Search Results

The Inter-Op Metasul Acetabular System is intended for use in cases of total hip replacement for treatment of the following:

• Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., 1. osteoarthritis, post traumatic arthritis or avascular necrosis and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis.
• Those patients with failed previous surgery where pain, deformity or dysfunction persists. 2.
• Revision of previously failed hip arthroplasty. 3.

The Inter-On Acetabular System is comprised of two components: (1) a polyethylene acetabular insert with an integral Metal inlay (inner diameter), and (2) a Metasul femoral head.

Inter-Op Metasul Acetabular Insert: The Inter-On Metasul Acetabular Insert is a hemispherical polyethylene component manufactured from UHMWPE (ASTM F648). The outer diameter of the insert is machined with locking features that mate with one of the previously cleared Inter-Op metallic acetabular shells. The inner diameter which forms the bearing surface of the insert features a metallic Metasul inlay that is integrally locked to the polyethylene insert. The metal inlay is manufactured from Protasul -21WF, a wrought forged CoCrMo alloy (ISO 5832). This inlay is polished to a mirrorfinish and hot-pressed into the UHMWPE backing. Just prior to hot-pressing, two Protasul-10 (CoCr alloy, ASTM F562) pins are press fit into the design of the inlay to help provide added rotational stability. The Metasul inlay is designed for use only with the Metasul head component. The Inter-Op Metasul Acetabular Insert component is available with outside diameters of 49mm to 81mm (in 2mm increments) with an inner diameter of 28mm.

Metasul Femoral Head: The Metasul Femoral Heads are manufactured from the same Protasul-21WF (CoCr, ISO 5832) material as the metal inlay of the acetabular component. The design incorporates a 12/14 morse type female taper with beveled face for ease of reduction intraoperatively. The female taper matches the 12/14 male taper used on Sulzer Orthopedics femoral stems. The Metasul femoral heads are designed specifically to articulate with the Metasul inlay of the High precision manufacturing allows for optimal articulating surface acetabular component. geometry (e.g., clearance between the Metasul head and the Metasul inlay). These devices are manufactured within tight tolerances because the success of the system is dependent on optimal performance at this articulating interface. The Metasul heads are available in 28mm diameter with four neck lengths: short (-4mm), medium (neutral), long (+4mm) and extra long (+8mm).

The provided document is a 510(k) summary for a medical device (Inter-Op Metasul Acetabular System), which is a premarket notification to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission generally does not include studies on device performance against specific acceptance criteria in the way a clinical trial for a new drug or a novel AI diagnostic device would.

The substantial equivalence determination for this device is based on comparison to existing predicate devices (McKee-Farrar Total Hip, Ring Total Hip L, Sivash Total Hip), focusing on material, design, and intended use, rather than a prospective study with performance metrics against a defined ground truth.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and adjudication methods cannot be extracted from this document as it does not contain such information.

Specifically:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on demonstrating substantial equivalence to predicate devices, not on proving performance against a new set of acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not applicable. There is no test set or clinical study described in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication process is described.
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 device is a hip implant system, not an AI diagnostic tool, so MRMC studies involving human readers and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth for device performance is established in the context of this 510(k) submission.
8. The sample size for the training set: Not applicable. There is no training set for a machine learning model.
9. How the ground truth for the training set was established: Not applicable. There is no training set mentioned.

In summary, the provided 510(k) summary is for a physical medical device (hip implant) seeking substantial equivalence, not a diagnostic or AI-driven device requiring extensive performance testing against acceptance criteria using patient data, ground truth, or expert review.

Ask a specific question about this device