Search Results

The HIPSTAR hip stem is a sterile, single-use device intended for total hip arthroplasty.
Indications:

• noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• rheumatoid arthritis (excepting the Osteolock™ HA Acetabular Cup and Peri-Apatite coated prostheses);
• correction of functional deformity;
• revision procedures where other treatments or devices have failed; and,
• treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  intended for cementless fixation.

The Hipstar Femoral Stem is a straight hip stem manufactured from titanium alloy, The Hipstar Temoral Stein is a Statight any varies a flare for rotational stability, with a TMZF - - The Fripstal Inp realersbility. The body of the stem, with the exception of the narrow unstal stem for implain cases arrit blasted for increased bone to implant interface. The subject hip stem has a 127° neck angle.

This submission (K063822) describes the HIPSTAR Femoral Stem, a total hip joint replacement prosthesis. The submission focuses on establishing substantial equivalence to a predicate device (K051223) rather than presenting a study with specific acceptance criteria and performance data for a new, innovative device that would typically involve such a study.

Therefore, the provided text does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, expert involvement, or statistical analyses that would typically be found in a performance study for a novel device or software.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and reported device performance:

• Missing. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain specific acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity) or reported device performance against such criteria. The "performance" assessment for this type of device typically involves demonstrating similar materials, design, and intended use as the predicate.

2. Sample size used for the test set and data provenance:

• Not applicable. This is a physical medical device (femoral stem). Performance is typically assessed through mechanical testing, biocompatibility, and clinical history of substantially equivalent devices, not through a "test set" of data in the way a diagnostic or AI device would be evaluated.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

• Not applicable. See point 2.

4. Adjudication method for the test set:

• Not applicable. See point 2.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size:

• No. This is not an MRMC study. This is a submission for a physical implantable device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

• Not applicable / Implicit. For a physical implant like this, "ground truth" would relate to its structural integrity, biocompatibility, and clinical history of similar devices. The 510(k) process relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective. The "proof" is largely based on engineering design, material specifications, and comparison to the predicate, rather than an independent "ground truth" established by experts on a test set.

8. The sample size for the training set:

• Not applicable. This isn't a machine learning model; thus, there is no "training set."

9. How the ground truth for the training set was established:

• Not applicable. See point 8.

Summary of what the document does provide:

• Device Name: HIPSTAR Femoral Stem
• Intended Use: Total hip arthroplasty.
• Indications: Noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, correction of functional deformity, revision procedures, treatment of nonunion/fractures of the proximal femur, intended for cementless fixation.
• Substantial Equivalence: The device is a modification of a previously cleared Hipstar stem (K051223). The substantial equivalence is based on similarities in intended use, design, and sterilization to the predicate device.
• Materials: Manufactured from titanium alloy.
• Design Features: Straight hip stem, varies in flare for rotational stability, TMZF material, narrow distal stem, grit blasted for increased bone-to-implant interface, 127° neck angle.

In conclusion, the K063822 submission for the HIPSTAR Femoral Stem is a 510(k) Premarket Notification seeking to demonstrate substantial equivalence to an existing predicate device. It is not a performance study in the sense implied by the questions, which are more relevant to the evaluation of diagnostic devices, AI/ML software, or novel therapeutic devices requiring extensive clinical trials or performance assessments against specific criteria.

Ask a specific question about this device