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The ICONACY I-Hip is indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The ICONACY I-Hip consists of femoral stem and acetabular cup (i.e. shell) porous coated components intended for cementless, press-fit fixation.

The ICONACY I-Hip consists of a collarless, tapered, forged titanium allov femoral stem mated to a cobalt chrome alloy modular femoral head. Forty percent of the femoral stem is circumferentially coated with a titanium coating designed to attain a cementless, press-fit fixation. This femoral construct articulates with an acetabular device assembly.

The acetabular device assembly consists of a hemispherical titanium alloy cup coupled with a highly cross linked ultra-high molecular weight polyethylene (HXL-UHMWPE) liner. The acetabular cup is machined from forged Ti-6Al-4V ELI alloy and is available in standard, finned and spike configurations. The acetabular cup has a threaded polar hole for insertion. The standard and finned cups have screw holes for additional fixation.

The outer hemispheric surface of the acetabular cup has a titanium plasma spray coating for cementless, press-fit fixation. A titanium locking ring is fixed into a groove on the cup to engage a groove on the HXLUHMWPE liner. Standard instrumentation is used to implant the device.

The current submission addresses modifying the standard and finned acetabular cups to add a third screw hole. The acetabular cup materials, porous coating and indication for use remain the same. No additional sizes are being added to the product line. No new instruments are required. The spiked cups are unchanged with no screw holes.

The compatible femoral stems, femoral heads, acetabular liners and bone screws remain unchanged from those cleared under K121034.

The provided text is a 510(k) summary for the ICONACY I-Hip, a hip joint prosthesis. The document focuses on showing substantial equivalence to a predicate device, specifically regarding a minor modification to the acetabular cup. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not discussed in this medical device submission.

The document states: "Clinical testing was not required to establish equivalency of the device." and "Finite Element Analysis (FEA) confirmed that adding a third screw hole to the acetabular cups had little impact on cup stiffness." This indicates that the safety and effectiveness were established through non-clinical means (FEA) and comparison to a legally marketed predicate device, rather than a clinical study with performance metrics in the way your request implies for an AI/ML device.

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The ICONACY I-Hip is indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, theumatoid 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The ICONACY I-Hip consists of femoral stem and acetabular cup (i.e. shell) porous coated components intended for cementless, press-fit fixation.

The ICONACY I-Hip consists of a collarless, tapered, forged titanium alloy femoral stem mated to a modular femoral head. This femoral construct articulates with an acetabular device assembly. The acetabular device assembly consists of a hemispherical titanium alloy cup (i.e., shell) coupled with a highly cross-linked ultra-high molecular weight polyethylene (HXL-UHMWPE) liner. Forty percent of the femoral stem is circumferentially coated with a titanium coating designed to attain a cementless, press-fit fixation. The acetabular cup is machined from forged Ti-6Al-4V ELI alloy. The cup has a threaded polar hole for insertion. The outer hemispheric surface of the cup has a titanium plasma spray coating for cementless, press-fit fixation. Titanium bone screws may be used for additional fixation. A titanium locking ring is fixed into grooves on the cup to engage grooves on the HXL-UHMWPE liner. Standard instrumentation is used to implant the device.

The current submission adds ceramic femoral heads in 28, 32 and 36mm diameters and modified CS Acetabular Liners to the system. Compatible femoral stems, acetabular cups, locking rings, bone screws and apex hole plug were cleared in K121034, K131279, K133228 and K132572.

The provided text is a 510(k) summary for the ICONACY™ I-Hip™ Total Hip System, which is a medical device. This document describes the device, its indications for use, and the basis for its substantial equivalence to predicate devices. However, it does not include information about AI/ML algorithms, studies proving device performance against acceptance criteria in the context of an AI/ML algorithm, or details about ground truth establishment, sample sizes for training/test sets, or expert adjudication.

The "PERFORMANCE DATA" section states: "Pre-fatigue burst, fatigue, post-fatigue burst, pull-off, wear testing, wear testing under adverse conditions and biocompatibility testing confirm that the ICONACY I-Hip Ceramic Femoral Heads and CS Acetabular Liners meet pre-determined acceptance criteria and are expected to be safe and effective for the proposed indications."

And "CLINICAL TESTING: Clinical testing was not required to determine substantial equivalence with the predicate devices."

Therefore, I cannot provide the requested information for an AI/ML device because the document describes a mechanical medical device (hip implant) and not an AI/ML algorithm.

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The ICONACY I-Hip System is indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, theumatoid 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The ICONACY I-Hip System consists of femoral stem and acetabular cup (i.e. shell) porous coated components intended for cementless, press-fit fixation.

The ICONACY I-Hip System consists of a collarless, tapered, forged titanium alloy femoral stem mated to a cobalt chrome alloy modular femoral head. This femoral construct articulates with an acetabular device assembly. The acetabular device assembly consists of a hemispherical titanium alloy cup (i.e., shell) coupled with a highly cross linked ultra-high molecular weight polyethylene (HXL-UHMWPE) liner. Forty percent of the femoral stem is circumferentially coated with a titanium coating designed to attain a cementless, press-fit fixation. The acetabular cup is machined from forged Ti-6Al-4V ELI alloy. The cup has a threaded polar hole for insertion. The outer hemispheric surface of the cup has a titanium plasma spray coating for cementless, press-fit fixation. A titanium locking ring is fixed into grooves on the cup to engage grooves on the HXL-UHMWPE liner. Standard instrumentation is used to implant the device.

The current submission adds stems with additional offsets to the I-Hip System. Compatible femoral heads, acetabular cups, acetabular liners, locking rings and bone screws were cleared in K121034 and K131279.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ICONACY™ I-Hip™ System:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes performance data conducted on the device components (femoral stems) and does not refer to a "test set" in the context of diagnostic or clinical evaluation. Instead, it refers to biomechanical testing. The sample sizes for these specific tests are not provided in the document. The data provenance is also not specified (e.g., country of origin, retrospective/prospective). It can be inferred that these were laboratory-based engineering tests.

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

This information is not applicable as the described studies are biomechanical engineering tests on device components, not studies requiring expert interpretation of clinical data for ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as #3.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "CLINICAL TESTING: Clinical testing was not required for determining substantial equivalence with the predicate devices."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This information is not applicable. This device is a physical orthopedic implant, not an AI algorithm or software. Therefore, the concepts of "standalone performance" or "human-in-the-loop performance" do not apply.

7. The Type of Ground Truth Used:

The "ground truth" for the performance data in this context refers to established engineering standards and specifications (ISO 7206-6, ISO 7206-4) for mechanical properties and the performance of the predicate device for range of motion.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a physical orthopedic implant, not a machine learning model.

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

This information is not applicable for the same reasons as #8.

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The ICONACY I-Hip System is indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, theumatoid 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The ICONACY I-Hip System consists of femoral stem and acetabular cup (i.e. shell) porous coated components intended for cementless, press-fit fixation.

The ICONACY I-Hip consists of a collarless, tapered, forged titanium alloy femoral stem mated to a cobalt chrome alloy modular femoral head. This femoral construct articulates with an acetabular device assembly. The acetabular device assembly consists of a hemispherical titanium alloy cup coupled with a highly cross linked ultra-high molecular weight polyethylene (HXL-UHMWPE) liner. Forty percent of the femoral stem is circumferentially coated with a titanium coating designed to attain a cementless, press-fit fixation. The acetabular cup is machined from forged Ti-6Al-4V ELI alloy. The cup has a threaded polar hole for insertion. The outer hemispheric surface of the cup has a titanium plasma spray coating for cementless, press-fit fixation. A titanium locking ring is fixed into a groove on the cup to engage a groove on the HXL-UHMWPE liner. Standard instrumentation is used to implant the device.

The current submission is for modifications to the acetabular cups and locking rings cleared in K121034, and the addition of spiked and finned acetabular cups in the same sizes and materials as those cleared in K120134. The compatible femoral heads, acetabular liners and bone screws are unchanged from those cleared in K121034.

Here's a breakdown of the acceptance criteria and the study information for the ICONACY™ I-Hip™ System, based on the provided document:

This 510(k) submission (K131279) is for modifications to existing components and the addition of new acetabular cups, not for an entirely new device. Therefore, the "study" described focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical trial for novel device performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of a traditional clinical study with patient samples. The performance data is derived from in vitro mechanical testing of the device components.

• Sample Size for Mechanical Testing: Not explicitly stated (e.g., number of cups tested, number of forces applied).
• Data Provenance: This is an in vitro engineering study, not human or animal data. The origin would be the testing facility of ICONACY Orthopedic Implants, LLC.

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

Not applicable. The "ground truth" for this type of submission is based on engineering principles and established mechanical testing protocols. There is no mention of external human experts establishing a ground truth for the in vitro test results in this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable, as this was an in vitro mechanical testing study, not a clinical study requiring adjudication of patient outcomes or imaging interpretations. The determination of "substantial equivalence" based on these tests would be made internally by the sponsor and reviewed by the FDA.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not a study involving AI, human readers, or medical imaging. It is a submission for an orthopedic implant.

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

Not applicable. This is not an algorithmic device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission's performance data is based on mechanical testing standards and engineering specifications designed to ensure the modified components are as robust and perform similarly to the predicate device. The goal is to demonstrate that the physical properties and performance under stress (push-out, lever-out, torque-out) meet acceptable thresholds for orthopedic implants of this type and are comparable to the previously cleared predicate.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" in this 510(k) submission, as it does not involve machine learning or AI.

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

Not applicable, as there is no training set for this device submission.

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