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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 Corin MetaFix Hip 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) or congenital dysplasia of the hip (CDH)
The MetaFix Hip is intended for cementless use only.

The Metafix Hip is a tapered stem manufactured from titanium (Ti6Al4V) with a layer of hydroxyapatite (HA) Coating applied. The Metafix™ Hip is available in a 135° standard offset (collared and collarless), 135° lateralized high offset (collarless), a 125° standard offset (collared and collarless), a 125° short neck (collared) and a 135° short neck (collared). The device is intended to be used with 12/14 modular taper heads.

This is a 510(k) premarket notification for a medical device called the Corin MetaFix Hip Stem, not an AI/ML device. Therefore, the requested information about acceptance criteria and studies proving the device meets them, particularly regarding AI performance, is not applicable.

The document states:

• "Clinical testing was not necessary in this Traditional 510(k)." (Page 4, Section 13)
• The submission is primarily to "modify the labeling to remove an indications for use for the MetaFix Hip Stem, for clarity to ensure safe or effective use." (Page 4)
• The device design and compatible components are "identical to that of the predicate device" (K082525, K120362, K121439, K130634, K131952 and K153381). (Page 4)
• The substantial equivalence is based on similarities in "design, materials, coating, sizes and similar in terms of intended use/indications for use." (Page 4, Section 11)

Therefore, the information for establishing acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details as they relate to an AI/ML device's performance are not provided in this document. The FDA's review concluded substantial equivalence based on non-clinical data and comparison to predicate devices, which is typical for traditional 510(k) submissions of non-AI devices.

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Total Hip Arthroplasty and Hemi Hip Arthroplasty

Total hip replacement or hip arthroplasty is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
3. Avascular necrosis of the femoral head.
4. Non-union of femoral neck fractures.
5. Certain high subcapital and femoral neck fractures in the elderly.
6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemi-arthroplasty.

HA coated stems of the Corail Hip System are indicated for cementless use only.

The Corail AMT Hip is a tapered stem available both collarless and collared. The stems are manufactured from titanium alloy (Ti6Al4V) and plasma-sprayed with a biocompatible hydroxyapatite (HA) coating for bone fixation. The Corail AMT stems feature a 12/14 modular taper that accepts 12/14 heads with a wide range of diameters. The compatible components for the hip hemi-arthroplasty application are bipolar heads cleared via 510(k) K812672 and unipolar heads cleared via 510(k) K903084. Corail AMT stems are indicated for cementless use only.

The provided document describes the Corail AMTTM Hip Prosthesis, an orthopaedic device. The submission is a 510(k) to expand the cleared indication for use to include hip hemi-arthroplasty surgical application.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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

• Non-clinical (Performance) Tests: The document does not specify the exact sample sizes (number of devices tested) for the "Validation of the taper/heads dimensional compatibility" or the "Fatigue Resistance tests." It only states that these tests were performed. Given the nature of these tests, they would typically involve a defined number of test articles to meet industry standards (e.g., ISO or ASTM standards for implant testing).
• Clinical Evaluation: No new clinical tests were conducted. The clinical evaluation utilized a "systematic literature review of Corail Hip System for the treatment of femoral neck fractures." The provenance of the data in this systematic review would depend on the included studies, but the document does not provide details on country of origin or whether these studies were retrospective or prospective. It is a compilation of retrospective existing scientific literature.

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 relies on non-clinical performance testing and a literature review for clinical evaluation, not on a test set requiring expert ground truth for interpretation of images or other data.

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

Not applicable. There was no clinical test set requiring expert adjudication.

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 a medical device for hip arthroplasty, not an AI-based diagnostic or imaging device that would typically involve MRMC studies or AI assistance for human readers.

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

Not applicable. This is a hip prosthesis, not an algorithm or AI.

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

• Non-clinical (Performance) Tests: Ground truth for these tests is based on engineering specifications, material properties, and established test standards (e.g., demonstrating mechanical compatibility and fatigue life under simulated physiological conditions).
• Clinical Evaluation: The "ground truth" for the clinical evaluation is based on the outcomes data and findings reported in the systematic scientific literature review regarding the safety and effectiveness of the Corail Hip System for femoral neck fractures, by extension supporting the expanded indications for hemi-arthroplasty.

8. The sample size for the training set

Not applicable. This is a medical device for hip arthroplasty, not an AI or machine learning model that requires a training set.

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

Not applicable. As above, there is no training set for this type of device submission.

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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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