per ISO 5832-3). The device will have Tantalum markers per ASTM F-560.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CeSpace PEEK Intervertebral Body Fusion System (Plasmapore® Coated), K123909.

Due to the nature of the provided document (a 510(k) summary for a medical device), the acceptance criteria and study details are focused on proving substantial equivalence to a predicate device through non-clinical performance testing, rather than establishing clinical efficacy through traditional clinical trial metrics like sensitivity/specificity, or human reader performance with AI. The document primarily reports engineering and materials testing results.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document details non-clinical performance testing (mechanical and material tests) rather than clinical studies with human participants. Therefore, the concept of a "test set" in the context of clinical data provenance (country, retrospective/prospective) and sample size (e.g., number of patients/cases) is not applicable here. The "sample" in this context refers to the manufactured devices or test coupons. The specific number of devices or test samples used for each test (e.g., number of constructs for static torsion) is not specified in the provided summary.

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

This information is not applicable as the "ground truth" was established through standardized engineering and materials testing (e.g., ASTM standards), not by expert human interpretation of data where consensus is required (like reading medical images).

4. Adjudication Method for the Test Set

This is not applicable for non-clinical performance testing. The "adjudication" is inherent in the pass/fail criteria of the ASTM and guidance-specified tests.

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

This is not applicable. The device is an intervertebral body fusion system, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or would be relevant.

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

This is not applicable. The device is an implant, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth for demonstrating substantial equivalence was based on:

• Compliance with established mechanical testing standards (ASTM F2077, ASTM F2267).
• Compliance with established material and coating testing standards (ASTM F1854, ASTM F1147, ASTM F1044, ASTM F1160, ASTM F1978).
• Meeting performance levels equivalent to or exceeding those of the predicate devices as demonstrated through these non-clinical tests.

Essentially, the "ground truth" is the physical and mechanical properties of the device as measured by validated engineering methods, compared against a known-safe and effective predicate device.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of an implantable medical device undergoing non-clinical substantial equivalence testing. The concept of a training set is relevant for machine learning algorithms.

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

This is not applicable for the reasons stated in point 8.

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The S4 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 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 S4 Spinal System consists of polyaxial screws and monoaxial screws of varying diameters and lengths, various hook styles, rods of varying lengths, fixed and adjustable cross-connectors, and various styles of rod connectors. All implant components are top loading and top tightening. The S4 Spinal System is manufactured from Titanium and Titanium alloy in accordance with ISO 5832/3 and ISO 5832/2.

The provided document describes the Aesculap® Implant Systems (AIS) S4 Spinal System Modification Lateral Offset Connectors and its premarket notification (K130291). The study proving the device meets acceptance criteria is a non-clinical performance study comparing the modified device to predicate devices.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document mentions "non-clinical testing" was performed, which typically suggests a laboratory-based test with a specific number of samples for each test type, but the exact count is not provided.
• Data Provenance: Not applicable in the context of clinical data. This refers to laboratory-based mechanical performance testing.

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

• Not applicable. This was a non-clinical, mechanical performance study, not a study requiring expert clinical assessment for ground truth. The "ground truth" here is the physical performance data itself, measured according to industry standards.

4. Adjudication Method for the Test Set

• Not applicable. This was a non-clinical, mechanical performance study. Adjudication methods are typically associated with clinical studies involving interpretation of data or images by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This document describes a non-clinical mechanical performance study, not a clinical MRMC study.

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

• Not applicable. This device is a physical spinal implant component, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Mechanical performance data a per ASTM standards: The ground truth for this study was the quantifiable mechanical performance (e.g., strength, stiffness, fatigue resistance) measured according to the specified ASTM F1717-12 standards.

8. The Sample Size for the Training Set

• Not applicable. This was a mechanical performance study, not a machine learning or AI study that would typically involve a "training set."

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

• Not applicable. As above, this was a mechanical performance study, not an AI study.

Summary of the Study:

The study conducted was a non-clinical performance study on the S4 Lateral Offset Rod Connectors. It involved standardized mechanical tests (Static Axial Compression Bending, Dynamic Axial Compression Bending, and Static Torsion) as recommended by FDA Guidance for Spinal System 510(k)s and according to ASTM F1717-12. The acceptance criterion was that the modified device "meet or exceed the performance of the predicate devices" in these tests. The results demonstrated that the device successfully met this criterion, leading to a determination of substantial equivalence.

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The Columbus REVISION Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity, or dysfunction persist, and for patients suffering from corrective valgus or varus deformity and moderate flexion contracture.

The Columbus REVISION Knee System is designed for use with bone cement.

The cemented Columbus REVISION Knee System is a semi-constrained cemented prosthesis system. The system offers femoral and tibial augments as well as stems to provide options for use during reconstructive surgery, particularly revision cases. The system is manufactured from CoCrMo with the exception of the tibial "gliding surfaces" which are manufactured from UHMWPE and the tibial mask which is made of PEEK. The system is made up of numerous components available in various sizes. All components are sterile and for single use only. All components manufactured from CoCrMo are also available with a ZrN (Zirconium nitride) coating which has been cleared in Aesculap Columbus AS Knee submission (K071220) and described in cleared Columbus Revision submission (K083772).

The provided text describes a 510(k) premarket notification for a medical device, the Columbus REVISION Knee System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or safety through clinical trials with defined acceptance criteria for device performance as would be seen in a PMA or De Novo submission.

Therefore, much of the requested information regarding acceptance criteria, specific studies proving performance against those criteria, sample sizes, expert ground truth, MRMC studies, and standalone algorithm performance, is not applicable or not present in this type of regulatory document.

However, I can extract information related to the performance data provided in the 510(k) submission.

Here's a breakdown of the available information based on your request:

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

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

• Sample Size: The document does not specify the number of samples (individual devices or components) used for the endurance testing.
• Data Provenance: The study was "Customized endurance testing based on ASTM F 2722-08," implying it was a laboratory-based, prospective engineering test. There is no information on country of origin of data in the context of clinical studies as this was a bench test.

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

• Not applicable. This was a mechanical endurance test, not a clinical study requiring expert interpretation or ground truth establishment in that typical sense. The "ground truth" here is the performance of the predicate device under the same test conditions.

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

• Not applicable. This was a mechanical endurance test, not a clinical study involving human assessment and adjudication.

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

• Not applicable. This device is a knee implant, not an AI or diagnostic imaging device. No MRMC study was performed.

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

• Not applicable. This device is a knee implant; it does not involve algorithms or AI. The endurance testing evaluated the device's mechanical integrity on its own.

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

• For the endurance test, the "ground truth" or reference point was the performance of the legally marketed Columbus REVISION Knee System (the predicate device) under the same customized ASTM F 2722-08 test conditions. The goal was to show "similarity" rather than an absolute performance benchmark.

8. The sample size for the training set

• Not applicable. This device is a medical implant, not an AI algorithm requiring a training set.

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

• Not applicable. This device is a medical implant, not an AI algorithm.

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The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical fixation in skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is intended to be used as an adjunct to fusion in the 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 S4 Spinal System consists of polyaxial screws and monoaxial screws of varying in The SF Opinar Oystom "Oneice" or styles, rods of varying lengths, and fixed and various styles of rod connectors. All implant components are top loading and top tightening. The Styles of Four connectors: Annoufactured from Titanium alloy in accordance with 150 5832/3 and ISO 5832/2.

Acceptance Criteria and Device Performance Study for the S4 Spinal System

This document outlines the acceptance criteria and the study conducted to demonstrate the performance of the Aesculap® Implant Systems S4 Spinal System, specifically focusing on the line extension to add a new parallel rod connector.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA guidance for spinal system 510(k) submissions recommends non-clinical testing to demonstrate substantial equivalence. The acceptance criteria for these tests are implicitly defined as demonstrating performance that is at least equivalent to the identified predicate devices.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated in the provided documents. The studies likely involve a sufficient number of test samples to be statistically significant for mechanical tests as per ASTM standards, but the exact count is not given.
• Data Provenance: The studies were non-clinical mechanical tests conducted in a laboratory setting. The country of origin for the data is not specified but would typically be where these tests were performed (e.g., within Aesculap's facilities or a designated testing laboratory). This is retrospective data in the sense that it's generated for pre-market notification to compare a new device against existing standards and predicates.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. For non-clinical mechanical performance testing of medical devices like spinal systems, "ground truth" is established through physical measurements and adherence to recognized industry standards (e.g., ASTM F1717-11a), rather than expert consensus on diagnostic images or clinical outcomes. The "experts" involved would be engineers and technicians proficient in conducting and interpreting these specific biomechanical tests.

4. Adjudication Method

• Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation of data (e.g., medical images). For mechanical testing, the results are quantitative and objective, measured directly from the physical testing.

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

• No. An MRMC study is not relevant for this type of non-clinical mechanical performance testing. MRMC studies are used to assess the impact of a diagnostic or assistive AI device on human reader performance, which doesn't apply to the S4 Spinal System's mechanical properties.

6. Standalone Performance Study

• Yes. The described performance data focuses on the "subject Aesculap S4 Parallel Rod Connector" itself, indicating a standalone evaluation of its mechanical properties. The tests (Static Axial Compression Bending, Dynamic Axial Compression Bending, Static Torsion) evaluate the device's inherent mechanical performance against established ASTM standards and in comparison to predicate devices, without human interaction as part of the performance metric.

7. Type of Ground Truth Used

• Standardized Mechanical Test Results and Predicate Device Performance Data: The ground truth for these tests is based on the quantitative results obtained from applying recognized ASTM standards (ASTM F1717-11a) to the device and comparing these results to the known performance of legally marketed predicate devices. The "truth" is whether the new connector's performance metrics meet or exceed those of the established predicate devices under the specified test conditions.

8. Sample Size for the Training Set

• Not Applicable. This is a non-clinical mechanical performance study, not an AI or algorithm-based study that requires a training set.

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

• Not Applicable. As no training set was used, this question is not applicable.

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