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The Portland Ceramic (Biolox-Forte) Femoral Head has the following indications for use:

• The patient should be skeletally mature.

· The patient's condition should be due to one or more of the following:

1. Osteoarthritis.

2. Rheumatoid arthritis.

3. Tumor conditions involving the upper third of the femur or of the Acetabular.

4. Ankylosing spondylitis.

5. Psoriatic arthritis.

6. Old osteomyelitis - with a long infection-free period and a normal WBC, ESR and Creactive protein.

7. Non union of femoral neck fracture or avascular necrosis of the femoral head.

8. Post-traumatic fracture/dislocation of the hip.

9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling.

10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.

11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.

The Portland Portland Ceramic (Biolox-Forte) Femoral Head is provided as a single component. The device is manufactured from an Alumina Oxide (Biolox-Forte) and is available in various sizes. The internal bore of the femoral head is designed to taper look (12/14) with the external male taper on a femoral hip stem providing articulation with a suitable acetabular module.

The provided document pertains to a 510(k) premarket notification for the Portland Ceramic (Biolox-Forte) Femoral Head, a ceramic femoral head prosthesis. It describes the device, its indications for use, and a summary of testing performed to demonstrate substantial equivalence to predicate devices.

However, the document does not contain information typically associated with acceptance criteria and studies for AI/ML-driven medical devices.
Instead, it details the regulatory submission for a physical medical implant. Therefore, the questions about AI/ML device performance, ground truth, expert adjudication, and training/test set sizes are not applicable to this document.

The "SUMMARY of TESTING" section states that "Portland Orthopaedics, Ltd. has provided analytical and mechanical testing to demonstrate the substantial equivalence of and compliance to standards for the Ceramic (Biolox-Forte) Femoral Head." This suggests that the acceptance criteria for this medical device relate to its material properties, mechanical performance, and compliance with established standards for ceramic femoral heads, rather than diagnostic accuracy or algorithmic performance.

Without further information on the specific analytical and mechanical testing conducted, it is not possible to provide a table of acceptance criteria and reported device performance in the format requested for AI/ML devices.

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The M-COR Modular Hip System has the following indications for use:

• · The patient should be skeletally mature.
• · The patient's condition should be due to one or more of the following:
  • Osteoarthritis. 1.
  • 2. Rheumatoid arthritis.
  • 3. Ankylosing spondylitis
  • 4. Psoriatic arthritis.
  • 5. Tumor conditions involving the upper third of the femur or of the acetabulum
  • Old osteomyelitis with a long infection-free period and a normal WBC, ESR 6. and C-reactive protein.
  • 7. Non-union of femoral neck fracture or avascular necrosis of the femoral head.
  • 8. Post-traumatic fracture/dislocation of the hip.
  • Revision of an unsuccessful arthrodesis with either poor positioning or pain in 9. the hip, or where low back pain or knee pain is becoming disabling.
  • 10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.
  • 11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.

The M-COR (Modular – Center of Rotation) Hip Replacement System is a modular femoral neck and stem component system, to be used for cementless applications.

The M-COR Hip Replacement System is comprised of two units: the first is a Commercially Pure Titanium (CPT) coated femoral stem component manufactured from titanium alloy (Ti-6Al-4V). The second is a femoral neck component from either titanium alloy (Ti-6Al-4V) or cobalt-chrome.

The provided text describes a 510(k) summary for the M-COR Modular Hip System. This document focuses on demonstrating substantial equivalence to predicate devices through design, material, and manufacturing similarities, supported by analytical and mechanical testing. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way typically associated with AI/ML device evaluations.

Therefore, many of the requested fields cannot be filled from the provided text.

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

• 1. A table of acceptance criteria and the reported device performance: This information is not present. The document mentions "analytical and mechanical testing" and "compliance to standards" but no specific acceptance criteria or performance metrics are detailed.
• 2. Sample sized used for the test set and the data provenance: Not applicable in this context. The testing is mechanical/analytical, not based on a "test set" of patient data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not a component of this submission.
• 4. Adjudication method (e.g., 2+1, 3+1, none) 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 is a hip replacement system, not an AI/ML diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a mechanical device. The "ground truth" for a hip implant would be its physical properties and mechanical performance against established standards, not clinical outcomes in the same vein as diagnostic algorithms.
• 8. The sample size for the training set: Not applicable. No "training set" in the AI/ML sense is mentioned.
• 9. How the ground truth for the training set was established: Not applicable.

What is present and relevant to a traditional medical device submission:

The document states that the M-COR Modular Hip System underwent:

• Analytical and mechanical testing to demonstrate substantial equivalence and compliance to standards.
• The comparison was against predicate devices: S-ROM Femoral Hip Stem, the Apex Modular Hip, and the Margron Hip Replacement.
• The basis for substantial equivalence was similarities of design, intended use, material, and manufacturing methods.
• The conclusion was that "differences in the M-COR Modular Hip System™ do not raise any new issues of safety and effectiveness."

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The Equator Plus™ Acetabular Cup System has the following indications for use:

• The patient should be skeletally mature.
• The patient's condition should be due to one or more of the following:
  1. Osteoarthritis.
  2. Rheumatoid arthritis.
  3. Tumor conditions involving the upper third of the femur or of the Acetabular.
  4. Ankylosing spondylitis.
  5. Psoriatic arthritis.
  6. Old osteomyelitis with a long infection-free period and a normal WBC, ESR and C-reactive protein.
  7. Non union of femoral neck fracture or avascular necrosis of the femoral head.
  8. Post-traumatic fracture/dislocation of the hip.
  9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling.
  10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.
  11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.

The Equator Plus™ Acetabular Cup System is comprised of two units the first is a coated outer shell manufactured from titanium alloy (Ti-6A1-4V). The second unit is a ultra high molecular weight polyethylene (UHMWPE) liner force fitted into an outer cobalt chrome metal dome casing. The UHMWPE liner is provided as a single pre-assembled component. The Equator Plus™ Acetabular Cup System is to be used as part of a modulary total hip replacement system in a cementless application.

Here's a breakdown of the acceptance criteria and study information for the Equator Plus™ Acetabular Cup System, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (an acetabular cup system), which primarily focuses on demonstrating substantial equivalence to predicate devices through testing and material qualification. It does not present a clinical study or performance data in the way one would for an AI/algorithm-based diagnostic or assistive device. Therefore, many of the requested fields related to clinical performance, ground truth, expert review, and AI specific metrics (like MRMC or standalone performance) will be answered as "Not Applicable" or "No information provided," as these types of studies are not relevant to the approval process described in this document for an orthopedic implant.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: In the context of this 510(k), acceptance criteria for orthopedic implants are typically centered around demonstrating substantial equivalence to already approved predicate devices. This is achieved through:

• Material compatibility and strength: Ensuring the chosen materials (titanium alloy, UHMWPE, cobalt chrome) meet industry standards and perform as expected under physiological conditions.
• Mechanical performance: Testing to ensure the components (shell, liner, interface) can withstand loads and stresses encountered in the body, resist wear, and maintain structural integrity. This is often done via analytical and mechanical testing, comparing results to those of predicate devices or established standards.
• Biocompatibility: Ensuring the materials are safe for implantation and do not elicit adverse biological responses.
• Design validation: Confirming that the device design facilitates proper surgical implantation and long-term function.

The document states that "Testing and materials qualification have demonstrated that the differences in the Equator Plus™ Acetabular Cup System do not raise any new issues of safety and effectiveness" and that the device has "proved and compliance to standards." This is the general statement of performance proving it met the (implied) acceptance criteria for substantial equivalence. Specific quantitative performance metrics (e.g., tensile strength values, wear rates) are not provided in this summary but would have been part of the detailed testing report submitted to the FDA.

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

• Sample Size: No information provided. This type of device approval relies on mechanical and analytical testing of the device itself and its components, not on a "test set" of patient data or images.
• Data Provenance: No information provided for clinical data, as it was not a clinical study. Mechanical and analytical testing data would originate from laboratory settings.

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

• Number of Experts: Not applicable. Ground truth, in the sense of clinical diagnoses or image interpretations by experts, is not relevant for this type of device submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Not applicable. (No clinical test set as described for an AI/algorithm device).

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

• No. This is an orthopedic implant, not an AI-assisted diagnostic or imaging device.

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

• Not applicable. This is an orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

• For the testing described, the "ground truth" would be established engineering and material science standards and specifications (e.g., ASTM standards for mechanical testing, ISO standards for biocompatibility, material properties of the chosen alloys and polymers). These define the expected performance thresholds and material characteristics. The device's performance against these standards constitutes its "truth" for this approval process.
• No "expert consensus," "pathology," or "outcomes data" in the typical clinical study sense were used as ground truth for initial device approval, as this is a pre-market notification demonstrating substantial equivalence through physical testing, not a clinical trial proving efficacy and safety in patients.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of an orthopedic implant approval. Device design and material selection are based on engineering principles and established medical knowledge, not machine learning training.

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

• Not applicable.

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The MARGRON™ Hip Replacement System is intended for primary or revision restruction, without bone cement, of the femoral portion of a severely disabled and/or very painful hip joint, where radiographic evidence of sufficient sound bone is present. The patient should be skeletally mature. The patient's condition should be due to one or more of the following: Osteoarthritis, Rheumatoid arthritis, Tumor conditions involving the upper third of the femur or the acetablym, Ankylosing spondylitis, Psoriatic arthritis, Old osteomyelitis - with a long infection-free period and a normal WBC. ESR and C-reactive protein, Non union of femoral neck fracture or avascular necrosis of the femoral head, Post-traumatic fracture/dislocation of the hip, Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling, Revision of an unsuccessful cemented or un-cemented hip replacement stem, providing sufficient bone stock is present, Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.

The MARGRON 100 hip replacement stem has been designed to be used in an uncemented mode in bone which is of good quality physiologically and which will heal quickly. The MARGRON TM Femoral Stem is a modular prosthesis consisting of - A tapering stem cone with two different speed external threads and longitudinal . derotation columns. - A neck component which allows the optimum angle of anteversion to be selected ● after stem insertion. - . Precision milling and tapping is used to prepare the femur and stem insertion is by "screw home" rotation. - . A unique set of instruments have been designed to insert and extract the prosthesis.

The provided document is limited to a Special 510(k) Notification for the MARGRON™ Hip Replacement System, asserting substantial equivalence to an existing predicate device (K992158). This type of submission generally relies on demonstrating that changes to a previously cleared device do not introduce new questions of safety or effectiveness.

Therefore, the document does not contain the detailed information typically found in a study demonstrating performance against specific acceptance criteria for a novel device. It refers to the testing of the original design of the predicate device.

Based on the provided text, here's what can be extracted and what cannot:

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

This information is not provided in the document. The document states: "All materials used in the fabrication of this MARGRON™ Hip Replacement System were evaluated with the original design through physical testing (fatigue, torque and corrosion testing) and biocompatibility testing. It has been shown to be substantially equivalent to the predicate device."

This implies that the original device underwent testing, and the current device's materials are equivalent to those used in the original. However, specific acceptance criteria for these tests and the detailed results are not presented.

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. The document makes generic statements about "physical testing" and "biocompatibility testing" of the "original design," but no details about sample sizes or data provenance are given.

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 information is not applicable/provided. Since this is a physical medical device (hip replacement system) and not a diagnostic AI/software, the concept of "ground truth" established by human experts in the context of a test set (e.g., for image interpretation) does not apply. The testing mentioned (fatigue, torque, corrosion, biocompatibility) are laboratory-based physical and chemical tests, not clinical evaluations requiring expert interpretation of results in the same way.

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

This information is not applicable/provided for the same reasons as point 3.

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 information is not applicable/provided. This is a physical hip replacement implant, not an AI or diagnostic tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are irrelevant to this device.

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

This information is not applicable/provided. This is a physical hip replacement implant, not an algorithm or software.

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

This information is not applicable/provided. As explained in point 3, the testing involves physical and chemical property assessments, not diagnostic evaluations requiring a "ground truth" derived from expert consensus, pathology, or outcomes data. The "ground truth" for material properties would be established by validated scientific methodologies and standards.

8. The sample size for the training set

This information is not applicable/provided. The concept of a "training set" applies to machine learning and AI, which is not relevant to this physical implant device.

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

This information is not applicable/provided for the same reasons as point 8.

In summary:

The provided document is a regulatory submission for a hip replacement system, focusing on demonstrating substantial equivalence to a predicate device based on similar design and materials. It does not provide details about specific acceptance criteria or performance studies in the format requested, as these are typically part of a full Premarket Approval (PMA) application or a more extensive 510(k) for a novel device, especially for AI/software products. The testing mentioned pertains to the physical and biocompatible properties of the materials used in the original design of the predicate device.

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The Margron™ Hip Replacement System is intended for primary or revision restruction, without bone cement, of the femoral portion of a severely disabled and/or very painful hip joint, where radiographic evidence of sufficient sound bone is present.

The patient should be skeletally mature. The patient's condition should be due to one or more of the following:

• Osteoarthritis
• Rheumatoid arthritis
• Ankylosing spondylitis
• Psoriatic arthritis
• Old osteomyelitis with a long infection free period and a normal WBC, C- Reactive protein and ESR
• Non union of femoral neck fracture or avascular necrosis of the femoral head
• Post-traumatic fracture/dislocation of the hip
• Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling
• Revision of an unsuccessful uncemented or cemented hip replacement stem, providing sufficient bone stock is present
• Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.

The Margron™ hip replacement stem has been designed to be used in an uncemented mode in bone which is of good quality physiologically and which will heal quickly.

The Margron™ Femoral Stem is a modular prosthesis consisting of:

• A tapering stem cone with two different speed external threads and longitudinal derotation columns.
• A neck component which allows the optimum angle of anteversion to be selected after stem insertion.
• Precision milling and tapping is used to prepare the femur, and stem insertion is by 'screw home' rotation.
• A unique set of instruments have been designed to insert and extract the prosthesis.

The provided document is a 510(k) summary for the Margron™ Hip Replacement System. This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device, rather than novel devices requiring extensive clinical trials to demonstrate safety and effectiveness.

Therefore, the document does not contain information about a study designed to prove the device meets specific acceptance criteria in the way a clinical trial for a new drug or a novel medical device would. Instead, it focuses on demonstrating substantial equivalence to existing, legally marketed devices.

Because of this, I cannot extract the following information about acceptance criteria and a study proving their fulfillment:

1. A table of acceptance criteria and the reported device performance: This document doesn't define quantitative clinical "acceptance criteria" for the Margron system or report clinical performance against such criteria. The "Mechanical Characteristics" section mentions fatigue, torque, and corrosion tests were performed, and the results showed "substantial equivalence to the predicate devices," but no specific numerical criteria or performance data are provided.
2. Sample size used for the test set and the data provenance: Not applicable, as there's no clinical "test set" in the context of a comparative effectiveness study mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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 hip replacement system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a clinical performance study. The "ground truth" for substantial equivalence is defined by comparison to predicate devices, which involves design, materials, and intended use, not clinical outcomes from a specific study outlined here.
8. The sample size for the training set: Not applicable, as there's no 'training set' in the context of a clinical performance study for this type of device submission.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding "acceptance criteria" and "proof":

The "acceptance criteria" for marketing approval of the Margron™ Hip Replacement System under a 510(k) pathway are based on demonstrating substantial equivalence to predicate devices already on the market.

Study/Evidence for Substantial Equivalence:

The document states:

• "The Margron Hip is similar in design, materials and intended use to" a list of predicate devices (Metagen Modular Femoral Hip System, Biomet Impact, Mallory-Head, S-ROM, Infinity, Modular Hip System).
• Mechanical Characteristics: "The Margron Hip System has been evaluated by use of the fatigue, torque and corrosion tests. It has been shown to be substantially equivalent to the predicate devices." (Page 3)
• Materials: The material composition (Chrome Cobalt, Calcium Phosphate Coating) is specified and stated to be "implant grade materials." (Page 3)
• Intended Use/Indications: The stated indications for use are similar to those typically found for hip replacement systems and are implied to be consistent with the predicate devices. (Page 2, Page 5)

In summary, for a 510(k) submission like this, the "study" is a comparison to predicate devices, and the "acceptance criteria" revolve around proving substantial equivalence in terms of design, materials, manufacturing processes, and performance (often assessed through non-clinical testing like mechanical tests). This is distinct from a clinical trial that evaluates specific performance metrics in human subjects against predefined clinical acceptance criteria.

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