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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 OMNI Anseris Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex Interface™ Acetabular System. The Apex Interface™ Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for hip arthroplasty to treat 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 Anseris Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head. For further details, please refer to the Apex Bipolar Head Instructions for Use.

The OMNI Anseris Stem is a "fit and fill" femoral stem with a tapered conical design and is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex Interface™ Acetabular System.

This document is a 510(k) premarket notification for a medical device called the "OMNI Anseris Hip Stem." It details the manufacturer's claim of substantial equivalence to existing predicate devices, rather than proving the device meets acceptance criteria through a standalone study of its performance in a clinical setting.

Therefore, the information typically found in a study proving acceptance criteria for an AI/algorithm-based device (like sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or ground truth establishment) is not present in this document because it describes a physical implantable device, not a software algorithm.

However, I can extract the information related to the device's non-clinical testing which serves as the "study" proving it meets specific engineering/physical acceptance criteria.

Here's the information parsed from the provided text, focusing on the nearest equivalent to your request:

Acceptance Criteria and Device Performance for OMNI Anseris Hip Stem (Non-Clinical Testing)

This document describes the non-clinical testing performed to demonstrate substantial equivalence of the OMNI Anseris Hip Stem to predicate devices. The "acceptance criteria" here refer to meeting specific engineering and performance standards for a hip implant, rather than clinical performance metrics of an AI algorithm.

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

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

• Sample Size: Not explicitly stated in terms of individual units tested, but the document refers to "the results of testing of the proposed Anseris Hip Stems." For mechanical testing, this typically refers to a specific number of samples required by the standard (e.g., n=6 or more for fatigue testing). The document does not specify the exact number of physical stems tested.
• Data Provenance: The testing was carried out by the manufacturer, OMNIlife Science. The data is internal to the company's testing processes as part of their 510(k) submission. There is no mention of country of origin of data in a clinical sense, nor is it retrospective or prospective as it's mechanical testing of a physical device.

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

• Not Applicable. This is a physical device being cleared through substantial equivalence to existing predicate devices based on non-clinical (mechanical and material) testing. There is no "ground truth" derived from expert consensus like in an AI/imaging study. The "ground truth" here is the pass/fail criteria of established international and industry standards (ISO, ASTM).

4. Adjudication method for the test set

• Not Applicable. As there are no human readers or interpretations of data akin to an AI study, there's no adjudication method. The tests are designed to provide objective, quantifiable results against predefined engineering specifications.

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 physical hip implant, not an AI software or diagnostic imaging tool. Therefore, MRMC studies are not relevant.

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. The "standalone performance" is the performance of the hip stem in a mechanical testing environment.

7. The type of ground truth used

• For the non-clinical testing, the "ground truth" refers to compliance with established international and industry standards for hip implants, such as ISO 7206-6, ISO 7206-4, ISO 21535, and ASTM F2996-13, as well as biocompatibility standards (e.g., SAL of 10-6 for sterility, endotoxin limits).

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an algorithm undergoing machine learning.

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

• Not Applicable. As there is no training set, there is no ground truth for it.

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The OMNI Skirted Heads are intended for use in combination with the NOVAE® Dual Mobility Acetabular Cup and are indicated for total hip replacement, which includes:
• Osteoarthritis
• Femoral neck fracture
• Dislocation risk
• Osteonecrosis of the femoral head
• Revision procedures where other treatments or devices have failed and if bone reconstruction so permits.

SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use.

The OMNI Skirted Heads are intended to be used in the primary/revision total hip replacement procedures in combination with the SERF Dual Mobility Acetabular Cup. These femoral heads are manufactured from cobalt chromium (CoCr) and are designed to be used with the SERF Dual Mobility Acetabular cup. These heads offer a skirted feature and when used with the Dual Mobility cups, the skirt extends over the exposed femoral taper and reduces the contact between the SERF polyethylene liner and machined surface of the K1 stem trunnion. SERF obtained clearance to use the OMNI K1 stem with its Dual Mobility NOVAE Acetabular Cup under K111572. In this submission, OMNI proposes two sizes for these skirted heads – 28mm+7 and 22mm+3.5 diameter and neck length respectively.

This is not an AI/ML device and as a result, the acceptance criteria and study information points outlined in the request are not applicable. The device is the OMNI Skirted Heads, which are part of a hip joint prosthesis. The provided document is a 510(k) premarket notification for this medical device, demonstrating its substantial equivalence to previously marketed devices.

However, I can extract information relevant to the device's performance testing and justification for substantial equivalence.

Here's a summary of the available information:

1. Acceptance Criteria and Reported Device Performance:

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

• Test Set: The document mentions "Range of Motion testing was conducted." It does not specify the exact sample size for this testing.
• Data Provenance: Not explicitly stated, but it's internal testing conducted by the manufacturer (OMNIlife Science) to support their 510(k) submission.

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

• Not applicable/provided. This device is a mechanical implant, and its performance criteria are based on engineering and material standards (e.g., ISO 21535), not expert interpretation of outputs.

4. Adjudication method for the test set:

• Not applicable. Performance is based on objective measurements against engineering standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, this type of study is not applicable as this is a mechanical medical device, not an AI/ML-driven diagnostic or assistive tool.

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

• Not applicable, as this is not an algorithm or AI device.

7. The type of ground truth used:

• Engineering Standards and Specifications: The "ground truth" for this device appears to be the requirements of relevant ISO standards (e.g., ISO 21535 for Range of Motion) and the performance characteristics of predicate devices.

8. The sample size for the training set:

• Not applicable, as 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.

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The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cup are intended for uncemented fixation and single use implantation. These prostheses 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 fractures of the proximal femur.

Apex Modular Head sizes 28, 32, 36, and 40 mm with a + 10.5mm offset

Here's an analysis of the provided text regarding the acceptance criteria and study for the Apex Modular Heads, +10.5mm offset:

Acceptance Criteria and Device Performance Study for Apex Modular Heads, +10.5mm offset

This submission (K101575) is for a medical device seeking substantial equivalence to previously cleared predicate devices. Therefore, the "acceptance criteria" are primarily established by demonstrating equivalency to the predicate devices through non-clinical testing, rather than defining novel performance thresholds for clinical outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for substantial equivalence based on non-clinical testing, the "acceptance criteria" are implicitly met by demonstrating that the subject device's performance is comparable to or better than previously cleared predicate devices for relevant mechanical and material properties. The device performance is reported as meeting the specified standards, thereby indicating compliance with the implicit acceptance criteria for safety and effectiveness in comparison to the predicates.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in terms of number of physical units tested beyond the mention of "tests were conducted." For mechanical and material testing, sample sizes are typically defined by the specific ASTM/ISO standards referenced (e.g., minimum number of specimens for fatigue testing). The provided text indicates that the tests were conducted, implying adequate sample sizes were used as required by the standards.
• Data Provenance: Not explicitly stated (e.g., specific country or lab). The tests are described as "Non-Clinical Test Summary," meaning they were laboratory-based and not derived from human subjects. The reference to ISO and ASTM standards suggests internationally recognized testing protocols. Retrospective or prospective designations are not applicable as these are non-clinical lab tests.

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

• Not applicable. For this type of mechanical and material performance testing, "ground truth" is established by adherence to recognized international standards (ISO, ASTM) and the results obtained from the tests themselves using calibrated equipment. There is no concept of expert consensus for establishing ground truth in this context, unlike clinical studies involving image interpretation or diagnosis.

4. Adjudication Method for the Test Set

• Not applicable. As described above, the "test set" refers to the mechanical and material testing of the device components. Adjudication methods (like 2+1, 3+1) are employed in clinical studies, particularly in situations where there is subjective human interpretation or diagnostic agreement required (e.g., radiology reads).

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

• No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC comparative effectiveness study was conducted. This device is seeking clearance based on substantial equivalence to predicate devices through non-clinical performance data and material specifications.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device is a physical medical implant (hip prosthesis), not a software algorithm or AI-powered diagnostic tool. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. Type of Ground Truth Used

• Engineering and Material Standards Compliance, and Mechanical Test Results: The "ground truth" for this device's performance is established by demonstrating compliance with recognized international standards (ISO, ASTM) for mechanical properties, material composition, and manufacturing processes relevant to hip implants. The results of the non-clinical tests (ROM, FEA, Fatigue Strength) serve as the evidence to support this compliance and demonstrate substantial equivalence to the predicate devices.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical implant and does not involve AI or machine learning algorithms that require a "training set."

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

• Not applicable. No training set was used or required for this device.

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The Apex ARC Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis 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 fractures of the proximal femur.

The Apex ARC Hip Stem consists of a curved, rectangular tapered stem, and modular necks that connect to the tapered hole in the stem. The femoral stems are manufactured from titanium alloy and the modular necks are manufactured from cobalt chromium alloy. Three neck sizes are offered, with a neutral, 8 degree, and 12 degree varus-valgus angle, respectively. The necks are compatible with the modular heads that are part of the Apex Modular and Apex K2 hip systems (K000788, K012918, and K073150) and may be used with head diameters and offsets up to a maximum offset of +7 mm. These configurations allow the user to choose a combination of stem, neck, and head components to appropriately fit the anatomy of the patient. The Apex ARC Hip Stem may be used in conjunction with the Apex Modular™ Acetabular Cup (K031110, K062489, and K073150) for total hip arthroplasty.

The provided document describes the 510(k) Summary for the Apex ARC™ Hip Stem (K090845). This is a medical device submission to the FDA, and as such, it focuses on demonstrating "substantial equivalence" to predicate devices rather than proving performance against specific acceptance criteria through a traditional clinical study with defined endpoints as would be expected for a novel AI/software device.

Therefore, the requested information elements (acceptance criteria, study details, sample sizes, expert ground truth, MRMC, standalone performance) are not directly applicable in the context of this device's submission type and the information provided. Traditional clinical trials with acceptance criteria and statistical analysis are typically not required for Class II devices demonstrating substantial equivalence through non-clinical testing.

However, I can extract the relevant information regarding the non-clinical tests conducted which serve a similar purpose to demonstrating the device's functional integrity and safety, and compare them to the general characteristics of the predicate devices.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a mechanical implant, "acceptance criteria" are not explicitly defined in terms the performance metrics commonly associated with AI/software (e.g., sensitivity, specificity, AUC). Instead, the device's "performance" is demonstrated through non-clinical mechanical and material testing based on recognized international and ASTM standards. The acceptance criterion for these tests is generally successful completion of the test without failure, meeting the requirements of the specified standard, and demonstrating equivalence to predicate devices.

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

• Sample Size: Not specified in terms of number of physical devices tested for each non-clinical test. For mechanical tests, representative samples are typically used to meet the requirements of the standards. For material properties, it refers to the composition. The document doesn't detail the number of physical units tested.
• Data Provenance: The tests are non-clinical, meaning they were performed in a laboratory setting, not on human subjects. No country of origin is specified for the testing, but the submitter (OMNI life science, Inc.) is based in E. Taunton, MA, USA. This is a prospective assessment for market clearance, meaning the tests were conducted specifically for this submission.

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

This question is not applicable to this 510(k) summary. For mechanical devices, "ground truth" typically relates to objective physical measurements or material properties as defined by engineering standards, not expert consensus as in diagnostic imaging. The "experts" involved would be the engineers and technicians conducting and validating the tests, adhering to the specified ISO and ASTM standards. Their qualifications are inherent in the rigorous nature of these testing facilities.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical findings, not for objective mechanical test results. The results of the non-clinical tests are binary (pass/fail compliance with the standard).

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 total hip replacement device, not an AI/software diagnostic tool, and therefore no MRMC study was performed.

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

The "ground truth" for this device's evaluation is primarily based on engineering standards (ISO, ASTM) for mechanical performance and material properties. This includes objective measurements of fatigue strength, fretting potential, disassembly strength, torsional strength, range of motion, and material composition. Biocompatibility (ETO residuals) is also assessed against established standards.

8. The sample size for the training set

Not applicable. This is a physical 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 this type of device.

In summary: The Apex ARC™ Hip Stem, a Class II medical device, demonstrates its safety and effectiveness for market clearance by showing substantial equivalence to existing predicate devices (Apex K2™ Hip System and Aesculap Metha® Hip System) through a detailed comparison of design, materials, and intended use, and by successfully completing a series of non-clinical mechanical and material tests according to recognized international standards (ISO, ASTM) and FDA guidance documents. No clinical studies or AI-related evaluations were performed for this submission.

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The Apex Hip System is intended for primary and revision total hip replacement. The femoral hip stem and acetabular cup are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup Liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K1 Hip in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for total hip arthroplasty to treat 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.

ApeX-LNK Poly™ Acetabular Cup Liners are manufactured of compression molded, cross-linked and stabilized ultrahigh molecular weight polyethylene oxide. The articular geometry of the liners are compatible with existing Apex Modular femoral heads, manufactured from cobalt chrome or alumina ceramic, 40 mm diameter, with various offsets.
Apex Modular Heads have a standard tapered bore that corresponds to the mating taper on the modular neck (ASTM F1636). Various industry standard head diameters are included to allow use of a wide range of acetabular cups, at the discretion of the orthopaedic surgeon.

Here's an analysis of the provided text, focusing on acceptance criteria and study details.

Analysis based on the provided document:

The provided document is a 510(k) premarket notification for ApeX-LNK Poly™ Acetabular Cup Liners and Apex Modular Heads. It is a regulatory submission for medical devices, primarily focused on demonstrating substantial equivalence to predicate devices, rather than establishing numerical performance acceptance criteria through clinical studies in the way an AI/software device would.

Therefore, the requested information categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable in the context of this medical device submission. These categories are typically relevant for AI/ML-based diagnostic or screening devices where performance is measured against a ground truth from human expert interpretation or pathology.

This document demonstrates equivalence through design, materials, manufacturing processes, and in some cases, performance testing (often mechanical bench testing) to ensure safety and effectiveness are comparable to legally marketed devices. It does not involve "performance metrics" in the sense of diagnostic accuracy (sensitivity, specificity) or human reader improvement with AI.

Here's a breakdown of the relevant information from the document, acknowledging the difference in context:

1. Table of Acceptance Criteria (for Substantial Equivalence) and Reported Device Performance

For this type of device, "acceptance criteria" are primarily established by the requirements for demonstrating substantial equivalence to a legally marketed predicate device. The "performance" is judged by meeting these equivalence criteria and by ensuring the device functions as intended and is safe.

• ApeX-LNK Poly™ Acetabular Cup Liners: Used with Apex Modular Acetabular Cup, with Apex Modular, Apex K2 Hip, articulating with metal (cobalt chromium) or ceramic (alumina) femoral head for conditions like degenerative joint disease, rheumatoid arthritis, functional deformity, congenital dislocation, revision procedures, and fractures.
• Apex Modular Heads: Used in total hip replacement, compatible with various acetabular cups. |
  | Operating Principle ("ball-in-socket" cobalt chromium-UHMWPE articular bearing components) | Meets Predicate: "Same operating principle: 'ball-in-socket' cobalt chromium-UHMWPE articular bearing components" |
  | Materials (UHMWPE for liners, wrought cobalt chromium for heads as per specific ASTM standards) | Meets Predicate: "Same materials as predicates: the ApeX-LNK Acetabular Cup Liners are manufactured from ultra high molecular weight polyethylene (UHMWPE, ASTM F648) with identical specifications and processing parameters as the predicate ApeX-LNK Acetabular liners; the Apex Modular Heads are manufactured from the same material as the predicate Apex Modular Heads (wrought cobalt chromium per ASTM F1537)" |
  | Basic Design (UHMWPE liners, cobalt chromium heads, identical modular interface dimensions, surface finish, taper dimensions, locking features) | Meets Predicate: "Same basic design: UHMWPE liners, cobalt chromium heads; identical modular interface dimensions and specifications as the predicates, including surface finish, taper dimensions, and locking features"
• Liner Engagement: 19° taper and PE locking ring (same as ApeX-LNK predicate K073150).
• Liner Options: Neutral and 10° hooded (same as ApeX-LNK predicate K073150).
• Taper Design (Heads): Identical (size "N" bore in ASTM F1636-95) (same as Apex Modular Femoral Heads predicate K000788).
• Offsets (Heads): -3.5, +0, +3.5, +7 (same as Apex Modular Femoral Heads predicate K000788). |
  | Shelf Life (5 years from date of manufacture) | Meets Predicate: "Same shelf life: 5 years from date of manufacture." |
  | Packaging & Sterilization (ETO, SAL 10^-6^) | Meets Predicate: "Packaged and sterilized using the same materials and processes: ETO, SAL 10^-6^*."
• Packaging: Paper board box, Foil outer pouch, Double Tyvek inner pouch (same as ApeX-LNK predicate K073150 and Apex Modular Femoral Heads predicate K000788). |
  | Functional Equivalence (demonstrated via performance testing, design comparisons, functional analysis) | Meets Predicate: "Performance testing, design comparisons, and functional analysis conducted on these devices demonstrate that they are equivalent to the predicate devices." (Specific details of any new performance testing are not provided in this summary, but would typically involve mechanical tests for wear, fatigue, static strength, etc., to support the safety and effectiveness of the new sizes, not a clinical study comparing outcomes to a "ground truth" established by experts). The modifications are limited to the addition of a 40mm size head and a 40mm ID liner. |

Regarding the other requested points:

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

  • N/A. This is a medical device 510(k) submission, not a study evaluating an AI/ML diagnostic algorithm. "Test sets" in the context of this document refer to mechanical testing of physical device components, not data for an AI model.

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

  • N/A. Ground truth from experts is not applicable here. Mechanical tests typically compare physical measurements or observed failures against engineering specifications, often established by material science experts or engineers.

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

  • N/A. Not applicable for a device 510(k) 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:

  • N/A. This is not an AI/ML device.

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

  • N/A. This is a physical medical device (hip implants), not an algorithm.

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

  • N/A in the context of AI. For this device, the "ground truth" for demonstrating safety and effectiveness relies on established engineering principles, material science data from ASTM standards, and performance characteristics (e.g., strength, wear resistance) that are comparable to previously approved, equivalent predicate devices.

• 8. The sample size for the training set:

  • N/A. This is not an AI/ML device.

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

  • N/A. This is not an AI/ML device.

In summary: The provided document is a regulatory submission for a physical medical device. It demonstrates substantial equivalence to predicate devices based on design, materials, intended use, manufacturing processes, and fundamental operating principles. The concepts of "acceptance criteria" and "studies" as typically applied to AI/ML software performance (e.g., diagnostic accuracy, reader studies) are not relevant to this document. The "study" here is the entire 510(k) submission process, which involves demonstrating that the new device is as safe and effective as a legally marketed one, often supported by detailed engineering and mechanical testing data (which is not fully detailed in this summary document).

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1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
5. Revision of previously failed total hip arthroplasty.

The Medallion Modular Hip System is a complete system of femoral stem implants. The implants have a proximal female dovetail groove attachment site that is utilized for attaching various modular trunnions. The modular trunnions have a distal male semi-dovetail projection that engages the female dovetail groove on one side in such a way that a keyway is defined between the two components. The implants also include a key that is to be wedged in the keyway to lock the three components together and prevent relative sliding.

The provided text is a 510(k) summary for the Medallion Modular Hip System. This document describes a medical device, and the information requested pertains to the acceptance criteria and detailed study information typically found for diagnostic devices or AI/ML-driven devices.

Based on the provided text, the Medallion Modular Hip System is an orthopedic implant (a total hip femoral component). For such devices, "acceptance criteria" usually refer to mechanical performance standards (e.g., strength, fatigue life, wear resistance) rather than diagnostic accuracy metrics.

Therefore, many of the requested categories are not applicable to this type of device and the information is not present in the provided 510(k) summary. I will answer what can be gleaned from the text.

Acceptance Criteria and Reported Device Performance

For an orthopedic implant like the Medallion Modular Hip System, acceptance criteria are typically related to mechanical strength and durability. The document states:

Study Details (Based on provided text)

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

   • Sample Size: Not specified for any specific test set.
   • Data Provenance: Not specified. It is implied that typical non-clinical bench testing was performed, likely in a laboratory setting.

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

   • Not applicable / Not specified. Ground truth in the context of diagnostic accuracy for expert consensus is not relevant for an orthopedic implant's mechanical testing.

3. Adjudication method for the test set:

   • Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used for reconciling expert opinions in diagnostic studies, which is not relevant here.

4. 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 is not an AI/ML-driven diagnostic device. No MRMC study was conducted.

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

   • No. This is not an algorithm-driven device.

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

   • Not applicable. For mechanical testing, the "ground truth" would be the measured mechanical properties of the device components compared to engineering specifications and performance of predicate devices.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of AI/ML or diagnostic models.

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

   • Not applicable.

Summary of what the document explicitly states regarding studies:

• Non-Clinical Testing: "The information presented demonstrates that the Medallion Modular Hip System is substantially equivalent to currently marketed predicate devices. The differences between the Medallion Modular Hip System and the predicates are not significant and have shown not to present additional safety or efficacy issues." This implies mechanical bench testing was performed.
• Clinical Testing: "No clinical testing was conducted for this design." This is a key statement, indicating that the device's substantial equivalence was based solely on non-clinical data and comparison to predicate devices.

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The Apex Modular™ Alumina Femoral Head is intended for use in combination with the Apex Modular Hip Stem as the femoral component in total hip replacement procedures. This ceramic head is intended to articulate with a polyethylene or metal-backed polyethylene acetabular cup component. This prosthesis is intended for single use implantation, and 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 fractures of the proximal femur. ●

The Apex Modular™ Alumina Heads are manufactured of Biolox® forte alumina (high purity aluminum oxide ceramic) by CeramTec AG (Biolox® is a registered trademark of CeramTec AG). The bore on this ball was designed and tested for compatibility with the neck taper on the Apex Modular Hip Stem (K000788). These modular heads are available in 28 mm and 32 mm diameters, with three offset options for each head size: -3.5, 0, and +3.5 mm (28 mm diameter heads) and -4, 0, and +4 mm (32 mm diameter heads).

The provided document is a 510(k) premarket notification for a medical device, specifically the Apex Modular™ Alumina Femoral Head. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

However, this document does not contain information about acceptance criteria for device performance, nor does it describe a study proving the device meets such criteria in terms of clinical or diagnostic performance.

The document focuses on demonstrating substantial equivalence to existing legally marketed devices (Smith & Nephew Biolox Alumina Ceramic Heads and Plus Orthopedics Biolox® forte Alumina Ceramic Heads) for regulatory approval. This is typically done by showing that the new device has the same intended use, similar technological characteristics, and performs as safely and effectively as the predicate devices.

The only "testing" mentioned is:

• "Burst and fatigue testing of these alumina heads on the Apex Modular 12/14 taper have been completed as per the relevant FDA guidance document."

This refers to mechanical engineering tests to ensure the physical integrity and durability of the ceramic head, not studies related to diagnostic accuracy, clinical outcomes, or human reader performance.

Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment as these details are not present in the provided text.

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