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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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The Libertas™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to fix and support the components.

Total hip replacement is indicated for the following conditions:

• · Non-inflammatory degenerative joint diseases including osteoarthritis and avascular necrosis.
• · Rheumatoid arthritis.
• · Congenital hip dysplasia.
• · Acute traumatic fracture of the femoral head or neck.
• · Certain cases of Ankylosis.
• · Dislocation of the hip.
• · Correction of functional deformity.
• · Revision of failed joint reconstruction or treatment.
• · Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur.

Note

· The Modular Shell, Uncemented Stem and Taper Uncemented Femoral Stem are intended for press-fit, uncemented use only.

· The Cemented stem is intended for cemented use only.

This 510k is intended to add a Modular Liner made from Vitamin E containing HXLPE (E-XLPE) to the Libertas™ - Hip Replacement System and Libertas™ Acetabular Hooded Liner cleared under K180973 and K183365, respectively. These Modular Liners are designed to be used with the Libertas components already cleared under K180973. These are available in different sizes i.e. MA, MB, MD, MF, MH, MJ, MK and different variants for each size Viz, neutral offset, "+4 mm offset", "Elevated wall", "10° Oblique", "15° Oblique" and "+4 mm offset 10° Oblique".

This looks like a 510(k) summary for a medical device called the Libertas™ E-XLPE Modular Liner, which is a component for hip replacement systems. The document states that the device is substantially equivalent to previously cleared predicate devices.

However, the provided text does not contain information about a study proving the device meets acceptance criteria in the way typically seen for AI/ML-powered medical devices. The "Non-clinical Performance data" section describes a series of mechanical and material tests for the physical hip implant component, not a clinical study or AI/ML performance evaluation.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance studies (like sample size for test sets, expert qualifications, MRMC studies, standalone performance, training set details, or ground truth establishment).

Here's an analysis of what is present in relation to "acceptance criteria" and "proof":

Analysis of Provided Information Regarding Acceptance Criteria and Proof

The document focuses on demonstrating substantial equivalence to predicate devices through mechanical and material testing, which is the standard pathway for many Class II medical devices like this hip implant component. The "acceptance criteria" are implicitly tied to meeting the performance standards of these established predicate devices and the relevant ASTM/ISO standards.

The "study that proves the device meets the acceptance criteria" refers to the set of non-clinical bench tests listed.

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

Since this is a mechanical device, the "acceptance criteria" are the passing criteria for the referenced ASTM and ISO standards for properties like axial disassembly, offset pull-out, torque-out disassembly, impingement, range of motion, and material characteristics. The document states that these tests were "conducted to evaluate device function/mechanical performance and to demonstrate substantial equivalence," implying that the device met the acceptance criteria defined by these standards. However, the specific quantitative results of these tests and the exact thresholds for acceptance are not provided in this summary.

Implied Acceptance Criteria and Reported Performance (Based on available info):

2. Sample size used for the test set and the data provenance: Not applicable. These were non-clinical bench tests on physical devices, not a test set of data like in AI/ML.

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 refers to the results of the bench tests against established standards, not expert adjudication of medical images or data.

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 not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the non-clinical tests would be the measured physical and material properties meeting the specifications outlined in the referenced ASTM and ISO standards.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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The Corin Optimized Positioning System Functional Hip Analysis (OPS™ FHA) is indicated for preoperative analysis of primary total hip arthroplasty. Corin OPS™ FHA is intended to be used as a pre-operative tool which provides the Surgeon with functional acetabular cup orientations based on the patient pelvic kinematics and presents a visualisation of the patient's hemipelvis.

The Corin OPS™ FHA is intended for use with the Corin Trinity Acetabular System (K093472, K11481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty.

The Corin Optimized Positioning System Functional Hip Analysis (OPS™ FHA) consists of a pre-operative patient specific analysis and two patient specific reports: Functional Hip Analysis (FHA) report and Patient Specific Visualisation (PSV) report.

The Corin OPS™ FHA assists the surgeon in determining a patient specific target orientation for the acetabular cup using anatomical landmarks of the pelvis obtained from pre-operative CT scan and X-ray data and a subsequent functional pelvic kinematic analysis (FHA report), and visualisation of the patient's 3-dimensional anatomy (PSV report).

The provided text describes the Corin Optimized Positioning System Functional Hip Analysis (OPS™ FHA) and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving performance.

Here's a breakdown of what can be extracted and what is missing:

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

The document mentions a "Reproducibility and Repeatability study" was performed and that it demonstrated the process used to generate the FHA report is "reliable and repeatable." However, it does not provide specific numerical acceptance criteria or the reported performance metrics (e.g., specific values for reproducibility, repeatability, accuracy, precision).

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

The document mentions a "Reproducibility and Repeatability study" was performed but does not specify the sample size used, the country of origin of the data, or whether the data was retrospective or prospective.

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 provided in the document.

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

This information is not provided in the document.

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

The document states, "Clinical testing was not necessary for this Traditional 510(k)." This implies that a MRMC comparative effectiveness study was not performed as part of this submission. The device is a pre-operative analysis tool to assist surgeons, not a diagnostic tool requiring human reader improvement comparison.

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

The "Reproducibility and Repeatability study" described likely assessed the standalone performance of the FHA report generation process. However, specific metrics of this standalone performance are not provided.

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

The document describes the device as providing "functional acetabular cup orientations based on the patient pelvic kinematics." The ground truth for the reproducibility and repeatability study would presumably relate to the consistency of these calculated orientations, but the specific method of establishing "ground truth" (e.g., comparing to a gold standard measurement, or internal consistency checks) is not detailed.

8. The sample size for the training set

The document describes the device as being substantially equivalent to a predicate and mentions "non-clinical testing" including a reproducibility and repeatability study. It does not provide information about a training set size, which is typically relevant for machine learning or AI-based devices. The OPS™ FHA seems to be based on anatomical landmark analysis and kinematic modeling rather than a deep learning model trained on a large dataset.

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

Since information regarding a training set is not provided, how its ground truth was established is also not available in the document.

Summary of available information regarding acceptance criteria and study:

• Study Type: Reproducibility and Repeatability study.
• Purpose: To demonstrate that the process used to generate the FHA report is reliable and repeatable.
• Outcome (general): The study demonstrated reliability and repeatability.
• Clinical Testing: Not deemed necessary for this 510(k).

Missing Information:

• Specific numerical acceptance criteria.
• Detailed reported device performance metrics/values.
• Sample size for the reproducibility and repeatability study.
• Data provenance for the study (country, retrospective/prospective).
• Number and qualifications of experts involved in any ground truth establishment.
• Adjudication method.
• Specific details on how "ground truth" was established for the non-clinical study.
• Information on training set size or ground truth establishment for a training set.

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