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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."

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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 Corin Optimized Positioning System Plan (OPS™ Plan) is indicated for pre-operative planning for primary total hip arthroplasty. OPS™ Plan is intended to be used as a pre-operative tool to assist the Surgeon in the selection (for example, lateralised or standard stem), sizing and positioning of components of primary total hip arthroplasty.

The Corin OPS™ Plan is intended to be used with the Corin TriFit TS (K121563, K153772), MetaFix (K082525, K121439, K131952, K153381), TaperFit (K142761, K153725), MiniHip (K083312, K11046, K131986) and TriFit CF (K173880) Femoral Hip Stems.

The Corin Optimized Positioning System™ Plan (OPS™ Plan) is a pre-operative templating tool to assist the Surgeon in the planning of primary total hip arthroplasty using any Corin femoral stem. The Corin OPS™ Plan assists in selection (for example, lateralised or standard stem), sizing and placement of implant components (stem, head, cup) using anatomical landmarks of the femur and pelvis obtained from pre-operative CT scan and AP X-ray. The OPS™ Plan consists of the OPS™ Plan Report and the OPS™ Plan Appendix. The OPS™ Plan report is a static report which displays the selection (for example, lateralised or standard stem), sizing and placement of implant components. OPS™ Plan Appendix presents the steps taken by the Engineer on behalf of the Surgeon during the preoperative planning process, which include the identification of anatomical landmarks as well as sizing and positioning of the implants.

The Corin OPS™ Plan process begins with booking the OPS case to final release of the OPS Plan Report. OPS™ case booking details and required CT and X-ray imaging in DICOM format are electronically transferred to the manufacturer via the online end-user interface, the OPS™ Portal. Image processing is completed by an Corin Simulation Engineer with results of the OPS™ analysis provided in the OPS™ Plan Report. The Surgeon does not actively interact with the image processing, implant positioning and/or report generation. Final acceptance of the OPS™ Plan by the Surgeon is confirmed following any modifications or clarifications of the reported results.

The OPS™ Plan was originally cleared in K171847. The purpose of this submission is to include TriFit CF (K173880) to the Femoral Hip systems intended to be used with the OPS™ Plan.

The design and all the other compatible components for use with the OPS™ Plan subject of this submission are identical to that of the predicate device K171847.

The provided text describes the Corin Optimized Positioning System (OPS) Plan, a pre-operative planning tool for total hip arthroplasty. However, it explicitly states that clinical testing was not necessary for this Traditional 510(k) submission. Instead, the submission relies on non-clinical testing to demonstrate safety and effectiveness.

Therefore, the following information, which typically relies on clinical or comparative studies, is either not applicable or not detailed in the provided document:

1. A table of acceptance criteria and the reported device performance: The document does not provide a table with specific acceptance criteria (e.g., minimum accuracy percentages, error margins) and reported performance against those criteria as would be found in a clinical study report. It generally states that "accuracy and performance of the system is adequate to perform as intended."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No details on sample size, data provenance, or whether data was retrospective or prospective from a test set for clinical performance are provided, as no clinical testing was performed for this submission.

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, as no external expert-validated test set for clinical performance is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a planning tool, and a clinical MRMC study evaluating human reader improvement with AI assistance is not mentioned. The "Surgeon does not actively interact with the image processing, implant positioning and/or report generation" (page 4), suggesting a standalone planning process rather than an AI-assisted reading scenario for the surgeon.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document mentions "Image processing is completed by an Corin Simulation Engineer with results of the OPS™ analysis provided in the OPS™ Plan Report. The Surgeon does not actively interact with the image processing, implant positioning and/or report generation. Final acceptance of the OPS™ Plan by the Surgeon is confirmed..." This describes a process where the engineer uses the system to generate a plan, which the surgeon then approves. While not a fully automated 'algorithm only' in the sense of no human intervention, it is a standalone planning tool that an engineer operates, rather than direct human-in-the-loop diagnostic assistance. The non-clinical testing assessed the "processing of patient imaging to produce accurate, repeatable and reproducible implant selection, sizing and placement of components," which supports a standalone performance claim for the system's output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Since clinical testing was not performed and no direct ground truth for a clinical comparison is mentioned, the ground truth for the non-clinical testing would likely be based on engineering benchmarks, simulated scenarios, or established anatomical measurements against which the system's output (implant selection, sizing, placement) could be validated for accuracy, repeatability, and reproducibility. These details are not elaborated in the provided text.

8. The sample size for the training set: The document does not mention a training set size, as it focuses on the regulatory submission and non-clinical testing, not on the underlying machine learning model development (if any, as the system predates this specific submission). The device was originally cleared in K171847, and this submission is for an expanded list of compatible femoral hip stems.

9. How the ground truth for the training set was established: Not applicable, as details on a training set are not provided.

Summary from the provided text regarding acceptance criteria and study:

• Acceptance Criteria (Implied / Stated Goals):

  • Accuracy: The system must produce accurate implant selection, sizing, and placement of components.
  • Repeatability: The system must produce repeatable results.
  • Reproducibility: The system must produce reproducible results.
  • Usability: The OPS™ Plan provided to the Surgeon must be usable.
  • Adequate Performance: The system's accuracy and performance must be adequate to perform its intended use as a pre-operative planning tool.

• Reported Device Performance (from Non-Clinical Testing):

  • "Non-clinical testing was performed to assess the safety and effectiveness of the device, to demonstrate the processing of patient imaging to produce accurate, repeatable and reproducible implant selection, sizing and placement of components, and the usability of the OPS™ Plan that is provided to the Surgeon. Testing verified that the accuracy and performance of the system is adequate to perform as intended." (Page 5)

• Study That Proves the Device Meets Acceptance Criteria:

  • Title/Type: Non-Clinical Testing.
  • Objective: To assess safety and effectiveness by demonstrating accurate, repeatable, and reproducible implant selection, sizing, and placement, and usability of the OPS™ Plan.
  • Sample Size (Test Set): Not specified.
  • Data Provenance: Not specified.
  • Number of Experts for Ground Truth: Not specified.
  • Qualifications of Experts: Not specified.
  • Adjudication Method: Not specified.
  • MRMC Comparative Effectiveness Study: No.
  • Standalone Performance: Yes (demonstrated through non-clinical testing assessing the system's processing of patient imaging to produce results).
  • Type of Ground Truth: Not explicitly stated but inferred to be engineering benchmarks, simulated scenarios, or established anatomical measurements for validating the accuracy, repeatability, and reproducibility of the system's output.
  • Training Set Sample Size: Not specified.
  • Ground Truth for Training Set: Not specified.

It is important to note that this submission (K183038) is for an update to an already cleared device (K171847) to include a new femoral hip stem. The non-clinical testing mentioned reaffirms the system's core functionalities in light of this update, rather than being a comprehensive clinical validation of a new or significantly altered device.

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The Corin Optimized Positioning System Plan (OPS™ Plan) is indicated for pre-operative planning for primary total hip arthroplasty. OPS™ Plan is intended to be used as a pre-operative tool to assist the Surgeon in the selection (for example, lateralised or standard stem), sizing and positioning of components of primary total hip arthroplasty.

The Corin OPS™ Plan is intended to be used with the Corin TriFit TS (K121563, K153772), MetaFix (K082525, K121439, K131952, K131952, K153381), TaperFit (K142761, K153725), MiniHip (K083312, K11046, K131986) Femoral Hip Stems.

The Corin Optimized Positioning System™ Plan (OPS™ Plan) is a pre-operative templating tool to assist the Surgeon in the planning of primary total hip arthroplasty using any Corin femoral stem. The Corin OPS™ Plan assists in selection (for example, lateralised or standard stem), sizing and placement of implant components (stem, head, cup) using anatomical landmarks of the femur and pelvis obtained from pre-operative CT scan and AP X-ray. The OPS™ Plan report is a static report which displays the selection (for example, lateralised or standard stem), sizing and placement of implant components.

The Corin OPS™ Plan process begins with booking the OPS case to final release of the OPS Plan Report. OPS™ case booking details and required CT and X-ray imaging in DICOM format are electronically transferred to the manufacturer via the online end-user interface, the OPS™ Portal. Image processing is completed by an OPS™ Simulation Engineer with results of the OPS™ analysis provided in the OPS™ Plan Report. The Surgeon does not actively interact with the image processing, implant positioning and/or report generation. Final acceptance of the OPS™ Plan by the Surgeon is confirmed following any modifications or clarifications of the reported results.

The provided text describes the Corin Optimized Positioning System (OPS™) Plan, which is a pre-operative templating tool for primary total hip arthroplasty. Here's a breakdown of the acceptance criteria and the study information based on the provided document:

Acceptance Criteria and Device Performance for Corin Optimized Positioning System (OPS™) Plan

The document does not explicitly state numerical acceptance criteria in a table format. However, it outlines the general performance aspects that were tested.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the sample size (number of cases or patients) used for the non-clinical testing.
• Data Provenance: Not explicitly stated. The manufacturer, Optimized Ortho Pty Ltd, is located in Pymble NSW, Australia, suggesting the data may originate from Australia or other regions where Corin operates. The document only mentions "patient imaging in DICOM format are electronically transferred to the manufacturer." It does not specify if these were retrospective or prospective studies.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the non-clinical testing. The process described for generating the OPS™ Plan states that "Image processing is completed by an OPS™ Simulation Engineer," and "Final acceptance of the OPS™ Plan by the Surgeon is confirmed following any modifications or clarifications of the reported results." This implies a Surgeon's clinical judgment is the ultimate arbiter, but detailed information about their role in establishing ground truth for testing is missing.

4. Adjudication Method for the Test Set

The document does not mention a formal adjudication method (e.g., 2+1, 3+1). The process involves an "OPS™ Simulation Engineer" generating the plan and the "Surgeon" confirming final acceptance. For testing purposes, the method by which ground truth was definitively established from multiple expert opinions is not detailed.

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

• No, a MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary for this Traditional 510(k)." The testing described is "Non-Clinical testing."

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

The device is described as a "pre-operative templating tool" where "Image processing is completed by an OPS™ Simulation Engineer," and the "Surgeon does not actively interact with the image processing, implant positioning and/or report generation." This indicates a human (the OPS™ Simulation Engineer) is in the loop during the generation of the plan. Therefore, a purely standalone algorithm evaluation without human interaction is not explicitly described or implied for the final output generation. However, the "accuracy, repeatability and reproducibility" testing could have involved testing specific algorithmic components in a standalone manner, but the overall system performance evaluated includes human involvement.

7. The Type of Ground Truth Used

The type of ground truth used for non-clinical testing is implied to be based on established anatomical landmarks and surgical planning principles, likely validated by expert surgical opinion or established surgical methodology. The document mentions "selection (for example, lateralised or standard stem), sizing and placement of implant components (stem, head, cup) using anatomical landmarks of the femur and pelvis obtained from pre-operative CT scan and AP X-ray." However, it does not explicitly state whether this involved pathology, outcomes data, or a formal expert consensus process as the ground truth standard for the testing.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set.

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

The document does not provide any information on how ground truth was established for a training set. Given that it's a 510(k) submission not requiring clinical trials, and the process involves human engineers and surgeon confirmation, it's possible that a formal machine learning training set with expert-labeled ground truth in the typical sense was not explicitly detailed or a primary focus of the submission documentation provided.

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The indications for the Corin MetaFix Hip as a total hip arthroplasty, and when used in combination with a Corin hemi arthroplasty head, as a hip hemi-arthroplasty, include:
• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union and femoral neck fractures
• Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
The MetaFix Hip is intended for cementless use only.

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

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

The document states:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

Summary of the Study:

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

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