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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 Trinity™ Dual Mobility System is intended for use in the following indications:

• 1. Non-inflammatory degenerative joint disease, including osteoarthritis & avascular necrosis
• 2. Rheumatoid Arthritis
• 3. Correction of functional deformity
• 4. Revision of previously failed total hip arthroplasty,
• 5. Patients at increased risk of dislocation
• 6. Developmental dysplasia of the hip (DDH)

The TrinityTM Dual Mobility System is indicated for cementless use only.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Not applicable. MRMC studies are associated with the evaluation of diagnostic performance for imaging systems or AI algorithms where human interpretation plays a role. This document concerns a physical implant.

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

Not applicable. This device is not an algorithm.

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

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

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

8. The sample size for the training set:

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

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

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

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

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

The MiniHip Stem is indicated for cementless use only.

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

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

• Not applicable. No clinical study was performed.

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

• Not applicable. No clinical study was performed.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical study was performed.

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

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

6. Standalone Performance Study:

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

7. Type of Ground Truth Used:

• Not applicable. No clinical study was performed.

8. Sample Size for the Training Set:

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

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

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

Summary of the Device Submission:

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

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The indications for the Trinity Acetabular System as a total hip arthroplasty include:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
  The Trinity Acetabular System is intended for cementless, single use only.

The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium allov shell; acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW; and ceramic and CoCrMo modular heads. The ceramic and CoCrMo modular heads are compatible with Corin titanium femoral stems.
The purpose of this submission is to add 32mm (+7mm offset), 36mm (+8mm offset), and 40mm (+8mm offset) CoCrMo and BIOLOX delta™ ceramic extralong femoral heads to the Trinity Acetabular System.

This document describes a 510(k) submission for the Corin Trinity Acetabular System with Extra Long Heads. It is a modification to an existing hip prosthesis system. The key takeaway is that no clinical studies were conducted to demonstrate the device meets acceptance criteria. Instead, it relies on non-clinical testing and substantial equivalence to predicate devices. Therefore, many of the requested fields regarding clinical study details cannot be populated.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable: No clinical test set was used. Non-clinical testing (fatigue testing) typically involves a small number of samples (e.g., 6-12 samples per condition) tested under specified load conditions, but the exact sample sizes are not provided in this summary. The data provenance would be from laboratory testing.

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

• Not Applicable: Given that no clinical studies were performed and the device relies on non-clinical testing and substantial equivalence, there was no "ground truth" established by experts in the context of a clinical test set.

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

• Not Applicable: No clinical test set and thus no adjudication method for ground truth determination.

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

• Not Applicable: This device is a hip implant, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or applicable.

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

• Not Applicable: This is a physical medical device (hip prosthesis), not a software algorithm.

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

• Not Applicable: For the non-clinical testing, the "ground truth" would be the engineering specifications and performance standards for fatigue resistance. For the regulatory submission, the "ground truth" is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not Applicable: No training set was used as this is not a machine learning or AI device.

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

• Not Applicable: No training set was used.

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