(172 days)
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.
| Acceptance Criteria Category | Device Performance (How Met) |
|---|---|
| Substantial Equivalence | Claimed substantial equivalence to predicate devices (Corin MetaFix Hip Stem (K082525, K121439, K120362, K130634) and Corin Trinity Acetabular System with XL Heads (K130343)). |
| Materials | Manufactured from Titanium (TiAl, V.) alloy conforming to ASTM F136-12a and coated with plasma sprayed hydroxyapatite conforming to ASTM F1185-03(2009). Modular CoCrMo and BIOLOX delta™ Ceramic Femoral Heads also conform to existing material standards and previous clearances. |
| Intended Use/Indications | Identical to predicate devices for total hip arthroplasty and hemi-arthroplasty (non-inflammatory degenerative joint disease, rheumatoid arthritis, correction of functional deformity, treatment of non-union/fractures, developmental/congenital dysplasia of the hip), and cementless use only. |
| Design | The MetaFix Stems are identical to predicate devices. The modification involves adding compatible modular femoral heads in an extra-long offset, which are identical to compatible components cleared in the predicate Trinity Acetabular System with XL Heads (K130343) in terms of materials, intended use, indications, and similar in design. |
| Non-Clinical Testing | Conducted to demonstrate substantial equivalence, including a "comparison of compatible components with the predicate devices." (No specific test results or metrics are provided in this summary). |
| Clinical Testing | Not necessary to determine substantial equivalence. |
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.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.