(47 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 or ceramic femoral heads and cemented cups, or with Co-Cr-Mo or ceramic femoral heads and Delta TT Acetabular System. When used in partial hip arthroplasty, the Master 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 CoCrMo alloy femoral heads (K112158) or Biolox Delta ceramic femoral heads and with either a Limacorporate Cemented Cups or Limacorporate Delta TT Acetabular System cup. When used in partial hip arthroplasty. the Master" femoral stem is used with a Limacorporate CoCrMo alloy femoral heads coupled with a Lock Bipolar Head (Limacorporate K112158).
The Master® femoral stem is made of Ti6Al4V conforming to ASTM F1472 – ISO 5832-3. The proximal 1/2 of the stem has 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 CoCrMo allov or Biolox Delta ceramic 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 Masters stem is available 13 sizes in both standard and lateralized versions with different CCD angles.
The Biolox Delta ceramic head is a femoral ceramic head with a female 12/14 taper for coupling to the male 12/14 taper of the femoral stem. The Biolox Delta ceramic heads are available in diameters of 28, 32, and 36 mm in three (3) neck lengths (S, M, L); the 36 mm diameter head is also available with a XL neck length.
This document describes a 510(k) premarket notification for a medical device called the Master® Femoral Stem. It is not a study report that details acceptance criteria and device performance. The information provided is primarily for regulatory clearance based on substantial equivalence to predicate devices, rather than a detailed performance study with acceptance criteria.
Therefore, most of the requested information cannot be extracted directly from this document. However, I can still provide the limited information that is present and indicate where the document does not contain the requested details.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or provide a table of reported device performance values. It focuses on demonstrating substantial equivalence to predicate devices through material and design similarities, and non-clinical testing already performed on those predicate devices.
2. Sample size used for the test set and the data provenance
The document explicitly states: "Non-Clinical Testing: ...the tests provided in K140975 and K141327 are therefore applicable...". It does not report new non-clinical test data or sample sizes for a "test set" in the context of a new performance study for the Master® Femoral Stem. The tests referenced are from previous 510(k) clearances (K140975 for the Master Femoral Stems and K141327 for the Minima S Hip Stem and Biolox Delta Heads). No information on data provenance (country of origin, retrospective/prospective) is provided for these referenced tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as there is no mention of a "test set" or ground truth established by experts in this regulatory submission.
4. Adjudication method for the test set
This information is not applicable as there is no mention of a "test set" or adjudication in this regulatory submission.
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
This is not applicable. The device is a physical orthopedic implant (femoral stem) and not an AI-powered diagnostic or decision support system. Therefore, no MRMC study or AI-related effectiveness analysis would be conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical orthopedic implant and does not involve any algorithm or AI components.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This is not applicable. The document refers to non-clinical testing (material properties, design specifications, etc.) rather than a study requiring ground truth established by medical experts or pathology for diagnostic accuracy.
8. The sample size for the training set
This is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This is not applicable. There is no mention of a "training set".
Summary of available information related to performance/testing:
The document primarily relies on the concept of substantial equivalence for regulatory clearance. This means that the device is considered safe and effective because it is very similar to legally marketed predicate devices, and the differences do not raise new questions of safety or effectiveness.
Key points:
- Non-Clinical Testing: The submission states that non-clinical testing was deemed sufficient and refers to tests provided in previous 510(k) clearances (K140975 and K141327) for predicate devices. It emphasizes that since the materials, design, femoral head sizes, and acetabular components are the same as described in these predicate clearances, "no new issues of safety and effectiveness are introduced."
- Clinical Testing: The document explicitly states: "Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence."
Therefore, this document does not present a standalone study with specific acceptance criteria and reported device performance for the Master® Femoral Stem itself. Instead, it leverages the existing regulatory clearances and associated testing of its predicate devices to demonstrate equivalence.
§ 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.