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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, 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 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 ultrahigh 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-UHMVPE liner. Standard instrumentation is used to implant the device.

The current submission adds angled face, lateralized and extended wall acetabular liners and an apex hole plug to the I-Hip Total Hip System. The compatible femoral heads, acetabular cups, locking rings and bone screws were cleared in K121034. Additional compatible acctabular cups and locking rings were cleared in K131279.

The provided text describes a 510(k) premarket notification for a medical device, the ICONACY™ I-Hip™ System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through clinical or standalone performance studies like those common for AI/ML-enabled devices.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable to this document. The device is a total hip system, which is a physical implant, not an AI/ML-enabled device or software.

Here's a breakdown of what can be extracted and what is not relevant:

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

• Not Applicable. This document does not describe specific numerical acceptance criteria typical for AI/ML performance metrics (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to a predicate device.
• Reported Device Performance: The only performance data explicitly mentioned is:
  • "Range of motion analyses were completed for the acetabular liners to ensure that adequate range of motion was maintained."
  • "Characterization and biocompatibility data for color additives is provided in a Master File."
  • No specific quantitative results from these analyses are provided in this summary.

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

• Not Applicable. No test set in the context of AI/ML evaluation is mentioned or performed. The demonstration of substantial equivalence is based on design, materials, function, and indications for use compared to predicate devices.

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" establishment in the context of an AI/ML test set mentioned.

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

• Not Applicable. No test set or adjudication method is described.

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. MRMC studies are relevant for evaluating AI-assisted diagnostic tools. This device is a physical orthopedic implant.

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

• Not Applicable. This device is a physical implant, not an algorithm.

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

• Not Applicable. Ground truth in the context of AI/ML validation is not applicable here.

8. The sample size for the training set

• Not Applicable. There is no AI/ML model, hence no training set.

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

• Not Applicable. No training set or ground truth for it exists in this submission.

Summary of Device Acceptance and Study:

The ICONACY™ I-Hip™ System met the criteria for substantial equivalence to its predicate device (ICONACY I-Hip Total Hip System, K121034) by demonstrating similarities in design, materials, function, and indications for use.

• Acceptance Criteria (for regulatory clearance): Substantial Equivalence to a legally marketed predicate device.
• Study Proving Acceptance: The regulatory submission (510(k)) itself, which included comparisons of the device's characteristics to the predicate.
• Performance Data Mentioned:
  • Range of motion analyses for acetabular liners to ensure adequate range of motion.
  • Characterization and biocompatibility data for color additives (referenced in a Master File).
• Clinical Testing: Explicitly stated as "Clinical testing was not required for determining substantial equivalence with the predicate devices."

In essence, the "study" for this type of device clearance is a comparative analysis against a predicate device based on technical specifications and existing regulatory precedents, not a performance study in the same vein as those for AI/ML-enabled devices.

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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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