(55 days)
The Master stems are indicated for use in partial or total hip arthroplasty and are intended for press-fit (uncemented) use. When used in total hip arthroplasty, the Master Stems are intended for use with Co-Cr-Mo femoral heads and cemented cups or with Co-Cr-Mo femoral heads and Delta TT Acetabular System. When used in partial hip arthroplasty, the MasterSL stems are intended for use with Lock Bipolar Heads.
Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- · non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
- · rheumatoid arthritis;
- · treatment of femoral head and neck fractures;
- · revisions in cases of good remaining femoral bone stock.
The Master femoral stem is a monolithic, collarless, tapered wedge shaped stem intended for press-fit uncemented partial or total hip arthroplasty. When used in total hip arthroplasty the stem is coupled to a Limacorporate Femoral Heads (K112158) and used with either a Limacorporate Cemented Cups (K112158) or Limacorporate Delta TT Acetabular System cup (K112898). When used in partial hip arthroplasty the Master" femoral stem is coupled to a Limacorporate Femoral Heads (K112158) and used with a Lock Bipolar Head (Limacorporate K112158).
The Master" femoral stem is made of Ti6A14V alloy conforming to ASTM F1472 - ISO 5832-3; the proximnal 1/2 of the stem a plasma sprayed coating of titanium alloy (ASTM F1472 - ISO 5832-3). The stem has a tapered rectangular section and the distal anterior and posterior surfaces have a vertical groove for rotational stability. The stem provides a neck with a 12/14 conical taper to couple to Limacorporate Femoral Heads and the necks are mirror-polished and lowered to reduce accidental abrasion and contact between the stem neck and the acetabular cup. The Master stems is available 13 sizes in both standard and lateralized versions with different CCD angles.
Here's an analysis of the provided text regarding the MasterSL Femoral Stem, focusing on acceptance criteria and the supporting study:
Acceptance Criteria and Device Performance for MasterSL Femoral Stem
Disclaimer: The provided document is a 510(k) summary for a medical device (femoral stem). This type of submission primarily focuses on demonstrating "substantial equivalence" to a predicate device through non-clinical testing and comparison of design, materials, and intended use, rather than setting and meeting quantitative performance acceptance criteria through clinical studies typical for AI/software devices. Therefore, the tables below will reflect the nature of this submission.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a prosthetic implant, the "acceptance criteria" are related to compliance with recognized standards and similarity to predicate devices, rather than specific performance metrics (e.g., sensitivity, specificity) common in software or diagnostic device submissions.
| Acceptance Criteria Category | Specific Acceptance Criteria (Method/Standard) | Reported Device Performance and Compliance |
|---|---|---|
| Material Composition | Ti6A14V alloy conforming to ASTM F1472 - ISO 5832-3. | The MasterSL femoral stem is made of Ti6A14V alloy conforming to ASTM F1472 - ISO 5832-3. Proximnal 1/2 has a plasma sprayed coating of titanium alloy (ASTM F1472 - ISO 5832-3). |
| Fatigue Resistance | According to ISO 7206-4 and ISO 7206-6. | The MasterSL stems were tested in worst-case configurations for fatigue resistance according to ISO 7206-4 and ISO 7206-6. (Implied |
| Pass/Compliance to standard, as no failure is reported and substantial equivalence was granted.) | ||
| Range of Motion (ROM) | Analysis using the worst-case construct. | The ROM of the MasterSL hip stem was analyzed using the worst-case construct. (Implied adequate ROM, as no issues reported and substantial equivalence was granted.) |
| Coating Characterization | Conformity to FDA guideline and referenced standards. (Specific standards not listed in the provided text). | The Titanium Plasma Spray coating was characterized to verify conformity to FDA guideline and referenced standards. (Implied Pass/Compliance.) |
| Substantial Equivalence (Overall) | Comparable to predicate devices in intended use, indications for use, design, and materials. | "The Master stems are substantially equivalent to the predicate devices in terms of intended use, indications for use, design and materials." Details on similarity to specific predicates provided in text. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission relies on non-clinical (bench) testing and comparison to predicate devices, not human or animal clinical trials. The "test set" in this context refers to the physical devices subjected to fatigue and ROM testing. The number of physical units tested is not specified in this summary.
- Data Provenance: Not applicable for a traditional "test set" as understood in a clinical study. The non-clinical tests were performed by the manufacturer, Limacorporate S.p.A. The origin is therefore the manufacturer's testing facilities in Italy.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For non-clinical, bench testing of a medical implant, "ground truth" is established by adherence to recognized international standards (e.g., ISO, ASTM) and engineering principles, rather than expert consensus on a test set. The results of the physical tests themselves serve as the outcome.
- Qualifications of Experts: Not applicable in the context of human expert review for "ground truth." The expertise involved would be in biomedical engineering, materials science, and quality assurance to conduct and interpret the non-clinical tests.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Since there's no clinical "test set" requiring expert review or labeling, there's no adjudication method in the sense of resolving discrepancies among human reviewers. Test results are typically evaluated against pre-defined criteria from the relevant standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. An MRMC study is relevant for evaluating the impact of a diagnostic or AI-assisted device on human interpretation (e.g., radiologists reading images). This submission is for a prosthetic hip stem and does not involve human readers interpreting data.
- Effect Size of Human Readers' Improvement with AI vs. Without AI: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study Done: Not applicable. This device is a physical implant, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant. The "performance" is inherent in the physical properties of the implant itself.
7. Type of Ground Truth Used
- Type of Ground Truth: For the non-clinical testing, the "ground truth" is defined by international engineering standards (e.g., ISO 7206-4, ISO 7206-6 for fatigue) and material specifications (e.g., ASTM F1472, ISO 5832-3 for Ti6A14V alloy). The tests simulate physiological conditions and material requirements. For the overall submission, the ground truth for substantial equivalence is the performance and characteristics of the legally marketed predicate devices.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set. The design of the MasterSL Femoral Stem is based on established engineering principles, clinical experience with similar implants, and perhaps internal design iterations, rather than machine learning from data.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of 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.