Mg-PSZ Ceramic Femoral Head

• K Number: K220336
• Device Name: Mg-PSZ Ceramic Femoral Head
• Manufacturer: Theken Companies
• Date Cleared: 2022-09-30 ( 235 days)
• Product Code: LPH , LZO , OQG , OQI
• Regulation Number: 888.3358
• Type: Special
• Panel: OR
• Reference & Predicate Devices: K161184 , K912641 , K925682 , K172501 , K192071 , K191936

Intended Use

The iNSitu Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:

· A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia;

· Acute traumatic fracture of the femoral head or neck;

· Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.

The iNSitu Total Hip System femoral stems are intended for cementless fixation. The iNSitu Total Hip System acetabular cup is intended for cementless fixation. The porous structured surfaces provide biological fixation in a cementless application.

Device Description

The subject device Mg-PSZ Ceramic Femoral Head is manufactured from Zirconia Mg-PSZ ceramic material, which is the same material that comprises the predicate BioPro Ziralloy modular ceramic head. The subject device Mg-PSZ Ceramic Femoral Heads, including all sizes and offsets, have the same or similar design features and indications for use as the primary predicate device (Biolox Delta ceramic femoral head). The NextStep Arthropedix Mg-PSZ Ceramic Femoral Heads are packaged and sterilized using identical processes as the primary predicate device Biolox Delta femoral heads.

AI/ML Overview

The provided text does not contain information about an AI/ML-driven medical device, its acceptance criteria, or a study proving that an AI/ML device meets these criteria. Instead, it is an FDA 510(k) clearance letter for a Mg-PSZ Ceramic Femoral Head, a physical medical device used in hip replacements.

Therefore, I cannot extract the information required for an AI/ML device, such as:

1. Acceptance criteria and reported device performance (for an AI/ML device): The document reports on mechanical performance of a physical hip implant (static burst strength, fatigue testing, disassembly testing), not performance metrics for an AI/ML algorithm (e.g., sensitivity, specificity, AUC).
2. Sample size for test set and data provenance: Not applicable to a physical implant's mechanical testing.
3. Number of experts and qualifications for ground truth: Not applicable to engineering tests of a physical implant.
4. Adjudication method for test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a physical device, not an AI assisting human readers.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Ground truth here refers to actual physical properties and performance under stress, measured in laboratories, not clinical diagnoses or outcomes for AI.
8. Sample size for training set (for an AI/ML device): Not applicable, as there is no AI training. The "training" for this device would be its design and manufacturing process.
9. How ground truth for training set was established: Not applicable.

The document discusses preclinical performance testing for the Mg-PSZ Ceramic Femoral Head to evaluate its strength and performance characteristics and demonstrate substantial equivalence to predicate devices. This involves:

• Testing per ISO7206-10 and ASTMF2345 for:
  • Static Burst-Strength Testing
  • Fatigue Testing
  • Static Burst-Strength, Post-Fatigue Testing
• Disassembly testing per ISO7206-10 and ASTM F2009, and torque testing per ISO 7206-13 for:
  • Static Pull-Off (Axial) Strength
  • Static Torque-Off/Strength
• Material requirements per ASTM F2393.
• Bacterial endotoxin testing per FDA guidance and ANSI/AAMI ST72.

The conclusion is that based on "comparison of technological characteristics and performance testing," the device is substantially equivalent to predicate devices.

To provide the requested information, the input text would need to describe an AI/ML-powered medical device and a study evaluating its clinical or diagnostic performance.

Regulation Number and Section

§ 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.