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The BiPolar-i is intended for use in the following indications: Non-inflammatory degencrative joint disease including osteoarthritis and avascular necrosis in which the acetabulum does not require replacement, Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur, Revision of failed partial hip replacements in which the acetabulum does not require replacement. The BiPolar-i is indicated for cementless use only.

The Trinity Acetabular System is indicated for use in non-intlammatory degenerative joint disease including osteoarthritis and avascular necrosis, rheumatoid arthritis, correctional deformity, developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH). The Trinity Acctabular System is intended for cementless, single use only.

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

The indications for the MiniHip Stem as a total hip arthroplasty include: Non-inflammatory degenerative joint disease including osteoarthriis and avascular necrosis Rheumatoid arthritis Correction of functional deformity. Developmental dysplasia of the hip (DDH) and congenital dysplasia of the hiniHip Stem is indicated for cementless use only.

The indications for the TrinityTM Accabular System as a total hip arthroplasty include: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Rheunatoid arthritis, Correction of functional deformity, Developmental dysplasia of the hip (DDH), and congenital dysplasia of the hip (CDH). The Trinity Acctabular System is intended for cementless, single use only.

The Trinity Dual Mobility System is intended for use in the following indications: 1. Non-inflammatory degenerative joint disease, including osteoarthritis & avascular necrosis 2. Rheumatoid Arthritis 3. Correction of functional deformity 4. Revision of previously failed total hip arthroplasty 5. Patients at increased risk of dislocation 6. Developmental dysplasia of the hip (DDH). The Trinity TM Dual Mobility System is indicated for cementless use only.

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

The MobiliT Cup, for cemented and cementless use, are indicated for primary replacement of the hip joint: - In degenerative pathologies: primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis - For patients who have a high risk of dislocation - In cases of necrosis of the femoral head - In cases of fracture of the neck of the femur - In cases of congenital luxation. The MobiliT Cup, for cemented and cementless use, are indicated for revision when the bone tissue remains sufficient after the removal of the previous acetabular cup. The cementless MobiliT standard Cup, with flanges or with flanges and hook are indicated for cementless use only. The cemented MobiliT Cup is indicated for cemented use only.

The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: Femoral neck and trochanteric fractures of the proximal femur. Osteonecrosis of the femoral head, Revision procedures where other devices or treatments for these indications have failed.

The OMNI Hip system Ceramic Femoral Heads are intended for use in combination with the OMNI Hip System Stems as the femoral component in total hip replacement procedures. This ceramic head is intended to articulate with the OMNI Interface Acctabular System or bipolar component. This prosthesis is intended for single use may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation; Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fiactures of the proximal femur.

The indications for use of the OMNI Modular Hip Stems in hip arthroplasty include the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis: Correction of functional deformity; Congenital dislocation: Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur. The OMNI Modular Hip stems are indicated for cementless use only and single use implantation.

The indications for use of the OMNI Modular Hip Stems in hip arthroplasty include the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis: Correction of functional deformity; Congenital dislocation: Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur. The OMNI Modular Hip stems are indicated for cementless use only and single use implantation.

The Revival Modular Revision Hip Stem is indicated in revision surgery of femoral components, following failure of primary cemented or un-cemented prosthesis. The REVIVAL™ Hip Stem 100mm distal component is also indicated in primary total hip arthroplasty. The indications for the Revival TM Modular Revision Hip Stem include: Non-inflammatory degenerative joint disease including primary and secondary osteoarthritis. Rheumatoid arthritis, Correction of functional deformity, Treatment of non-union and femoral neck fractment of traumatic dislocations of the hip, Failures of osteotomy, Treatment of arthrodesis. The Revival ™ Revision Hip Stem is indicated for cementless, single use only.

TaperFirM Hip Stem is indicated for the relief of pain and restoration following the effects of femoral neck fracture, osteo, theumatory arthritis, post- traumatic disease effects, avascular necrosis and total hip revision. The Taper it Hip Stem is indicated for hemi-arthroplasty when used in combination with Corin hemiarthroplasty femoral heads. The TaperFitTM Hip Stem is indicated for cemented, single use only.

The indications for use of the K 1 Hip arthroplasty include the following conditions, as appropriate: Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis: Rheumatoid arthritis: Correction of functional deformity: Congenital disfocation: Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur. The K 1 Hip Stem is indicated for cementless use only and single use implantation.

The indications for the TriFit CF Hip Stem as a total hip arthroplasty and as a hip hemiarthroplasty include: Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Rheumatoid arthritis, Correction of functional deformity, Treatment of non-union and femoral neck fractures, Developmental Dysplasia of the Hip (DDH), Previously failed hip surgery. The Trifit CF Hip Stem is indicated for cementless use only.

The indications for the Corin TriFit TSTM Hip atthroplasty, and when used in combination with a Corin hemi arthroplasty head, as a hip hemi-arthroplasty, include: Non-inflammatory degenerative joint disease including osteoadhritis and avascular necrosis, Rheumatoid arthritis, Correction of functional deformity, Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur, Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH). The Tril'it TS Hip is intended for cementless use only.

The subject and predicate devices are one in the same and are comprised of several legally marketed Corin Ltd. hip products, which include OMNIIfe Sciences and Apex Surgical hip products. The subject devices include acetabular cups and liners, bone fixation screws, screw hole occluders, cemented and cementless femoral hip stems for primary and revision hip arthroplasty, fixation screws, modular necks, CoCrMo alloy and ceramic femoral heads, dual mobility acetabular systems, and bipolar heads. The purpose of this 510(k) is to notify the FDA of Corin's engineering assessment of the cross-compatibility of the subject devices, identification of conflicts, and updates to the product labeling. The subject hip devices components are manufactured from a variety of materials which include cobalt-chromium-molybdenum alloy, stainless steel alloy, unalloyed titanium, calcium phosphate (Bonit™ coating) Alumina Matrix Composite ceramic (Biolox Delta), and ultrahigh molecular weight polyethylene (UHMWPE), all of which conform to ASTM or ISO standards, or internal standards. The subject femoral hip stems and heads possess the same 12/14 taper design and reference system for determining head and neck offsets.

I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance as typically seen in a medical device submission beyond general statements of substantial equivalence. The document is a 510(k) summary for hip replacement components, primarily focusing on cross-compatibility of various existing devices.

The text outlines:

• Device identification and manufacturer information.
• List of numerous predicate devices.
• Detailed descriptions of the indications for use for many hip components (e.g., Corin BiPolar-i, Trinity™ Acetabular System, MetaFix™ Hip, MiniHip™, Trinity™ Dual Mobility, MobiliT™ Cup, OMNI Bipolar Head, OMNI Delta Ceramic Femoral Head, OMNI MOD Hip System, OMNI K1/K2 Hip Systems, Revival™ Modular Hip Stem, TaperFit™, TriFit™ CF/TS Hip). These indications primarily relate to non-inflammatory degenerative joint disease, rheumatoid arthritis, correction of functional deformity, avascular necrosis, fractures, and revision surgeries.
• A "Performance Data" section which describes the types of engineering analyses and bench testing performed to establish cross-compatibility (e.g., ceramic head burst testing, head pull-off, fretting-corrosion, impingement testing, range of motion assessment, comparison of taper geometries, fatigue strength assessment, and contact stress/wear potential).

However, it does not provide:

1. A specific table of acceptance criteria and reported device performance for the types of tests mentioned (e.g., what burst pressure was required vs. achieved). It only lists the types of tests done.
2. Sample sizes used for test sets or data provenance.
3. Number of experts and their qualifications for establishing ground truth (as this pertains to clinical studies, which are not detailed here for performance).
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information.
6. Standalone algorithm performance (as this is not an AI/algorithm-driven device).
7. Type of ground truth used (again, this is not a diagnostic device with "ground truth" in the typical sense).
8. Sample size for training set.
9. How ground truth for the training set was established.

The document's purpose is to demonstrate substantial equivalence of a range of hip components, including their cross-compatibility when used together. The "performance data" refers to the engineering and bench testing conducted to ensure this compatibility rather than clinical performance against specific metrics as one would find for a diagnostic or AI-driven device.

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

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• DDH/CDH
• Revision procedures where other treatments or devices have failed
• Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  The MiniHip Stem is indicated for cementless use only.

The MiniHip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The MiniHip Stem uses a short stem philosophy to provide a bone-conserving option to the use of a standard total hip prosthesis. The stem is manufactured from Titanium (TiAIsV4) alloy and is proximally coated with plasma sprayed hydroxyapatite over plasma sprayed pure titanium in order to enhance primary fixation. The stem is designed to be used in conjunction with Corin Eurocone CoCr modular femoral heads (K003666) and Corin Zyranox Zirconia Ceramic modular femoral heads (K992235), both of which mate with Corin Cenator Acetabular Cups (K925866). The stem is available in six sizes, each with the provision of a 130° CCD (Caput-Collum-Diaphysis) neck angle with a polished distal section for guidance and to minimize distal fixation and reduce proximal stress-shielding.

The provided text describes a 510(k) premarket notification for the MiniHip Stem, a femoral hip stem. It details the device's description, intended use, and claims of substantial equivalence to predicate devices. However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics such as accuracy, sensitivity, or specificity.

The "Non-Clinical Testing" section mentions "mechanical fatigue testing, range of motion testing and coating characterization," and states that "The results of this testing show that the MiniHip Stem is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device." However, it does not provide the quantitative acceptance criteria for these tests, nor the reported performance data from these tests.

The "Clinical Testing" section explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the MiniHip Stem and the predicate devices." This means no human-based clinical studies, including those for the purpose of demonstrating clinical performance or comparative effectiveness (MRMC studies), were conducted or submitted for this 510(k).

As a result, I cannot populate the requested table or answer most of your specific questions related to acceptance criteria and device performance studies because the information is not present in the provided text.

Here's a summary of what can be extracted or directly inferred:

1. Table of Acceptance Criteria and Reported Device Performance

• Cannot be provided. The document states that non-clinical testing (mechanical fatigue, range of motion, coating characterization) was performed, and the results showed the device is "expected to be safe and effective" and "substantially equivalent." However, it does not list specific quantitative acceptance criteria (e.g., "fatigue strength must exceed X N at Y cycles") or the device's measured performance against those criteria.

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

• Not applicable / Not provided. No clinical or standalone device performance testing data on a "test set" (in the context of AI/diagnostic device evaluation) is presented. The non-clinical tests would have used physical device samples, but details on their quantity or "data provenance" are not given.

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

• Not applicable / Not provided. No test set or ground truth establishment by experts is mentioned.

4. Adjudication method for the test set

• Not applicable / Not provided.

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

• No. The document explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the MiniHip Stem and the predicate devices." This includes MRMC studies.

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

• No. The device is a physical medical implant (femoral hip stem), not an algorithm or diagnostic software that operates in a "standalone" mode.

7. The type of ground truth used

• Not applicable / Not provided. In the context of a hip stem, "ground truth" would typically relate to mechanical properties, biocompatibility, and clinical outcomes. The document relies on non-clinical testing for mechanical and material properties, and substantial equivalence to predicate devices for clinical safety and effectiveness rather than direct clinical ground truth generation.

8. The sample size for the training set

• Not applicable / Not provided. The device is a physical implant, not an AI model that requires a "training set."

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

• Not applicable / Not provided.

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The indications for the Corin Metafix Hip Stem as a total hip 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
• DDH/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 (TiAI.V.) alloy for surgical implant applications, conforming to ASTM F136-2 and is coated with plasma sprayed hydroxyapatite conforming to ASTM F-1185-88. The stem is designed to be used in conjunction with Corin Eurocone CoCr modular femoral heads (K003666) and Corin Zyranox Zirconia Ceramic modular femoral heads (K992235), both of which mate with Corin Cenator Acetabular Cups (K925866). The stem is available in 9 sizes (Size 2 to Size 10), each available in three lateral offsets including standard, lateralized, and Coxa Vara.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Corin Metafix Hip Stem, structured as requested. It's important to note that the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel device performance against specific, pre-defined acceptance criteria in the way a new drug or high-risk device might.

Acceptance Criteria and Study for Corin Metafix Hip Stem

This document describes a 510(k) submission for the Corin Metafix Hip Stem, asserting its substantial equivalence to a predicate device (Depuy Orthopaedics Corail AMT Hip System). The concept of "acceptance criteria" in this context is primarily focused on demonstrating that the new device performs at least as well as the predicate for its intended use, rather than meeting novel performance thresholds.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as a numerical sample size of "cases" or "patients" in the context of clinical data. The "test set" here refers to the specimens used for the non-clinical mechanical testing (fatigue, static tensile, range of motion). The exact number of hip stems tested for each mechanical evaluation is not provided in this summary.
• Data Provenance: The mechanical testing described (fatigue, static tensile, range of motion) is non-clinical. The origin of the data is therefore laboratory-based testing performed by the manufacturer (Corin USA) or a contracted lab. It is prospective in the sense that the tests were conducted specifically for this submission. There is no mention of geographical provenance for the subjects being tested as it's not human data.

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

This information is not applicable as the "test set" described consists of non-clinical mechanical performance tests. Ground truth in this context would be the objective measurement of physical properties, not expert opinion.

4. Adjudication Method for the Test Set

This is not applicable as the "test set" consists of non-clinical mechanical performance tests. No adjudication of expert opinions or interpretations was involved.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is common for AI/imaging devices involving human interpretation, but it is entirely irrelevant for a mechanical orthopedic implant like a hip stem.

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

No. A standalone algorithm performance study was not done. This device is a mechanical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the non-clinical mechanical tests, the "ground truth" would be the objective, empirically measured physical properties of the device (e.g., force to fracture, cycles to failure, range of motion limits under load). This is based on established engineering principles and ASTM standards for materials and testing.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device being a mechanical implant. AI models have training sets, but this product does not involve AI.

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

This information is not applicable. As there is no "training set," there is no ground truth to establish for it.

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The T2™ Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2TM components consist of a series of end caps, baskets, and covers which must be attached to a T2 XVBR™ expanding centerpiece to form a complete construct. The final construct is to be used with supplemental fixation. The T2 SCEPTOR™ components also serve as a vertebral body replacement device for the same intended use in the thoracolumbar spine. The T2 SCEPTOR™ end caps and endcleats must be attached to a PYRAMESH-C® device to form a complete construct. Both constructs (T2 XVBR™ and T2 SCEPTOR™) must be used with supplemental fixation to form a final construct. Specifically, the construct is to be used with the Medtronic ZPLATE IITM Anterior Fixation System, the DYNALOK CLASSIC® Spinal System, the VANTAGE™ Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2™ Spinal System construct is intended to be used with bone graft.

The T2TM Spinal System is a distractible system used in corpectomy procedures. This construct is inserted between two vertebral bodies in the thoracic and/or lumbar spine and is expanded to aid in the surgical correction and stabilization of the spine. The construct is not intended to be used as a stand alone device. The construct is intended to be used with either anterior and/or posterior supplemental spinal fixation systems already cleared for thoracic and lumbar spine stabilization.
The T2 XVBR™ expanding cage is made of titanium alloy, cobalt chrome, and nitinol. The T2 XVBR™ end caps, baskets, and covers are attached to the T2 XVBR™ expanding cage to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

T2™ Spinal System constructs may not be used with stainless steel supplemental fixation devices. Titanium constructs comprised from one of the following Medtronic spinal systems or their successors must be used with the T2TM Spinal System.

This document is a 510(k) summary for the T2™ Spinal System, which is a medical device. Based on the provided text, it's not a study proving device performance against acceptance criteria in the typical sense of a clinical or analytical performance study for an AI/diagnostics device. Instead, it's a submission to demonstrate substantial equivalence to previously cleared devices. Therefore, many of the requested categories are not applicable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This document is a 510(k) submission asserting substantial equivalence to predicate devices, not a performance study against specific acceptance criteria. The "performance" being demonstrated is the T2™ Spinal System's similarity in intended use, technology, and safety/effectiveness to existing devices.

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

Not applicable. No test set or data provenance related to a performance study is described. The submission is based on comparison to predicate devices, material testing, and design specifications.

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

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method for the test set

Not applicable. No test set or adjudication method 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. This device is a physical spinal implant, not an AI or diagnostic tool.

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

Not applicable. This device is a physical spinal implant, not an algorithm.

7. The type of ground truth used

Not applicable. No ground truth as typically understood for a performance study is described. The basis for clearance is "Substantial Equivalence" to legally marketed predicate devices, meaning the device's design, materials, and intended use are comparable to already approved devices.

8. The sample size for the training set

Not applicable. No training set is described.

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

Not applicable. No training set or ground truth establishment for it is described.

Summary of the K082112 510(k) Pre-market Notification (T2™ Spinal System):

This document is a 510(k) summary for a vertebral body replacement system. The core of this submission is to demonstrate substantial equivalence to predicate devices already on the market. This means the manufacturer is asserting that their new device is as safe and effective as existing legally marketed devices, based on similarities in intended use, technological characteristics, and performance (often demonstrated through bench testing and material compatibility, though not detailed here).

The FDA's letter (pages {2} and {3}) confirms that a substantial equivalence determination was made, allowing the device to be marketed. This regulatory pathway does not typically involve a clinical performance study with acceptance criteria and a test set like those for AI or diagnostic devices. Instead, the "proof" is in the successful demonstration of equivalence to existing, approved devices.

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