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This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• 1. Non-inflammatory degenerative joint disease such as osteoathritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• 2. Inflammatory degenerative joint disease such as rheumatoid arthritis;
• 3. Correction of function deformity;
• 4. Revision procedures where other treatments or devices have failed; and
• 5. Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
     This device is a single use implant and intended for cementless use only.

The U2 Hip Stem, Ti plasma spray is composed of a metallic femoral stem, which is designed to articulate with commercially available U1 and U2 acetabular components and They are manufactured from titanium alloy (ASTM F620). The stems femoral heads. are designed to provide secure fit and fixation in revision hip arthroplasty for anteroposterior bone loss, calcar area defects, metaphyseal bone loss situation. The U2 Hip Stem have a 130° neck angle and Morse taper to receive modular femoral heads. The U2 Hip Stem are available in with collar and collarless types. Each type is available in two lengths, 180mm and 230mm, and 7 diameters: 11mm, 12mm, 13mm, 14mm, 15mm, 16.5mm, 18mm. Distally, the stem is cylindrical with a polished bullet shape tip. The 180mm U2 Hip Stem is available as a straight stem, the 230mm femoral stem has an anterior bow for left and right specific applications. The U2 Hip Stem are fully coated with CP Ti (ASTM F1580). The coating is sprayed with CP Ti powder in thickness 500 um +/-100 um using 200~350 um powder to establish a rough surface for press-fit fixation. This device is a single use implant and intended for cementless use only.

This 510(k) summary (K062978) for the U2 Hip Stem, Ti Plasma Spray, does not contain specific acceptance criteria or details of a study proving the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity, as would be expected for an AI/ML powered device.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices based on materials, design, and indications for use. For medical implants like this hip stem, the "acceptance criteria" primarily relate to demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through characterization of its mechanical properties, biocompatibility, and manufacturing processes, rather than performance metrics measured against a ground truth.

Therefore, many of the requested categories related to AI/ML device studies (like sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of traditional medical device submission.

Here's a breakdown of the information that is available or implied in the provided text:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria (Implied for Substantial Equivalence): The primary "acceptance criteria" for a 510(k) submission for this type of device is demonstrating substantial equivalence to predicates. This means showing that the U2 Hip Stem is as safe and effective as the predicate devices, the Reach® Hip Stem, Ti plasma spray (K000760) and United U2 HA/Ti Plasma Spray (K003237). This is typically achieved by demonstrating comparable performance in areas like:

  • Material composition (ASTM F620 titanium alloy, CP Ti coating per ASTM F1580).
  • Design features (130° neck angle, Morse taper, cylindrical distal stem, collar/collarless options, lengths, diameters, anterior bow for 230mm stem).
  • Intended Use/Indications (same clinical conditions as predicates).
  • Mechanical properties, fatigue strength, and wear characteristics (though not detailed in this summary, these would be evaluated in the full submission).
  • Biocompatibility of materials.
  • Manufacturing processes (implicitly assessed for consistency and quality).

• Reported Device Performance: The summary states: "Features comparable to predicate devices, United U2 HA/Ti Plasma Spray (K003237), Reach® Hip Stem, Ti Plasma Spray (K000760), include same materials, design and indications." This is the core "performance" claim for substantial equivalence. No specific quantitative performance metrics (e.g., in vivo survival rates, specific biomechanical test results) are provided in this summary document beyond the physical characteristics.

Regarding items 2-7 (which are primarily relevant for AI/ML device studies):

These items are not applicable to this 510(k) submission for a mechanical implant. This document is a summary for a traditional medical device, not an AI/ML software device or diagnostic tool. Therefore, there's no discussion of test sets, training sets, ground truth derived from experts or pathology, or multi-reader studies.

However, to address them directly for completeness:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* N/A. This device is a mechanical implant, not an AI/ML diagnostic tool requiring a test set of data. Substantial equivalence is typically proven through bench testing, material characterization, and comparisons to predicate device designs and indications.

3. 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)
* N/A. No expert ground truth establishment for a diagnostic test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* N/A.

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
* N/A.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* N/A. The "ground truth" for this device type would be established standards for implant design, material science, and biocompatibility, as well as clinical experience with similar predicate devices.

8. The sample size for the training set
* N/A. This is not an AI/ML device.

9. How the ground truth for the training set was established
* N/A. This is not an AI/ML device.

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1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
5. Revision of previously failed total hip arthroplasty.

The Medallion Modular Hip System is a complete system of femoral stem implants. The implants have a proximal female dovetail groove attachment site that is utilized for attaching various modular trunnions. The modular trunnions have a distal male semi-dovetail projection that engages the female dovetail groove on one side in such a way that a keyway is defined between the two components. The implants also include a key that is to be wedged in the keyway to lock the three components together and prevent relative sliding.

The provided text is a 510(k) summary for the Medallion Modular Hip System. This document describes a medical device, and the information requested pertains to the acceptance criteria and detailed study information typically found for diagnostic devices or AI/ML-driven devices.

Based on the provided text, the Medallion Modular Hip System is an orthopedic implant (a total hip femoral component). For such devices, "acceptance criteria" usually refer to mechanical performance standards (e.g., strength, fatigue life, wear resistance) rather than diagnostic accuracy metrics.

Therefore, many of the requested categories are not applicable to this type of device and the information is not present in the provided 510(k) summary. I will answer what can be gleaned from the text.

Acceptance Criteria and Reported Device Performance

For an orthopedic implant like the Medallion Modular Hip System, acceptance criteria are typically related to mechanical strength and durability. The document states:

Study Details (Based on provided text)

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

   • Sample Size: Not specified for any specific test set.
   • Data Provenance: Not specified. It is implied that typical non-clinical bench testing was performed, likely in a laboratory setting.

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

   • Not applicable / Not specified. Ground truth in the context of diagnostic accuracy for expert consensus is not relevant for an orthopedic implant's mechanical testing.

3. Adjudication method for the test set:

   • Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used for reconciling expert opinions in diagnostic studies, which is not relevant here.

4. 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:

   • No. This is not an AI/ML-driven diagnostic device. No MRMC study was conducted.

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

   • No. This is not an algorithm-driven device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable. For mechanical testing, the "ground truth" would be the measured mechanical properties of the device components compared to engineering specifications and performance of predicate devices.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of AI/ML or diagnostic models.

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

   • Not applicable.

Summary of what the document explicitly states regarding studies:

• Non-Clinical Testing: "The information presented demonstrates that the Medallion Modular Hip System is substantially equivalent to currently marketed predicate devices. The differences between the Medallion Modular Hip System and the predicates are not significant and have shown not to present additional safety or efficacy issues." This implies mechanical bench testing was performed.
• Clinical Testing: "No clinical testing was conducted for this design." This is a key statement, indicating that the device's substantial equivalence was based solely on non-clinical data and comparison to predicate devices.

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Cemented and non-cemented total joint replacement in cases of:

1. Noninflamatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
5. Revision of previously failed total hip arthroplasty

Each stem consists of two separate parts, a proximal metaphyseal segment and a distal stem. A variety of stem lengths and proximal segment sizes allow the surgeon to "construct" the proper sized implant while in surgery. All pieces are interchangeable. The device utilizes a modular femoral head taper fit on to the stem at the time of surgery. The proximal segment is designed to replace the proximal portion of the femur in cases of severe bone loss. The device is porous coated. The proximal components are available in 5 resection levels and 7 widths. A hole through the proximal component gives the surgeon the option of using a trochanter plate and trochanter bolt or a trochanter claw. This assembly will allow the greater trochanter to be compressed against the prosthesis for enhanced fixation and proximal stability. Distal stems are available in six lengths, 165mm, 200mm, 240mm, 250mm and 300mm. Stems are available with 40%, 80% or 100% of the stem porous coated, as well as a non-coated, splined configuration. Since the stems are modular, left and right components are not necessary. The proximal and distal segments are joined by means of a Morse locking taper similar to that used to attach the modular head components to most hip stems. Additional fixation is achieved through a locking screw inserted through the driving platform on the metaphyseal component and engaging with the stem taper.

The provided document is a 510(k) premarket notification for a medical device (Mallory-Head® Modular Calcar Femoral Component). It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it explicitly states:

• Clinical Testing: None provided.

Therefore, there is no information in this document regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details. This type of submission relies on demonstrating substantial equivalence to predicates through non-clinical testing (engineering analysis, finite element analysis, and mechanical testing) rather than new clinical data.

In summary, as per the provided document:

There is no information available regarding:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for a test set or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or its effect size.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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