(29 days)
MicroPort hip instruments are accessory devices and are intended to be used to assist in the implantation of MicroPort Hip Systems in their cleared indications for use.
MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative ioint disease such as rheumatoid arthritis:
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed
Rough grit blast surfaces and the hydroxyapatite and titanium plasma spray coatings applied to implant surfaces are intended for uncemented arthroplasty.
Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty. LINEAGE® and DYNASTY® modular shells with porous metal bead coating are intended only for uncemented arthroplasty.
PRIME shells are intended only for uncemented arthroplasty.
The device modification consists of an alteration to the sterilization instructions for FDAcleared MicroPort Orthopedics' (MPO) non-sterile hip orthopedic joint replacement instruments. The subject instruments are part of MicroPort Orthopedics' hip product lines and are required to facilitate total hip arthroplasty procedures. The modification will allow the option to sterilize the subject instruments using an FDA-cleared containment device. The subject devices will be placed in an FDA-cleared containment device, which will be wrapped in an FDA-cleared CSR wrap or similar type nonwoven, medical grade wrapping material, and then steam sterilized.
The modified sterilization process of the subject instruments was successfully challenged and validated through worst-case load configurations using an FDA-cleared containment device. The intended use and sterilization parameters, such as cycle, temperature, and exposure time, remain identical to the predicate devices.
The review document provides details on the 510(k) submission for MicroPort Orthopedics Inc.'s MPO Hip Instruments, focusing on a modification to their sterilization instructions.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Validation | Device withstands sterilization cycles and achieves sufficient sterility. | "MicroPort non-sterile orthopedic joint replacement instruments are able to withstand the reported sterilization cycles and achieve sufficient device sterility." |
| Steam Sterilization (Single-level tray) | Meets requirements of AAMI ST77:2013 | "Steam Sterilization Validation of MicroPort orthopedic joint replacement instruments using FDA-cleared containment device (single-level tray) per AAMI ST77:2013" - studies confirm that the device passed this validation. |
| Steam Sterilization (Double-level tray) | Meets requirements of AAMI ST79:2017 | "Steam Sterilization Validation of MicroPort orthopedic joint replacement instruments using FDA-cleared containment device (double-level tray) per AAMI ST79:2017" - studies confirm that the device passed this validation. |
| Vibration Test | Meets requirements of ISTA 2A | "Vibration Test of MicroPort orthopedic joint replacement instruments using FDA-cleared containment device per ISTA 2A." - studies confirm that the device passed this validation. |
| Intended Use | Remains consistent with predicate devices for total hip arthroplasty. | "The intended use and sterilization parameters, such as cycle, temperature, and exposure time, remain identical to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes (number of instruments) used for the sterilization validation or vibration testing. It refers to "worst-case load configurations" for the sterilization validation, implying that a representative selection of instruments was tested under challenging conditions. The data provenance is not specified, but it would typically be generated from internal testing conducted by MicroPort Orthopedics, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided. The evaluations for sterilization validation and vibration testing rely on established standards (AAMI ST77, AAMI ST79, ISTA 2A), where "ground truth" is determined by meeting the specified physical and biological parameters within the standards, not by expert consensus in the typical sense of clinical image interpretation.
4. Adjudication Method for the Test Set:
Not applicable. The tests performed are compliance-based (meeting standards) rather than requiring adjudication of subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was done. This device is an orthopedic instrument, and its effectiveness is not assessed through human interpretation of cases. The study focuses on the safety and efficacy of its reprocessing (sterilization).
6. Standalone Performance:
Standalone performance was implicitly assessed through the non-clinical testing. The instruments themselves, within the specified containment devices and sterilization cycles, directly underwent the validation tests to demonstrate their ability to achieve sterility and withstand integrity challenges. There is no "algorithm only without human-in-the-loop performance" as this is not an AI/software device.
7. Type of Ground Truth Used:
The ground truth used for these tests is based on accepted industry standards and scientific principles for sterilization and product integrity:
- Sterility: Achieved by demonstrating a Sterility Assurance Level (SAL) through biological indicators and physical parameters outlined in AAMI ST77 and AAMI ST79.
- Physical Integrity: Maintained by demonstrating the instrument's ability to withstand vibration during transit as per ISTA 2A.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" in the context of the reported studies. The modification is related to the reprocessing of physical instruments.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.