Search Results

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

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

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

The document states:

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

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

Ask a specific question about this device

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

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

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

This document is a 510(k) premarket notification for a medical device called the Corin Metafix Hip Stem. It's an FDA submission, not a study report. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance.

The document discusses the device's intended use, indications, and claims of substantial equivalence to previously marketed predicate devices. It mentions that non-clinical mechanical fatigue testing and range of motion analysis were performed, but no clinical testing was deemed necessary to establish substantial equivalence.

Here's a breakdown of why this document cannot provide the requested information:

• Acceptance Criteria & Reported Performance: These are typically quantitative metrics set for a medical device's performance, often established in clinical trials or specific engineering tests. This document doesn't provide such a table.
• Sample Size (Test Set) & Data Provenance: This refers to the number of patients or samples used in a study to evaluate the device's performance. Since no clinical study was conducted for this submission, this information is not present.
• Number of Experts & Qualifications: This is relevant for studies where expert opinion is used to establish ground truth or evaluate outcomes. Not applicable here.
• Adjudication Method: Also relevant for studies involving human interpretation of data. Not applicable here.
• MRMC Comparative Effectiveness Study: This is a specific type of clinical study comparing human reader performance with and without AI. The device described, a hip stem, is a physical implant, not an AI or imaging device, so this type of study is irrelevant.
• Standalone Performance (Algorithm only): This refers to the performance of an AI algorithm without human involvement. Not applicable to a physical hip stem.
• Type of Ground Truth: This refers to the definitive determination of a condition or outcome in a study. Since no clinical study is presented, no ground truth is established in this document.
• Sample Size (Training Set) & Ground Truth for Training Set: This is relevant for AI/machine learning models where data is used to 'train' the algorithm. Not applicable to a physical hip stem.

In summary, this document is a regulatory submission for a hip implant, not a clinical or AI performance study. It does not contain the detailed information you requested about acceptance criteria and study data.

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 Corin hemi-arthroplasty femoral heads, as a hemi-arthroplasty, include:

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

The Corin MetaFix Hip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from Titanium (TiAl, V.) alloy for surgical implant applications, conforming to ASTM F136-12a and is coated with plasma sprayed hydroxyapatite conforming to ASTM F1185-03(2009). The Corin MetaFix Hip Stem is available in 10 sizes marked 1 through 10. With size 2 to 10 available in three offsets, including Standard (1359), Lateralized, (1359), and Standard (125°) and size 1 available in two offsets Standard (135°), Lateralized (135°). The Corin MetaFix Hip Stems were originally cleared in K082525 & K121439 and indications and contraindications of hemi arthroplasty and compatible components were added in K120362 & K130634.
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 40mm with +8mm offset (extra-long), were added to the range of heads available in K130343.
Modular BIOLOX delta™ 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 MetaFix Hip Stern was originally cleared in K082525, K121439, K120362 and K130634 and as cleared, compauble with short, standard and long offsets modular femoral heads. The purpose of this submission is to modify the labeling for the Corin MeraFix Hip 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, the Corin MetaFix Hip Stem. It's important to note that this document is for a hip prosthesis, not an AI/ML software device. Therefore, the questions related to AI/ML specific criteria (like readers, ground truth establishment, training sets, etc.) are not applicable in this context.

Here's the analysis based on the provided text, focusing on the device and study information available:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of performance metrics (like accuracy, sensitivity, specificity) for an AI/ML device. Instead, it focuses on demonstrating substantial equivalence to predicate devices. For a hip prosthesis, this typically involves material properties, mechanical integrity, and design similarity to already cleared devices.

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

This information is not applicable as this is a hip prosthesis, not an AI/ML software device that typically utilizes test sets of data. The "test set" in this context would refer to the physical hip stem components or possibly mechanical test samples. The document does not provide details on the number of hip stems or components used for non-clinical testing, nor does it mention data provenance as it would for clinical data.

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 is not applicable as this is a hip prosthesis and does not involve establishing ground truth from expert readings for a test set in the context of an AI/ML device.

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

This is not applicable as this is a hip prosthesis and does not involve expert adjudication for an AI/ML test set.

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

An MRMC study is not applicable as this is a hip prosthesis. The document explicitly states "Clinical testing was not necessary to determine substantial equivalence."

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

This is not applicable as this is a hip prosthesis, not an algorithm/software device.

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

This is not applicable as this is a hip prosthesis. The "ground truth" for a physical device like this is typically established through engineering specifications, material standards, and validated mechanical testing methods, rather than expert consensus on medical images or pathology.

8. The sample size for the training set

This is not applicable as this is a hip prosthesis, not an AI/ML software device.

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

This is not applicable as this is a hip prosthesis.

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 Corin hemi-arthroplasty femoral heads, as a hemi-arthroplasty, include:

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

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

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

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

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

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

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

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

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

Ask a specific question about this device