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The Aesculap Implant Systems® activL® Next Generation Instrumentation are indicated for the successful implantation of the Aesculap activL® device. These instruments are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of the activL® device.

The activl ® Next Generation Instrumentation would allow successful implantation of the Aesculap activL® device. These are manual surgical instruments which aid in selecting, placing, and revising the activL® device. These activL® instruments device comprises of trial, trial holders, single and double chisels, implant inserter, depth stop, depth stop driver, and impaction caps.

This document is a 510(k) Premarket Notification from the FDA regarding the activL® Next Generation Instrumentation. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving a device meets specific acceptance criteria based on metrics like sensitivity, specificity, or AUC for an AI/CADe device.

Therefore, the requested information regarding acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found or inferred from the provided text. The document pertains to manual surgical instrumentation, not an AI or diagnostic device that would typically undergo such rigorous performance evaluation.

The "Performance Testing Summary" section (Page 4, {4}) briefly mentions:

• Simulated use/Functional testing
• Transit testing
• Sterilization/Cleaning validation

These are standard engineering and manufacturing performance tests for reusable surgical instruments, not clinical performance studies with human subjects or AI algorithm evaluations. The conclusion explicitly states the device is substantially equivalent based on "indication, design, materials, function, and performance" relative to predicate devices, and that performance testing demonstrated it "do not introduce any new question of safety or effectiveness."

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The CoreHip® System is intended to replace a hip joint. The device is intended for:

· Patients suffering from severe hip pain and disability due to rheumatoid arthritis, 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 epiphysis
• · Patients suffering from disability due to previous fusion
• · Patients with acute femoral neck fractures

The CoreHip® System is available with two (2) types of femoral stem is manufactured from CoCrMo and is intended for cemented fixation and the other femoral stem is manufactured from Ti with Plasmapore® and is intended for uncemented (pressfit) fixation.

The CoreHip System includes cemented and uncemented (pressfit) stems. The CoreHip uncemented (pressfit) Stem is offered as CoreHip uncemented (pressfit) Primary and CoreHip uncemented (pressfit) Extended which are manufactured from Ti with a Ti plasma spray coating (Plasmapore®) proximally and rough-blasted distally. The Cemented Stem is offered as CoreHip Cemented Primary stem which is manufactured from CoCrMo. The CoreHip System includes stem variants of varus, neutral, valgus and dysplasia is offered in CoreHip uncemented (pressfit) Primary only), which have different medial curves in order to address different patient morphologies. The femoral stems will be offered in a 12/14 external taper in stem sizes 1 to 11 for the uncemented (pressfit) design (primary (except size 1 dysplasia) and extended) and sizes 1-11 for the cemented design.

This document is a 510(k) premarket notification for a hip implant system, not an AI/ML device study. Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for AI/ML device is not present in this document.

The document discusses the substantial equivalence of the CoreHip® System to predicate devices. It focuses on the safety and effectiveness of the traditional medical device (hip implant) through:

• Indications for Use: Defining for which patient conditions the device is intended.
• Technological Characteristics Comparison: Comparing materials, fixation types, stem sizes, and geometry with predicate devices.
• Performance Data: This section details non-clinical performance testing, primarily mechanical endurance testing, to demonstrate the device's substantial equivalence to previously cleared devices.

Here's what can be extracted regarding performance, even though it's not related to AI:

Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria with specific numerical targets and reported device performance values in the way you might expect for a diagnostic or AI device. Instead, the performance claims are based on compliance with established standards and comparison to predicate devices.

Key Performance Statements:

• "Endurance properties of the CoreHip cemented and uncemented (pressfit) stem, head and neck were evaluated in accordance to Guidance for Industry and FDA Staff Non-clinical Information for Femoral Prostheses, September 17, 2007; ASTM F2068-15; ISO 7206-4 and ISO 7206-6."
• "Additional Femoral head/Taper testing was completed."
• "Range of Motion (ROM) analysis to satisfy the requirements of ISO 21535 was completed."
• "Testing demonstrated that the subject device is substantially equivalent to the Primary and reference predicate devices."
• "PYROGEN TESTING: LAL testing was completed and met the pyrogen limit of 20 E.U./device."

Essentially, the acceptance criteria are implicitly met by:

1. Adherence to recognized industry standards: ASTM F2068-15, ISO 7206-4, ISO 7206-6, and ISO 21535.
2. Demonstrating substantial equivalence to legally marketed predicate devices in terms of performance and safety.
3. Meeting specific pyrogenicity limits: LAL testing confirmed meeting the pyrogen limit of 20 E.U./device.

As this is a 510(k) for a physical implant, specific "reported device performance" in terms of accuracy, sensitivity, or specificity (relevant to AI/ML) is not applicable. The performance is assessed on mechanical integrity, fatigue life, and biocompatibility, which are demonstrated through testing against relevant standards.

The remaining points of your request are not applicable to the provided document as it describes a non-AI medical device submission.

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The VEGA Knee System is indicated for use in reconstruction of the diseased by ostearthritis, theumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties 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 aon-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.

The VEGA Knee is designed for use with bone cement.

The Columbus Total Knee System is indicated for use in reconstruction of the diseased by osteoarthritis, theumatord arthritis, post-traumatic arthritis, the need to revise failed arthroplasties 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 and on non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.

The Columbus Knee is designed for use with bone cement.

All Poly Tibia posterior stabilizing and cruciate retaining implants are a line extension to the VEGA Knee System® and Columbus Total Knee System, respectively. The posterior stabilizing version is being introduced to the VEGA Knee System® and the cruciate retaining, deep dish version is being introduced to the Columbus Total Knee System. The subject implants are available with an optional centralizer.

VEGA Knee System® is a semi-constrained cemented prosthesis with a posterior stabilized (PS) design. Columbus Total Knee System includes both cruciate retaining and posterior stabilizing variants of the femoral, tibial and meniscal components.

For both knee systems, the femoral component, tibial plateau and extension stems are manufactured from Cobalt Chromium Molybdenum alloy (CoCrMo), available with an optional Zirconium nitride (ZrN) coating. The tibial gliding surface (insert), patella and All Poly Tibia are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The optional centralizer, designed to be used with the All Poly Tibia is made of polymethyl methacrylate (PMMA). The patella and All Poly Tibia incorporate X-ray markers. The materials of the X-ray markers in the patella are wrought stainless steel and the All Poly Tibia X-ray markers consist of a titanium peg and a tantalum ball. The tibial plug is made of PEEK.

VEGA and Columbus Knee Systems are made up of numerous components available in various sizes. The VEGA Knee System® is compatible with Aesculap Columbus cruciate retaining/posterior stabilizing tibial plateaus (CR/PS and CRA/PSA) and augments.

VEGA and Columbus components are sterile and intended for single use only.

The provided document is a 510(k) premarket notification for the VEGA Knee System® and Columbus Total Knee System, specifically regarding the introduction of All Poly Tibia posterior stabilizing and cruciate retaining implants with an optional centralizer. It describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, the document does not contain acceptance criteria for device performance or a study proving that the device meets such criteria.

Instead, it focuses on demonstrating substantial equivalence to predicate devices by addressing technological characteristics and manufacturing processes. The "Performance Data" section briefly mentions:

• A risk analysis.
• Biomechanical testing.
• A comparison evaluation of wear.
• Biocompatibility of X-ray markers.
• Validation and verification of new instruments.

The conclusion of this section is that these analyses "raised no new issues of safety and efficacy for the design modifications described herein." This indicates that the intent was to show that the new components did not negatively impact the established safety and efficacy of the existing systems, rather than to present new acceptance criteria or a study demonstrating achievement of those criteria.

Therefore, I cannot provide the requested information from the given text as it is not present. The document focuses on regulatory approval through substantial equivalence, not on quantifiable performance acceptance criteria and a study demonstrating their achievement.

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