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The Novae® Dual Mobility and Hype® Hip Systems are indicated for total hip replacement, which includes:

• · Osteoarthritis,
• · Femoral neck fracture,
• · Dislocation risk,
• · Osteonecrosis of the femoral head,
• · Revision procedures where other treatments or devices have failed and if bone reconstruction so permits.

Sunfit TH, Novae® E TH, and Coptos TH acetabular cups are intended for press-fit use and Novae® Stick acetabular cup is indicated for cemented use.

Hype® SCS, SCC, SCV, SCC mini, and SCLA mini hip stems are intended for press-fit use.

The Novae® Dual Mobility System consists of cemented acetabular shells and a polyethylene liner. Novae® XPEO-E liners are made from highly crosslinked vitamin E stabilized polyethylene and are spherical in geometry for dual mobility articulation. The inner articular surface mates and retains a Biolox® delta ceramic or CoCrMo metal femoral head. The outer articular surface articulates within the highly polished inner diameter of Novae® cementless or cemented cups. Novae® cups are manufactured from stainless steel, with pressfit options coated with titanium and hydroxyapatite (HA). Pegs and cortical bone screws for optional ancillary fixation are made from stainless steel.

Hype® press-fit hip stems are compatible with the Novae® Dual Mobility System and Serf CoCrMo and Biolox® delta femoral heads. Hype® press-fit hip stems are made from titanium alloy coated with titanium and HA.

The primary purpose of this 510(k) notification is a line extensions to the 510(k) cleared Novae® acetabular cups (K111572) that are compatible with: (1) liner option made from highly crosslinked and vitamin E stabilized polyethylene (XPEO-E), (2) femoral heads made from CoCrMo alloy and Biolox® delta ceramic, and (3) Hype® press-fit hip stems.

The Novae® Dual Mobility System and Hype® Hip System did not conduct a clinical study to prove the device meets acceptance criteria. Instead, the device's substantial equivalence was established through laboratory testing and engineering analyses, comparing its performance to predicate devices. Therefore, several of the requested information points (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not applicable in this context.

Here's the available information:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The study involved laboratory bench testing and engineering analyses, not a clinical test set with patient data.

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)

Not applicable. Ground truth was established through adherence to industry standards and objective measurements in laboratory settings, not by expert consensus on clinical data.

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

Not applicable. There was no clinical test set requiring adjudication.

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 mechanical implant, not an AI-assisted diagnostic or treatment system.

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

Not applicable. This device is a mechanical implant.

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

The ground truth for the performance testing was established by internationally recognized and industry-accepted standards (e.g., ISO, ASTM) and engineering principles for mechanical and material properties, wear, and biocompatibility of orthopedic implants.

8. The sample size for the training set

Not applicable. This device is a mechanical implant; there was no training set in the context of machine learning. The "training" in this context refers to standard design, manufacturing, and quality control processes to meet the specified performance criteria.

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

Not applicable. Refer to point 8.

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BI-MENTUM™ Dual Mobility System is indicated for total hip replacement, which includes:

• Osteoarthritis
• Femoral neck fracture
• Dislocation risk
• Osteonecrosis of the femoral head
• Revision procedures where other treatments or devices have failed and if bone reconstruction so permits
  BI-MENTUM™ PressFit Cup, BI-MENTUM™ Plus Cup and BI-MENTUM™ Revision Cup are intended for press-fit use and BI-MENTUMTM Cemented Cup is indicated for cemented use.

The BI-MENTUM™ dual mobility system is composed of a metallic shell fixed in the acetabulum and a polyethylene liner.
Cemented metallic shell: BI-MENTUM™ Cemented Cup: the cemented metallic shell is made of stainless steel according to ISO 5832- 1. The outer surface is sandblasted and presents macro-volumes to augment contact between the implant and the cement. The inner surface is highly polished.
Cementless metallic shell: The cementless metallic shell is made of stainless steel according to ISO 5832-1 and is coated with a CP titanium and hydroxyapatite plasma spray (double layer coating) on the outer surface and is highly polished on the inner surface.
Three cementless metal-backs are available:

• BI-MENTUM™ PressFit Cup: this version is available without the pegs and screw, and is a press fit only.
• BI-MENTUM™ Plus Cup: it has 3 fixation points (2 divergent pegs towards the pubis and ischium and 1 cortical screw through a flange towards the ilium).
• BI-MENTUM™ Revision Cup: it has 5 fixation points (2 divergent pegs towards the pubis and ischium, cortical screws through 2 flanges towards the ilium and 1 foramen hook).
  Liner: The liner is made of Ultra-High-Molecular-Weight Polyethylene according to ISO 5834-2. The liner is mobile (free) in the metallic shell and retained on the prosthetic femoral head. Liners can be used with Ø22,2 or 28 mm prosthetic femoral heads.
  Pegs and cortical screws: When applicable, primary fixation can be reinforced by impacted pegs and self-tapping cortical screws made of stainless steel according to ISO 5832-1.

The provided text details the 510(k) summary for the BI-MENTUM™ dual mobility system, claiming substantial equivalence to a previously cleared device, the NOVAE® Dual Mobility Acetabular Cup (K111572). The document outlines non-clinical testing performed to support this claim.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical or qualitative acceptance criteria for these tests are not provided in the submitted text. The document only states that the acceptance criteria were met.

2. Sample Size Used for the Test Set and Data Provenance

The provided text only mentions "new cup/head + stem assembly were validated" and lists non-clinical tests. It does not specify sample sizes for these tests, nor does it provide information on data provenance (e.g., country of origin, retrospective or prospective) as these were non-clinical, in-vitro tests, not studies involving patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The tests performed were non-clinical mechanical and wear studies, not studies requiring expert interpretation of medical images or patient data for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable, as no expert-based ground truth establishment or adjudication was involved in these non-clinical tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC comparative effectiveness study was conducted. The evaluation was based on non-clinical testing and substantial equivalence to a predicate device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No. This device is a physical medical implant (hip prosthesis components), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" would be the established engineering and biomechanical standards and specifications for hip prostheses. This would involve:

• Physical measurements and material properties: Conforming to ISO standards like ISO 5832-1 (stainless steel), ISO 5834-2 (UHMWPE).
• Biomechanical performance metrics: Such as those for head insertion/pull-out force, range of motion, and wear, as defined by relevant ISO standards or industry best practices for similar devices.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical implant device.

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Cl../..X liner for NOVAE® Dual mobility Acetabular Cup is indicated for total hip replacement, which includes:

• . Osteoarthritis
• . Femoral neck fracture
• Dislocation risk ●
• Osteonecrosis of the femoral head
• . Revision procedures where other treatments or devices have failed and if bone reconstruction so permits

SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use

The Cl../..X liner for NOVAE® Dual Mobility Acetabular Cup is made of cross-linked Ultra-High-Molecular-Weight Polyethylene which meet the strength requirements of the ASTM F648 and the testing listed in the ASTM F2565. The liner is mobile (free) in the NOVAE® metallic shell (clearance K111572) and retained on the prosthetic femoral head. Liners can be used with Ø22.2 or 28 mm prosthetic femoral heads.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them.

The document is a 510(k) premarket notification letter from the FDA regarding a medical device called "CI../..X liner for NOVAE® Dual Mobility Acetabular Cup." While it mentions that "Acceptance criteria were met for each test," it does not explicitly state what those acceptance criteria are nor does it provide a detailed description of the study that proves the device meets those criteria.

Specifically, the following information you requested is missing from the provided text:

• A table of acceptance criteria and the reported device performance: The text only generally states that "Acceptance criteria were met."
• Sample size used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth and their qualifications: Not applicable for this type of mechanical testing.
• Adjudication method: Not applicable for this type of mechanical testing.
• Multi reader multi case (MRMC) comparative effectiveness study: The document explicitly states "No clinical studies were performed."
• Standalone (algorithm only without human-in-the-loop performance) study: Not applicable as this is a physical medical device, not an AI algorithm.
• Type of ground truth used: For mechanical tests, the ground truth would be the physical measurements themselves against established standards, but details are not provided.
• Sample size for the training set: Not applicable as this is a physical medical device, not an AI algorithm.
• How the ground truth for the training set was established: Not applicable.

The document only lists the types of non-clinical tests performed:

• Dimensional analysis
• Head insertion force
• Head lever out force
• Wear analysis

And states that these tests were conducted to demonstrate substantial equivalence to predicate devices, focusing on design, materials, and mechanical performance according to ASTM standards. It concludes that the device is substantially equivalent based on these non-clinical tests.

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NOVAE® Dual mobility Acetabular Cup is indicated for total hip replacement, which includes:

• . Osteoarthritis
• . Femoral neck fracture
• . Dislocation risk
• . Osteonecrosis of the femoral head
• Revision procedures where other treatments or devices have failed and if bone . reconstruction so permits
  SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use.

The NOVAE® Dual Mobility Acetabular Cup is composed of a metallic shell fixed in the acetabulum and a polyethylene liner.
Cemented metallic shell:

• NOVAE STICK: the cemented metallic shell is made of stainless steel according to ISO 5832-1:2007. The outer surface is sandblasted and presents macro-volumes to augment contact between the implant and the cement. The inner surface is highly polished.
  Cementless metallic shell:
  The cementless metallic shell is made of stainless steel according to ISO 5832-1:2007 and is coated with a CP titanium and hydroxyapatite plasma spray (double layer coating) on the outer surface and is highly polished on the inner surface.
  Three cementless metal-backs are available:
• SUNFIT TH: the SUNFIT TH version is available without the pegs and screw, and is a press fit onlv.
• NOVAE E TH: the NOVAE E TH has 3 fixation points (2 divergent pegs towards the pubis and ischium and 1 cortical screw through a flange towards the ilium).
• COPTOS TH: the COPTOS TH has 5 fixation points (2 divergent pegs towards the pubis and ischium, cortical screws through 2 flanges towards the ilium and 1 foramen hook).
  Liner:
  The liner is made of Ultra-High-Molecular-Weight Polyethylene according to ISO 5834-2:2006. The liner is mobile (free) in the metallic shell and retained on the prosthetic femoral head. Liners can be used with Ø22,2 or 28 mm prosthetic femoral heads.
  Pegs and cortical screws:
  When applicable, primary fixation can be reinforced by impacted pegs and self tapping cortical screws made of stainless steel according to ISO 5832-1:2007.

This summary describes the validation of the NOVAE® Dual Mobility Acetabular Cup.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each non-clinical test. The tests were non-clinical, meaning they were likely conducted in a laboratory setting. Therefore, there is no data provenance in terms of country of origin or retrospective/prospective data for human subjects.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable. The tests are non-clinical (mechanical and material characterization), and ground truth is established by engineering specifications and standards, not expert clinical interpretation.

4. Adjudication Method for the Test Set

Not applicable. As the tests are non-clinical, there is no human interpretation or adjudication required in the same way as, for example, a clinical image review. The results are a direct measurement against predefined engineering criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical implant (an acetabular cup for total hip replacement), not an algorithm or AI system. Therefore, the concept of standalone algorithmic performance is not relevant. The "performance" being evaluated is the mechanical and material integrity of the device itself.

7. Type of Ground Truth Used

The ground truth used for these non-clinical tests is based on engineering specifications, material standards (e.g., ISO 5832-1:2007, ISO 5834-2:2006), and predefined acceptance thresholds for mechanical and material properties.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical implant, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical medical device.

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