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The BiPolar-i is intended for use in the following indications: Non-inflammatory degencrative joint disease including osteoarthritis and avascular necrosis in which the acetabulum does not require replacement, Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur, Revision of failed partial hip replacements in which the acetabulum does not require replacement. The BiPolar-i is indicated for cementless use only.

The Trinity Acetabular System is indicated for use in non-intlammatory degenerative joint disease including osteoarthritis and avascular necrosis, rheumatoid arthritis, correctional deformity, developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH). The Trinity Acctabular System is intended for cementless, single use only.

The indications for the Corin MctaFixM Hip Stem as a total hip arthroplasty, and when used in combination with a Corin hemi arthroplasty head, as a hip hemi-arthroplasty, 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) and congenital dysplasia of the hip (CDH). The Corin MetaFixTM Hip Stem is indicated for cementless use only.

The indications for the MiniHip Stem as a total hip arthroplasty include: Non-inflammatory degenerative joint disease including osteoarthriis and avascular necrosis Rheumatoid arthritis Correction of functional deformity. Developmental dysplasia of the hip (DDH) and congenital dysplasia of the hiniHip Stem is indicated for cementless use only.

The indications for the TrinityTM Accabular System as a total hip arthroplasty include: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Rheunatoid arthritis, Correction of functional deformity, Developmental dysplasia of the hip (DDH), and congenital dysplasia of the hip (CDH). The Trinity Acctabular System is intended for cementless, single use only.

The Trinity Dual Mobility System is intended for use in the following indications: 1. Non-inflammatory degenerative joint disease, including osteoarthritis & avascular necrosis 2. Rheumatoid Arthritis 3. Correction of functional deformity 4. Revision of previously failed total hip arthroplasty 5. Patients at increased risk of dislocation 6. Developmental dysplasia of the hip (DDH). The Trinity TM Dual Mobility System is indicated for cementless use only.

The indications for the Corin Trinity™ PLUS Accabular Shell as a total hip arthroplasty include: Non-inflammalory degenerative joint disease including ostoarthritis and avascular necrosis. Rheumatoid arthritis. Correction of functional deformity, Revision of previously failed total hip arthroplasty, Developmental dysplasia of the hip (DDH). The Trinity TM PLUS Acctabular Shell is indicated for cement less use only.

The MobiliT Cup, for cemented and cementless use, are indicated for primary replacement of the hip joint: - In degenerative pathologies: primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis - For patients who have a high risk of dislocation - In cases of necrosis of the femoral head - In cases of fracture of the neck of the femur - In cases of congenital luxation. The MobiliT Cup, for cemented and cementless use, are indicated for revision when the bone tissue remains sufficient after the removal of the previous acetabular cup. The cementless MobiliT standard Cup, with flanges or with flanges and hook are indicated for cementless use only. The cemented MobiliT Cup is indicated for cemented use only.

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

The OMNI Hip system Ceramic Femoral Heads are intended for use in combination with the OMNI Hip System Stems as the femoral component in total hip replacement procedures. This ceramic head is intended to articulate with the OMNI Interface Acctabular System or bipolar component. This prosthesis is intended for single use may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation; Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fiactures of the proximal femur.

The indications for use of the OMNI Modular Hip Stems in hip arthroplasty include the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis: Correction of functional deformity; Congenital dislocation: Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur. The OMNI Modular Hip stems are indicated for cementless use only and single use implantation.

The indications for use of the OMNI Modular Hip Stems in hip arthroplasty include the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis: Correction of functional deformity; Congenital dislocation: Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur. The OMNI Modular Hip stems are indicated for cementless use only and single use implantation.

The Revival Modular Revision Hip Stem is indicated in revision surgery of femoral components, following failure of primary cemented or un-cemented prosthesis. The REVIVAL™ Hip Stem 100mm distal component is also indicated in primary total hip arthroplasty. The indications for the Revival TM Modular Revision Hip Stem include: Non-inflammatory degenerative joint disease including primary and secondary osteoarthritis. Rheumatoid arthritis, Correction of functional deformity, Treatment of non-union and femoral neck fractment of traumatic dislocations of the hip, Failures of osteotomy, Treatment of arthrodesis. The Revival ™ Revision Hip Stem is indicated for cementless, single use only.

TaperFirM Hip Stem is indicated for the relief of pain and restoration following the effects of femoral neck fracture, osteo, theumatory arthritis, post- traumatic disease effects, avascular necrosis and total hip revision. The Taper it Hip Stem is indicated for hemi-arthroplasty when used in combination with Corin hemiarthroplasty femoral heads. The TaperFitTM Hip Stem is indicated for cemented, single use only.

The indications for use of the K 1 Hip arthroplasty include the following conditions, as appropriate: Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis: Rheumatoid arthritis: Correction of functional deformity: Congenital disfocation: Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur. The K 1 Hip Stem is indicated for cementless use only and single use implantation.

The indications for the TriFit CF Hip Stem as a total hip arthroplasty and as a hip hemiarthroplasty include: Noninflammatory 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), Previously failed hip surgery. The Trifit CF Hip Stem is indicated for cementless use only.

The indications for the Corin TriFit TSTM Hip atthroplasty, and when used in combination with a Corin hemi arthroplasty head, as a hip hemi-arthroplasty, include: Non-inflammatory degenerative joint disease including osteoadhritis 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 Tril'it TS Hip is intended for cementless use only.

The subject and predicate devices are one in the same and are comprised of several legally marketed Corin Ltd. hip products, which include OMNIIfe Sciences and Apex Surgical hip products. The subject devices include acetabular cups and liners, bone fixation screws, screw hole occluders, cemented and cementless femoral hip stems for primary and revision hip arthroplasty, fixation screws, modular necks, CoCrMo alloy and ceramic femoral heads, dual mobility acetabular systems, and bipolar heads. The purpose of this 510(k) is to notify the FDA of Corin's engineering assessment of the cross-compatibility of the subject devices, identification of conflicts, and updates to the product labeling. The subject hip devices components are manufactured from a variety of materials which include cobalt-chromium-molybdenum alloy, stainless steel alloy, unalloyed titanium, calcium phosphate (Bonit™ coating) Alumina Matrix Composite ceramic (Biolox Delta), and ultrahigh molecular weight polyethylene (UHMWPE), all of which conform to ASTM or ISO standards, or internal standards. The subject femoral hip stems and heads possess the same 12/14 taper design and reference system for determining head and neck offsets.

I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance as typically seen in a medical device submission beyond general statements of substantial equivalence. The document is a 510(k) summary for hip replacement components, primarily focusing on cross-compatibility of various existing devices.

The text outlines:

• Device identification and manufacturer information.
• List of numerous predicate devices.
• Detailed descriptions of the indications for use for many hip components (e.g., Corin BiPolar-i, Trinity™ Acetabular System, MetaFix™ Hip, MiniHip™, Trinity™ Dual Mobility, MobiliT™ Cup, OMNI Bipolar Head, OMNI Delta Ceramic Femoral Head, OMNI MOD Hip System, OMNI K1/K2 Hip Systems, Revival™ Modular Hip Stem, TaperFit™, TriFit™ CF/TS Hip). These indications primarily relate to non-inflammatory degenerative joint disease, rheumatoid arthritis, correction of functional deformity, avascular necrosis, fractures, and revision surgeries.
• A "Performance Data" section which describes the types of engineering analyses and bench testing performed to establish cross-compatibility (e.g., ceramic head burst testing, head pull-off, fretting-corrosion, impingement testing, range of motion assessment, comparison of taper geometries, fatigue strength assessment, and contact stress/wear potential).

However, it does not provide:

1. A specific table of acceptance criteria and reported device performance for the types of tests mentioned (e.g., what burst pressure was required vs. achieved). It only lists the types of tests done.
2. Sample sizes used for test sets or data provenance.
3. Number of experts and their qualifications for establishing ground truth (as this pertains to clinical studies, which are not detailed here for performance).
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information.
6. Standalone algorithm performance (as this is not an AI/algorithm-driven device).
7. Type of ground truth used (again, this is not a diagnostic device with "ground truth" in the typical sense).
8. Sample size for training set.
9. How ground truth for the training set was established.

The document's purpose is to demonstrate substantial equivalence of a range of hip components, including their cross-compatibility when used together. The "performance data" refers to the engineering and bench testing conducted to ensure this compatibility rather than clinical performance against specific metrics as one would find for a diagnostic or AI-driven device.

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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 alloy shell; acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW; and BIOL.OX delta™ ceramic and CoCrMo modular heads. The ceramic and CoCrMo modular heads are compatible with Corin utanium femoral stems.
The purpose of this submission is to add 28mm (-5mm offset), 32mm (-6mm offset), 36mm (-8mm offset), and 40mm (-8mm offset) CoCrMo extra short femoral heads to the Trinity Acetabular System, and complete the line of extra long heads with the addition of a 28mm (+7mm offset) CoCrMo heads.

This document describes the Corin Trinity Acetabular System with Extra short Heads and 28mm Extra long Head (K131647).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain explicit acceptance criteria in the traditional sense of performance metrics with specific thresholds (e.g., sensitivity, specificity, accuracy for an AI device). Instead, the submission focuses on demonstrating substantial equivalence to predicate devices for new components being added to an existing system.

The "performance" demonstrated for these new components is primarily through non-clinical testing.

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

This submission pertains to the addition of new components (extra short and extra long femoral heads) to an existing hip prosthesis system. The evaluation relies on non-clinical testing (mechanical tests) rather than human clinical data. Therefore, the concepts of "test set" and "data provenance" as typically applied to AI/software performance studies are not directly applicable here. The "sample size" would refer to the number of physical components tested in the lab, but this detail is not provided in the summary.

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

Not applicable. As this is a medical device (hip prosthesis components) and the evaluation relies on non-clinical mechanical testing, there is no "ground truth" established by human experts in the context of diagnostic or interpretive performance. The "ground truth" for mechanical testing would be derived from engineering standards and test protocols.

4. Adjudication Method for the Test Set

Not applicable. Since the evaluation is based on non-clinical mechanical testing, an adjudication method for human interpretation is not relevant.

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 submission is for physical medical device components, not an AI or software device that assists human readers.

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

Not applicable. This submission is for physical medical device components, not an AI or software algorithm.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" would be established by engineering specifications, established test methods, and industry standards for mechanical performance of hip prosthesis components. For example, fatigue tests would have pre-defined failure criteria based on regulatory guidance or consensus standards.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" in this type of physical medical device submission, as it does not involve machine learning or data-driven model development.

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

Not applicable, as there is no training set involved.

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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 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 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 indicated for cementless, single use only.

The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell with, ultra high molecular weight polyethylene (UHMWPE), highly cross-linked polyethylene (HXLPE) and vitamin E highly cross-linked polyethylene (ECiMa) acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW. The Trinity system also includes, BIOLOX delta™ ceramic and CoCr modular heads which are intended for use with Corin titanium femoral stems. The acetabular shell comes in two variants, a standard Trinity (K093472 and K110087) and a Trinity-i (K122305) shell, both coated with a rough titanium plasma spray with an additional top layer of electrochemically deposited calcium phosphate (BONIT™). The Trinity and Trinity-i acetabular shells are provided with screw holes and come assembled with titanium occluders in place. Dedicated titanium screws are also provided for additional fixation if required.

The purpose of this submission is to add two more acetabular shell variants to the Trinity Acetabular System, the standard Trinity No Hole acetabular shell and the Trinityi No Hole acetabular shell. Both of these variants, subject of this submission, are similar to the standard Trinity Acetabular shells previously cleared (K093472, K110087 and K122305) with the only difference being the shells subject of this submission do not have screw holes in them.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Corin Trinity Acetabular System (K130128):

1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance:

No explicit acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, precision) or a standalone performance study of the device's diagnostic or therapeutic efficacy are presented in this 510(k) summary.

Instead, the acceptance criteria are met through demonstrating:

The study underpinning this submission focuses on non-clinical testing to demonstrate substantial equivalence to predicate devices, rather than a standalone clinical performance study verifying new performance metrics for the modified device.

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

No specific "test set" in the context of clinical trials or data analysis is mentioned because this submission relies on demonstrating substantial equivalence to previously cleared devices. The testing conducted was "non-clinical testing" including comparisons of designs, materials, intended use, indications, and dimensions. Therefore, there is no sample size for a test set or data provenance from a patient population.

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

Not applicable. As described above, there was no clinical test set or ground truth established by experts in the context of diagnosing or categorizing patient data.

4. Adjudication Method for the Test Set:

Not applicable. There was no clinical test set or adjudication process for diagnostic outcomes.

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

No. An MRMC study was not performed. The submission relies on establishing substantial equivalence through non-clinical testing and comparison to predicate devices, not on proving improved human reader performance with AI assistance. The device in question is a physical medical device (hip prosthesis components), not an AI-powered diagnostic tool.

7. Type of Ground Truth Used:

For the purpose of this 510(k) submission, the "ground truth" is effectively the established safety and effectiveness of the predicate devices (Corin Trinity Acetabular System K093472, K110087, K122305, and DePuy Pinnacle 100 Acetabular Shell K001534). The current device's "no hole" variants are considered substantially equivalent if they match the predicates in key aspects.

8. Sample Size for the Training Set:

Not applicable. This device is a modified physical implant, not an algorithm that requires a training set of data.

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

Not applicable. As stated above, there is no training set for an algorithm.

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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 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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