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The Prevision Hip System is intended for cementless revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. The Prevision Hip System is intended for revision only.

The Recon Ring is intended to bridge the areas of acetabular bone loss in patients with acetabular bone deficiency. In addition, the Recon Ring is intended to provide support for an all polyethylene acetabular implant in a cemented application.

Diagnostic indications for use of this device include acetabular dysplasia, osteoporosis, protrusion acetabuli, cystic acetabular roof, reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery.

The general indications associated with the use of the Recon Ring in total hip arthroplasty include:

• Advanced joint destruction resulting from degenerative, posttraumatic or rheumatoid arthritis.
• Fracture or avascular necrosis of the femoral head,
• Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty and total hip replacement.

The Prevision Hip System is a modular system which consists of a proximal body, distal stem and a tension nut. The three individual components utilize a modular junction. The individual components may be assembled by the surgeon in the operating room or in situ to allow independent sizing of the proximal body and distal stem. All proximal components are able to mate with all distal components providing a comprehensive range of combinations offering optimal flexibility. It is designed for use with currently available Aesculap Implant Systems femoral heads, acetabular components and Bipolar cups.

The Prevision Hip System is manufactured from Titanium Alloy and intended for cementless use. The proximal body is plasma sprayed (Plasmapore®) with a secondary coating of Calcium Phosphate (u-CaP®).

The Recon Ring will be offered in three sizes with left and right configurations. The Recon Ring is manufactured from Titanium. It is designed to be used with the PE acetabular cup cleared in BiContact (K040191).

The provided text describes a medical device submission (K102424) for the "Prevision Hip System with Recon Ring." However, it does not contain the detailed information requested regarding clinical study findings, acceptance criteria, or performance metrics in a format that would allow for a direct numerical comparison of acceptance criteria vs. device performance.

Instead, the document states:

"Testing of the Aesculap Implant Systems Prevision Hip System was performed in accordance with ISO 7206 and ASTM F 2068 and the results were found to be similar to other legally marketed predicate devices."

This indicates that the device's performance was evaluated against established industry standards for hip implants and compared to predicate devices, but no specific numerical acceptance criteria or performance data for the device itself are provided. The FDA's letter of clearance confirms substantial equivalence based on this information but does not elaborate on specific performance metrics.

Therefore, an exhaustive answer to your request is not possible with the provided document. I can, however, extract the relevant information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in numerical terms within the document. The general acceptance criterion appears to be "similarity to other legally marketed predicate devices" and compliance with ISO 7206 and ASTM F 2068 standards.
• Reported Device Performance: "the results [of testing per ISO 7206 and ASTM F 2068] were found to be similar to other legally marketed predicate devices." No specific numerical performance values are given.

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

• The document implies that the testing was pre-clinical/bench testing rather than a clinical study with human subjects. Thus, terms like "test set" in the context of clinical data provenance are not directly applicable.
• Sample Size for Test Set: Not specified.
• Data Provenance: Not applicable in the context of human data. The testing was conducted in accordance with referenced ISO and ASTM standards, which are international/US standards for medical device testing.

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

• This information is not applicable. The testing described is mechanical and material testing, not a study involving expert assessment of images or clinical outcomes.

4. Adjudication Method for the Test Set:

• Not applicable, as it's not a clinical study involving human assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

• No, a MRMC comparative effectiveness study was not done. The document describes pre-clinical testing, not a clinical study.

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

• Not applicable. This is a physical medical device (hip implant), not a software algorithm.

7. The Type of Ground Truth Used:

• For the pre-clinical performance testing, the "ground truth" would be established by the specified test methods and acceptance limits defined in ISO 7206 and ASTM F 2068 standards. These standards typically define how performance (e.g., fatigue strength, wear resistance) is measured and what constitutes acceptable results.

8. The Sample Size for the Training Set:

• Not applicable. As this is a physical medical device and the described testing is pre-clinical, there is no "training set" in the context of machine learning or algorithms.

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

• Not applicable for the same reasons as above.

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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 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.

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