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The indications for the Trinity Acetabular System as a total hip arthroplasty include:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
  The Trinity Acetabular System is intended for cementless, single use only.

The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium allov shell; acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW; and ceramic and CoCrMo modular heads. The ceramic and CoCrMo modular heads are compatible with Corin titanium femoral stems.
The purpose of this submission is to add 32mm (+7mm offset), 36mm (+8mm offset), and 40mm (+8mm offset) CoCrMo and BIOLOX delta™ ceramic extralong femoral heads to the Trinity Acetabular System.

This document describes a 510(k) submission for the Corin Trinity Acetabular System with Extra Long Heads. It is a modification to an existing hip prosthesis system. The key takeaway is that no clinical studies were conducted to demonstrate the device meets acceptance criteria. Instead, it relies on non-clinical testing and substantial equivalence to predicate devices. Therefore, many of the requested fields regarding clinical study details cannot be populated.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable: No clinical test set was used. Non-clinical testing (fatigue testing) typically involves a small number of samples (e.g., 6-12 samples per condition) tested under specified load conditions, but the exact sample sizes are not provided in this summary. The data provenance would be from laboratory testing.

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

• Not Applicable: Given that no clinical studies were performed and the device relies on non-clinical testing and substantial equivalence, there was no "ground truth" established by experts in the context of a clinical test set.

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

• Not Applicable: No clinical test set and thus no adjudication method for ground truth determination.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable: This device is a hip implant, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or applicable.

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

• Not Applicable: This is a physical medical device (hip prosthesis), not a software algorithm.

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

• Not Applicable: For the non-clinical testing, the "ground truth" would be the engineering specifications and performance standards for fatigue resistance. For the regulatory submission, the "ground truth" is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not Applicable: No training set was used as this is not a machine learning or AI device.

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

• Not Applicable: No training set was used.

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The indications for the Corin Metafix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-arthroplasty femoral heads, as a hemi-arthroplasty, include:

• . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
• Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip . (CDI-I)

The Corin Metafix Hip Stem is intended for cementless use only.

The Corin Metafix Hip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from Titanium (TiAL6V4) alloy for surgical implant applications, conforming to ASTM F136-11 and is coated with plasma sprayed hydroxyapatite conforming to ASTM F-1185-03(2009). The Corin Metafix Hip Stern is available in 10 sizes marked 1 through 10. Each size is available in three offsets, including Standard (1359), Lateralized, (135°), and Standard (125°) apart from the size 1 which is available in two offsets, Standard (135°) and Lateralized (135°).

The Corin Metafix Hip Stem was originally cleared in K082525, K120362 & K121439. The purpose of this submission is to modify the labeling to include additional contraindications for the Metafix stem when used for hemi arthroplasty, for clarity to ensure safe or effective use. The indications and components for use with the Corin Metafix stem subject of this submission are identical to that of the predicate devices K082525, K120362 & K121439.

The provided document describes a medical device, the Corin Metafix Hip Stem, and its regulatory submission (K130634). However, this document does NOT contain information about acceptance criteria, device performance, a study proving the device meets acceptance criteria, sample sizes, ground truth establishment, or human reader effectiveness with AI assistance.

This submission is a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving the device meets specific performance criteria through new studies.

Here's how the requested information relates to the provided text:

1. Table of acceptance criteria and reported device performance: Not provided. The document states "Non-Clinical Testing: A comparison of indications for use and contraindications demonstrate substantial equivalence" and "Clinical Testing: Clinical testing was not necessary to determine substantial equivalence between the Corin Metafix Hip Stem with modified labeling to the predicate devices." This indicates that no new performance data was generated for this specific submission to meet acceptance criteria.
2. Sample size used for the test set and data provenance: Not applicable. No new test set or clinical study was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new test set or ground truth was established.
4. Adjudication method for the test set: Not applicable. No new test set or adjudication was performed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a hip implant, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. See point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No new ground truth was established.
8. The sample size for the training set: Not applicable. No new training set was involved in this 510(k) submission.
9. How the ground truth for the training set was established: Not applicable.

In summary: The provided 510(k) summary (K130634) for the Corin Metafix Hip Stem is a regulatory document asserting substantial equivalence to existing devices. It explicitly states that "Clinical testing was not necessary to determine substantial equivalence." Therefore, it does not contain the information requested about acceptance criteria, device performance studies, sample sizes, ground truth, or AI-related metrics.

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The indications for the Corin Metafix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-arthroplasty femoral heads, as a hemi-arthroplasty, include:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
• Developmental dysplasia of the hip (DDH) and congenital dysplasia of the hip (CDH)
  The Corin Metafix Hip Stem is indicated for cementless use only.

The Corin Metafix Hip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from Titanium (TiAL6V4) alloy for surgical implant applications, conforming to ASTM F136-11 and is coated with plasma sprayed hydroxyapatic conforming to ASTM F-1185-03(2009). The stem is currently available in nine sizes (2-10), each available in three offsets including Standard (1359), Lateralized 135°, and Standard (125°).
The Corin Metalix Hip Stem was originally cleared in K082525. This submission is for one additional stem size, size 1 in two available offsets, Standard (1359 and Lateralized 135°. Like the originally cleared Metafix Stems, the additional stem size features a low profile lateral shoulder, a tapered metaphyseal flare as well as a vertically and horizontally grooved stem, providing for rotational and axial stability.
The indications and compatible components for use with the Corin Metafix size 1 are identical to that of the predicate devices (K082525 & K120362).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Corin Metafix Hip Stem:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The non-clinical testing section only mentions "mechanical fatigue testing of the neck and stem" without specifying the number of samples or units tested.
• Data Provenance: Not explicitly stated. The nature of the testing (mechanical fatigue) suggests laboratory-based testing rather than patient data.

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

• Not applicable. This study involved non-clinical mechanical testing, not a diagnostic or prediction study requiring expert-established ground truth from images or clinical assessments.

4. Adjudication Method for the Test Set

• Not applicable. This study involved non-clinical mechanical testing, not a diagnostic or prediction study requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No. This is a submission for a hip stem, a medical device, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant.

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

• No. As mentioned above, this is for a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on mechanical test standards and engineering principles. The device's ability to withstand specified loads and cycles (fatigue testing) according to ASTM standards (F136-11, F-1185-03(2009)) serves as the basis for determining its safety and effectiveness.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

• Not applicable. As there is no training set for a machine learning model, this question is irrelevant.

Summary of the Study:

The study described is a non-clinical engineering evaluation to demonstrate the substantial equivalence of an additional size (size 1) of the Corin Metafix Hip Stem to previously cleared predicate devices. The primary method of proof relies on mechanical fatigue testing of the neck and stem. The results of this testing are expected to show that the new size is safe and effective for its proposed indications and design compared to the predicate devices. No clinical testing, human-reader studies, or AI-related evaluations were deemed necessary for this submission. The "ground truth" for this type of device is adherence to recognized mechanical testing standards and performance comparable to legally marketed predicates.

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The Unity Total Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.

General total knee arthroplasty indications include:

• Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis
• Post-traumatic loss of knee joint configuration and function
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function
• Revision of previous unsuccessful knee replacement or other procedure, where soft tissue stability is adequate
• Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques
• The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface geometries with increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament

The Unity Total Knee System is indicated for cemented, single use only.

The Corin Unity Knee System is a fixed bearing total knee replacement system that consists of a femoral component, tibial insert, tibial tray and all-polyethylene patellar component for use in primary total knee arthroplasty. The Unity Knee System is provided in two variants, cruciate retaining (CR) and posterior stabilized (PS). The Unity CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is present. The Unity posterior stabilized variant is utilized when total knee replacement is indicated, and the posterior cruciate ligament is non-functioning or absent, resulting in joint instability. The Unity system patellar component is optional and is used in situations where replacement of the articular surface of the patella is required. The system also provides augment components including femoral wedges, tibial wedges, a short keel extension and stem extensions with offset connections.

The provided document describes the Unity™ Total Knee System, a medical device for knee arthroplasty. It states that "Clinical testing was not necessary to determine substantial equivalence between the Unity Total Knee System and the predicate devices." Therefore, the document does not contain information regarding acceptance criteria, reported device performance from a test set, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML-based device.

Instead, the document focuses on non-clinical testing to establish substantial equivalence to predicate devices. This type of evaluation is common for mechanical medical devices, where performance is assessed through bench testing rather than clinical trials with human subjects interacting with software.

Here's a breakdown of what the document does provide regarding the device's evaluation, as per your request related to acceptance criteria, but reinterpreted for a mechanical device:

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

Explanation: The "acceptance criteria" here are implied by adherence to industry standards, specifically ASTM F2083, which outlines specifications for total knee prostheses. The "reported device performance" is a general statement that the device met these criteria, thus deeming it "safe and effective for the proposed indications and substantially equivalent to the predicate devices."

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

• Sample Size: Not applicable in the context of clinical data for AI/ML. For mechanical bench testing, the "sample size" would refer to the number of device components tested (e.g., number of femoral components, tibial trays, inserts). This information is not specified in the provided text, but it would typically be defined within the test protocols conforming to ASTM F2083.
• Data Provenance: Not applicable in the context of clinical data. The tests were performed "in accordance with ASTM F2083 Standard Specification for Total Knee Prosthesis." This implies controlled laboratory conditions for mechanical testing rather than patient data collection.

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

• Not applicable as the evaluation was based on mechanical bench testing against engineering standards, not expert interpretation of clinical data.

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

• Not applicable as the evaluation was based on mechanical bench testing against engineering standards, not expert adjudication of clinical findings.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This device is a mechanical total knee system, not an AI/ML diagnostic or assistive tool. Therefore, a MRMC study for AI assistance is not relevant to its evaluation.

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

• No. This device is a mechanical total knee system.

7. The type of ground truth used:

• Engineering Standards and Specifications: The "ground truth" for this device's performance is established by the requirements and test methods outlined in ASTM F2083 Standard Specification for Total Knee Prosthesis. Compliance with these established industry standards (e.g., specific deflection limits, fatigue life, wear rates, constraint magnitudes) serves as the basis for determining the device's mechanical integrity and functional performance.

8. The sample size for the training set:

• Not applicable. This device is a mechanical knee prosthesis, not an AI/ML system that requires a "training set."

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

• Not applicable. This device is a mechanical knee prosthesis.

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The indications for the Corin Metafix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-arthroplasty femoral heads, as a hemi-arthroplasty, include:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
• Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
  The Corin Metafix Hip Stem is intended for cementless use only.

The Corin Metafix Hip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from Titanium (TiAL,V ) alloy for surgical implant applications, conforming to ASTM F136-11 and is coated with plasma sprayed hydroxyapatite conforming to ASTM F-1185-03(2009). The stem is indicated for use with Corin CoCr modular femoral heads and ceramic modular femoral heads with a 12/14 taper. (NOTE : the ceramic modular heads are not subject of this 510(k) submission.) The stem is available in nine sizes, each available in three offsets including standard (135°), lateralized 135°, and standard (125°).

The Corin Bipolar Head (K925897) is comprised of an outer CoCr shell, an inner liner of ultra high molecular weight polyethylene (UHMWPE), and an inner CoCr head. The Bipolar head is available in a range of outer diameter sizes and a variety of head offsets and is compatible with all Corin 12/14 taper femoral stems. The Corin Optimom Modular Head (K111911) is a polished, truncated CoCr alloy sphere with a high tolerance internal female taper and is available in a range of diameters with a variety of offsets. It is compatible with Corin 12/14 taper titanium and stainless steel femoral stems. The Bipolar and the Optimom Modular Heads are indicated for hip hemi-arthroplasty.

The purpose of this submission is to modify the labeling for the Metafix Femoral Hip Stem to include hip hemi-arthroplasty to the indications for use when the stem is mated with a Corin CoCr hemi-arthroplasty femoral head.

The provided text describes a 510(k) premarket notification for a medical device, the Corin Metafix Femoral Stem for Hemi-arthroplasty. This document is a regulatory submission for pre-market clearance, not a study evaluating device performance against acceptance criteria in the way a clinical trial would.

Here's an analysis based on the information provided, specifically addressing why certain sections of your request cannot be fulfilled:

1. Table of Acceptance Criteria and Reported Device Performance

This information is typically found in a clinical study report or a design verification/validation report, neither of which is present in the provided 510(k) summary. The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against pre-defined acceptance criteria through a specific study.

The document states:

• "A comparison of design, materials, size range, and indications for use demonstrate substantial equivalence with the predicate components."
• "Testing was submitted in the predicate 510(k) submissions and as demonstrated in the substantial equivalence table, the Metafix Femoral Stem, when coupled with the Corin hip hemi-arthroplasty heads is substantially equivalent to the predicate devices and expected to be safe and effective for the proposed indications."

Therefore, there are no specific performance acceptance criteria or reported device performance metrics in this document. The "performance" is implicitly tied to the established performance of the predicate devices.

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 a clinical study or performance evaluation is discussed. The submission relies on equivalence to predicate devices, which would have had their own historical data, but that data is not detailed here.

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. No "ground truth" establishment by experts for a test set is described.

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

Not applicable. No adjudication method is described as there is no test set in the context of this submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical hip prosthesis, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not applicable. This device is a physical hip prosthesis, not an algorithm.

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

Not applicable. No specific ground truth determination process is described for the device itself. The established safety and effectiveness of the predicate devices serve as the "ground truth" for the equivalence claim.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary of the Study (as described in the document):

The document describes a Substantial Equivalence Study documented in a 510(k) premarket notification (K120362).

• Study Goal: To demonstrate that the Corin Metafix Femoral Stem for Hemi-arthroplasty is substantially equivalent to legally marketed predicate devices, particularly for an expanded indication for hip hemi-arthroplasty.
• Methodology:
  • Comparison to Predicate Devices: The Metafix Femoral Stem (K082525), Corin Optimom Modular Heads (K111911), and Corin Bipolar Heads (K925897) were identified as predicate devices.
  • Basis of Equivalence: The submission argues that the Corin Metafix Hip Stem, when used for hemi-arthroplasty with compatible Corin CoCr hemi-arthroplasty femoral heads, is substantially equivalent based on:
    • Identical Intended Use/Indications for Use (for the heads): The Optimom and Bipolar heads are identical to predicate femoral heads in these aspects.
    • Identical Design, Materials, and Sizes: For the Metafix Femoral Stem, it is identical to the previously cleared Metafix Femoral Stem (K082525) in materials and sizes. The subject of the submission is a modification of Indications for Use.
    • Similar Components: The inner 26mm Eurocone CoCr femoral head of the Corin Bipolar Head is manufactured of the same material, is similar in design, and is within the range of previously indicated compatible components for the Metafix Femoral Stem.
  • Non-Clinical Testing: The document states, "Testing was submitted in the predicate 510(k) submissions." This implies that the current submission relies on the non-clinical testing performed for the predicate devices to support the equivalence claim, rather than presenting new non-clinical tests for the modified indication. This non-clinical data would have included mechanical testing, material characterization, etc.
  • Clinical Testing: The document explicitly states, "Clinical testing was not necessary to determine substantial equivalence between the Metafix Femoral Stem for total hip arthroplasty and the Metafix Femoral Stem for Hemi-arthroplasty." This indicates that no new clinical study was conducted for this specific submission to demonstrate performance.

In essence, the "study" is a regulatory comparison against existing, cleared devices, rather than a de novo performance study against defined acceptance criteria.

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The indications for the Trinity Acetabular System as a total hip arthroplasty include:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
  The Trinity Acetabular System is intended for cementless use only.

The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell, acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW, ceramic and Co-Cr modular heads and titanium femoral stems.
The purpose of this submission is to add ECIMA acetabular liners to the Trinity Acetabular System. Corin's ECIMA is a cold irradiated, mechanically annealed, vitamin E blended ultra high molecular weight polyethylene.

The provided document is a 510(k) summary for the Corin Trinity Acetabular System ECIMA Liners. It focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through a clinical trial or a standalone algorithm performance study.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be stated based on the provided text:

• Acceptance Criteria/Device Performance: The document does not describe specific acceptance criteria for performance metrics in a clinical context. Instead, it relies on non-clinical testing to demonstrate performance in various aspects (tensile strength, impact strength, wear, etc.) and states that the new components are "similar to the predicate devices in terms of intended use and indications, materials, sizes, designs and performance." The implicit acceptance criterion is "substantial equivalence" to the predicate device based on these similarities and the non-clinical test results.

• Study Proving Acceptance Criteria Met: No clinical study is presented to prove the device meets acceptance criteria.

Let's address the specific points you asked for, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not applicable. No clinical test set. The non-clinical tests would have their own sample sizes but these are not disclosed in the summary.
• Data Provenance: Not applicable. No clinical data is presented.

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

• Not applicable. No clinical test set or ground truth established by experts.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set.

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

• Not applicable. No clinical study, and no human-in-the-loop AI component discussed.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not applicable. This device is a physical medical implant, not an algorithm or AI system.

7. Type of Ground Truth Used

• For the non-clinical tests, the ground truth would be the objectively measured values of the material and mechanical properties. For the purpose of the 510(k), the "ground truth" for substantial equivalence is the predicate device's characteristics and performance, against which the new device's non-clinical test results are compared.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical implant, not an AI model requiring a training set.

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

• Not applicable.

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The Corin Optimom Modular Head is indicated for hemi-arthroplasty in cemented and uncemented primary or revision femoral stem applications whose indications include procedures for patients suffering pain and disability due to osteoarthritis, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required.

The device is intended for prescription use only.

The Corin Optimom Modular Head is a polished, truncated sphere with a high tolerance internal female taper. It is a device modification of the internal female taper of the Corin Unipolar Modular Heads (K063791) to provide for compatibility with an additional range of Corin femoral hip stem designs with a 12/14 male taper. The materials and dimensions of the internal female taper are substantially equivalent to the CoCr Modular Heads cleared in K003666 and K010243 and the Trinity Modular Heads cleared in K110087. The Optimom Modular Head is manufactured from Cobalt-Chrome alloy conforming to ASTM F75 and is available in diameters ranging from 40-56mm with a variety of offsets.

The provided text describes a 510(k) premarket notification for the "Corin Optimom Modular Head," a hip joint femoral prosthesis component. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study proving performance against specific acceptance criteria for a new type of device or AI algorithm.

Therefore, many of the requested categories regarding acceptance criteria, study design, and ground truth are not applicable to this type of submission.

Here's a breakdown of the requested information based on the provided text:

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

• Not Applicable. This document is a 510(k) submission for substantial equivalence. It does not present specific quantitative acceptance criteria or performance metrics for a novel technology that would typically be evaluated against such criteria. Instead, it argues that the device's design, materials, and intended use are similar enough to existing devices that no new performance testing to specific criteria is needed for market clearance beyond demonstrating equivalent physical properties.

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 clinical test set data is presented as clinical testing was not deemed necessary for this submission. The "test set" in this context would refer to physical device samples undergoing engineering tests.

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. This submission does not involve expert review or ground truth establishment in the way an AI/CADe device would.

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

• Not Applicable. No expert adjudication of a test set 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. This is not a study involving human readers or AI assistance.

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

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

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

• Not Applicable. No ground truth in the sense of a medical diagnosis or outcome is established for a study. The "ground truth" for this submission is based on the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device requiring a training set.

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

• Not Applicable. This is not an AI/machine learning device.

Summary of the Study/Evidence Presented in the Document:

The "study" in this context is a non-clinical engineering assessment and comparison to legally marketed predicate devices, rather than a clinical trial or performance evaluation against new, pre-defined acceptance criteria.

Key Information from the Document:

• Device: Corin Optimom Modular Head
• Purpose: To demonstrate substantial equivalence to predicate devices (Corin Unipolar Modular Head, Corin Taperfit Total Hip System, Corin Tri-Fit Femoral Stem, Trinity Modular Heads).
• Methodology (Non-Clinical Testing):
  • Comparison of designs.
  • Comparison of materials.
  • Comparison of intended use and indications.
  • Comparison of dimensions.
  • Specific engineering tests conducted: Fatigue, rotational torque, axial pull-off, and fretting corrosion. The results of these tests are not provided in the summary but were conducted to support the substantial equivalence claim.
• Conclusion: Based on these comparisons and non-clinical tests, the Optimom Modular Heads are believed to be substantially equivalent to the predicate devices.
• Clinical Testing: "Clinical testing was not necessary to determine substantial equivalence between the Corin Optimom Modular Heads and the predicate devices." (Page 1)

In essence, the document states that specific engineering tests were performed (fatigue, rotational torque, axial pull-off, fretting corrosion) to show that the new device performs comparably to the predicate devices in these critical aspects. The "acceptance criteria" implicitly would be that the new device meets or exceeds the performance of the predicate device for these tests, demonstrating equivalent safety and efficacy. However, the specific quantitative results or acceptance thresholds are not detailed in this 510(k) summary.

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The indications for the Trinity Acetabular System as a total hip arthroplasty include:

• o Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis o
• o Correction of functional deformity
• Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH) o

The Trinity Acetabular System is intended for cementless use only.

The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell (48mm through 68mm in 2mm increments) for use with ultra high molecular weight polyethylene (UHMWPE) liners (28mm and 32mm inner diameters in neutral, +4mm offset, EPW and 10° hooded designs) and a dedicated range of 28mm and 32mm modular 12/14 taper femoral heads providing ceramic (i.e., zirconia and Biolox delta in the USA) or metal on UHMWPE articulation for use in total hip replacement procedures using Corin titanium femoral stems with a 12/14 taper connection. The acetabular shell is coated with a rough titanium plasma spray with an additional top layer of electrochemically deposited calcium phosphate (Bonit™). The acetabular shell is provided with screw holes permitting the use of dedicated titanium bone screws to provide additional fixation if required. Titanium occluders are provided to occlude unused screw holes and an apical introducer hole.

The purpose of this submission is to modify the labeling for the Trinity Acetabular System to include additional Corin titanium femoral stems with a 12/14 taper connection as compatible components, intended for use with the Trinity Acetabular Cup and Liner and the Trinity CoCr Femoral Heads.

The Trinity Acetabular System is intended for use in 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 provided text describes a 510(k) submission for the Trinity Acetabular System, which proposes to modify the labeling to include additional Corin titanium femoral stems as compatible components. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically required for AI/ML device evaluations. This submission is for a medical device (hip prosthesis) and its expanded compatibility, not a diagnostic or prognostic AI system.

However, based on the provided text, I can infer the acceptance criteria and the study in the context of demonstrating substantial equivalence for this device modification.

Acceptance Criteria and Study for K103518: Trinity Acetabular System

Given that this is a 510(k) submission primarily focused on modifying the labeling of an existing device to include additional compatible components, the "acceptance criteria" revolve around demonstrating that the modified device (Trinity Acetabular System with new femoral stems) is substantially equivalent to the previously cleared Trinity Acetabular System.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not applicable in the context of a traditional "test set" for AI. The "test" for this device was a combination of direct comparisons of specifications and specific non-clinical evaluations. The document does not specify a "sample size" for the range of motion study, but it would involve a limited number of test configurations or specimens rather than a large patient dataset.
• Data Provenance: The studies mentioned ("comparison of materials, designs and taper characteristics" and "range of motion study") are non-clinical tests. This means they were likely conducted in a laboratory setting (e.g., in vitro, cadaveric, or simulation) rather than using patient data. The country of origin for the data is not explicitly stated but would presumably be associated with the manufacturer's R&D facilities.

3. Number of Experts and Qualifications for Ground Truth

• Experts: Not applicable. The "ground truth" for this submission is established through engineering specifications, material science principles, and biomechanical testing standards, rather than expert clinical consensus on patient data.
• Qualifications: N/A

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable in the traditional sense for AI/ML performance. The "adjudication" for substantial equivalence would be performed by the FDA based on the submitted non-clinical test reports and comparisons.

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

• MRMC Study: No. This is not an AI/ML diagnostic or image analysis device, so a MRMC study is irrelevant to this submission.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: No. This is a physical medical device (hip prosthesis components), not a software algorithm.

7. Type of Ground Truth Used

• Ground Truth: The "ground truth" for this submission is based on:
  • Engineering specifications and material properties for component comparisons (materials, design, taper characteristics).
  • Biomechanical performance standards and measurements from the range of motion study.
  • The predicate device's established safety and effectiveness as the benchmark for substantial equivalence.

8. Sample Size for Training Set

• Sample Size: Not applicable. There is no "training set" as this is not an AI/ML device. The development of the components would involve engineering design and iterative testing, but not machine learning training.

9. How Ground Truth for Training Set Was Established

• Ground Truth Establishment: Not applicable. There is no "training set" for ground truth establishment.

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The indications for the Trinity Acetabular System as a total hip arthroplasty include:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Developmental dysplasia of the hip (DDH) and congenital dysplasia of the hip (CDH)
  The Trinity Acetabular System is intended for cementless use only.

The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell (48mm through 68mm in 2mm increments) for use with ultra high molecular weight polyethylene (UHMWPE) liners (28mm and 32mm inner diameters in neutral, +4mm offset and 10° hooded designs) and a dedicated range of 28mm and 32mm zirconia and cast cobalt chrome alloy modular 12/14 taper femoral heads providing ceramic or metal on UHMWPE articulation for use in total hip replacement procedures using Corin Tri-fit femoral stems with a 12/14 taper connection. The UHMWPE is previously cleared. The acetabular shell is coated with a rough titanium plasma spray with an additional top layer of electrochemically deposited calcium phosphate (Bonit™). The acetabular shell is provided with screw holes permitting the use of dedicated titanium bone screws to provide additional fixation if required. Titanium occluders are provided to occlude unused screw holes and an apical introducer hole. The Trinity Acetabular System is intended for use in 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.

This document is a 510(k) summary for the Trinity Acetabular System Hip Prosthesis. It does not describe an AI medical device or a study proving its performance against specific acceptance criteria in the way you've outlined for AI/software-based devices.

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed devices, which is the primary pathway for 510(k) clearances. The "acceptance criteria" here are implicitly tied to the performance characteristics of the predicate devices.

Therefore, I cannot populate the requested table and answer the questions related to AI/software performance studies as this is a traditional orthopedic implant device submission.

Here's a breakdown of why the requested information isn't present in the document provided:

• Type of Device: The Trinity Acetabular System is a physical medical device (a hip prosthesis), not an AI/software-as-a-medical-device (SaMD).
• Regulatory Pathway: It's a 510(k) premarket notification for a Class II device. This pathway relies heavily on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance acceptance criteria through clinical trials for novel technology.
• "Study" type: The "study" described is entirely non-clinical (bench testing and coating characterization), not a clinical trial or performance study against a ground truth.

Key takeaways from the document that relate to its "acceptance":

• Substantial Equivalence: The primary "acceptance criteria" is that the device is "substantially equivalent" to legally marketed predicate devices. This means it performs at least as safely and effectively as those predicates.
• Non-Clinical Testing: A range of bench tests were performed to support substantial equivalence, including:
  • Retention mechanism testing (push-out, lever-out, torque-out)
  • Range of motion analysis
  • Bone screw testing (torque-out, pull-out, range of motion)
  • Oxidative index testing (for UHMWPE)
  • Impingement testing (for UHMWPE)
  • Wear testing (for UHMWPE)
  • Coating characterization: porosity, pore size, surface roughness, mechanical strength (static tensile, static shear, shear fatigue), taper abrasion for CPTi coating.
  • Calcium phosphate coating characterization as per FDA guidance.
  • Shell stiffness, shell occluder locking strength, fretting/corrosion testing, and pull-off testing of the femoral head.
• No Clinical Testing: The document explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the Trinity Acetabular System and the predicate devices."

In summary, the provided text describes a traditional orthopedic device's regulatory submission, not an AI or software device. The acceptance is based on substantial equivalence demonstrated through non-clinical bench testing, not an AI performance study with ground truth.

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The indications for the MiniHip Stem as a total hip arthroplasty include:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• DDH/CDH
• Revision procedures where other treatments or devices have failed
• Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  The MiniHip Stem is indicated for cementless use only.

The MiniHip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The MiniHip Stem uses a short stem philosophy to provide a bone-conserving option to the use of a standard total hip prosthesis. The stem is manufactured from Titanium (TiAIsV4) alloy and is proximally coated with plasma sprayed hydroxyapatite over plasma sprayed pure titanium in order to enhance primary fixation. The stem is designed to be used in conjunction with Corin Eurocone CoCr modular femoral heads (K003666) and Corin Zyranox Zirconia Ceramic modular femoral heads (K992235), both of which mate with Corin Cenator Acetabular Cups (K925866). The stem is available in six sizes, each with the provision of a 130° CCD (Caput-Collum-Diaphysis) neck angle with a polished distal section for guidance and to minimize distal fixation and reduce proximal stress-shielding.

The provided text describes a 510(k) premarket notification for the MiniHip Stem, a femoral hip stem. It details the device's description, intended use, and claims of substantial equivalence to predicate devices. However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics such as accuracy, sensitivity, or specificity.

The "Non-Clinical Testing" section mentions "mechanical fatigue testing, range of motion testing and coating characterization," and states that "The results of this testing show that the MiniHip Stem is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device." However, it does not provide the quantitative acceptance criteria for these tests, nor the reported performance data from these tests.

The "Clinical Testing" section explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the MiniHip Stem and the predicate devices." This means no human-based clinical studies, including those for the purpose of demonstrating clinical performance or comparative effectiveness (MRMC studies), were conducted or submitted for this 510(k).

As a result, I cannot populate the requested table or answer most of your specific questions related to acceptance criteria and device performance studies because the information is not present in the provided text.

Here's a summary of what can be extracted or directly inferred:

1. Table of Acceptance Criteria and Reported Device Performance

• Cannot be provided. The document states that non-clinical testing (mechanical fatigue, range of motion, coating characterization) was performed, and the results showed the device is "expected to be safe and effective" and "substantially equivalent." However, it does not list specific quantitative acceptance criteria (e.g., "fatigue strength must exceed X N at Y cycles") or the device's measured performance against those criteria.

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

• Not applicable / Not provided. No clinical or standalone device performance testing data on a "test set" (in the context of AI/diagnostic device evaluation) is presented. The non-clinical tests would have used physical device samples, but details on their quantity or "data provenance" are not given.

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

• Not applicable / Not provided. No test set or ground truth establishment by experts is mentioned.

4. Adjudication method for the test set

• Not applicable / Not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. The document explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the MiniHip Stem and the predicate devices." This includes MRMC studies.

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

• No. The device is a physical medical implant (femoral hip stem), not an algorithm or diagnostic software that operates in a "standalone" mode.

7. The type of ground truth used

• Not applicable / Not provided. In the context of a hip stem, "ground truth" would typically relate to mechanical properties, biocompatibility, and clinical outcomes. The document relies on non-clinical testing for mechanical and material properties, and substantial equivalence to predicate devices for clinical safety and effectiveness rather than direct clinical ground truth generation.

8. The sample size for the training set

• Not applicable / Not provided. The device is a physical implant, not an AI model that requires a "training set."

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

• Not applicable / Not provided.

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