(78 days)
The S-ROM Zirconia Ceramic Femoral Head is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped femoral epiphysis, and disability due to previous fusion.
The S-ROM Zirconia Ceramic hip head is manufactured of Yttrium Stabilized Zirconium Oxide (Zirconia), also known as PROZYR®. The S-ROM ceramic hip heads are designed to be used with the S-ROM Total Hip System femoral stems.
Here's an analysis of the provided text regarding the S-ROM Zirconia Ceramic Femoral Head:
This document is a 510(k) premarket notification for a medical device and therefore, is a request for substantial equivalence. It does not typically contain detailed acceptance criteria and study data in the way a clinical trial report or a PMA (Premarket Approval) submission would for a novel device. The primary goal of a 510(k) is to demonstrate that the new device is as safe and effective as a legally marketed predicate device.
Given this, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. These elements are not typically part of a 510(k) summary for a device seeking substantial equivalence based on material and design similarity to already cleared devices.
However, I can extract the information that is present in the document.
Acceptance Criteria and Study Information for the S-ROM Zirconia Ceramic Femoral Head
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable for a 510(k) substantial equivalence submission. This type of regulatory filing demonstrates equivalence to a predicate device rather than presenting novel performance criteria against specific benchmarks.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The submission focuses on equivalence to predicate devices, not on a new clinical study with a test set. The data provenance would be from the predicate device's existing clearance.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
Not applicable. Ground truth establishment with experts is typical for diagnostic algorithms, not for orthopedic implants in a 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable. No new test set for performance on diagnostic tasks is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
Not applicable. MRMC studies are used for diagnostic imaging devices to assess human reader performance with and without AI assistance. This document is for a hip prosthesis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical hip implant, not an algorithm.
7. The Type of Ground Truth Used
Not applicable in the context of diagnostic performance evaluation. The "ground truth" for this device's safety and effectiveness is established by its substantial equivalence in material properties, design, and intended use to previously cleared devices.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is a physical product, not an AI algorithm.
Summary of Device Equivalence (from the provided text, as this is the "study" context for a 510(k)):
The "study" presented here is a demonstration of substantial equivalence to predicate devices already on the market.
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Predicate Devices:
- P.F.C. Zirconia Ceramic Hip Head (K# 962248, K# 933275)
- S-ROM Zirconia Ceramic Hip Head (K# 921111)
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Basis for Equivalence:
- Material: Identical in material (PROZYR® Yttrium Stabilized Zirconium Oxide) to the P.F.C. Zirconia Ceramic Hip Head.
- Function/Indicated Use: Identical to the P.F.C. Zirconia Ceramic Hip Head and the S-ROM Zirconia Ceramic Hip Head (K# 921111).
- Design: Identical in design (drawing specifications) to the S-ROM Zirconia Ceramic Hip Head (K# 921111).
- Packaging and Sterilization: Same as the predicate device.
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Limitation Noted by FDA: The S-ROM Zirconia Ceramic Femoral Hip Heads are to be used only with titanium alloy (Ti6Al4V) hip stems with the 11/13 Morse taper trunnions.
In essence, the "study" for this 510(k) is a comparison of the new device's specifications against those of previously cleared devices, asserting that because they are sufficiently similar, the new device is also safe and effective.
§ 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.