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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).

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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 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 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 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 re numeratured from Ti with Plasmapore with or without u-CaP®. The Metha® Hip System (uncemented, press-fit fixation) is intended to replace a hip joint. The device is intended for: skeletally mature individuals undergoing primary surgery for total hip replacement . 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 provious 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 Aesculap Implant Systems BIOLOX® OPTION Ceramic Femoral Head System consist of a ceramic head manufactured from an alumina matrix composite available in diameters of 28, 32, and 36 mm and a titanium adapter for the femoral stem cone with a range of neck lengths. The BIOLOX® OPTION Ceramic head provides the surgeon another option to both the metal and alumina ceramic femoral heads for use in total hip arthroplasty. Two Metha® XL Heads are available. The CoCrMo head is offered in two diameters (28mm and 32mm). The BIOLOX® delta ceramic head is composed of an alumina matrix composite and is available in two diameters (32mm and 36mm).

The provided text describes a medical device submission (K090299) for the BIOLOX® OPTION Ceramic Femoral Head System and Metha® XL Heads. It outlines the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain information regarding acceptance criteria or a study proving the device meets those criteria in the context of performance metrics like sensitivity, specificity, accuracy, or other statistical measures typically found in clinical studies or performance evaluations for AI/ML devices.

Instead, the "Performance Data" section lists various guidance documents from the FDA that were followed for testing. This suggests that the "acceptance criteria" for this device are related to compliance with these established standards and guidelines for orthopedic implants, rather than statistical performance thresholds from a specific study.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, experts, adjudication, MRMC studies, standalone performance, and ground truth for a clinical or AI/ML study cannot be extracted from this document.

Here's an attempt to answer based on the available information:

1. Table of acceptance criteria and the reported device performance:

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

• Not applicable/Not provided. The document refers to engineering and material testing standards, not a clinical "test set" with patient data.

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

• Not applicable/Not provided. Ground truth in this context would refer to material science and mechanical engineering standards, not expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set:

• Not applicable/Not provided. This concept is for clinical studies with human review of data.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not done. The document focuses on regulatory compliance for mechanical and material properties of an implant, not clinical effectiveness studies comparing human readers with and without AI assistance.

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

• Not applicable/Not provided. This device is a physical orthopedic implant, not an algorithm or software.

7. The type of ground truth used:

• The "ground truth" for this device's performance would be established through material property testing, mechanical performance testing, and biocompatibility assessments based on the referenced FDA guidance documents and recognized international standards (e.g., ISO standards for implants, not specified in detail here but implied by "where applicable"). This is not "expert consensus, pathology, or outcomes data" in the typical sense of AI/ML evaluation.

8. The sample size for the training set:

• Not applicable/Not provided. There is no "training set" in the context of an AI/ML algorithm for this physical device.

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

• Not applicable/Not provided. There is no "training set" or corresponding ground truth for an AI/ML algorithm for this physical device.

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