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The Excia Hip 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 ephiphysis

• · Patients suffering from disability due to previous fusion
• · Patients with acute femoral neck fractures

The Excia Hip System is available with two (2) femoral stems. One is manufactured from CoCr and intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without uCaP®.

Excia T cemented femoral stem is manufactured from CoCrMo. The femoral stem will be offered in a 12/14 taper in stem sizes 10 to 20. The stems are designed without a trochanter wing and features a shorter stem length with an asymmetrical distal tip.

Excia T femoral stem is intended for cemented use.

The provided document is a 510(k) premarket notification for a medical device, specifically the Excia Total Hip System. This type of document is a regulatory submission to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, not a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study would for an AI/CADe device.

Therefore, many of the requested categories are not applicable or cannot be extracted from this type of document. The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and pre-clinical performance data (e.g., endurance testing), rather than clinical performance measured against acceptance criteria with patient outcomes.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Not Applicable / Not Provided in this format. This document is a 510(k) for a medical implant (total hip system), not an AI/CADe device. The "acceptance criteria" here relate to demonstrating substantial equivalence to a predicate device through material, design, and mechanical testing, rather than clinical performance metrics (like sensitivity, specificity, AUC) for an AI algorithm.
• The performance data mentioned are related to mechanical endurance properties, not clinical outcomes or diagnostic accuracy.

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 / Not Provided. No "test set" in the context of an AI algorithm is mentioned. The testing described is mechanical (endurance properties) on physical device samples, not on 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 / Not Provided. There is no mention of experts establishing a "ground truth" related to patient data, as this is a hip implant, not a diagnostic device.

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

• Not Applicable / Not Provided. No adjudication method is mentioned for any "test set."

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 / Not Provided. This is not an AI-assisted device. No MRMC study was done, nor is there any mention of human readers or AI assistance.

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

• Not Applicable / Not Provided. This is not an algorithm.

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

• Not Applicable / Not Provided. The "performance data" refers to "Endurance properties" of the medical device itself, evaluated against mechanical standards (ASTM, ISO). The "ground truth" for these tests would be the physical properties predicted by the standards, not clinical outcomes or expert consensus.

8. The sample size for the training set

• Not Applicable / Not Provided. There is no "training set" for an AI algorithm mentioned.

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

• Not Applicable / Not Provided. There is no "training set" for an AI algorithm mentioned.

Summary regarding the provided document:

The provided document is a 510(k) premarket notification for a hip implant system. It focuses on demonstrating substantial equivalence to previously cleared devices based on:

• Technological Characteristics: Indications for Use, design, materials of construction, manufacturing process, and range of sizes.
• Performance Data (Pre-clinical): Endurance properties of the stem, head, and neck evaluated according to industry standards (ASTM F2068-09; ISO 7206-4 and ISO 7206-6). The document states: "Testing demonstrated that the subject device is substantially equivalent to the predicate devices."

This document does not contain information about acceptance criteria or studies related to AI/CADe device performance, clinical trials with patient outcomes, or expert reviews for establishing ground truth, as it is a regulatory filing for a different type of medical device (a mechanical implant).

Ask a specific question about this device

The Excia Hip 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 ephiphysis. Patients suffering from disability due to previous fusion. Patients with acute femoral neck fractures. The Excia Hip System is available with two (2) femoral stems. One is manufactured for cemented fixation. The other femoral stem is for uncemented from Ti with Plasmapore with or with or without yCaP®.

Excia T femoral stem is manufactured from Titanium (Ti) with a Plasmapore coating. The femoral stem will be offered in a 12/14 taper in stem sizes 8 to 20. The stems are designed without a trochanter wing and features a shorter stem length with an asymmetrical distal tip. Excia T femoral stem is intended for uncemented use.

The provided text describes a 510(k) premarket notification for the Excia T femoral stem, a component of the Aesculap Implant Systems Excia Total Hip System. This submission aims to demonstrate substantial equivalence to previously cleared predicate devices, not to establish novel performance criteria for a new device type through extensive clinical trials or complex AI model validation. Therefore, many of the requested categories for acceptance criteria and study details are not fully applicable or explicitly stated in the context of a Class II medical device 510(k) submission focused on a line extension.

Here's an attempt to extract and interpret the information based on the provided text, acknowledging the limitations inherent in a 510(k) for a hip implant component:

The acceptance criteria and study that proves the device meets the acceptance criteria are as follows:

The core acceptance criterion for a 510(k) submission, especially for a line extension like the Excia T femoral stem, is demonstrating substantial equivalence to existing, legally marketed predicate devices. This means the new device must be as safe and effective as the predicate device(s) and does not raise different questions of safety and effectiveness.

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

• Indications for Use
• Design
• Materials of Construction
• Manufacturing Process
• Range of Sizes Offered | The Excia T femoral stem was found to be "substantially equivalent" to the predicate devices (Aesculap Implant Systems Excia Total Hip System (K092143 and K060918) and Smith & Nephew Synergy Hip System) based on:
• Indications for Use
• Design
• Materials of Construction
• Manufacturing Process
• Range of Sizes Offered |
  | Mechanical/Endurance Properties: The device's mechanical performance (e.g., fatigue strength) must meet established standards for femoral prostheses to demonstrate safety and integrity under physiological loading. | Testing demonstrated that the subject device is "substantially equivalent" to the predicate devices. Specific standards followed include:
• Guidance for Industry and FDA Staff Non-clinical Information for Femoral Prostheses, September 17, 2007
• ASTM F2068-09
• ISO 7206-4
• ISO 7206-6 |

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 explicitly stated as a number of devices. Non-clinical testing typically involves a set number of test articles (e.g., typically 6-12 samples per test condition for fatigue testing), but the exact count is not provided. The data would be generated from new test articles manufactured for the purpose of this submission.
• Data Provenance: The data is likely prospective, generated specifically for this 510(k) submission through laboratory testing performed by or for the manufacturer (Aesculap Implant Systems, LLC, located in Center Valley, PA). The country of origin for the data generation would be the USA (or wherever the testing laboratory is located).

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

This question is not applicable in the context of this 510(k) submission. "Ground truth" as applied to clinical data or AI systems with human expert consensus is not part of a non-clinical, mechanical testing report for a hip implant component. The "ground truth" here is adherence to engineering standards and comparison to predicate device specifications. The "experts" involved are likely biomechanical engineers and material scientists conducting and interpreting the tests.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of images or symptoms. For mechanical testing, the results are quantitative measures against established standards or predicate device performance. There is no "adjudication" in this sense. The test results are typically reviewed and approved by internal engineering and regulatory teams along with notified bodies/FDA.

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

This question is not applicable. MRMC studies are used for evaluating diagnostic devices, particularly those involving medical imaging interpreted by human readers, often comparing AI-assisted performance to unassisted human performance. The Excia T femoral stem is a surgical implant, not a diagnostic device or an AI system.

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

This question is not applicable. The Excia T femoral stem is a physical medical device, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

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

The "ground truth" in this context is established by:

• Engineering Standards: Adherence to recognized national and international standards for hip prostheses (e.g., ASTM F2068-09, ISO 7206-4, ISO 7206-6). These standards specify test methods and acceptance criteria for mechanical properties.
• Predicate Device Performance: The established safety and effectiveness profile of the legally marketed predicate devices, against which the new device's technological characteristics and performance are compared to demonstrate substantial equivalence.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of a 510(k) for a mechanical implant. This concept is relevant for machine learning algorithms.

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

This question is not applicable for the same reason as point 8.

Ask a specific question about this device

The Excia Hip 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, 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 epiphysis Patients suffering from disability due previous fusion. Patients with acute femoral neck fractures. The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without u-CaP®.

The Excia M and ML femoral stem are available in one design. The femoral stem is manufactured from TI with a plasma spray coating (Plasmapore) with U-CaP®. The Excia M and ML femoral stem will be offered in an 8/10 or 12/14 taper. This component is intended for uncemented use.

The provided text is a 510(k) summary for the Excia Total Hip System M and ML Femoral Stem. It describes the device, its intended use, and substantial equivalence to predicate devices. However, the document does not include specific acceptance criteria, performance metrics, or details about a study designed to prove the device meets those criteria.

Instead, the "Performance Data" section 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."
• It lists several other guidance documents for orthopedic implant testing that were followed.

This indicates that the device underwent a battery of standardized tests required by the FDA for orthopedic implants. However, the document does not present:

• A table of specific acceptance criteria (e.g., minimum fatigue strength, maximum wear rate).
• Any reported device performance against such specific criteria.
• Details about a clinical study with human subjects or a comparison to AI.

Therefore, I cannot provide the requested information for the following points based only on the provided text:

1. A table of acceptance criteria and the reported device performance: Not explicitly stated.
2. Sample size used for the test set and the data provenance: Not mentioned. The testing refers to physical/mechanical performance rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is related to mechanical testing, not expert-adjudicated clinical data.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as the testing described is mechanical.
8. The sample size for the training set: Not applicable. This is not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The document indicates that the Excia Total Hip System M and ML Femoral Stem met necessary performance data requirements by undergoing various mechanical and material tests in accordance with FDA guidance documents for orthopedic devices. However, it does not specify the exact performance metrics or acceptance criteria for those tests, nor does it describe any studies involving human subjects, AI systems, or expert consensus adjudication. This 510(k) emphasizes substantial equivalence based on material, design, and indications for use, supported by adherence to recognized testing standards for physical implants.

Ask a specific question about this device

The Excia Hip 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, 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 epiphysis Patients suffering from disability due previous fusion. Patients with acute femoral neck fractures. The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or with or with of u CaP®.

The Excia 36mm Ceramic Head is manufactured from ceramic (Al2O3) and conforms to ISO 6474. The 36mm diameter head is offered in three different head lengths (-3.5 mm, 0 mm, and +3.5mm). These ceramic heads allow the surgeon further option to meet the patient's needs.

The provided text does not contain information about acceptance criteria for a device, nor does it describe a study proving the device meets particular acceptance criteria. Instead, it is a 510(k) summary for a medical device (Excia Total Hip System 36mm Ceramic Head), which focuses on establishing substantial equivalence to previously cleared devices.

The text details:

• Device Identification: Trade Name, Common Name, Classification Name, Product Code.
• Substantial Equivalence: It states that the device is a line extension and substantially equivalent to other cleared devices (K042344, K060918).
• Device Description: Material (Al2O3 ceramic), size (36mm diameter), and head lengths.
• Indications for Use: Detailed list of conditions for which the Excia Hip System is intended.
• Technological Characteristics: Comparison to predicate devices, stating similar shapes, sizes, and materials.
• Performance Data: This section mentions 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." It then lists several other specific guidance documents for orthopedic implants that were followed for testing. However, it does not present specific performance data, acceptance criteria, or the results of those tests. It only indicates that relevant guidance documents were followed.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth types, training set details) from the provided text, as this type of information is typically found in detailed study reports or performance data sections which are not included here. The document primarily serves as a declaration of substantial equivalence based on adherence to established guidelines and previous device clearances.

Ask a specific question about this device

The Excia Hip System is intended to replace a hip joint.

The device is intended for:

• Patients suffering from severe hip and disability due to rheumatoid arthritis, osteoarthritis, . traumatic arthritis, polyarthritis, collagen disorders, avascular necosis 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 Excia Hip System is available with two femoral stems. One is manufactured from CoCriMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without y CaP®.

The Excia lateral offset femoral stem is available in two designs and standard lengths. The stem is designed to provide an increased offset during total joint replacement. One is manufactured from Ti with a plasma spray coating (Plasmapore) with or with out u-CaP®. This component is intended for uncemented use. The other femoral component is manufactured from CoCrMo and is intended for cemented use.

The provided text describes a 510(k) premarket notification for the Excia Total Hip System Lateral Offset. This is for a medical device (a hip implant), not a software or AI device. Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI performance metrics (like accuracy, F1-score, sensitivity, specificity, etc.) and associated studies (like MRMC, standalone performance) does not directly apply here.

Instead, for a device like this, acceptance criteria are generally related to biocompatibility, mechanical performance, design specifications, and manufacturing quality, and the "study" demonstrating this involves various types of engineering and materials testing.

Based on the provided text, here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide explicit "acceptance criteria" with numerical targets like a software evaluation would. Instead, it references adherence to established guidance documents and material properties. The "performance data" section indicates that the device met the requirements outlined in these guidance documents.

• "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements"
• "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement"
• "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements"
• "Guidance Document for Testing Non-articulating, "Mechanically Locked" Modular Implant Components"
• "Draft Guidance Document for Testing Acetabular Cup Prostheses"
• "Points to Consider for Femoral Stem Prostheses"
• "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems"
• "Data Requirements for Ultrahigh Molecular Weight Poletheylene (UHMWPE) Used in Orthopedic Devices" | "All required testing... were done where applicable."
  The device met the requirements of the referenced guidance documents for the specified tests. This implies that the device's mechanical, material, and design performance was found to be satisfactory according to these established standards. |
  | Material equivalence to predicate devices (Ti with plasma spray coating / u-CaP, CoCrMo) | "The material used for the Aseculap device is the same as that used to manufacture the predicate devices." |
  | Design and size similarity to predicate devices | "The new lateral offset femoral stems of the Excia Total Hip System are offered in similar shapes and sizes as the predicate devices." |

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

• Sample Size: Not applicable in the context of this device. The testing described is primarily mechanical and materials-based, not involving patient data or test sets in the AI sense.
• Data Provenance: Not applicable. The "data" here refers to test results from laboratory experiments on the physical device and its materials, not collected patient information.

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

• Number of Experts: Not applicable. The "ground truth" for a hip implant's mechanical and material performance is established by scientific and engineering principles, standardized testing protocols, and regulatory guidance, not by expert consensus on data interpretation.
• Qualifications of Experts: Not applicable in the conventional sense of clinical experts interpreting data. The "experts" involved would be biomedical engineers, materials scientists, and regulatory specialists within the company and at the FDA, who define and evaluate the compliance with the testing guidance.

4. Adjudication Method:

• Not applicable. This is a concept related to resolving discrepancies in human interpretation of data, which is not relevant for the described device testing.

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

• No. An MRMC study is relevant for evaluating the impact of AI on human readers' diagnostic performance. This device is a physical implant, not an AI software.

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

• No. This refers to AI algorithm performance. The device is a physical product.

7. The Type of Ground Truth Used:

• Engineering and Material Standards/Specifications: The "ground truth" here is defined by industry standards, FDA guidance documents, and scientific principles governing the mechanical, chemical, and biological properties required for a safe and effective orthopedic implant. For example, a fatigue test will have a specified load and number of cycles that the implant must withstand without failure, based on established biomechanical understanding and regulatory requirements.

8. The Sample Size for the Training Set:

• Not applicable. There is no AI training set for this physical device.

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

• Not applicable. There is no AI training set for this physical device.

In summary, the provided document describes a 510(k) for a physical medical device (a hip implant). The "acceptance criteria" and "study" are focused on demonstrating substantial equivalence to predicate devices through adherence to established mechanical and material testing standards and regulatory guidance, rather than the performance metrics and study designs typically associated with AI/software devices.

Ask a specific question about this device

The Excia Hip System is intended to replace a hip joint. The device is intended for: Patients suffering from severe hip and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necosis 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 Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo. The other femoral stem is for uncemented fixation and manufactured from Ti with Ti plasma spray.

The Excia femoral component is available in two designs. One is manufactured from Ti with a plasma spray coating (Plasmapore). This component is intended for uncemented use. The other femoral component is manufactured from CoCrMo and is intended for cemented use. Both femoral components have a 12/14 trunnion. The ceramic heads are available in head diameters of 28mm, and 36mm in three neck lengths each. They are for use only with the Ti alloy cementless stems. The cemented or cementless femoral stems may be used with the CoCrMo head that was cleared in BiContact (K040191). The acetabular insert is UHMWPE and is available in a 36mm symmetrical design. The 12/14 femoral component and ceramic head are in conjunction with Plasmacup (K042344) for total hip arthroplasty.

The provided text is a 510(k) summary for the Excia Total Hip System with a 12/14 Trunnion and Ceramic Head. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain any information about acceptance criteria or a study proving the device meets specific performance metrics in the way your request describes (e.g., using a test set, ground truth, expert review, or MRMC studies).

Instead, the performance data section states:

"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 Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement',
• 'Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements',
• 'Guidance Document for Testing Non-articulating, "Mechanically Locked" Modular Implant Components',
• 'Draft Guidance Document for Testing Acetabular Cup Prostheses',
• 'Points to Consider for Femoral Stem Prostheses',
• 'Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems and
• 'Data Requirements for Ultrahigh Molecular Weight Poletheylene (UHMWPE) Used in Orthopedic Devices' was completed where applicable."

This indicates that various guidance documents were followed for testing, but it does not provide:

1. Specific acceptance criteria values.
2. Reported device performance values against those criteria.
3. Details of a study involving a test set, experts, ground truth, or statistical analysis (like sensitivity/specificity, AUC typical for AI/diagnostic devices).
4. Any mention of AI, human readers, or comparative effectiveness studies (MRMC).

The document is a regulatory submission for a medical device (hip implant) whose clearance is based on substantial equivalence to existing devices, supported by adherence to various mechanical and material testing standards rather than a clinical performance study as one might expect for a diagnostic or AI-driven device.

Therefore, I cannot populate the table or answer most of your specific questions based on the provided text. The questions seem to be geared towards an AI/software device evaluation, which is not what this 510(k) document describes.

If this were an AI/software device, the information would typically include:

1. Table of Acceptance Criteria and Reported Device Performance:
Not available in the provided text.

2. Sample size used for the test set and data provenance:
Not available in the provided text.

3. Number of experts used to establish the ground truth for the test set and qualifications:
Not available in the provided text.

4. Adjudication method for the test set:
Not available in the provided text.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and effect size:
Not applicable, as this is not an AI/diagnostic device described with MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI/diagnostic algorithm.

7. The type of ground truth used:
Not applicable, as the evaluation here is based on mechanical/material testing against standards, not diagnostic truth.

8. The sample size for the training set:
Not applicable, as there is no "training set" for this type of device evaluation.

9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" for this type of device evaluation.

Ask a specific question about this device

The Excia Hip System is intended to replace a hip joint.

The device is intended for:

• Patients suffering from severe hip 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 . epiphysis
• Patients suffering from disability due previous fusion .
• Patients with acute femoral neck fractures .

The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without µ CaP®.

The Excia Total Hip System is available with two femoral designs. One is manufactured from Ti with a plasma spray coating (Plasmapore) with or with out µ-CaP®. This component is intended for uncemented use. The other femoral component design is manufactured from CoCrMo and is intended for cemented use. Distal centralizers maintain the stem's alignment in the femoral canal. The centralizers are manufactured from PMMA.

The acetabular cup (Plasmacup) is manufactured from Ti and is coated with Plasmapore with or without µ-CaP® as well. Acetabular cup screws can be used for further cup fixation. The acetabular inserts are UHMWPE and are available in symmetrical and asymmetrical designs.

Two femoral heads are available. The CoCrMo and ceramic head can be used with the cemented femoral component. The CoCrMo head can also be used with the Cementless femoral stem.

The provided text describes a 510(k) premarket notification for the Excia Total Hip System with $\mu$-CaP®, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results to prove device performance against specific acceptance criteria.

Therefore, the document does not contain the requested information about acceptance criteria, a specific study proving the device meets those criteria, or the details about sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

Instead, the document states:

• "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."
• It lists several other guidance documents for specific aspects of orthopedic implant testing (e.g., modified metallic surfaces, plasma-sprayed coatings, modular implant components, femoral stem prostheses, calcium phosphate coating).
• The primary method of demonstrating approval is through Substantial Equivalence to legally marketed predicate devices (Excia Total Hip System (K042344), BiContact Hip System with $\mu$-CaP (K043079), and Trident Acetabular Shells: PS-HA (K001448)).

In the context of a 510(k) submission, "performance data" refers to non-clinical bench testing and adherence to relevant guidance documents to demonstrate that the new device is as safe and effective as a legally marketed predicate device. It does not typically involve the kind of detailed clinical study data with acceptance criteria and reader studies that would be common for AI/software-as-a-medical-device (SaMD) devices.

Therefore, I cannot populate the table or answer the specific questions as the necessary information is not present in the provided text.

Ask a specific question about this device

The Excia Hip 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, 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 epiphysis
• Patients suffering from disability due to previous fusion
• Patients with acute femoral neck fractures

The Excia Hip System is available with two femoral stems. One is manufactured from CoCr and is intended for cemented fixation. The other femoral stem is for uncemented fixation and is manufactured from Ti with a Ti plasma spray.

The Excia Total Hip System is available with two femoral designs. One is manufactured from Ti with a Ti plasma spray coating (Plasmapore). This component is intended for uncemented use. The other femoral component design is manufactured from CoCrMo and is intended for cemented use. Distal centralizers maintain the stem's alignment in the femoral canal. The centralizers are manufactured from PMMA.

The acetabular cup (Plasmacup) is manufactured from Ti and is coated with Plasmapore as well. Acetabular cup screws can be used for further cup fixation. The acetabular inserts are UHMWPE and available in symmetrical and asymmetrical designs.

Two femoral heads are available. The CoCrMo heads may be used with either the cemented or cementless femoral stems. However, the ceramic heads are for use only with the Ti alloy cementless stems.

The provided text describes the "Excia Total Hip System" and its clearance through the 510(k) premarket notification process by the FDA. This specific document is a 510(k) summary, which focuses on demonstrating substantial equivalence to already legally marketed devices, rather than presenting de novo clinical study data to prove novel acceptance criteria.

Therefore, the document does not contain information about:

• A table of acceptance criteria and reported device performance directly.
• Sample sizes used for a test set or its data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used (pathology, outcomes data, etc.) for this particular device's testing (as it relies on equivalence).
• Sample size for a training set or how its ground truth was established, because it is comparing to previously approved predicate devices, not training an AI algorithm.

Instead, the provided text indicates that the device met acceptance criteria by demonstrating substantial equivalence to existing predicate devices through comprehensive non-clinical testing.

Here's an overview of how the "acceptance criteria" are addressed in the context of this 510(k) submission:

Acceptance Criteria and Device Performance (Demonstrated by Substantial Equivalence):

The acceptance criteria for the Excia Total Hip System are implicitly that it performs as safely and effectively as its predicate devices, as demonstrated by meeting relevant industry standards and guidance documents for orthopedic implants.

• Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement
• Metallic Plasma Sprayed Coatings on Orthopedic Implants
• "Mechanically Locked" Modular Implant Components
• Acetabular Cup Prostheses
• Femoral Stem Prostheses
• Ceramic Ball Hip Systems
• Ultrahigh Molecular Weight Polyethylene (UHMWPE)

These tests confirmed the device's mechanical integrity and performance characteristics are comparable to or meet the requirements established for substantially equivalent predicate devices. |
| Biocompatibility (Material safety) | Implied by the use of standard materials like CoCr, Ti, Ti plasma spray, UHMWPE, and PMMA, which are well-established in orthopedic implants and have documented biocompatibility. No specific new testing is detailed, but adherence to guidance documents suggests material safety was considered. |
| Clinical Indications for Use (Safety and Effectiveness for specific patient populations) | The indicated uses for the Excia Hip System (rheumatoid arthritis, osteoarthritis, traumatic arthritis, avascular necrosis, etc.) are consistent with those of the predicate devices. The FDA's 510(k) clearance confirms substantial equivalence for these indications. |

Study Proving Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is primarily a non-clinical performance evaluation and a demonstration of substantial equivalence to predicate devices, rather than a de novo clinical trial with human subjects.

• Sample Size Used for Test Set and Data Provenance: Not applicable in the context of this 510(k) summary, as it describes non-clinical testing against established standards and comparison to predicate devices, not a clinical test set from human data. The "test set" would consist of the device components themselves undergoing specified mechanical and material tests.
• Number of Experts Used to Establish Ground Truth & Qualifications: Not applicable. Ground truth is established by engineering standards, material science, and the documented performance of predicate devices.
• Adjudication Method: Not applicable. Performance is measured against predetermined physical properties and regulatory standards.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is a medical device (hip replacement system), not an AI algorithm requiring MRMC studies.
• Standalone Performance (Algorithm Only): Not applicable, as this is a physical implant, not an algorithm.
• Type of Ground Truth Used: The ground truth is rooted in established engineering standards, material specifications, and the historical performance and regulatory clearance of the predicate devices. This includes mechanical properties, material composition, wear rates, and fixation attributes, as defined by the various guidance documents listed.
• Sample Size for Training Set: Not applicable. This device is not an AI algorithm and therefore does not have a "training set."
• How Ground Truth for Training Set was Established: Not applicable.

Summary of the Substantial Equivalence Claim:

Aesculap believes the Excia Total Hip System is substantially equivalent in design and performance to the following predicate devices:

• BiCONTACT Hip System (K040191)
• 36mm V40 Femoral Head Components (K022077)
• Alloclassic Zweymueller (K030373)
• SC Total Hip System (K031474)
• Smith & Nephew Hip System (K022902)
• Pinnacle Duofix HA Acetabular Cup (K031495)
• Trident Porous Ti Acetabular Component with Coating (K013475)

The FDA's clearance (K042344) indicates their agreement that the Excia Total Hip System is substantially equivalent to these predicate devices for its intended use. This substantial equivalence determination is the primary "proof" that the device meets the necessary safety and effectiveness criteria for market entry under the 510(k) pathway.

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