(91 days)
The hip prosthesis SMS is designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. Hip replacement is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, rheumatoid polyarthritis or congenital hip dysplasia
· Avascular necrosis of the femoral head
· Acute traumatic fracture of the femoral head or neck
· Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty.
The SMS femoral stem is a cementless bone preserving short stem designed for proximal fixation in total or partial hip arthroplasty for primary or revision surgery.
The SMS implants are comprised of the following products:
- SMS Cementless Solid Standard Stem (available in 11 sizes from size 3 to 13); and ●
- . SMS Cementless Solid Lateralized Stem (available in 11 sizes - from size 3 to 13).
Both are available on the US market via the clearance - K181693.
Concerning the new sizes of the solid version: 1V2, 2V2, size 14, and size 15; both STD and LAT versions have been introduced as a product range extension to the stems currently marketed as the SMS product line (K181693).
The SMS implants are line extensions to Medacta's Total Hip Prosthesis - AMIStem-H, Quadra-S and Quadra-H Femoral Stems (K093944), AMIStem and Quadra - Line Extension (K121011), AMIStem-P, AMIStem-P Collared and AMIStem-H Proximal Coating Femoral Stems (K173794), Quadra-H and Quadra-R Femoral Stems (K082792), AMIStem-H Proximal Coating (K161635), MiniMAX (K170845), and SMS (K181693).
The SMS implants are part of the Medacta Total Hip Prosthesis system. The Medacta Total Hip Prosthesis system consists of femoral stems, modular femoral heads and acetabular components. The acetabular components consist of metal cups and liners made of ultra-high molecular weight polyethylene (UHMWPE) or Highcross highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE). Acetabular components include the Mpact DM (K143453), VersafitCup (K083116 and K092265), VersafitCup CC Trio (K103352), Mpact (K103721 and K132879), Mpact 3D Metal (K171966) and Medacta Bipolar Head (K091967).
The SMS stems can be combined with the CoCr ball heads (K072857, K080885 and K103721), Endo Head (K111145) or with the MectaCer BIOLOX® Forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).
This is a 510(k) premarket notification for the "SMS Cementless Stem" (K201673), a hip prosthesis. The document details the device, its intended use, and a comparison to predicate devices, along with performance data.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document outlines various non-clinical performance tests conducted for the SMS Cementless Stem. However, it does not provide specific acceptance criteria values or the quantitative results of these tests in a table format. It only states that the testing was conducted "according to written protocols with acceptance criteria that were based on standards."
Here's what can be inferred for a table, but actual criteria values and results are missing in the document:
| Test (Standard) | Acceptance Criteria (Not provided explicitly, generally "meet standard requirements") | Reported Device Performance (Not provided explicitly, implied "met criteria") |
|---|---|---|
| Range of Motion (EN ISO 21535:2009) | Based on standard EN ISO 21535:2009 | Conducted |
| Fatigue Testing - Stemmed Femoral Components (ISO 7206-4:2010 + AME 1:2016) | Based on standard ISO 7206-4 | Conducted |
| Fatigue Testing - Head and Neck Region of Stemmed Femoral Components (ISO 7206-6:2013) | Based on standard ISO 7206-6 | Conducted |
| Pull-off Force Testing - Taper Connections (ASTM F2009-00 (Reapproved 2011)) | Based on standard ASTM F2009-00 | Conducted |
| Coating Tests - Hydroxyapatite (ISO 13779-1:2008) | Based on standard ISO 13779-1 | Conducted |
| Coating Tests - Tension Testing of Calcium Phosphate and Metal Coatings (ASTM F1147-99) | Based on standard ASTM F1147-99 | Conducted |
| Pyrogenicity - Bacterial Endotoxin Test (European Pharmacopoeia §2.6.14 / USP chapter ) | Based on European Pharmacopoeia §2.6.14 / USP chapter | Conducted |
| Pyrogenicity - Pyrogen Test (USP chapter ) | Based on USP chapter | Conducted |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical studies were conducted." Therefore, there is no test set in the context of human clinical data or patient outcomes. The "performance data" refers to non-clinical mechanical and material tests. The sample sizes for these mechanical tests are not provided in this summary. Data provenance is not applicable here as no human data was used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable as no clinical studies were conducted and no ground truth in the clinical sense was established. The "ground truth" for the non-clinical tests would be the specifications and requirements of the referenced ISO and ASTM standards.
4. Adjudication Method for the Test Set
Not applicable as no clinical studies were conducted which would require adjudication of expert opinions or outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No MRMC study was mentioned or performed, as "No clinical studies were conducted." This device is a mechanical implant, not an AI or diagnostic tool that would typically undergo MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hip implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the non-clinical performance and coating tests, the "ground truth" implicitly refers to the
requirements and specifications outlined in the referenced international standards (ISO and ASTM) and the European Pharmacopoeia/USP chapters. The device is expected to meet these pre-defined engineering and material standards. This is a form of engineering/material specification compliance as ground truth.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical implant, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device's approval.
§ 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.