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The indications for the Corin Icona Hip Stem as a total hip arthroplasty, and when used in combination with a Corin hemiarthroplasty head, as a hip hemiarthroplasty, include:

• · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• · Correction of functional deformity
• · Treatment of non-union and femoral neck fractures
• Developmental dysplasia of the hip (DDH) / congenital dysplasia of the hip (CDH)

The Corin Icona Hip Stem is indicated for cementless use only.

The Corin Icona Hip Stem is a tapered stem design manufactured from Titanium alloy (Ti6Al4V) (ASTM F136) with a layer of commercially pure titanium (ISO 5832-2, ASTM F1580) and an additional layer of electrochemically deposited calcium phosphate (ASTM F1609) applied.

The Icona Hip Stem is intended for use in hemiarthroplasty and total hip arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged hip joint articulation where there is evidence of sufficient sound bone to seat and support the components.

The design is a fully-coated titanium femoral hip stem featuring a polished neck with 12/14 tapered male trunnion for assembly with Corin modular femoral head components. Additionally, the Icona stem features a trapezoidal, tripled tapered body, providing for rotational and axial stability.

The Icona Hip Stem is a collared stem available in two different offsets (Standard and Lateralised) and twelve (12) different sizes, totaling 24 options.

The Icona Hip Stem is compatible with the following acetabular systems:

· Traditional – Trinity (K093472, K110087, K111481, K122305, K130128, K130343, K131647) and Trinity PLUS (K17255) · Dual mobility - Trinity Dual Mobility (K170359) and MobiliT (K191831)

· Bipolar - Bipolar-i (K183114)

This document is a 510(k) Premarket Notification from the FDA for a hip stem device (Icona Hip Stem). It does not describe an AI/ML medical device, but rather a traditional medical device (hip implant). Therefore, much of the requested information regarding acceptance criteria and studies for AI/ML performance metrics (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document.

However, I can extract the relevant information regarding the traditional device's performance criteria and supporting studies as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is typically not provided in detail within a 510(k) summary for mechanical testing of traditional orthopedic implants. The document states "Non-clinical testing and rationales provided to support substantial equivalence," but does not specify sample sizes for these mechanical tests (e.g., number of stems tested for fatigue).

• Provenance: The tests are non-clinical (laboratory/mechanical testing), not patient data.

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

Not applicable for a traditional orthopedic implant's mechanical testing or equivalence comparison to predicate devices. "Ground truth" in this context would refer to established engineering standards (ISO, ASTM) and the performance of predicate devices.

4. Adjudication Method

Not applicable for this type of device submission. Adjudication is relevant for expert review of data, often in clinical studies or for AI ground truth establishment.

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

No, this is not an AI/ML device, so an MRMC study comparing human readers with and without AI assistance is not applicable.

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

No, this is not an AI/ML device.

7. The Type of Ground Truth Used

For this traditional device, the "ground truth" used to establish substantial equivalence is primarily:

• Established engineering standards: ISO 7206-4, ISO 7206-6, ISO 21535, ASTM F136, ASTM F1580, ASTM F1609. The device's performance in these tests is compared against the performance of the predicate devices or the requirements of these standards.
• Performance of legally marketed predicate devices: The Icona Hip Stem's design, materials, and mechanical performance are compared to those of already cleared predicate devices. Substantial equivalence implies that the new device performs as safely and effectively as the predicate.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device; there is no "training set."

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

Not applicable, as there is no "training set."

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The text outlines:

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

However, it does not provide:

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

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

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The Corin Optimized Positioning System Functional Hip Analysis (OPS™ FHA) is indicated for preoperative analysis of primary total hip arthroplasty. Corin OPS™ FHA is intended to be used as a pre-operative tool which provides the Surgeon with functional acetabular cup orientations based on the patient pelvic kinematics and presents a visualisation of the patient's hemipelvis.

The Corin OPS™ FHA is intended for use with the Corin Trinity Acetabular System (K093472, K11481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty.

The Corin Optimized Positioning System Functional Hip Analysis (OPS™ FHA) consists of a pre-operative patient specific analysis and two patient specific reports: Functional Hip Analysis (FHA) report and Patient Specific Visualisation (PSV) report.

The Corin OPS™ FHA assists the surgeon in determining a patient specific target orientation for the acetabular cup using anatomical landmarks of the pelvis obtained from pre-operative CT scan and X-ray data and a subsequent functional pelvic kinematic analysis (FHA report), and visualisation of the patient's 3-dimensional anatomy (PSV report).

The provided text describes the Corin Optimized Positioning System Functional Hip Analysis (OPS™ FHA) and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving performance.

Here's a breakdown of what can be extracted and what is missing:

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

The document mentions a "Reproducibility and Repeatability study" was performed and that it demonstrated the process used to generate the FHA report is "reliable and repeatable." However, it does not provide specific numerical acceptance criteria or the reported performance metrics (e.g., specific values for reproducibility, repeatability, accuracy, precision).

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

The document mentions a "Reproducibility and Repeatability study" was performed but does not specify the sample size used, the country of origin of the data, or whether the data was retrospective or prospective.

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 information is not provided in the document.

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

This information is not provided in the document.

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

The document states, "Clinical testing was not necessary for this Traditional 510(k)." This implies that a MRMC comparative effectiveness study was not performed as part of this submission. The device is a pre-operative analysis tool to assist surgeons, not a diagnostic tool requiring human reader improvement comparison.

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

The "Reproducibility and Repeatability study" described likely assessed the standalone performance of the FHA report generation process. However, specific metrics of this standalone performance are not provided.

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

The document describes the device as providing "functional acetabular cup orientations based on the patient pelvic kinematics." The ground truth for the reproducibility and repeatability study would presumably relate to the consistency of these calculated orientations, but the specific method of establishing "ground truth" (e.g., comparing to a gold standard measurement, or internal consistency checks) is not detailed.

8. The sample size for the training set

The document describes the device as being substantially equivalent to a predicate and mentions "non-clinical testing" including a reproducibility and repeatability study. It does not provide information about a training set size, which is typically relevant for machine learning or AI-based devices. The OPS™ FHA seems to be based on anatomical landmark analysis and kinematic modeling rather than a deep learning model trained on a large dataset.

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

Since information regarding a training set is not provided, how its ground truth was established is also not available in the document.

Summary of available information regarding acceptance criteria and study:

• Study Type: Reproducibility and Repeatability study.
• Purpose: To demonstrate that the process used to generate the FHA report is reliable and repeatable.
• Outcome (general): The study demonstrated reliability and repeatability.
• Clinical Testing: Not deemed necessary for this 510(k).

Missing Information:

• Specific numerical acceptance criteria.
• Detailed reported device performance metrics/values.
• Sample size for the reproducibility and repeatability study.
• Data provenance for the study (country, retrospective/prospective).
• Number and qualifications of experts involved in any ground truth establishment.
• Adjudication method.
• Specific details on how "ground truth" was established for the non-clinical study.
• Information on training set size or ground truth establishment for a training set.

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The TaperFit Hip Stem is indicated for the relief of pain and restoration following the effects of femoral neck fracture, osteo, rheumatoid and inflammatory arthritis, post-traumatic disease effects, avascular necrosis and total hip The TaperFit Hip Stem is indicated for hemi-arthroplasty when used in combination with Corin Bipolar revision. Prosthesis hemi-arthroplasty femoral heads.

The TaperFit Hip Stem is indicated for cemented, single use only.

The TaperFit Hip Stem is a highly polished, double tapered, collarless, stainless steel femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from stainless steel in accordance with ISO 5832-9 -Implants for surgery -- Metallic materials -- Part 9: Wrought high nitrogen stainless steel and is provided with a polymethylmethacrylate (PMMA) Stem Centralizer. The stem is designed to be used in conjunction with Corin Eurocone (E100.XXX cleared in K003666) and Trinity CoCrMo modular femoral heads (E321.XXX cleared in K093472, K110087, K122305, K123705, K130128, K130343 and K131647). The stem is available in sizes, 0 through 4 with 3 offsets 50mm, 45mm, and 38mm, as well as a CDH option with a 36mm offset.

The TaperFit Hip Stem was originally cleared in K142761. This submission is being made to modify the indications for use to include hemi-arthroplasty when used with previously cleared Corin hemi-arthroplasty femoral heads as compatible components. The Corin CoCr Modular 26mm heads (E100.X26) have been cleared as compatible components of the Taper-Fit Hip stem (K003666). The Corin CoCr Modular 26mm heads (E100.X26) are part of the construct of the bipolar heads. Included in this submission is the Corin Bipolar Femoral Head (K925897) as a compatible component, which is indicated for hemi-arthroplasty.

This document is a 510(k) premarket notification for a medical device called the "TaperFit Hip Stem". It's a regulatory submission to the FDA, not a study evaluating device performance against acceptance criteria in the way described in the prompt. Therefore, much of the requested information (acceptance criteria, sample sizes for test/training sets, expert qualifications, etc.) is not present in this document because it pertains to a different type of evaluation.

Here's a breakdown of the information that is available or can be inferred, and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

• Absent. This document does not present a table of acceptance criteria or report specific performance metrics for the device. It refers to non-clinical testing data from previous submissions for establishing substantial equivalence.

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

• Absent. This document does not describe a "test set" in the context of an AI/algorithm performance evaluation. The "non-clinical testing" mentioned involved mechanical and fatigue testing, not a data-driven test set with human-equivalent performance.

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

• Absent. Not applicable to this type of regulatory submission. The ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus on medical images or data.

4. Adjudication method for the test set

• Absent. Not applicable.

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

• Absent. This is a hardware device (hip stem), not an AI algorithm. Therefore, MRMC studies and AI-assisted reading are not relevant.

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

• Absent. This is a hardware device, not an algorithm.

7. The type of ground truth used

• For the non-clinical testing mentioned, the "ground truth" would be engineering standards, material specifications (e.g., ISO 5832-9 for stainless steel), and the results of mechanical fatigue, static, rotational torque, and fretting/corrosion tests.

8. The sample size for the training set

• Absent. Not applicable. This is not an AI/ML device.

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

• Absent. Not applicable.

Summary of available information related to the device and its evaluation (from the document):

• Device Name: TaperFit Hip Stem
• Type of Device: Hip joint metal/polymer semi-constrained cemented prosthesis
• Indications for Use: Relief of pain and restoration of hip function following femoral neck fracture, osteo, rheumatoid and inflammatory arthritis, post-traumatic disease effects, avascular necrosis, and total hip revision. Also indicated for hemi-arthroplasty when used with Corin Bipolar Prosthesis hemi-arthroplasty femoral heads. Indicated for cemented, single use only.
• Predicate Devices:
  • Corin TaperFit Hip Stem (K142761)
  • Corin Taper-Fit Hip Stem (K992234, K003666)
• Substantial Equivalence Claim: The TaperFit Hip Stem (subject of this submission) is claimed to be identical in design, materials, coating, and sizes to K142761, and similar in intended use/indications. It's also claimed to be identical in materials and coating, and similar in design, sizes, and intended use/indications to K992234 and K003666. The main modification in this submission is an expanded indication for use to include hemi-arthroplasty with compatible Corin hemi-arthroplasty femoral heads.
• Non-Clinical Testing Mentioned: FEA (Finite Element Analysis), mechanical fatigue testing, static testing, rotational torque testing, fretting and corrosion testing, and range of motion testing. These tests were performed and submitted in previous TaperFit and Taper-Fit Hip Stem submissions (K142761, K992234, and K003666).
• Clinical Testing: "Clinical testing was not necessary in this Traditional 510(k)."

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

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

The Corin MetaFix Hip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from Titanium (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.

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