(270 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.
Note:
- · The Titanium coated Modular Shell is intended for press-fit, uncemented use only.
- · The Hydroxyapatite Coated Uncemented Femoral Stem is intended for press-fit, uncemented use only.
- · The Proximally Coated Uncemented Femoral Stem is intended for press-fit, uncemented use only.
- · The Cemented Femoral stem is intended for cemented use only.
- · The Modular Acetabular Liner is intended for use with Modular Acetabular Shell.
· The CoCr Modular Femoral Head is intended to articulate with Modular Liner to mate with uncemented stem or cemented stem.
• The Biolox® delta Modular Femoral Head is intended to articulate with Modular Liner and to mate with uncemented stem or cemented stem.
· The Bone Screw and Apical Hole Occluder are intended for use with Modular Acetabular shell.
- · The Centralizer and Cement Restrictor are intended for use with cemented stem only.
The Latitud™ Uncemented Femoral Stem is fabricated from Titanium alloy - ELI (Titanium-6 Aluminum-4 Vanadium Extra Low Interstitial). It has 12/14 taper at the top which mates with its 510(k) cleared Latitud™ Cobalt Chromium alloy and Biolox® delta Modular femoral head (Cleared under K172857). This stem is implanted without use of bone cement. Stem is coated with Hydroxyapatite (HA) by plasma spraying method. These stems are available in different sizes with neck angles of 135° standard, 135° lateral and 125° standard (Coxavera). Uncemented Femoral Stem is intended for press-fit uncemented use only.
The provided document is a 510(k) summary for the Meril Healthcare Pvt. Ltd. Latitud™ Hip Replacement System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in a clinical context.
The document primarily describes non-clinical performance data and biocompatibility testing to support the substantial equivalence claim. It does not include a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or details on ground truth establishment for a training set in the context of an AI/ML device. This is because the Latitud™ Hip Replacement System is a physical medical device (hip implant), not an AI/ML diagnostic or therapeutic system.
Therefore, many of the requested categories are not applicable to the content of this 510(k) summary. I will answer the applicable questions based on the provided text.
1. Table of acceptance criteria and the reported device performance
Since this is a physical medical device and not an AI/ML system, the "acceptance criteria" are related to mechanical and chemical properties, as well as biocompatibility, conforming to established ASTM and ISO standards. The document summarizes that the device was subjected to these tests and the results support its substantial equivalence. Specific quantitative acceptance criteria or detailed performance values are not explicitly listed in a comparative table within the summary.
Mechanical Tests:
| Test | Standard | Reported Performance |
|---|---|---|
| Bonding Strength | ASTM F1147-05 (Reapproved 2017)e1 | Tested in accordance with the standard to support substantial equivalence. |
| Shear static strength | ASTM F1044-05 (Reapproved 2017)e1 | Tested in accordance with the standard to support substantial equivalence. |
| Fatigue Shear test | ASTM F1160-14 (Reapproved 2017)e1 | Tested in accordance with the standard to support substantial equivalence. |
| Fatigue bending test | ASTM F1160-14 (Reapproved 2017)e1 | Tested in accordance with the standard to support substantial equivalence. |
Morphology Tests:
| Test | Standard | Reported Performance |
|---|---|---|
| Thickness and Porosity | ASTM F1854-15 | Tested in accordance with the standard to support substantial equivalence. |
| Roughness Ra/Rt | ISO 4288- 1998 | Tested in accordance with the standard to support substantial equivalence. |
| Scanning Electron Microscope (SEM) | FDA Guidance* | Tested in accordance with the FDA Guidance to support substantial equivalence. |
Chemical Tests:
| Test | Standard | Reported Performance |
|---|---|---|
| Trace elements and heavy metals by ICP | ISO 13779-2 (2018), ISO 13779-3 (2018) | Tested in accordance with the standards to support substantial equivalence. |
| Ca/P ratio and Phases and Crystallinity by XRD | ISO 13779-2 (2018), ISO 13779-3 (2018) | Tested in accordance with the standards to support substantial equivalence. |
| Fourier-transform infrared spectroscopy (FTIR) | FDA Guidance* | Tested in accordance with the FDA Guidance to support substantial equivalence. |
| Solubility | ISO 13779-6 (2015) | Tested in accordance with the standard to support substantial equivalence. |
| Dissolution | ASTM F1926/F1926M-14 | Tested in accordance with the standard to support substantial equivalence. |
Biocompatibility Tests: All tests were conducted according to ISO 10993 series standards (or USP General Chapter ). The conclusion states that the device is considered substantially equivalent, implying that these tests met the acceptance criteria.
| Test | Standard |
|---|---|
| Cytotoxicity Test | ISO 10993-5 |
| Skin Sensitization Study | ISO 10993-10 |
| Acute irritation/Intracutaneous reactivity test | ISO 10993-23 |
| Acute systemic toxicity study | ISO 10993-11 |
| Material mediated pyrogenicity | ISO 10993-11, USP General Chapter |
| Sub-chronic systemic toxicity test | ISO 10993-11 |
| Bone Implantation Study | ISO 10993-6 |
| Bacterial Reverse Mutation Test | ISO 10993-3 |
| In vitro Mammalian Chromosomal Aberration Test | ISO 10993-3 |
*FDA guidance document- "510(k) Information needed for Hydroxyapatite coated orthopedic implants. February 1997"
Applicable Questions:
As this is a 510(k) for a physical medical device (hip implant) and not an AI/ML software, the following points are not applicable from the provided text:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.