Search Results

The indications for the Corin Icona Hip Stem as a total hip arthroplasty, and when used in combination with a Corin hemiarthroplasty head, as a hip hemiarthroplasty, include:

• · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• · Correction of functional deformity
• · Treatment of non-union and femoral neck fractures
• Developmental dysplasia of the hip (DDH) / congenital dysplasia of the hip (CDH)

The Corin Icona Hip Stem is indicated for cementless use only.

The Corin Icona Hip Stem is a tapered stem design manufactured from Titanium alloy (Ti6Al4V) (ASTM F136) with a layer of commercially pure titanium (ISO 5832-2, ASTM F1580) and an additional layer of electrochemically deposited calcium phosphate (ASTM F1609) applied.

The Icona Hip Stem is intended for use in hemiarthroplasty and total hip arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged hip joint articulation where there is evidence of sufficient sound bone to seat and support the components.

The design is a fully-coated titanium femoral hip stem featuring a polished neck with 12/14 tapered male trunnion for assembly with Corin modular femoral head components. Additionally, the Icona stem features a trapezoidal, tripled tapered body, providing for rotational and axial stability.

The Icona Hip Stem is a collared stem available in two different offsets (Standard and Lateralised) and twelve (12) different sizes, totaling 24 options.

The Icona Hip Stem is compatible with the following acetabular systems:

· Traditional – Trinity (K093472, K110087, K111481, K122305, K130128, K130343, K131647) and Trinity PLUS (K17255) · Dual mobility - Trinity Dual Mobility (K170359) and MobiliT (K191831)

· Bipolar - Bipolar-i (K183114)

This document is a 510(k) Premarket Notification from the FDA for a hip stem device (Icona Hip Stem). It does not describe an AI/ML medical device, but rather a traditional medical device (hip implant). Therefore, much of the requested information regarding acceptance criteria and studies for AI/ML performance metrics (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document.

However, I can extract the relevant information regarding the traditional device's performance criteria and supporting studies as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is typically not provided in detail within a 510(k) summary for mechanical testing of traditional orthopedic implants. The document states "Non-clinical testing and rationales provided to support substantial equivalence," but does not specify sample sizes for these mechanical tests (e.g., number of stems tested for fatigue).

• Provenance: The tests are non-clinical (laboratory/mechanical testing), not patient data.

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

Not applicable for a traditional orthopedic implant's mechanical testing or equivalence comparison to predicate devices. "Ground truth" in this context would refer to established engineering standards (ISO, ASTM) and the performance of predicate devices.

4. Adjudication Method

Not applicable for this type of device submission. Adjudication is relevant for expert review of data, often in clinical studies or for AI ground truth establishment.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, this is not an AI/ML device, so an MRMC study comparing human readers with and without AI assistance is not applicable.

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

No, this is not an AI/ML device.

7. The Type of Ground Truth Used

For this traditional device, the "ground truth" used to establish substantial equivalence is primarily:

• Established engineering standards: ISO 7206-4, ISO 7206-6, ISO 21535, ASTM F136, ASTM F1580, ASTM F1609. The device's performance in these tests is compared against the performance of the predicate devices or the requirements of these standards.
• Performance of legally marketed predicate devices: The Icona Hip Stem's design, materials, and mechanical performance are compared to those of already cleared predicate devices. Substantial equivalence implies that the new device performs as safely and effectively as the predicate.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device; there is no "training set."

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

Not applicable, as there is no "training set."

Ask a specific question about this device

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.

Ask a specific question about this device

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

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

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

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

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

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

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

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document.

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

This information is not provided in the document.

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

Summary of available information regarding acceptance criteria and study:

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

Missing Information:

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

Ask a specific question about this device

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

The Trinity™ PLUS Acetabular Shell is a component of a modular cup system consisting of a hemispherical press fit, titanium alloy shell for use with cobalt chrome alloy (Dual Mobility articulations only) or polyethylene liners and a dedicated range of ceramic and cobalt chrome alloy modular 12/14 taper femoral heads providing ceramic on polyethylene and metal on polyethylene articulations for use in total hip replacement procedures using any Corin femoral stem with a 12/14 taper connection. The acetabular shell has an outer porous structure produced by additive manufacturing using titanium alloy powder (ASTM F3001). The shell is available with or without a layer of electrochemically deposited biomimetic calcium phosphate coating. The Trinity™ PLUS acetabular shell is available with or without screw holes which permit the use of dedicated titanium screws to provide additional fixation if required.

The provided text describes a 510(k) premarket notification for a hip implant device, the Corin Trinity™ PLUS Acetabular Shell. The notification focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving that the device meets specific acceptance criteria based on a study of its performance in a clinical setting against defined metrics.

Therefore, many of the requested categories (acceptance criteria, reported device performance, sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, ground truth type, training set size, how ground truth for training set was established) are not applicable to this type of submission.

Here's a breakdown based on the information available:

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

This information is not provided in the document as this is a 510(k) submission for substantial equivalence, not a clinical trial report with performance metrics. The "acceptance criteria" here are essentially proving the device is as safe and effective as predicate devices. The document details non-clinical testing to demonstrate this.

Non-Clinical Testing Conducted to Demonstrate Substantial Equivalence:

Conclusion from Non-Clinical Testing: The culmination of the results of the mechanical testing, characterization, and animal data indicate that the devices perform within their intended use and are substantially equivalent to the predicate devices.

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

Not Applicable for this 510(k) submission, as it relies on non-clinical testing and comparison to predicates, not a clinical test set with human subjects. The non-clinical tests would have their own sample sizes for mechanical specimens, but these are not specified in the document.

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

Not Applicable. Ground truth, in the context of clinical studies, is not established for this type of submission. The "ground truth" for a 510(k) is the performance and safety profile of the predicate devices.

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

Not Applicable. There is no clinical test set requiring adjudication in this 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:

Not Applicable. This is a medical device for total hip arthroplasty, not an AI-assisted diagnostic or imaging device for human readers. No MRMC study was conducted.

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

Not Applicable. This is a physical implantable device, not a software algorithm.

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

Not Applicable in the traditional sense of a clinical study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices, which the new device is being compared against.

8. The sample size for the training set:

Not Applicable. There is no "training set" in the context of a clinical study for this 510(k) submission. Non-clinical tests were performed on device samples.

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

Not Applicable. As there is no training set, there's no ground truth to establish for it in this context.

Ask a specific question about this device

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 TrinityTM Dual Mobility System is indicated for cementless use only.

The Trinity™ Dual Mobility System is a modular system consisting of two articulating surfaces in the same joint space. The system includes a highly polished Cobalt Chromium Alloy (CoCr) liner that articulates with an ECiMa™ (Vitamin E Ultra-High-Molecular-Weight Polyethylene) mobile insert. A Trinity™ femoral head, 22mm or 28mm CoCr or 28mm BIOLOX® delta heads, articulates within the ECiMa™ mobile insert to allow for a second articulation. The Trinity™ Dual Mobility System is intended to be used only with compatible Trinity™ acetabular Shells. The Trinity™ Dual Mobility System is designed for use with any Corin femoral stem with a 12/14 taper connection. The Trinity™ Dual Mobility System is intended for use in primary and revision total hip arthroplasty (THA) to provide increased stability and reduce pain by replacing the hip joint articulation where there is evidence of sufficient sound bone to seat and support the components.

The Trinity™ Dual Mobility System is intended to be used with the following approved devices:

• Trinity™ Acetabular Shells (Sizes 2- 5) (K093472, K123705, K122305, K130128) .
• 28mm CoCr heads (K110087, K131647) .
• . 28mm BIOLOX® delta Ceramic Heads (K103120)

This document is a 510(k) premarket notification for a medical device called the "Trinity Dual Mobility System," which is a hip prosthesis. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy in a de novo manner. Therefore, the information provided does not detail an acceptance criteria table or a study proving the device meets an algorithm's acceptance criteria in the way one might expect for a digital health or AI-driven device.

Based on the provided text, here's an analysis of the "acceptance criteria" and "study" that relate to this medical device:

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

The document does not present a formal table of acceptance criteria with specific numerical targets for performance in the context of an algorithm or diagnostic accuracy. Instead, the "acceptance criteria" for this device's FDA clearance revolved around demonstrating substantial equivalence to existing predicate devices through non-clinical testing.

The acceptance criteria are implied by the types of non-clinical tests performed and their successful outcomes, which showed the device is "expected to be safe and effective."

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

For this type of device (hip prosthesis), the "test set" refers to the physical prototypes and materials subjected to non-clinical mechanical and biological testing.

• Sample Size: The document does not specify the exact sample size for each non-clinical test (e.g., how many liners were subjected to wear testing or how many components to push-out tests). This level of detail is typically found in the full test reports, not the 510(k) summary.
• Data Provenance: The tests were conducted to evaluate the device itself. There's no "country of origin for data" in the sense of patient data. The tests would have been performed in a laboratory setting, likely in the country of manufacture or a certified testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This question is not applicable to a physical medical device like a hip prosthesis in the context of its 510(k) submission for substantial equivalence. "Ground truth" and "experts" in this sense typically refer to the validation of diagnostic accuracy for software or imaging devices. For this device, standard engineering and materials science testing methods are used, and the "ground truth" is established by adherence to recognized ASTM or ISO testing standards. The experts involved would be qualified engineers and scientists in fields such as mechanical engineering, materials science, and biocompatibility testing. Their qualifications are not specified in this summary.

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

Not applicable. Adjudication methods like "2+1" are used in studies involving human interpretation (e.g., radiologists reviewing images) to resolve discrepancies. The non-clinical tests for this device involve objective measurements against predetermined acceptance limits based on engineering standards.

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. MRMC studies are associated with the evaluation of diagnostic performance for imaging systems or AI algorithms where human interpretation plays a role. This document concerns a physical implant.

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

Not applicable. This device is not an algorithm.

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

The "ground truth" for the non-clinical testing of this device is established by:

• Engineering Standards: Compliance with industry-recognized ASTM, ISO, or other relevant standards for mechanical strength, wear, corrosion, and material properties.
• Predicate Device Performance: The performance characteristics of the legally marketed predicate devices serve as an established baseline that the new device must meet or exceed to demonstrate substantial equivalence.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of a physical hip prosthesis device or its 510(k) clearance process. This terminology applies to machine learning algorithms.

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.

Ask a specific question about this device

The TaperFit Hip Stem is indicated for the relief of pain and restoration following the effects of femoral neck fracture, osteo, rheumatoid and inflammatory arthritis, post-traumatic disease effects, avascular necrosis and total hip The TaperFit Hip Stem is indicated for hemi-arthroplasty when used in combination with Corin Bipolar revision. Prosthesis hemi-arthroplasty femoral heads.

The TaperFit Hip Stem is indicated for cemented, single use only.

The TaperFit Hip Stem is a highly polished, double tapered, collarless, stainless steel femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from stainless steel in accordance with ISO 5832-9 -Implants for surgery -- Metallic materials -- Part 9: Wrought high nitrogen stainless steel and is provided with a polymethylmethacrylate (PMMA) Stem Centralizer. The stem is designed to be used in conjunction with Corin Eurocone (E100.XXX cleared in K003666) and Trinity CoCrMo modular femoral heads (E321.XXX cleared in K093472, K110087, K122305, K123705, K130128, K130343 and K131647). The stem is available in sizes, 0 through 4 with 3 offsets 50mm, 45mm, and 38mm, as well as a CDH option with a 36mm offset.

The TaperFit Hip Stem was originally cleared in K142761. This submission is being made to modify the indications for use to include hemi-arthroplasty when used with previously cleared Corin hemi-arthroplasty femoral heads as compatible components. The Corin CoCr Modular 26mm heads (E100.X26) have been cleared as compatible components of the Taper-Fit Hip stem (K003666). The Corin CoCr Modular 26mm heads (E100.X26) are part of the construct of the bipolar heads. Included in this submission is the Corin Bipolar Femoral Head (K925897) as a compatible component, which is indicated for hemi-arthroplasty.

This document is a 510(k) premarket notification for a medical device called the "TaperFit Hip Stem". It's a regulatory submission to the FDA, not a study evaluating device performance against acceptance criteria in the way described in the prompt. Therefore, much of the requested information (acceptance criteria, sample sizes for test/training sets, expert qualifications, etc.) is not present in this document because it pertains to a different type of evaluation.

Here's a breakdown of the information that is available or can be inferred, and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

• Absent. This document does not present a table of acceptance criteria or report specific performance metrics for the device. It refers to non-clinical testing data from previous submissions for establishing substantial equivalence.

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

• Absent. This document does not describe a "test set" in the context of an AI/algorithm performance evaluation. The "non-clinical testing" mentioned involved mechanical and fatigue testing, not a data-driven test set with human-equivalent performance.

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

• Absent. Not applicable to this type of regulatory submission. The ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus on medical images or data.

4. Adjudication method for the test set

• Absent. Not applicable.

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

• Absent. This is a hardware device (hip stem), not an AI algorithm. Therefore, MRMC studies and AI-assisted reading are not relevant.

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

• Absent. This is a hardware device, not an algorithm.

7. The type of ground truth used

• For the non-clinical testing mentioned, the "ground truth" would be engineering standards, material specifications (e.g., ISO 5832-9 for stainless steel), and the results of mechanical fatigue, static, rotational torque, and fretting/corrosion tests.

8. The sample size for the training set

• Absent. Not applicable. This is not an AI/ML device.

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

• Absent. Not applicable.

Summary of available information related to the device and its evaluation (from the document):

• Device Name: TaperFit Hip Stem
• Type of Device: Hip joint metal/polymer semi-constrained cemented prosthesis
• Indications for Use: Relief of pain and restoration of hip function following femoral neck fracture, osteo, rheumatoid and inflammatory arthritis, post-traumatic disease effects, avascular necrosis, and total hip revision. Also indicated for hemi-arthroplasty when used with Corin Bipolar Prosthesis hemi-arthroplasty femoral heads. Indicated for cemented, single use only.
• Predicate Devices:
  • Corin TaperFit Hip Stem (K142761)
  • Corin Taper-Fit Hip Stem (K992234, K003666)
• Substantial Equivalence Claim: The TaperFit Hip Stem (subject of this submission) is claimed to be identical in design, materials, coating, and sizes to K142761, and similar in intended use/indications. It's also claimed to be identical in materials and coating, and similar in design, sizes, and intended use/indications to K992234 and K003666. The main modification in this submission is an expanded indication for use to include hemi-arthroplasty with compatible Corin hemi-arthroplasty femoral heads.
• Non-Clinical Testing Mentioned: FEA (Finite Element Analysis), mechanical fatigue testing, static testing, rotational torque testing, fretting and corrosion testing, and range of motion testing. These tests were performed and submitted in previous TaperFit and Taper-Fit Hip Stem submissions (K142761, K992234, and K003666).
• Clinical Testing: "Clinical testing was not necessary in this Traditional 510(k)."

Ask a specific question about this device

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

• · Non-inflammatory degenerative joint discase including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• · Correction of functional deformity
• · Development dysplasia of the hip (DDI-I) and congenital dysplasia of the hip (CDH)

The MiniHip Stem is indicated for cementless use only.

The MiniHip Stern is a titanium femoral hip stem featuring a 12/14 tapered male trumion for assembly with modular femoral head components. The MiniHip Stem uses a short stem philosophy to provide a bone-conserving option to the use of a standard total hip prosthesis. The stem is manufactured from Titanium (TiAI6V4) alloy and is proximally coated with plasma sprayed hydroxyapatite, conforming to ASTM F-1185-03(2009), over plasma sprayed purc titanium. The Corin MiniHip Stem is available in 7 sizes marked 3 through 9. The Corin MiniHip Stem was originally cleared in K083312 and K111046.

Modular CoCrMo Femoral Heads are available in a diameter of 28mm with -3.5mm (short), 0.0mm (standard) and, +3.5mm (long) offsets and diameter of 32mm, 36mm and 40mm heads with offsets of -4mm (short), 0mm (standard) and +4mm (long) as previously cleared in K093472 and K110087 submissions. The 32mm with +7mm offset (extra-long), and the 36mm and +0mm with +8mm offset (extra-long), were added to the range of heads available in K130343.

Modular BIOLOX detta™ Ceramic Femoral Heads are available in a diameter of 28mm with -3.5mm (short), 0mm (standard) and, +3.5mm (long) offsets and diameters of 32mm, 36mm and 40mm heads with offsets of -4mm (short), 0mm (standard) +4mm (long) as previously cleared in K103120 and K110087 submissions. The 32mm with +7mm offset (extra-long), and the 36mm and 40mm with +8mm offset (extra-long), were added to the range of heads available in K130343.

The Corin MiniHip Stem was originally cleared in K083312 and K111046 and as clearced compatible with short, standard and long offsets modular femoral heads. The purpose of this submission is to modify the labeling for the Corin MiniHip Stem to include an additional size of the compatible femoral heads. The addition is for three offsets in the CoCrMo and Ceramic extra-long heads, 32mm (+7mm), 36mm (+8mm) and 40mm (+8mm).

The provided text describes a 510(k) premarket notification for a medical device (Corin MiniHip Stem) and explicitly states that clinical testing was not necessary to determine substantial equivalence.

Therefore, the following information regarding acceptance criteria, study details, expert involvement, and ground truth establishment cannot be extracted from the given document as no such study was performed or required for this submission.

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable. No clinical study was performed, thus no acceptance criteria or corresponding device performance from such a study are reported.

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

• Not applicable. No clinical study was performed.

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

• Not applicable. No clinical study was performed.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical study was performed.

5. Multi-reader Multi-case (MRMC) Comparative Effectiveness Study:

• No. An MRMC study was not performed. The submission explicitly states "Clinical testing was not necessary to determine substantial equivalence between the MiniHip Stem and the predicate devices."

6. Standalone Performance Study:

• No. A standalone performance study (algorithm only) was not performed as this is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used:

• Not applicable. No clinical study was performed.

8. Sample Size for the Training Set:

• Not applicable. No training set for an algorithm was used as this is a physical medical device.

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

• Not applicable. No training set for an algorithm was used.

Summary of the Device Submission:

The submission for the Corin MiniHip Stem (K131986) was focused on modifying the labeling to include additional compatible modular femoral heads (32mm with +7mm, 36mm with +8mm, and 40mm with +8mm offsets). The device itself (MiniHip Stem) was already cleared in previous submissions (K083312 and K111046). The "substantial equivalence" claim was based on the fact that the MiniHip Stems in this submission are identical to predicate devices, and the additional compatible components are identical in material, intended use, and indications to components of an already cleared predicate device (Trinity Acetabular System with XL Heads, K130343). Therefore, no new clinical or performance studies were required.

Ask a specific question about this device

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.

Ask a specific question about this device

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 crosslinked polyethylene (ECiMa) acetabular liners in neutral offset, +4mm offset, +4mm oblique and 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 ttanium 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 Non-occluded Titanium Plasma Sprayed (TPS) acetabular shell and the Trinity-i Non-occluded Titanium Plasma Sprayed (TPS) acetabular shell. Both of these variants, subject of this submission, are coated with a rough titanium plasma spray, contain non-threaded holes for the use of titanium screw fixation and do not come pre-assembled with the hole occluders in place.

This document describes the premarket notification (510(k)) for the Corin Trinity Non-occluded Titanium Plasma Sprayed (TPS) Acetabular Shells. It clarifies that no clinical testing was deemed necessary to demonstrate substantial equivalence, and therefore, the concept of "acceptance criteria" as applied to device performance in a clinical study isn't directly applicable for this submission.

Instead, the submission relies on non-clinical testing to show that the new variants are substantially equivalent to previously cleared predicate devices. Substantial equivalence for this medical device (hip prosthesis components) is established by demonstrating that the new devices have the same intended use, indications for use, substrate materials, and similar design and coating characteristics as the predicate devices, and that non-clinical testing supports their safety and effectiveness.

Here's an analysis based on the provided document, addressing the specific points where information is available or noting its absence:

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

Since this is a 510(k) submission for substantial equivalence based on non-clinical testing, explicit "acceptance criteria" and "device performance" in terms of clinical outcomes are not defined in the provided text. The "performance" is demonstrated through substantial equivalence to predicate devices and non-clinical bench testing.

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

• Sample Size: Not explicitly stated for specific non-clinical tests in this 510(k) summary. These would typically be detailed in the full non-clinical test reports submitted to the FDA, but not in the summary.
• Data Provenance: Not applicable in the context of an AI device's test set for a clinical study, as this submission is for a medical implant and relies on non-clinical (bench) testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. No clinical test set or human expert review for establishing ground truth was used for this submission. The "ground truth" for substantial equivalence is derived from the characteristics of the predicate devices and the results of non-clinical engineering and material tests.

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

Not applicable. No clinical test set requiring adjudication was used.

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

Not applicable. This is not an AI device or a diagnostic imaging device requiring human reader assessment. It is a hip prosthesis component.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" in this context is the established safety and effectiveness of the predicate devices, as demonstrated through their own prior clearances (K093472, K110087, K122305, K050262) and the engineering and material science principles applied in the non-clinical testing. It's essentially equivalence to known performance of existing devices.

8. The sample size for the training set

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

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

Not applicable. This is not an AI device.

Ask a specific question about this device

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.

Ask a specific question about this device