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Mfinity femoral stems are indicated in patients requiring hip arthroplasty.

Total or partial hip arthroplasty is indicated in the following cases:

• Severely painful and/or disabled joint as a result of osteoarthritis, post-traumatic arthritis, inflammatory arthritis or hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute fracture of the femoral head.
• Acute fracture of the proximal femur, suitable to be treated by means of hip arthroplasty.
• Non-union of proximal femur fracture, suitable to be treated by means of hip arthroplasty.
• Primary pathology involving the femoral head but with a non-deformed acetabulum.
• Failure of previous hip surgery:
  • Conservative hip surgery.
  • Internal fixation.
  • Arthrodesis.
  • Partial or total hip arthroplasty.
  • Hip resurfacing replacement.

The Mfinity Femoral System includes implantable devices provided individually packed, sterile and single-use intended for cementless use in total or partial hip arthroplasty to replace the native femoral neck for primary or revision surgery. The product range is composed of three different versions (Mfinity collarless, Mfinity collared and Mfinity L) available in standard and lateral offset.

The Mfinity femoral stem can be combined with the CoCr ball head (K072857, K080885 and K103721), Endo Head (K111145), the MectaCer BIOLOX® forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).

The subject devices are made of titanium alloy according to ISO 5832-11 and coated with Titanium plasma spray according to ASTM F1580 and Hydroxyapatite according with ASTM F1185.

The provided text is an FDA 510(k) clearance letter for the Mfinity Femoral System, which is a hip prosthesis, not a diagnostic AI device. Therefore, the information requested regarding acceptance criteria and studies that prove a device meets those criteria, specifically concerning AI performance metrics, expert adjudication, training set, and test set details, is not applicable to this document.

The document discusses the substantial equivalence of the Mfinity Femoral System to predicate devices based on non-clinical performance data (fatigue tests, ROM evaluation, surface analyses, biocompatibility, shelf-life, pyrogenicity) and states that no clinical studies were conducted.

The acceptance criteria for this type of medical device (hip prosthesis) would typically involve demonstrating mechanical strength, durability, biocompatibility, and sterilization effectiveness based on recognized standards (e.g., ISO, ASTM, European Pharmacopoeia, USP). The "reported device performance" would consist of the results of these non-clinical tests meeting the specified limits of those standards.

Below is a general interpretation of what "acceptance criteria" and "reported device performance" would entail for a hip prosthesis based on the provided document, acknowledging that specific numerical details of these criteria and results are not explicitly stated in this letter but would be in the full 510(k) submission.

Based on the provided FDA 510(k) Clearance Letter for the Mfinity Femoral System:

This document describes the clearance of a hip prosthesis, not an AI-powered diagnostic device. Therefore, the typical elements of acceptance criteria and study designs relevant to AI (such as sensitivity, specificity, AUC, expert consensus, training/test set sizes, etc.) are not applicable to this submission.

The "acceptance criteria" for this device would generally refer to meeting established mechanical, material, and biological performance standards for medical implants. The "study that proves the device meets the acceptance criteria" refers to the non-clinical performance testing conducted.

Here's an attempt to populate the requested table and answer the questions based on the information available, while highlighting the irrelevance of AI-specific questions:

1. Table of Acceptance Criteria and the Reported Device Performance

• Pull-off strength of femoral head
• Range of Motion (ISO 21535) | - Mfinity Fatigue tests performed according to ISO 7206-4 and ISO 7206-6 (Results are assumed to have met specified limits)
• Pull-Off Test On CoCr Femoral Head performed (Results are assumed to have met specified limits)
• Evaluation of ROM according to ISO 21535 performed (Results are assumed to have met specified limits) |
  | Material Performance | - Coating characteristics (cross-section, SEM, XRD) | - Cross sectioned area evaluation of double coated implant surfaces performed
• Scanning Electron Microscopy pictures of double coated implant surfaces taken
• XRD analyses comparing HA coating on Mfinity stem and planar samples performed (Results are assumed to demonstrate acceptable coating properties) |
  | Biocompatibility | - Material safety
• Cytotoxicity, sensitization, irritation, genotoxicity, chronic toxicity, etc. | - Biocompatibility assessment performed (Results are assumed to demonstrate compliance with standards) |
  | Sterilization & Endotoxin| - Bacterial endotoxin levels (European Pharmacopoeia §2.6.14 / USP )
• Pyrogenicity (USP ) | - Bacterial endotoxin test (LAL test) performed
• Pyrogen test performed (Results are assumed to meet requirements, though note indicates not labeled as non-pyrogenic or pyrogen free) |
  | Shelf-Life | - Maintain integrity and performance over specified shelf-life | - Shelf-life evaluation performed (Results are assumed to demonstrate acceptable shelf-life) |

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

• Sample Size for Test Set: Not specified in the FDA letter. For non-clinical tests (like fatigue or material analysis), sample sizes would be determined by the specific ISO/ASTM standards referenced, but these are not diagnostic "test sets" in the AI context.
• Data Provenance: The data comes from the "Non-Clinical Studies" and "Performance Testing" conducted by Medacta International S.A. No country of origin is explicitly stated for the testing labs or data generation, but the company is based in Switzerland. The studies are by nature prospective in that they are conducted specifically to test the device's performance against standards.

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

• Not Applicable. This is a hip prosthesis, not an AI diagnostic device. There is no concept of "ground truth" established by experts in the context of interpreting images or medical conditions for this device. The "ground truth" for the performance tests would be the established scientific and engineering principles and the limits defined by the relevant ISO/ASTM standards.

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

• Not Applicable. As this is not an AI diagnostic device, no adjudication method was used. Performance is assessed directly against objective engineering and material standards.

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 prosthesis, not an AI-assisted diagnostic tool. No MRMC study was performed, and there is no AI assistance involved. The letter explicitly states: "No clinical studies were conducted."

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

• Not Applicable. This is not an algorithm or AI device. The device (a physical implant) is evaluated standalone based on its inherent properties and performance against physical and material standards.

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

• The "ground truth" for the non-clinical performance tests is based on established engineering and material science standards and specifications (e.g., ISO 7206, ISO 21535, ASTM F1580, ASTM F1185, European Pharmacopoeia, USP). The device's performance is compared against the requirements and acceptance limits set forth in these standards.

8. The sample size for the training set

• Not Applicable. This device did not involve machine learning or a "training set."

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

• Not Applicable. This device did not involve machine learning or a "training set."

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This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis.
2. Previously failed hip surgery.
3. Proximal femoral neck fractures or dislocation.
4. Idiopathic avascular necrosis of the femoral head.
5. Non-union of proximal femoral neck fractures.
6. Treatment of fractures that are unmanageable using other forms of therapy.
7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

The subject device is a set of smaller stems that extends the size range of the previously cleared Trivicta® stems (K233758).

Trivicta® is a single-piece, tapered, collared and non-collared, hydroxyapatite (HA) and sintered bead commercially pure (Cp) Titanium coated femoral hip stem designed for single use. The stem has a neck with a 12/14 trunnion taper for modular attachment to femoral heads. Trivicta® is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating and porous sintered bead coating.

The size range of the subject device is: lengths (97-101mm), horizontal offsets (36-43mm), vertical offsets (27-29mm), resection angle of 41°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar.

Trivicta® is compatible with the following Ortho Development® devices: CoCr Femoral Heads, Biolox Delta Ceramic Femoral Heads, Solitude™ Unipolar Head, Escalade Acetabular Cup System, Legend® Acetabular Liner, Escalade Legend® Acetabular Shell, and Tri-plus™ DCM Liner.

The provided text is an FDA 510(k) clearance letter and associated summary for a hip stem device. This type of document describes the device, its indications for use, and a comparison to predicate devices, along with performance data to demonstrate substantial equivalence.

However, the information requested in your prompt regarding acceptance criteria for a software device, specifically around AI performance metrics like sensitivity, specificity, MRMC studies, ground truth establishment, training data, etc., is not contained within this FDA clearance document.

The document states under "Clinical Testing" (Page 7): "No clinical testing is required to establish the safety and effectiveness of Trivicta." This indicates that the clearance was based on non-clinical performance data (sterilization, shelf life, biocompatibility, mechanical testing) and comparison to predicate devices, not on a study involving AI performance or human-in-the-loop assessments as would be typical for medical AI devices.

Therefore, I cannot fulfill your request for the specific AI-related acceptance criteria and study details because the provided document is for a mechanical orthopedic implant, not an AI-powered diagnostic or therapeutic device.

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1. Non-inflammatory degenerative joint disease Including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.

This device is a single use implant and intended for cementless use only.

Resolve Modular Revision Hip Stem is a modular stem optimized for femoral primary or revision surgery. It consists of three main components:
(1) Resolve Proximal Component (two types: With Hole or No Hole, each available with HA/Ti plasma spray or Ti plasma spray coating)
(2) Resolve Distal Stem (four types: Taper Stem, Clothespin Stem, Clothespin With Hole Stem, and Interlocking Stems. Taper Stem is uncoated; others are available with HA/Ti plasma spray or Ti plasma spray coating. Clothespin With Hole Stem and Interlocking stem provide holes for additional Distal Interlocking Screw fixation.)
(3) Resolve Distal Interlocking Screw (used with Resolve Clothespin With Hole Stem and Interlocking stem)

Resolve Modular Revision Hip Stem can be used with "United" metallic femoral heads (K994078, K022520, K111546, K122504, K152439, K162957, K221675) or ceramic femoral heads (K103497, K112463, K122185).

All components are manufactured from Ti-6Al-4V alloy (ASTM F136). The coatings (HA/Ti plasma spray and Ti plasma spray) comply with ASTM F1580 and ASTM F1185, ISO 13779-6. Proximal components have standard and high offset designs.

Based on the provided FDA 510(k) Clearance Letter for the "Resolve Modular Revision Hip Stem," it's crucial to understand that this document pertains to a physical medical device (an orthopedic implant), not a software-based medical device or AI/ML algorithm.

Therefore, the concepts of "acceptance criteria for an AI/ML algorithm," "test set," "ground truth establishment," "expert adjudication," "MRMC studies," and "standalone performance" do not apply to the information contained within this 510(k) filing.

The 510(k) process for a physical device like this hip stem primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through:

• Indications for Use Comparison: Showing the device is intended for the same medical purposes.
• Technological Comparison: Demonstrating similar fundamental scientific principles, materials, design, and operating conditions.
• Non-Clinical (Bench) Testing: Conducting a series of engineering and materials tests to ensure the device meets specified mechanical and material performance standards, and that it is as safe and effective as the predicate devices.
• No Clinical Studies (unless specifically required): The letter explicitly states "No clinical studies were required or provided," which is common for devices demonstrating substantial equivalence through bench testing.

There is no "AI/ML algorithm" or "software performance" to describe acceptance criteria or study results for in this context.

Instead, I can extract and present the relevant information about the acceptance of this physical medical device based on the given 510(k) letter.

Acceptance Criteria and Study for the Resolve Modular Revision Hip Stem (Physical Device)

The "acceptance criteria" for a physical device in a 510(k) submission are not typically presented as a table of accuracy metrics. Instead, they are demonstrated by meeting various engineering and material standards, and by showing that the device performs similarly (or better) than the predicate devices in specified non-clinical tests. The "study" refers to the non-clinical (bench) testing performed.

1. Table of "Acceptance Criteria" (represented by tests aligned with regulatory standards) and "Reported Device Performance" (implied compliance or successful test outcomes):

Explanation of "Reported Device Performance": The document states: "Based on the design rationale of the Subject device, the following tests were conducted to evaluate the safety and effectiveness of the subject device, and the test results indicated that this device is safe and effective." This implies that the device successfully met the requirements and specifications of each listed test and standard, thus demonstrating its safety and effectiveness. Specific numerical performance values are not typically included in the summary letter itself but would be detailed in the full submission.

2. Sample Size and Data Provenance:

• Sample Size: Not explicitly stated for each test (e.g., number of stems tested for fatigue). These are typically engineering bench tests on a representative sample of device components or full devices.
• Data Provenance: The tests are non-clinical (bench tests), meaning they were conducted in a laboratory setting, not with human patient data. The manufacturer, United Orthopedic Corporation, is based in Taiwan.

3. Number of Experts and Qualifications for Ground Truth:

• This concept is not applicable as this is a physical device clearance based on non-clinical bench testing, not an AI/ML algorithm requiring expert review for ground truth establishment.

4. Adjudication Method:

• Not applicable for a physical device and non-clinical bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This is a clearance for a physical orthopedic implant. The letter explicitly states: "No clinical studies were required or provided." MRMC studies are typically performed for imaging-based AI/ML devices to assess human reader performance with and without AI assistance.

6. Standalone Performance (Algorithm Only):

• Not applicable as there is no algorithm. The performance documented is the standalone mechanical and material performance of the physical implant itself through a series of bench tests.

7. Type of Ground Truth Used:

• For the physical device, the "ground truth" for acceptance is based on established engineering standards (e.g., ISO, ASTM) and regulatory guidance (FDA guidance documents) for mechanical, material, and biological compatibility properties of orthopedic implants. Compliance with these predetermined, objective standards serves as the "ground truth" for safe and effective performance.

8. Sample Size for Training Set:

• Not applicable. This is not a "training set" in the context of AI/ML. The device's design and manufacturing processes are developed based on extensive engineering principles, materials science, and prior knowledge from predicate devices.

9. How Ground Truth for Training Set was Established:

• Not applicable. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply. The "ground truth" for the device's design and material selection would be established through decades of orthopedic research, biomechanical principles, and clinical experience with similar implants.

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All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

Exactech Alteon HA femoral stems are intended for press-fit fixation.

The proposed Exactech Alteon HA Femoral Stems are intended for press-fit hip arthroplasty.

The Exactech Alteon HA Femoral Stems are manufactured from Ti-6A1-4V ELI (per ASTM F136, ASTM F620) with a grit blast surface and HA coating (per ISO 13779-2). The stem has a 12/14 taper. The Alteon HA Femoral Stems are available in various lengths with standard and extended neck offset configurations, and collarless configurations. The stem has a trapezoidal cross-sectional stem geometry with a distal taper, and it contains vertical and horizontal grooves along its bone contacting surfaces.

The Alteon HA Femoral Stems are compatible with the same femoral components as the predicate:

• Exactech Cobalt Chromium Alloy Femoral Heads (K041906, K121392)

• Exactech Ziramic Zirconia Femoral Heads (K050398, K060107)

• Exactech BIOLOX forte Alumina Femoral Heads (K032964, K051682)

• Exactech BioloxDelta and DeltaOption Femoral Heads and Adapters (K103012,K121392)

• AcuMatch L-series Unipolar endoprostheses (K010081)

• AcuMatch L-Series Bipolar Endoprostheses (K013211) .
  The Alteon HA Femoral Stems are compatible with the same acetabular components as the predicate:

• AcuMatch A-Series Acetabular Shells and Liners (K993082, K042906)

• AcuMatch A-Series Acetabular GXL Liners (K051556)

• AcuMatch A-Series Acetabular Cups, All-polyethylene, Cemented (K963313)

• Novation Crown Cup Acetabular Shells and Liners (K070479, K100269, K121392, K141960)

• Novation Crown Cup Acetabular Shells with InteGrip (K102975)

• Novation Crown Cup Constrained Liners and Rings (K071676)

• Exactech Integrip Acetabular Shells (K122798)

• Exactech Novation and AcuMatch E-HXL Acetabular Liners (K173583)

• Exactech Alteon Acetabular Cup System (K182502)

This document is a 510(k) premarket notification from the FDA for a medical device called "Alteon® HA Femoral Stems." It's important to understand that a 510(k) is a submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device, not a study proving device performance against specific acceptance criteria in the context of an AI/software device.

Therefore, the requested information pertaining to acceptance criteria and a study proving a device meets acceptance criteria in the context of an AI/software device is not applicable to this FDA submission. This submission is for a physical orthopedic implant (a femoral stem for hip replacement), not a "device" in the sense of an AI algorithm or diagnostic software.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, not on proving performance against specific acceptance criteria for a new, innovative diagnostic or AI-driven capability.

Here's a breakdown based on the context of the provided document, addressing why many of the requested fields cannot be filled:

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

   • Acceptance Criteria: Not explicitly stated in the context of performance metrics for an AI/software device. The "acceptance" here is the FDA's determination of substantial equivalence.
   • Reported Device Performance: The document describes non-clinical testing performed to show the new HA coating does not negatively impact the device's essential characteristics, maintaining equivalence to the predicate. Performance is demonstrated through engineering analyses (Range of Motion, Stem Neck Fatigue, Distal Stem Fatigue) and characterization of the new HA coating, ensuring it meets standards like ISO 21535:2007, ASTM F2068-2015, ISO 7206-6:2013, ISO 7206-4:2010, ISO 13779-2, and USP , USP , ANSI/AAMI ST72. No quantitative performance metrics in the sense of sensitivity, specificity, etc., for a diagnostic task are provided or relevant.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • This is not applicable. The "test set" in the context of this 510(k) refers to the physical devices undergoing mechanical and chemical testing. There's no data set of patient images or information from which "data provenance" would be relevant.

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. There is no ground truth, expert consensus, or image review involved for this type of medical device submission. The "ground truth" for a mechanical implant is its physical and chemical properties and mechanical integrity, which are assessed through engineering tests, not expert medical review.

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

   • Not applicable. This refers to adjudication of medical image interpretations, which is not part of this submission. Mechanical testing results are objective measurements against established standards.

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 for AI-powered diagnostic devices. The device in question is a physical orthopedic implant.

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

   • Not applicable. This is for AI algorithms.

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

   • Not applicable in the sense of a clinical ground truth for a diagnostic device. The "truth" for this device's performance is adherence to established engineering and material standards.

8. The sample size for the training set:

   • Not applicable. There is no AI model or "training set" for this physical implant.

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

   • Not applicable. There is no AI model or "training set" for this physical implant.

Summary of Relevant Information from the Document (Re-framed to align with the FDA 510(k) context):

The submission is for the Alteon® HA Femoral Stems, demonstrating substantial equivalence to the predicate device K162732 Exactech® Alteon® HA Femoral Stems. The key difference is the hydroxyapatite (HA) coating material/process.

The "study" conducted for this submission involves non-clinical testing and engineering analyses to demonstrate that the proposed device performs as intended and is substantially equivalent to the predicate.

Non-Clinical Tests and Analyses Done:

• Engineering analysis of Range of Motion (ROM): Per ISO 21535:2007.
• Engineering analysis of Stem Neck Fatigue Testing: Per ASTM F2068-2015 and ISO 7206-6:2013.
• Engineering analysis of Distal Stem Fatigue Testing: Per ASTM F2068-2015 and ISO 7206-4:2010.
• HA coating characterization: Per ISO 13779-2 and FDA Guidance document, "510(k) Information Needed for Hydroxyapatite Coated Orthopaedic Implants," dated February 1997.
• Bacterial endotoxins: Per USP , USP , and ANSI/AAMI ST72.

Conclusion from Testing:
The non-clinical testing and analysis found that the difference in the applied HA coating does not change the intended use, safety, or performance requirements of the proposed devices, nor does it adversely affect their safety or effectiveness. This supports the claim of substantial equivalence to the predicate device. No clinical testing was submitted.

To reiterate, the framework provided in the request is designed for evaluating AI/software-as-medical-device (SaMD) products, which is not what the Alteon® HA Femoral Stems are.

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Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

· Non-inflammatory degenerative ioint disease including osteoarthritis or avascular necrosis

• · Inflammatory joint disease including rheumatoid arthritis
• · Correction of functional deformity including congenital hip dysplasia
• · Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture

· Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics' World Cup components are intended for cementless fixation only.

The primary purpose of this Special 510(k) Device Modification to devices cleared as part of the World Cup System (K201278 and K241690) is to notify the FDA of additional geometrical variants of the World liner available in crosslinked UHMWPE (XLPE) and Vitamin-E Stabilized, 100kGy crosslinked UHMWPE (Vit-E HXLPE) material options.

The World Liners are compatible with World Acetabular Cups and are available in neutral, and hooded, lateralised, high wall, face changing and eccentric variants. The liners are designed to sit within an acetabular shell and articulate with a femoral head.

The provided document is an FDA 510(k) clearance letter for a medical device called "World Liner," which is a component of a hip replacement system. It primarily details the regulatory clearance process, the device's indications for use, and a comparison to predicate devices, emphasizing that the new "World Liner" variants are substantially equivalent to previously cleared versions.

However, this document does not contain any information about acceptance criteria, specific study designs (like MRMC or standalone performance studies), sample sizes for test or training sets, expert qualifications, or ground truth establishment methods as would be expected for an AI/ML-based device submission.

The "Performance Testing" section is extremely brief and only mentions "Engineering evaluations" and "Range of Motion assessment per ISO 21535." These are typical for mechanical devices to demonstrate physical performance and compatibility, not for evaluating the performance of an AI/ML algorithm.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance: This information is not present.
• Sample sizes used for the test set and data provenance: Not mentioned.
• Number of experts used to establish ground truth and qualifications: Not mentioned, as there is no apparent AI/ML ground truth evaluation.
• Adjudication method: Not mentioned.
• MRMC comparative effectiveness study details: Not mentioned.
• Standalone performance details: Not mentioned.
• Type of ground truth used: Not mentioned.
• Sample size for the training set: Not mentioned.
• How ground truth for the training set was established: Not mentioned.

This document is for a mechanical medical device (hip liner), not an AI/ML-driven device. As such, the type of performance data and evaluation criteria you are asking about (which are relevant for AI/ML) are not applicable or present in this context.

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The indications for the Corin Icona Hip Stem as a total hip arthroplasty, and when used in combination with a Corin hemiarthroplasty head, as a hip hemiarthroplasty, include:

• · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• · Correction of functional deformity
• · Treatment of non-union and femoral neck fractures
• Developmental dysplasia of the hip (DDH) / congenital dysplasia of the hip (CDH)

The Corin Icona Hip Stem is indicated for cementless use only.

The Corin Icona Hip Stem is a tapered stem design manufactured from Titanium alloy (Ti6Al4V) (ASTM F136) with a layer of commercially pure titanium (ISO 5832-2, ASTM F1580) and an additional layer of electrochemically deposited calcium phosphate (ASTM F1609) applied.

The Icona Hip Stem is intended for use in hemiarthroplasty and total hip arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged hip joint articulation where there is evidence of sufficient sound bone to seat and support the components.

The design is a fully-coated titanium femoral hip stem featuring a polished neck with 12/14 tapered male trunnion for assembly with Corin modular femoral head components. Additionally, the Icona stem features a trapezoidal, tripled tapered body, providing for rotational and axial stability.

The Icona Hip Stem is a collared stem available in two different offsets (Standard and Lateralised) and twelve (12) different sizes, totaling 24 options.

The Icona Hip Stem is compatible with the following acetabular systems:

· Traditional – Trinity (K093472, K110087, K111481, K122305, K130128, K130343, K131647) and Trinity PLUS (K17255) · Dual mobility - Trinity Dual Mobility (K170359) and MobiliT (K191831)

· Bipolar - Bipolar-i (K183114)

This document is a 510(k) Premarket Notification from the FDA for a hip stem device (Icona Hip Stem). It does not describe an AI/ML medical device, but rather a traditional medical device (hip implant). Therefore, much of the requested information regarding acceptance criteria and studies for AI/ML performance metrics (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document.

However, I can extract the relevant information regarding the traditional device's performance criteria and supporting studies as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is typically not provided in detail within a 510(k) summary for mechanical testing of traditional orthopedic implants. The document states "Non-clinical testing and rationales provided to support substantial equivalence," but does not specify sample sizes for these mechanical tests (e.g., number of stems tested for fatigue).

• Provenance: The tests are non-clinical (laboratory/mechanical testing), not patient data.

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

Not applicable for a traditional orthopedic implant's mechanical testing or equivalence comparison to predicate devices. "Ground truth" in this context would refer to established engineering standards (ISO, ASTM) and the performance of predicate devices.

4. Adjudication Method

Not applicable for this type of device submission. Adjudication is relevant for expert review of data, often in clinical studies or for AI ground truth establishment.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, this is not an AI/ML device, so an MRMC study comparing human readers with and without AI assistance is not applicable.

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

No, this is not an AI/ML device.

7. The Type of Ground Truth Used

For this traditional device, the "ground truth" used to establish substantial equivalence is primarily:

• Established engineering standards: ISO 7206-4, ISO 7206-6, ISO 21535, ASTM F136, ASTM F1580, ASTM F1609. The device's performance in these tests is compared against the performance of the predicate devices or the requirements of these standards.
• Performance of legally marketed predicate devices: The Icona Hip Stem's design, materials, and mechanical performance are compared to those of already cleared predicate devices. Substantial equivalence implies that the new device performs as safely and effectively as the predicate.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device; there is no "training set."

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

Not applicable, as there is no "training set."

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TheRay Collared and Collarless Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:
• A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia;
· Acute traumatic fracture of the femoral head or neck;
· Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.

TheRay Collared and Collarless Total Hip System femoral stems are intended for cementless fixation. The acetabular cup is intended for cementless fixation. The porous structured surfaces on the acetabular cup provide biological fixation in a cementless application.

The iNSitu Bipolar Hip System is intended for use in combination with the iNSitu Total Hip System Femoral Stem or TheRay Collared or Collarless Femoral Stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
· Femoral neck and trochanteric fractures of the proximal femur;
· Osteonecrosis of the femoral head;
· Revision procedures where other devices or treatments for these indications have failed.

TheRay Collared and Collarless Hip System includes the new subject femoral stems, along with previously cleared femoral heads (K161184, K220336), acetabular cups (additively manufactured – K161184 and K191936), acetabular liners (vitamin E polyethylene – K161184), acetabular bone screws (K161184), screw hole covers for the screw holes in the acetabular cups (K161184), and apical hole covers for the acetabular cups (K161184). The subject femoral stem implant features a forged triplaner Ti-6Al-4V ELI substrate and an applied dual coating comprised of plasma-sprayed commercially pure titanium (CPTi) and hydroxyapatite (HA). The collared version of the subject TheRay Femoral Stem features a collar on the medial aspect of the stem above the coating that is designed to seat on the native resected calcar. The collarless version of the subject TheRay Femoral Stem is identical to the collared version, less the medial collar.

The iNSitu Bipolar Hip System has been previously cleared for use in K191297 and consists of a factory assembled UHMWPE (ASTM F648) liner in a cobalt chrome (ASTM F75) outer shell, and UHMWPE (ASTM F648) retention ring with a Ti-6Al-4V ELI (ASTM F136) spring. These Bipolar Heads include outer diameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the patient anatomy. The smaller Bipolar Heads (38 to 43 mm) have an inner diameter that mates with a 22mm diameter Femoral Head; the larger Bipolar Heads (44 to 60 mm) have an inner diameter that mates with a 28 mm diameter Femoral Head. The iNSitu Bipolar Hip System may be used in conjunction with the subject TheRay Collared and Collarless Hip System Femoral Stems.

The provided text describes a medical device, "TheRay Collared and Collarless Femoral Stem," and its submission for FDA clearance. However, it does not include information about acceptance criteria or a study proving the device meets them in the context of an AI/ML enabled device.

The document is a 510(k) summary for a hip implant (a physical medical device), not a software device or an AI/ML product. The performance testing mentioned (Range of Motion, Distal stem fatigue, Neck fatigue, Femoral head disassembly, Biocompatibility) are standard tests for orthopedic implants, ensuring their mechanical integrity and safety for human implantation.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets them because the document describes a traditional medical device, not an AI/ML-enabled one.

To directly answer your request based on the absence of the information in the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document describes a physical hip implant, not an AI/ML device, and therefore does not have performance metrics like sensitivity, specificity, or F1-score with corresponding acceptance criteria typically associated with AI.
2. Sample size used for the test set and the data provenance: Not applicable. This information is relevant for AI/ML validation datasets. The document mentions "Extensive preclinical performance testing" but does not detail sample sizes in the context of data for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in this context usually refers to expert-labeled data for AI model training/validation. The document does not describe such a process.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to methods for resolving discrepancies in expert labeling for AI ground truth. The document does not describe such a process.
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 type of study is specific to AI-assisted diagnostic or decision-making tools to evaluate human performance with and without AI. The device described is a physical hip implant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to the performance of an AI algorithm on its own. The device described is a physical hip implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" here refers to data labeling for AI. For a hip implant, "ground truth" would relate to real-world clinical outcomes and mechanical performance, which are evaluated through different types of studies (e.g., clinical trials, bench testing per ISO standards).
8. The sample size for the training set: Not applicable. This refers to the dataset used to train an AI model.
9. How the ground truth for the training set was established: Not applicable. This refers to the process of creating labeled data for AI model training.

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Logical Liner and World Liner: Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are intended for:
· Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
· Inflammatory joint disease including rheumatoid arthritis
· Correction of functional deformity including congenital hip dysplasia
· Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
· Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

World Knee System: Patients should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis. The patient's need for knee replacement should be due to one or more of the following conditions: · Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis. · Inflammatory degenerative joint disease including rheumatoid arthritis. - · Functional deformity such as varus, valgus or flexion deformities. - · Revision procedures where other treatments or devices have failed. - · Fractures that are unmanageable using other techniques. Signature Orthopaedics' World Knee replacement components may be intended for cemented or cementless use.

The primary purpose of this Special 510(k) Device Modification to devices cleared as part of the Logical Cup, World Hip, and World Knee System, is to notify the FDA of the the change in materials used to manufacture the polyethylene components (Logical Liner, World Liners and World Knee Patella) to Vitamin-E Stabilized, 100 kGy crosslinked UHMWPE (Vit-E HXLPE) that is the subject of Masterfile MAF 2795. This 510(k) also notifies the FDA of minor design updates to the implants and reusable instruments. The Logical Acetabular System consists of an Acetabular Shell and a highly cross-linked polyethylene Acetabular Liner that is available in neutral, hooded and lateralized variants. The liner is designed to sit within an acetabular shell and articulate with a femoral head. The World Liners are compatible with World Acetabular Cups and are available in neutral, and hooded variants. The liners are designed to sit within an acetabular shell and articulate with a femoral head. The World Knee Patella is available in symmetrical and asymmetrical variants, with pegs. It is part of the World Knee System, which is a modular knee system consisting of a femoral component, meniscal inert, a patella and a tibial component.

The provided text does not contain information about acceptance criteria or a study proving that a device meets specific acceptance criteria in the context of an AI/ML medical device. Instead, it is a 510(k) premarket notification for orthopedic implants (hip and knee replacement components).

Therefore, I cannot provide a response with the requested information as it is not present in the input.

Reasoning for the absence of requested information:

• Device Type: The 510(k) is for physical orthopedic implants (Logical Liner, World Liner, World Knee Patella), not an AI/ML software device.
• Performance Metrics: The performance testing described focuses on material properties, mechanical integrity, and wear resistance relevant to physical implants (e.g., density, mechanical properties, melting point, fatigue crack propagation, oxidation challenge, ESR testing, wear for 5 million cycles). These are not the types of metrics typically associated with AI/ML diagnostic or prognostic performance (e.g., sensitivity, specificity, AUC).
• No AI/ML Components: There is no mention of algorithms, machine learning models, training data, ground truth establishment by experts, or any other elements common to AI/ML device evaluations.

Since the input is not about an AI/ML device, the questions regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for AI models are not applicable.

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This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis.
2. Previously failed hip surgery.
3. Proximal femoral neck fractures or dislocation.
4. Idiopathic avascular necrosis of the femoral head.
5. Non-union of proximal femoral neck fractures.
6. Treatment of fractures that are unmanageable using other forms of therapy.
7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Trivictal is a single-piece, tapered, collared and non-collared, hydroxyapatite (HA) and sintered bead commercially pure (Cp) Titanium coated femoral hip stem designed for single use. The stem has a neck with a 12/14 trunnion taper for modular attachment to femoral heads. Trivicta is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating and porous sintered bead coating. The stem has a variety of sizes to accommodate most patients encountered: lengths (101-119mm), horizontal offsets (38-53mm), vertical offsets (29-36mm), resection angle of 41°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar. Trivicta™ is compatible with the following Ortho Development devices: CoCr Femoral Heads, Biolox Delta Ceramic Femoral Heads, Solitude™ Unipolar Head, Escalade Acetabular Cup System, Legend® Acetabular Liner, Escalade Legend® Acetabular Shell, and Tri-plus™ DCM Liner.

This looks like a 510(k) summary for a medical device (Trivicta Hip Stem), not an AI/ML powered device. Therefore, the questions related to AI/ML performance criteria, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," training set information, and adjudication methods for ground truth, are not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices through design, materials, indications for use, and performance testing related to the physical characteristics and safety of the hip stem, not software performance.

Here's an analysis of the provided information, focusing on the available details:

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

The document does not present acceptance criteria in a structured, quantitative table with specific target values for performance attributes, as would be typical for an AI/ML device. Instead, it outlines the types of non-clinical mechanical tests performed and states that the device was found to be "safe for its intended use" and "performs as well as the legally marketed predicates" based on these tests.

However, based on the categories of testing performed, we can infer some general "acceptance criteria" and "reported performance":

• Range of Motion Test (ISO 21535:2023)
• Shear Fatigue Test (ASTM F1160-14)
• Neck Fatigue Test (ISO 7206-6:2013)
• Distal Stem Fatigue Test (ISO 7206-4:2010)
• Engineering analysis of impingement performance (ASTM F2582-20)"

The overall conclusion states: "The results of verification and validation activities demonstrate that Trivicta performs as well as the legally marketed predicates." This implies that the device met the performance requirements of these tests relative to the predicate devices and applicable standards. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document details tests on the physical medical device (hip stem), not a data-driven AI/ML model. Therefore, "sample size for the test set" typically refers to the number of physical device units or test specimens used in mechanical testing. The document does not specify the exact number of samples for each mechanical test, nor does it refer to "data provenance" in the context of patient data. The tests are in vitro (laboratory) tests on the device itself.

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. "Ground truth" in the context of AI/ML refers to expert labels on data. For a physical medical device like a hip stem, ground truth is established by objective engineering and scientific measurements and adherence to established material and mechanical standards. There are no human "experts" establishing ground truth in the AI/ML sense for these in vitro physical tests.

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

This question is not applicable as it relates to expert review for AI/ML ground truth, which is not relevant to the physical testing of a hip stem.

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 to evaluate the diagnostic performance of AI-assisted systems compared to human readers. This document describes a physical medical device, not an AI system.

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

This question is not applicable as it pertains to AI/ML algorithm performance.

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

For the physical device, the "ground truth" for its performance is based on:

• Adherence to recognized international and national standards (e.g., ISO 11137 for sterilization, ISO 11607 for shelf life/packaging, ISO 10993-1 for biocompatibility, ISO 21535, ASTM F1160, ISO 7206-6, ISO 7206-4, ASTM F2582 for mechanical testing).
• Objective physical and chemical measurements obtained during laboratory testing.
• Comparison to predicate devices that have established safety and effectiveness.

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device.

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

This question is not applicable as this is not an AI/ML device.

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Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
   Hemi hip replacement is indicated in the following conditions:
6. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treation.
7. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
8. Avascular necrosis of the femoral head.
9. Non-union of femoral neck fractures.
10. Certain high subcapital and femoral neck fractures in the elderly.
11. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
12. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.

The submission covers a portfolio of hip implants including Hip Stems, Acetabular Shells and Liners, Femoral Heads, and Hip Components. Specific device descriptions are provided for various product families within these categories, detailing materials, designs, and available sizes.

The provided document is a 510(k) Premarket Notification from DePuy Ireland UC to the FDA, related to expanding the labeling for their hip implant portfolio to include updated MRI compatibility information. The submission asserts that there is no change to the indications, intended use, safety, fit, form, or technological characteristics of the devices. Therefore, the study presented focuses solely on demonstrating the MRI conditional safety of these devices, not on their primary clinical performance or effectiveness for total hip replacement.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the devices are established by adherence to specific ASTM (American Society for Testing and Materials) standards for evaluating medical devices in the MR environment. The study aims to demonstrate that the hip implants meet the "MR Conditional" labeling.

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

The document does not specify a sample size for a "test set" in the context of clinical data for performance or effectiveness. The testing described is non-clinical for MRI compatibility. The data provenance is also non-clinical, deriving from tests conducted to ASTM standards for MRI safety of medical devices. There is no mention of country of origin for clinical data or whether data is retrospective or prospective, as the study is not a clinical one.

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

This information is not applicable as the described study is a non-clinical, in-vitro evaluation of MRI compatibility. "Ground truth" in the context of expert consensus or clinical outcomes is not relevant for this type of engineering performance testing.

4. Adjudication Method for the Test Set

This information is not applicable as the described study is a non-clinical, in-vitro evaluation of MRI compatibility. Adjudication methods typically apply to clinical studies where human assessment of outcomes or data labeling is involved.

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

There is no MRMC comparative effectiveness study mentioned in the document. The submission is for modifying existing device labeling to reflect MRI compatibility, not for an AI-assisted diagnostic or treatment system.

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

This is not applicable as the document describes an MRI compatibility study of hip implants, which are physical medical devices, not a software algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical study is defined by the objective measurements and pass/fail criteria specified within the referenced ASTM standards for MRI conditional safety (e.g., maximum temperature rise, maximum magnetically induced displacement force, maximum change in object-induced torque and image artifact size).

8. The Sample Size for the Training Set

There is no training set for the device described in the document. The devices are physical implants, and the testing performed is non-clinical for MRI safety.

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

This is not applicable as there is no training set mentioned or implied in the context of this 510(k) submission.

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