Search Results

The indications for the Trinity™ EVO Acetabular Shell 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)/Congenital dislocation of the hip (CDH)

The Trinity™ EVO acetabular shell is also indicated for use in revisions of a previously failed total hip arthroplasty.

The Trinity™ EVO Acetabular Shell is indicated for cementless use only.

The Trinity™ EVO acetabular shell forms part of a modular acetabular system. The Trinity™ EVO acetabular shell is a hemispherical press fit titanium alloy shell for use with cobalt chrome alloy (Trinity™ Dual Mobility 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 arthroplasty (THA) procedures using Corin metal stems with a 12/14 taper connection. The Trinity™ EVO acetabular shell has a porous structure manufactured from titanium alloy powder, produced via additive manufacturing using Laser Powder Bed Fusion (LPBF), and is available with or without an additional layer of electrochemically deposited calcium phosphate. The Trinity™ EVO acetabular shell is provided in sizes permitting the use of titanium bone screws to provide additional fixation, if required. The Trinity™ EVO acetabular shell is also available without screw holes. A titanium occluder is provided to occlude the apical introducer hole.

The Trinity™ EVO acetabular shell is intended for use in primary and revision THA in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged hip joint articulation when there is evidence of sufficient sound bone to seat and support the components.

The provided document is a 510(k) Clearance Letter for the Trinity EVO Acetabular Shell. This type of submission focuses on demonstrating substantial equivalence to a previously cleared device, not necessarily proving clinical efficacy through a direct comparative study like a Multi-Reader Multi-Case (MRMC) study for an AI-powered diagnostic device.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing conducted to show that the new device performs as safely and effectively as its predicate devices, rather than a clinical trial with human readers.

Here's a breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the standards and internal protocols cited for the non-clinical testing. The device is deemed to meet these criteria if the test results demonstrate comparable or acceptable performance to the predicate devices. The document states: "The results of this testing show that the Trinity™ EVO Acetabular Shell is substantially equivalent to the predicate devices."

Table of Acceptance Criteria and Reported Device Performance:

Study Information Specific to the Device Clearance (non-clinical)

The information provided in the 510(k) summary focuses on non-clinical testing. Questions related to "test set," "data provenance," "experts," "adjudication," "MRMC studies," "standalone algorithm performance," and "ground truth" are not applicable in the context of this specific regulatory submission as it's for a physical orthopedic implant, not a diagnostic AI software.

However, based on the general structure, here's what can be inferred or stated as "Not Applicable" for this type of device:

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

   • Test Set Sample Size: For mechanical testing, the "sample size" refers to the number of physical devices or representative specimens tested per condition, as per the respective ASTM/ISO standards. This specific number is not disclosed in the provided summary but would be detailed in the full submission.
   • Data Provenance: The data provenance is from the manufacturing and testing facility of Corin USA Limited, a medical device manufacturer. The tests are "non-clinical" and conducted on physical prototypes/products.

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

   • Not Applicable. This is a physical device, and "ground truth" is established by physical measurements and performance against established engineering standards and specifications, not expert interpretation of medical images or clinical outcomes in a diagnostic context. The "experts" involved would be engineers, materials scientists, and quality assurance personnel.

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

   • Not Applicable. Adjudication relates to resolving discrepancies in expert interpretations, which is relevant for diagnostic studies, not mechanical testing. Test results are objective measurements compared against predefined limits.

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

   • No. An MRMC study is relevant for evaluating the impact of AI algorithms on human reader performance in diagnostic tasks. This device is a passive, physical implant.

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

   • Not Applicable. This is a physical orthopedic implant, not a software algorithm.

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

   • Engineering Standards and Specifications. The "ground truth" for the device's performance is defined by established international standards (ASTM, ISO) and internal engineering design specifications that ensure the device's mechanical integrity, biocompatibility, and functional characteristics are met.

7. The sample size for the training set:

   • Not Applicable. This is a physical device, not an AI/ML algorithm that requires a "training set." The design and manufacturing processes are refined through engineering development and quality control, not machine learning.

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

   • Not Applicable. (See point 7).

In summary, the 510(k) for the Trinity EVO Acetabular Shell demonstrates "substantial equivalence" based on extensive non-clinical (mechanical, materials, and physical) testing to established engineering standards, asserting that it performs as safely and effectively as its predicate devices, rather than through clinical studies involving human readers or AI algorithms.

Ask a specific question about this device

ApolloHipX is indicated for use in assisting in Total Hip Replacement in which the use of radiological imaging may be appropriate.

ApolloHipX is a non-invasive intra-operative, image processing software intended to precisely measure the position of total hip replacement (THR) components. The software operates as a near-real time assistive device for THR, measuring component alignment, to assist in precise placement of THR components. The software is intended to be installed on certified hardware (Apollo Station) located outside the patient field. This is accomplished by:
• Transfer of intra-operative 2D imaging of the patient from a capture source e.g. an X-ray machine
• Registration of the 3D pre-operative patient data to the 2D intra-operative patient imaging
• Calculation and display of the component alignment (for final implants as well as intra-operative instruments e.g., broaches and trials) which can be compared to pre-operative target positions.
ApolloHipX is intended to precisely measure the position of THR components by measuring implant positions relative to bone structures identifiable from radiological images and providing information on component alignment.
Clinical judgment and experience of an orthopaedic surgeon are required to properly interpret the results from the software. The software is not for primary image interpretation.The Apollo Station is the physical structure used to host the power supply and contains two user interfaces (monitor and tablet) from which the user can interact with the software applications. It also houses non-surgical Software that manages the user authentication, system access, data transfer of surgical inputs and communication to Corin's cloudhosted ecosystem. The Apollo Station connects to the imaging device intra-operatively to receive the 2D radiological images.

The provided text describes the ApolloHipX device and its clearance (K241808) by the FDA. However, it does not contain detailed information about the acceptance criteria and the specific study findings in the format requested.

The document is primarily a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device (JointPoint K160284). While it mentions "Non-Clinical testing conducted to determine substantial equivalence," and lists several studies like "Algorithm Accuracy Study," it does not provide the acceptance criteria table or the detailed study results that prove the device meets these criteria. It also explicitly states "Not Applicable. No clinical testing performed to support substantial equivalence."

Therefore, based solely on the provided text, I cannot complete most of the requested information.

Here's what can be inferred/extracted from the provided text, and what is missing:

Acceptance Criteria and Device Performance:

A table of acceptance criteria and reported device performance is not provided in this document. The document lists "Algorithm Accuracy Study" as one of the non-clinical tests, implying that accuracy was measured, but no specific criteria or results are detailed.

Study Information (Based on available text):

• Sample size used for the test set and the data provenance: Not specified. The document mentions non-clinical tests including "Algorithm Accuracy Study," "Sawbone study," and "Cadaveric evaluation." The specific number of cases/samples in these studies is not provided, nor is the origin of the data (e.g., country of origin, retrospective/prospective).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. No information is given about the experts involved in establishing ground truth for any of the non-clinical studies.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study was done. The document states, "No clinical testing performed to support substantial equivalence." The device is intended to assist a surgeon ("Clinical judgment and experience of an orthopaedic surgeon are required to properly interpret the results from the software. The software is not for primary image interpretation."), but there's no study described on human performance with/without the device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: An "Algorithm Accuracy Study" was performed, which would be a standalone assessment. However, the results and specific metrics for this study are not provided.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the "Algorithm Accuracy Study," the type of ground truth is not specified. Given it's a non-clinical study for a measurement device, it likely involved highly precise measurements from physical models (sawbones or cadavers) or highly accurate imaging, but the exact method isn't detailed.
• The sample size for the training set: Not specified. The document describes non-clinical tests but does not provide details on the training data used for the algorithm's development.
• How the ground truth for the training set was established: Not specified.

Summary of what is Lacking (and crucial for a complete answer):

The provided FDA 510(k) clearance letter and summary confirm the device's clearance and its intended use as a measurement assistance tool for Total Hip Replacement. However, it explicitly states that no clinical testing was performed. While non-clinical tests like "Algorithm Accuracy Study" are mentioned, the document lacks the specific acceptance criteria, detailed results, sample sizes, ground truth methodology (for both test and training sets), and expert qualifications/adjudication methods that would describe how the device met its performance goals. This information is typically found in the detailed study reports submitted to the FDA, not necessarily in the public 510(k) summary.

Ask a specific question about this device

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 Unity Total Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is sufficient sound bone to seat and support the components.

The General total knee arthroplasty indications include:

· Painful, disabling joint disease of the resulting from: degenerative arthritis, theumatoid arthritis or post-traumatic arthritis

· Post-traumatic loss of knee joint configuration and function

• · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function
• · Revision of previous unsuccessful knee replacement or other soft tissue stability is adequate
• · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture management techniques
• · The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface with
• increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament

The Unity Total Knee System is intended for cemented use, single use only.

The Unity Total Knee System is a fixed bearing total knee replacement system that consists of a cobalt chromium alloy (CoCr) femoral component, a UHMWPE (Ultra-High-Molecular-Weight-Polyethylene) or ECiMa (Vitamin E enriched advanced polyethylene) tibial tray with a titanium alloy keel extension and all-polyethylene (UHMWPE) patellar component for use in primary and revision total knee arthroplasty. The Unity Total Knee System femoral component is provided in two variants, cruciate retaining (CR) and posterior stabilised (PS).

• The CR femoral component is intended for use in conjunction with the CR tibial insert or Medial Constrained (MC) tibial insert where the posterior cruciate ligament (PCL) is functional or in conjunction with a Condylar Stabilised (CS) tibial insert or MC tibial insert where the PCL is present but is lax or non-functioning or when the PCL is absent.
• The PS femoral component is intended for use in conjunction with the PS tibial insert where the posterior cruciate ligament is non-functioning or absent, resulting in joint instability, or in conjunction with the constrained posterior-stabilized (PS-C) tibial insert where is instability of the lateral collateral ligament and/or medial collateral ligament (LCL/MCL).

The Unity Total Knee System patellar component is optional and for use with either the CR or PS femoral variants and is intended for use where replacement of the articular surface of the patella is required. The system also provides titanium alloy augments including femoral augments, tibial augments, stem extensions and offset adapters.

The Unity Total Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the joint articulation where there is evidence of sufficient sound bone to seat and support the components.

The Unity Total Knee system was originally cleared in K113060. This submission is for the inclusion of an additional range of Unity Knee MC Tibial Inserts. The additional range of tibial inserts has the same intended purpose as those cleared in the original 510(k) submission (K113060).

The provided document is a 510(k) Premarket Notification from the FDA for the "Unity Total Knee System." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than on a clinical study proving device meets specific acceptance criteria in the way a de novo or PMA submission might.

However, it does outline the non-clinical tests performed to support substantial equivalence. While it doesn't present acceptance criteria and reported performance in a table with specific thresholds, it implies that the device met the requirements of the standards and analyses conducted.

Here's an attempt to structure the information based on your request, understanding that the scope of this document is a 510(k) and not a detailed clinical study report:

1. Table of Implied Acceptance Criteria and Reported Device Performance

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

This document does not specify sample sizes for mechanical testing. For example, for "Constraint determination," it doesn't state how many implants were tested.

• Sample Size (Test Set): Not explicitly stated for each test, but implied to be sufficient for the non-clinical tests mentioned.
• Data Provenance: Not explicitly stated (e.g., country of origin), but the tests are non-clinical (laboratory-based) and not human subject data. Retrospective/Prospective is not applicable to these types of non-clinical tests.

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

Not applicable. The ground truth for these non-clinical tests is established by the accepted scientific and engineering principles codified in the referenced ASTM and ISO standards, and by established scientific methods, not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical data interpretation or image annotation, not for mechanical or material testing of devices. The "judgment" for these tests comes from adherence to the test standard and engineering analysis.

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

No. This document does not describe an MRMC comparative effectiveness study. The submission is for a 510(k) clearance based on substantial equivalence, which often relies on non-clinical performance and comparison to predicate devices rather than direct human clinical trials for effectiveness in the same way a new drug or novel device might require.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical medical device (total knee system), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on:

• Standardized Test Methods: Adherence to established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards (e.g., ASTM F1223-20, ISO 21536:2023, ASTM F2723-21). These standards define procedures and acceptable performance metrics.
• Engineering Principles and Benchmarking: Comparison to known performance characteristics of the legally marketed predicate devices, as well as established material properties.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model or software algorithm that would require a training set.

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

Not applicable for the reasons mentioned in point 8.

Ask a specific question about this device

The Unity Knee™ PS-C Tibial Insert is intended for use in the Unity Total Knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.

The General total knee arthroplasty indications include:

· Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis

· Post-traumatic loss of knee joint configuration and function

• · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function
• · Revision of previous unsuccessful knee replacement or other soft tissue stability is adequate
• · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture management techniques
• · The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface with
• increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament

The Unity Total Knee System is intended for cemented use, single use only.

The Unity Total Knee System is a fixed bearing total knee replacement system that consists of a cobalt chromium alloy (CoCr) femoral component, an ultra-high molecular weight polyethylene (UHMWPE) tibial insert, a CoCr tibial tray with a titanium alloy keel extension and all-polyethylene patellar component for use in primary and revision total knee arthroplasty. The Unity Total Knee System femoral component is provided in two variants, cruciate retaining (CR) and posterior stabilised (PS).

• The CR femoral component is intended for use in conjunction with the CR tibial insert where the posterior cruciate ligament (PCL) is functional or in conjunction with a Condylar Stabilised (CS) tibial insert where the PCL is present but is lax or non-functioning or when the PCL is absent.
• . The PS femoral component is intended for use in conjunction with the PS tibial insert where the posterior cruciate ligament is non-functioning or absent, resulting in joint instability, or in conjunction with the constrained posterior-stabilized (PS-C) tibial insert where is instability of the lateral collateral ligament and/or medial collateral ligament (LCL/MCL).

The Unity Total Knee System patellar component is optional and for use with either the CR or PS femoral variants and is intended for use where replacement of the articular surface of the patella is required. The system also provides titanium alloy augments including femoral augments, tibial augments, stem extensions and offset adapters.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

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

The document does not explicitly present a table of acceptance criteria. Instead, it describes various non-clinical tests performed and states that the "results of the specific mechanical testing performed on the Unity Knee PS-C Tibial Insert show that the device is substantially equivalent to the predicate devices." This implies that the acceptance criteria are met if the new device performs comparably to the predicate devices in these tests.

However, we can infer the tested parameters and the general outcome:

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

The document describes non-clinical (mechanical) testing only. Therefore, the concept of a "test set" in the context of patient data (retrospective/prospective, country of origin) is not applicable. The sample size for mechanical tests is not explicitly stated but would refer to the number of physical samples of the device components subjected to testing. This information is typically detailed in the full test reports, which are not provided here.

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)

Since this is a submission for a mechanical medical device (a knee implant component), the concept of "ground truth" established by medical experts for a "test set" (e.g., image-based diagnosis) is not applicable. The ground truth for mechanical performance is established by the specifications of the predicate devices and the performance standards (ASTM, ISO). The "experts" involved would be engineers and testing technicians who design and execute the tests and analyze the results against these standards. Their qualifications are not specified in this summary.

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

Not applicable as this is not a study involving human readers or image interpretation.

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 document pertains to the clearance of a mechanical orthopedic implant, not an AI-assisted diagnostic device.

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

Not applicable. As noted above, this is about a mechanical implant, not an algorithm.

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

The ground truth for the non-clinical tests is based on established engineering standards and specifications (ASTM F1223-20, ISO 21536:2023, ASTM F2083-21) and the performance characteristics of the legally marketed predicate devices (Apex PS Knee System, PS-C Insert K111184; Unity Total Knee System K113060). The new device's performance is compared against these benchmarks to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable, as this is a mechanical device, not a machine learning model requiring a training set.

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

Not applicable, as there is no training set for a mechanical device.

Ask a specific question about this device

ApolloKnee is indicated to aid the surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during total knee arthroplasty.

Apollo Robot and BalanceBot are optional accessories and are specifically indicated for use in total knee arthroplasty with the ApolloKnee system.

ApolloKnee is compatible with the following implant systems:

• · Apex Knee™ System.
• · Unity Knee™ System.

ApolloKnee is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate.

ApolloKnee™ (formerly OMNBotics) is a robotic-assisted stereotaxic surgery system that aids the surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during total knee replacement (TKR). ApolloKnee is composed of eight sub-systems that integrate to form the ApolloKnee system. Four of these sub-components (Station, Tracking System, Communication Module and Nonsurgical Application) form the main structure of Corin's core platform for robotic or computer assisted surgeries. This core platform is referred to as "Apollo". Future Corin technologies are intended to be developed on the basis of the Apollo core platform. ApolloKnee is one such technology built upon the Apollo common platform. ApolloKnee includes four system specific sub-components (Apollo Robot, BalanceBot, TKR Instruments and ApolloKnee Software),

ApolloKnee is an evolution of the former OMNIBotics Knee System. ApolloKnee is the first launched under Corin Ltd following acquisition of the OMNIBotics' prior manufacturer OMNIlife Science. ApolloKnee differs from OMNIBotics Knee System (as previously marketed under K200888) in branding (for commercial reasons), as well as redesigns of the station and software, and introduction of additional surgical instrumentation, namely the BalanceBot Pre-Resection Paddles, Tibial Cutting Guide and V-Array.

This document, a 510(k) Summary for the ApolloKnee device, details the premarket notification to the FDA. However, it does not contain the specific information required to answer your prompt about acceptance criteria and a study proving the device meets them.

The sections you've highlighted (Non-Clinical Testing, Conclusion) mention "Accuracy testing per custom protocols and ASTM F2554-22" and "surgeon user validation studies (cadaver evaluations)." While these indicate testing was performed, the document does not provide the acceptance criteria or detailed results of these studies.

Therefore, I cannot provide the requested information from this document. It lacks:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Information on MRMC studies or effect sizes.
• Standalone performance data.
• Specific type of ground truth used.
• Sample size for training sets.
• How ground truth for training was established.

This document primarily focuses on establishing substantial equivalence to a predicate device based on design, intended use, and general non-clinical testing categories, rather than presenting a detailed clinical or performance study report with specific acceptance criteria and detailed outcomes.

Ask a specific question about this device

The indications for the Corin MetaFix™ 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 MetaFix™ Hip Stem is indicated for cementless use only.

The MetaFix™ Hip is a tapered stem manufactured from titanium alloy (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 (collared and 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.
The MetaFix™ hip is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

I apologize, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets those criteria. Instead, the document is a 510(k) premarket notification for a medical device called the "Corin MetaFix™ Hip Stem."

This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving the device meets specific performance acceptance criteria through a clinical or non-clinical study in the way you've outlined.

The key points from the provided text are:

• Substantial Equivalence: The document asserts that the Corin MetaFix™ Hip Stem is substantially equivalent to predicate devices (other MetaFix Hip Stems). This is a regulatory pathway for medical devices in the U.S. that does not always require new clinical trials to prove efficacy or safety from scratch, but rather demonstrates it's as safe and effective as a device already on the market.
• Non-Clinical Testing: It mentions "mechanical fatigue testing of the neck and stem" and a "range of motion assessment." These are non-clinical (laboratory) tests used to support the claim of substantial equivalence, likely ensuring the new variations perform comparably to the predicates under simulated conditions.
• Clinical Testing: The document explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the Corin MetaFix™ Lateralized Collared Hip Stem, Corin MetaFix™ Collared Short Neck Hip Stem and the predicate devices."

Therefore, I cannot provide the information requested in your numbered points (acceptance criteria table, sample size, expert ground truth, MRMC study, standalone performance, etc.) because the scope of this FDA document is to establish substantial equivalence for a hip stem, not to validate an AI/algorithm-based device and its performance against detailed acceptance criteria that your questions imply for such a device.

Ask a specific question about this device

The OMNIVision™ system is intended to be used as an intra-operative system to assist in the alignment of prosthetic components during Total Hip Arthroplasty, where a reference to a rigid anatomical structure can be identified. The system achieves this by displaying intra-operative measurements of the acetabular component to the user calculated from visual information from a camera detecting fiducial markers.

The OMNIVision™ system is compatible for use with the legally marketed products

• · OPSInsight™ and
• · the Corin TrinityTM Acetabular System,
• · Trinity-iTM Acetabular shells and
• · TrinityTM non-occluded titanium plasma sprayed (TPS) acetabular shells.

The OMNI Vision™ system is indicated for use with the posterior, anterior surgical approaches for primary Total Hip Arthroplasty.

The OMNIVision™ system is an image-based navigation system intended to assist the surgeon in delivering a target acetabular cup placement during Total Hip Arthroplasty (THA). The system consists of a Camera Assembly, OMNIVision™ software application installed onto the laptop, fiducial markers used to track the position of the surgical instruments, and a single use sterile drape. The fiducial markers and camera drape are supplied in packaged and EtO sterilized condition.

The OMNIVision™ system displays real-time intraoperative information, cup alignment and cup depth, with augmented and virtual reality views using a fixed reference attached to the patient's pelvis. The workflow of the OMNIVision™ system involves instrument calibration, registration of patient anatomy, and determination of cup alignment. The system uses image-based registration of the patient's anatomy and matches it to the pre-operative CT images of the patient's anatomy, the OMNIVision System to intra operatively calculate and display the information relative to the patient's anatomy, and independent of the patient's intra-operative pelvic position.

The OMNIVision™ System is designed for use with the Corin Trinity Acetabular System components and compatible with the Corin OPSInsight™ system for pre-operative planning.

The OMNIVision system is an image-based navigation system intended to assist the surgeon in delivering a target acetabular cup placement during Total Hip Arthroplasty (THA). The acceptance criteria for the OMNIVision system were evaluated through various studies, including cadaver surgeries and software bench testing.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Cadaver Studies: The document states "Surgeon-user verification studies of performance measures and accuracy performed by cadaver surgeries." The sample size for cadavers is not specified.
• Data Provenance: The cadaver studies are likely prospective, as they involve newly performed surgeries under controlled conditions to test the device. The country of origin of this data is not specified.
• Software Bench Testing: A "phantom device developed with guidance from ASTM-F2554" was used. The sample size for this testing is not specified (e.g., number of test runs or simulations).
• Data Provenance: This is a controlled laboratory environment testing, hence prospective. The country of origin is not specified, though the manufacturer is based in Australia.

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

• Cadaver Studies: "Surgeon-user verification studies" implies surgeons were involved in the testing and evaluation. However, the number of experts and their specific qualifications (e.g., years of experience, specialization) used to establish ground truth or assess performance in the cadaver studies are not specified.
• Software Bench Testing: Ground truth for software bench testing would likely be based on predefined precise phantom measurements. No human experts are explicitly mentioned for establishing ground truth in this context, only in performing the tests.

4. Adjudication Method for the Test Set

The document does not specify any formal adjudication method (e.g., 2+1, 3+1, none) for either the cadaver studies or the software bench testing. The "surgeon-user verification" suggests a direct assessment by the operating surgeons for the cadaver studies.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The studies described focus on the standalone performance of the device without explicit comparison to human readers with and without AI assistance for effect size quantification.

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

• Yes, a standalone performance study was done through software bench testing. This testing "demonstrated mean positional accuracy of ±1° for angular position and ±1mm for linear position" using a phantom device. This represents the algorithm's performance in a controlled, non-human-interaction scenario.
• The cadaver studies represent a human-in-the-loop scenario, where surgeons used the device to achieve the reported accuracy.

7. Type of Ground Truth Used

• Cadaver Studies: The ground truth for the cadaver studies is implied to be actual measurements taken post-implantation, based on the stated "accuracy of the OMNIVision™ System in implanting an acetabular cup." This would be a direct measurement of the implanted component's position relative to known anatomical landmarks.
• Software Bench Testing: The ground truth for software bench testing was based on a "phantom device developed with guidance from ASTM-F2554." This is a precisely engineered physical model with known, accurate measurements.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size for any training set for the OMNIVision system's software. The system uses "image-based registration of the patient's anatomy and matches it to the pre-operative CT images of the patient's anatomy," implying some form of image processing or machine learning, but no details on training are given.

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

As no information is provided about a training set or its sample size, there is no information on how the ground truth for any potential training set was established.

Ask a specific question about this device

OPSInsight™ is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.

OPSInsight™ is an interactive software for preoperative planning of Total Hip Arthroplasty. It enables 3D sizing and placement of implants in the patient's anatomy, calculates biomechanical measurements and performs functional analysis based on landmarks and anatomical models derived from patient-specific radiographic imaging and the templated implants. The biomechanical measurements include measurements relating to leg length, offset and femoral version, and the functional analysis includes determination of pelvic parameters, cup orientation calculation during flexion and extension, and impingement detection.

The software uses 2D and 3D patient-specific radiographic data. The implant data required by the software is contained within a controlled database. OPSInsight™ is a closed platform. Please refer to the Instructions for Use for compatible implant systems.

The provided text describes the 510(k) submission for the Optimized Positioning System (OPS) Insight™, a preoperative surgical planning software for total hip arthroplasty. However, the document does not contain the specific details about the acceptance criteria and the study that proves the device meets those criteria.

The 510(k) summary (sections 13 and 14) states:

• "Non-clinical testing was performed, assessing the usability and performance testing that was conducted on the predicate device. In addition to this, nonclinical testing was performed to assess the performance of the bony impingement feature in OPSInsight to demonstrate that the feature functions as intended."
• "Software verification and validation testing was conducted according to IEC 62304 and documentation provided as recommended by FDA's Guidance for the Industry: 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'"
• "Clinical testing was not necessary for this Traditional 510(k)."

This indicates that while performance testing was done on the bony impingement feature, the document does not provide the specific acceptance criteria, the methodology of that testing (e.g., sample size, ground truth, experts), nor details typical of a comparative effectiveness study or standalone performance study as requested in the prompt. The statement that "clinical testing was not necessary" further confirms the absence of a large-scale human-in-the-loop study as would be described in point 5 or 6 of your request.

Therefore, based solely on the provided text, I cannot complete the table or answer most of the questions as the information is not present.

Based on the provided text, here's what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified for the performance testing of the bony impingement feature.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "patient-specific radiographic imaging," but not the source of the test set data.

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

• Not specified. The document only mentions the "end user" as being orthopedic surgeons but doesn't detail their role in establishing ground truth for testing.

4. Adjudication method for the test set:

• Not specified.

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

• No. The document explicitly states: "Clinical testing was not necessary for this Traditional 510(k)." This implies no MRMC study was conducted.

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

• The text mentions "nonclinical testing was performed to assess the performance of the bony impingement feature... to demonstrate that the feature functions as intended." While this is a standalone performance assessment of the feature, the specific metrics and methodology (e.g., how "functions as intended" was quantified) are not detailed. It's implied, but the specifics are absent.

7. The type of ground truth used:

• Not specified. For the "bony impingement feature," it might have involved simulated data or expert review against CAD models, but the document does not elaborate.

8. The sample size for the training set:

• Not specified. The device uses "anatomical models derived from patient-specific radiographic imaging" and "implant data required by the software is contained within a controlled database." This alludes to data used for development, but no specific training set size is mentioned.

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

• Not specified. It's broadly stated as "landmarks and anatomical models derived from patient-specific radiographic imaging." Details on the establishment of ground truth for these models (e.g., expert annotation, consensus, pathological confirmation) are not provided.

Ask a specific question about this device

The Corin OPS™ Femoral is intended to be used as a patient-specific surgical instrument to assist the surgeon in delivering a target femoral neck osteotomy, based on a pre-operative plan with implant sizing, type and placement.

The Corin OPS™ Femoral is intended to be used with OPS™ Plan and compatible components. The dislocating Femoral Guide is intended for use with the posterolateral surgical approach and the in-site Ferrorel. Guide is intended for use with the direct anterior surgical approach.

The Corin OPSTM Femoral PSI is intended for single use only.

The Corin Optimized Positioning System (OPS™) Femoral consists of Femoral Patient Specific Instruments (PSI) and reusable instrumentation. The Femoral Patient Specific Instruments include a Femoral Guide and an optional Trial Femoral Head (Bone Model).

The Femoral Guide is shape-matched to the patient's femoral anatomy and provides a guide for the femoral neck osteotomy during total hip arthroplasty. The planned femoral resection, or target osteotomy, is defined by a preoperative plan (either OPS™ Plan (K171847, K183038) or OPS™ Insight (K192656)). OPS™ Plan and OPS™ Insight are pre-operative tools used by the Surgeon for the selection, sizing and placement of implant components using anatomical landmarks of the femur and pelvis identified from pre-operative CT scan and AP X-ray.

Corin OPS™ Femoral was originally cleared under K181061. The purpose of this submission is to include OPS™ Insight (K192656) to the Indications for Use as an alternative compatible component. The design and manufacturing process of the device subject of this submission is identical to that of the predicate device K181061.

OPS™ Plan was previously cleared under K171847 and K183038; OPS™ Insight (K192656) is currently under review with FDA. OPS™ Plan (K171847, K183038) and OPS™ Insight (K192656) are not submitted for review in this 510k submission.

The provided text describes a 510(k) summary for the Corin Optimized Positioning System (OPS) Femoral. A 510(k) submission is typically for demonstrating substantial equivalence to a predicate device, and it often does not require new clinical studies for acceptance criteria in the same way a Premarket Approval (PMA) would.

Based on the provided document, here's an analysis of the acceptance criteria and the study (or lack thereof) that supports the device meeting those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a tabled format, nor does it present specific performance metrics from a study that would directly map to such criteria for the current 510(k) submission. Instead, it refers to "non-clinical testing" for safety and effectiveness.

The closest we get to performance assessment is the statement in Section 13: "Testing verified that the accuracy and performance of the device is adequate to perform as intended."

Given the nature of this 510(k):

• Acceptance Criteria (Implied): The device, Corin OPS™ Femoral, should exhibit sufficient "accuracy and performance" to assist in delivering a target femoral neck osteotomy, consistent with its intended use and equivalent to the predicate device (K181061). This implicitly means it should be able to guide the surgeon accurately and reliably for the pre-planned osteotomy. The non-clinical tests would have aimed to confirm this.
• Reported Device Performance: The document only provides a qualitative summary: "Testing verified that the accuracy and performance of the device is adequate to perform as intended." No specific accuracy values (e.g., in mm or degrees) are reported in this summary. The testing included "quantitative assessments of clinical accuracy," but the results of these quantitative assessments are not provided here.

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

The document states in Section 14: "Clinical testing was not necessary for this Traditional 510(k)." This means there was no new clinical test set (i.e., patient data) generated for this specific submission with human subjects to evaluate the device's performance in a clinical setting.

The "non-clinical testing" mentioned in Section 13 would typically involve bench testing, mechanical tests, and potentially simulations, not patient data. Therefore, details like data provenance (country of origin, retrospective/prospective) and sample size for a test set based on human data are not applicable to the studies supporting this 510(k). The validation of the device relies on its substantial equivalence to a previously cleared device for which clinical or performance data might have been presented in its original 510(k).

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

Since no new clinical test set with human patients was acquired for this 510(k) submission (as stated in Section 14), there is no information provided about experts establishing ground truth for such a test set.

For the non-clinical tests (e.g., accuracy of the guide), the "ground truth" would likely be established by engineering measurements against known specifications or designs, rather than expert consensus on patient data.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical test set with human data was used for direct evaluation in this 510(k) submission.

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

No. The document explicitly states that "Clinical testing was not necessary for this Traditional 510(k)." An MRMC study would be a type of clinical study involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

The device is described as a "patient-specific surgical instrument to assist the surgeon". It is a physical guide, not an AI algorithm. Therefore, the concept of a "standalone" algorithm performance is not applicable. The core function relates to its physical accuracy and fit for guiding the osteotomy, which was assessed through "non-clinical testing."

7. The Type of Ground Truth Used

For the "quantitative assessments of clinical accuracy" during non-clinical testing (Section 13), the ground truth would likely refer to:

• Design Specifications: The accuracy of the guide compared to the pre-operative plan's target osteotomy.
• Physical Measurements: Using metrology tools to verify the dimensions and functional features of the manufactured surgical guides against the design.

It is not based on expert consensus, pathology, or outcomes data from human patients for this submission.

8. The Sample Size for the Training Set

The Corin OPS™ Femoral is a physical patient-specific instrument. It is not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning. The design and manufacturing process are validated, and the device's effectiveness is based on its physical accuracy and design principles, not on being trained on a dataset.

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

As explained in point 8, there is no "training set" for this device in the context of an AI/ML algorithm. The "ground truth" during its development would refer to engineering specifications, anatomical references from medical imaging (CT scans), and surgical principles validated through design controls and manufacturing processes.

Ask a specific question about this device