(211 days)
The Latitud™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is an evidence of sufficient sound bone to fix and support the components.
Total hip replacement is indicated for the following conditions:
- · Non-inflammatory degenerative joint diseases including osteoarthritis and avascular necrosis.
- · Rheumatoid arthritis.
- Congenital hip dysplasia.
- · Acute traumatic fracture of the femoral head or neck.
- · Certain cases of Ankylosis.
- Dislocation of the hip.
- · Correction of functional deformity.
- · Revision of failed joint reconstruction or treatment.
- · Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur.
Latitud™ Hip Replacement System cleared under K172857 consists of modular acetabular cup system, femoral heads, femoral stems and related accessories.
Purpose of this 510(k) is to add following acetabular cup system and femoral stem under previously 510 (k) cleared Latitud Hip Replacement System (K172857).
- Latitud TM Triad Acetabular Cup System .
- Latitud™ Proximally coated Uncemented femoral stem .
Latitud™ Triad - Acetabular Cup System is a modular cup system. It includes Modular shells, Modular liners and Bone screws.
- . Modular Shell: Modular shells are intended for uncemented, press fit fixation with prepared acetabulum. They are designed for use with Modular liners. The Modular shells are fabricated from Ti-6Al-4V-ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). Modular shells are available in different sizes. The outer surface of the Modular shell is coated with commercially pure Titanium.
- Modular Liner: Modular liners are designed to be used with Modular shell. Modular liners . are intended to be articulated with a range of dedicated Cobalt chromium alloy or Biolox® delta Modular femoral heads previously cleared under K172857. Modular liners are fabricated from Highly Cross-Linked Polyethylene (HXLPE). It is available in different sizes.
- Bone Screw: Bone screw is used if additional fixation of Modular shell is required. Bone . screw is self tapping and is fabricated from Titanium alloy - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). Bone screw is available in 6.5 mm diameter with different lengths.
The proximally coated uncemented femoral stem is fabricated from Titanium alloy - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial) and it is intended to be used with Femoral head (CoCr and Biolox Delta ceramic) previously cleared under K172857. The proximal portion of the stem is coated with commercially pure Titanium with plasma spray method. The proximal coated femoral stem is available in two designs (Standard i.e. full profile design and distally reduced design). Each design is available in different sizes with three neck angles (132° Standard, 132° Lateral, and 128° Standard).
The provided text is a 510(k) Summary for the Latitud™ Hip Replacement System. This document details the device's design, indications for use, and a comparison to predicate devices to demonstrate substantial equivalence. However, it does not describe an AI medical device or a study proving its performance against acceptance criteria. It focuses solely on the mechanical and material performance of a hip replacement system.
Therefore, I cannot provide a detailed response to your request, as the information regarding acceptance criteria, device performance, sample sizes, expert involvement, multi-reader multi-case studies, or ground truth establishment for an AI device is not present in the provided text.
Based on the information available, here's what can be extracted, although it doesn't align with your request for an AI medical device:
Device: Latitud™ Hip Replacement System
Device Type: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis (Class II)
510(k) Number: K183532
Applicant: Meril Healthcare Private Limited
Non-clinical Performance Data (similar to "studies" for this type of device):
The document lists various non-clinical tests conducted to evaluate device function/mechanical performance and demonstrate substantial equivalence to predicate devices, including:
- Locking Strength: per ASTM F1820-13
- Wear test: (ASTM F1877-05, ISO 14242-3-2009)
- Impingement Test: (ASTM F2582-14)
- Evaluation of torsion properties, pull out properties, driving torque, and self tapping performance of Bone Screw: per ASTM F543-13e
- Proximal fatigue test: (ISO 7206-6:2013)
- Distal fatigue test: (ISO 7206-4:2010)
- Range of motion test: (ISO 21535-2007/Amd 1:2016)
- Axial pull-off test: (ISO 7206-10:2003)
- Fretting corrosion: (ASTM F1875-98; Reapproved 2014)
- Evaluation of Ceramic femoral head (includes Burst test, Post fatigue burst test, Pull-off test and Torque test): (ISO 7206-10:2003, ASTM F1820-13)
- Ti coating adhesion (shear) test: (ASTM F1044-05; Reapproved 2017)
- Material Characterization of HXLPE: (ASTM F2565-13, ASTM F2759-11, ASTM F648-14, ASTM F2003-15, ISO 5834-3 and ISO 5834-2)
- Endotoxin testing
Conclusion from the document: Based on performance testing results and similarities in intended use, device design/technological characteristics, materials, and sterilization method, the Latitud™ Hip Replacement System is considered substantially equivalent to the previously cleared predicate devices.
Missing Information (Relevant to your request for an AI device but not present in this document):
The document does not contain any of the following information pertinent to an AI medical device study:
- A table of acceptance criteria and reported device performance for an AI
- Sample sizes used for a test set (beyond the components tested in mechanical studies)
- Data provenance (country of origin, retrospective/prospective)
- Number of experts used to establish ground truth
- Qualifications of experts
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study results
- Standalone (algorithm only) performance
- Type of ground truth used (expert consensus, pathology, outcome data)
- Sample size for a training set
- How ground truth for a training set was established
Therefore, I cannot fulfill your request as it pertains to an AI medical device study based on the provided text.
§ 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.