(70 days)
The MS-30 Lateral Femoral Stem is intended for cemented use in treatment of the following:
- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
- Revision of previously failed hip arthroplasty.
The MS-30 Lateral Femoral Stem intended for cemented use, is a highly polished, collarless femoral component manufactured from forged stainless steel (Protasul S-30, ISO 5832-9). The lateral version offers the surgeon 12% more offset than with the standard version. The stem features a three dimensional conical wedge shape with rounded edges to aid in rotational stability, self-centering in the femoral canal and creation of a favorable cement mantle. The proximal portion of the stem has a male 12/14 taper for attachment of a Sulzer Orthopedics metallic or ceramic femoral head with a neck that accepts an optional Proximal Positioner, The distal portion is designed to accept the optional existing and new Distal Centralizer. It is available in six sizes.
The optional new distal centralizer manufactured from Sulene -PMMA (poly-methyl-methacrylate/poly-styrene, ISO 5833-1), is intended for use with the MS-30 Standard and Lateral Femoral Stems. The centralizer is conically shaped and designed with four wings for better centering of the stem within the diaphysis of the femur providing a favorable cement mantle. One of the wings is longer than the others indicating its position on the lateral side of the stem. It is offered in two sizes for each of the six stem sizes.
The MS-30 also features an optional proximal positioner which is manufactured from Sulene -PMMA. The proximal positioner, intended for cemented use, centers the femoral stem in the anterior/posterior plane. It inserts into the extraction hole and snaps onto the neck of the stem. Once the bone cement has polymerized, the upper portion of the positioner is removed leaving the cemented U-shaped portion creating a favorable cement mantle.
This submission describes a medical device, the Sulzer Orthopedics MS-30 Lateral Femoral Stem, which is a hip joint prosthesis. The document is a 510(k) summary for premarket notification to the FDA, indicating that the device demonstrates substantial equivalence to previously marketed devices. Therefore, this document does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria.
The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its performance against specific quantitative acceptance criteria through a clinical study with detailed statistical analysis and ground truth establishment.
However, based on the provided text, I can infer some aspects relevant to the concepts requested, even if direct answers are not present:
Key Takeaways from the Provided Document:
- Device Type: This is a cemented femoral stem component for hip replacement surgery.
- Approval Type: 510(k) premarket notification. This pathway relies on demonstrating substantial equivalence to a predicate device, rather than proving efficacy and safety through de novo clinical trials with rigorous performance metrics.
- No Performance Acceptance Criteria or Study: The document explicitly states "Analysis indicated that the device would survive physiologic loading." This is the closest mention to any 'performance' assessment, but it's not presented as a formal study with acceptance criteria and results in the format requested.
- Focus on Substantial Equivalence: The primary aim of this submission is to show that the MS-30 Lateral Femoral Stem is similar in intended use, materials, and general design to existing, legally marketed devices.
Given this context, I cannot populate the requested table or answer most of your detailed questions about acceptance criteria and study design because the provided text does not describe such a study or criteria for this specific device.
Here's a breakdown of why each numbered point cannot be fully addressed by the provided text:
- A table of acceptance criteria and the reported device performance: Not provided. The document confirms the device "would survive physiologic loading," which is a general statement about its mechanical integrity, not a specific performance metric against a defined acceptance criterion.
- Sample sized used for the test set and the data provenance: Not applicable. No test set or clinical study is described. The "analysis" of physiologic loading likely refers to bench testing or simulation, not human data.
- 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. No test set or ground truth establishment is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication process is described.
- 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 device is a mechanical implant, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth is established for device performance in the context of a clinical study.
- The sample size for the training set: Not applicable. No training set is implied for this type of device submission.
- How the ground truth for the training set was established: Not applicable.
Conclusion:
The provided document is a 510(k) summary for a medical device (femoral stem). It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with defined acceptance criteria and associated results. Therefore, the specific information requested about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not present in the given text.
The "analysis" that indicated the device would "survive physiologic loading" is the extent of performance information provided, and it lacks the detailed structure of a study report with acceptance criteria.
§ 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.