(25 days)
The subject hip stem is a single-use, sterile device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40™ femoral heads that can be mated with a TMZF® 5° 40' BG trunnion.
Indications:
- Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
- Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- Revision procedures where other treatments or devices have failed.
The Short Citation® hip is an anatomic stem with a 132° neck angle. The device is manufactured from TMZF® Titanium metal and features a circumferential coating of CP titanium plasma spray and hydroxyapatite coating on the proximal body. Both the neck and the proximal stem are anteverted for proximal fill. The Short Citation® hip is available in 10 sizes with right and left orientation.
The provided text is related to a 510(k) premarket notification for a medical device called the "Short Citation® Femoral Stem." This document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for certain medical devices.
This document describes a physical medical device (femoral stem for hip replacement), not an AI/Software as a Medical Device (SaMD). Therefore, the typical "acceptance criteria" and "studies" related to the performance metrics, ground truth, expert consensus, and reader studies for AI/SaMD are not applicable in this context.
The "study" in this document refers to the regulatory review process for substantial equivalence to a predicate device, which is based on similar intended use, design, and sterilization. It doesn't involve performance metrics like sensitivity, specificity, or AUC, nor does it detail a clinical trial or a performance study in the way one would for an AI/SaMD.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not present or relevant to this type of regulatory submission for a physical orthopedic implant.
Here's how I can address the prompts based on the provided text, while clarifying the differences:
1. A table of acceptance criteria and the reported device performance
For this type of physical orthopedic implant, "acceptance criteria" and "reported device performance" are primarily related to safety, design similarity to a predicate device, and successful manufacturing validation. The document does not specify quantitative performance metrics in the way an AI/SaMD would (e.g., sensitivity, specificity).
The implicit "acceptance criteria" for a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device.
| Criteria | Reported Device Performance (as per 510(k)) |
|---|---|
| Intended Use | "The subject hip stem is a single-use, sterile device intended for use in total hip replacement... intended for primary reconstruction of the proximal femur or revision total hip arthroplasty." - Similar to predicate. |
| Indications for Use | - Cementless primary hip surgery (osteoarthritis, avascular necrosis, rheumatoid arthritis, functional deformity correction). |
- Treatment of nonunion, femoral neck/trochanteric fractures.
- Revision procedures where other treatments failed. - Similar to predicate. |
| Design | "an anatomic stem with a 132° neck angle. The device is manufactured from TMZF® Titanium metal and features a circumferential coating of CP titanium plasma spray and hydroxyapatite coating on the proximal body. Both the neck and the proximal stem are anteverted for proximal fill." - Similar to predicate (Citation® TMZF® femoral stem K993768). |
| Sterilization | (Implicitly similar to predicate, as it's a sterile device). - Similar to predicate. |
| Biocompatibility (inferred) | (Materials like TMZF Titanium, CP titanium plasma spray, hydroxyapatite are standard in orthopedic implants, implying biocompatibility established for predicate). - Similar to predicate. |
| Mechanical Properties (inferred) | (Not explicitly detailed, but implied to be equivalent to predicate through design similarity and materials). - Similar to predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This is not a study with a "test set" in the context of AI/SaMD performance evaluation. The "test" here is a regulatory review for substantial equivalence based on descriptive and comparative information.
- Data Provenance: Not applicable. The submission refers to a comparison with a predicate device (Citation® TMZF® femoral stem K993768).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. "Ground truth" in the context of expert consensus for AI performance is not relevant for this physical device submission. The "truth" is established by the accepted design and performance characteristics of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no "test set" or adjudication method in this regulatory process.
5. 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
- Not applicable. This is a physical medical device, not an AI/SaMD. MRMC studies are not relevant for demonstrating substantial equivalence for an orthopedic implant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the AI/SaMD sense. The "ground truth" for substantial equivalence is the predicate device itself and its established safety and effectiveness.
8. The sample size for the training set
- Not applicable. There is no "training set" for a physical device in this context.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" for a physical device.
§ 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.