Search Results

EXPRT™ Revision Hip System is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.

The EXPRT™ Revision Hip System includes non-porous distal femoral stem implants and nonporous proximal body implants, with bolt, all made from titanium alloy (Ti6Al4V) per ASTM F1472. System specific instrumentation allows the surgeon to prepare the bone to accept the EXPRT™ Revision Hip System implants.

The provided document is a 510(k) premarket notification for a medical device called the EXPRT™ Revision Hip System. This type of notification is submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, and it typically does not include extensive clinical study data with acceptance criteria for device performance as would be found in a PMA (Premarket Approval) application or a more comprehensive clinical trial report for AI/software devices.

Instead, the document focuses on demonstrating substantial equivalence based on indications for use, material, design features, dimensions, surgical implantation technique, intended use, packaging, sterilization, and non-clinical testing.

Therefore, many of the requested items regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment are not applicable or not provided in this specific FDA 510(k) document.

However, I can extract the information that is present:

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

The document does not provide a table with specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics often associated with AI/diagnostic devices. Instead, the "performance" here refers to the device's ability to meet non-clinical testing standards and be substantially equivalent to predicates.

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

This information is not provided as a formal clinical test set with specific sample sizes. The "testing" mentioned refers to non-clinical fatigue and endotoxin testing, not a clinical study on human subjects with a test set.

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)

This information is not applicable as there was no clinical study or test set requiring expert-established ground truth for performance evaluation of a diagnostic or AI algorithm.

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

This information is not applicable as there was no clinical study or 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

An MRMC study is not applicable as this is a physical medical device (hip replacement system), not an AI or diagnostic software.

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

This is not applicable as this is a physical medical device.

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

This is not applicable for the purpose of this 510(k). The "ground truth" for the device's safety and effectiveness is largely based on its similarity to legally marketed predicate devices and its ability to pass non-clinical engineering and material tests.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI/machine learning algorithm that requires a training set.

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

This is not applicable as this is a physical medical device.

Ask a specific question about this device

Exprt™ Revision Hip System is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.

The EXPRT™ Revision Hip System includes non-porous distal femoral stem implants and nonporous proximal body implants, with bolt, all made from titanium alloy (Ti6Al4V) per ASTM F1472. System specific instrumentation allows the surgeon to prepare the bone to accept the EXPRT™ Revision Hip System implants.

This document is a 510(k) summary for the EXPRT™ Revision Hip System, a medical device. It does not describe an AI/ML medical device, and therefore the requested information regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of AI/ML performance metrics, is not present.

The document is a regulatory submission for a traditional medical device (a hip replacement system). The "acceptance criteria" and "study" mentioned here refer to the non-clinical and pre-clinical testing required for substantial equivalence, not performance metrics for an AI algorithm.

Here's a breakdown of why the requested information cannot be extracted from this document:

• No AI/ML Component: The device is a physical hip implant (EXPRT™ Revision Hip System). There is no mention of any AI or machine learning component.
• "Acceptance Criteria" Context: For a physical device like a hip implant, "acceptance criteria" typically relate to mechanical strength, biocompatibility, material properties, and manufacturing quality, not diagnostic performance or AI model accuracy.
• "Study" Context: The document mentions "Non-Clinical Testing: ROM testing and distal fatigue testing," and "Endotoxin Assessment," which are standard tests for orthopedic implants to determine their mechanical integrity and safety. It explicitly states, "Clinical Testing: Clinical testing was not required." This indicates that the substantial equivalence was based on non-clinical data comparing it to existing predicate devices.

Therefore, it is impossible to provide the requested information in the format specified because it pertains to an AI/ML context that is not applicable to this document.

Ask a specific question about this device

The DePuy RECLAIM Revision Hip System is indicated for cementless use in the treatment of failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.

The ReClaim Revision Hip System is a modular tapered hip stem system that is intended for use in revision hip arthroplasty.

Here's an analysis of the provided text regarding the acceptance criteria and study for the DePuy RECLAIM Revision Hip System:

The provided document describes a 510(k) submission for a medical device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device meets specific clinical acceptance criteria through clinical trials. Therefore, much of the requested information regarding clinical study design, ground truth, expert consensus, and human reader performance is not applicable to this type of submission.

The "acceptance criteria" discussed here are primarily technical and performance-based to show the new device is as safe and effective as existing legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

This is not applicable as there was no clinical test set in the traditional sense. The "test set" was generated through non-clinical mechanical testing (fatigue tests).

• Sample Size: Not explicitly stated for the mechanical tests, but implied multiple units would be tested to demonstrate conformance to ISO standards and for comparison against predicate devices.
• Data Provenance: Laboratory testing data, likely conducted by the manufacturer or a contracted lab. No country of origin for clinical data as none was used. The focus is on the device's physical properties.
• Retrospective/Prospective: Not applicable to mechanical testing.

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

This is not applicable. For mechanical testing, the "ground truth" is defined by the established ISO standards and the physical properties of the materials and design, measured by engineering specialists. No human experts were used to establish a "ground truth" for diagnostic or clinical outcomes from a patient dataset.

4. Adjudication Method for the Test Set

This is not applicable. Mechanical test results are objective measurements against established engineering standards, not subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical testing was required to demonstrate substantial equivalence." Therefore, no effect size of human readers improving with AI vs. without AI assistance can be reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable. The device is a physical hip implant, not an AI algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was based on:

• International Standards: Adherence to ISO-7206-6:1992 for neck fatigue and ISO 7206-4:1989 for distal fatigue.
• Comparative Performance: The mechanical performance (e.g., maximum loads prior to failure) was compared directly to legally marketed predicate devices (DePuy Spectrum Modular System, K033893, and DePuy Solution Hip System, K060581).

8. The Sample Size for the Training Set

This is not applicable. There was no "training set" as this device is a physical implant, not an AI/ML algorithm that requires training data.

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

This is not applicable, as there was no training set.

Ask a specific question about this device

Total hip components are indicated for uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitits with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew MDF Revision Hip System components are intended for single use only and are to be implanted without bone cement.

The Smith & Nephew MDF Revision Hip System is comprised of a stem, modular neck, and modular sleeve component. The components of the revision hip system modularly connect together to form the complete MDF Revision Hip System construct. The MDF hip stem is a straight, tapered, distally fixed, modular stem designed to match the geometry of the femur. The stems are proportionally sized and shaped in sizes 11 through 25 and have modular neck and sleeve options to address patient anatomy. The stems and sleeves are manufactured from titanium alloy (Ti-6Al-AV) and the necks are manufactured from cobalt chrome. Each modular sleeve is coated with Smith & Nephew's Stiktite porous coating. A hydroxylapatite (HA) coating will be applied to the porous coated areas of the MDF modular sleeve by a plasma spray technique.

This is a 510(k) premarket notification for a medical device (MDF Revision Hip System). The provided documents are an FDA clearance letter and the manufacturer's summary of safety and effectiveness, which primarily focuses on establishing substantial equivalence to existing predicate devices.

Consequently, the documents do not contain information related to acceptance criteria, specific device performance studies with sample sizes, expert involvement, ground truth establishment, or comparative effectiveness studies (MRMC or standalone) as typically found in clinical trial reports or performance validation studies for AI/software devices.

The 510(k) process for this type of device relies on demonstrating that the new device is as safe and effective as a legally marketed device (predicate device) and does not generally require new clinical studies to prove performance against pre-defined acceptance criteria in the same way an AI/software device would. Instead, it relies on design, material, and functional equivalence to a known safe and effective predicate.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and performance studies because the provided text does not contain this information. The document focuses on regulatory clearance through substantial equivalence.

Ask a specific question about this device

The general indications associated with the use of the Precedent Revision Hip System without HA in total hip arthroplasty include:

• Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (UD), e.g., rheumatoid arthritis.
• Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
• Revision of previously failed arthroplasty.
  The Precedent Revision Hip System without HA is intended only for use without bone cement.

The Precedent Revision Hip System is manufactured from either wrought or forged titanium alloy. The Precedent Revision Hip System features a threaded Sulzer 12/14 configured neck trunnion for attachment to Sulzer Orthopedics' currently marketed femoral heads, including Biolox and Zirconia heads, employing a Sulzer 12/14 configured bore. The Precedent Revision Hip System is available in both a collared and collarless design to address surgeon preference. The entire length of the Precedent Revision Hip System, except the neck region and the distal tip, is roughened via the process of grit blasting. The distal portion of the Precedent Revision Hip System employs flutes which cut into the distal cortices of the prepared femoral canal, thereby providing rotational stability to the hip stem. In addition, the Precedent Revision Hip System employs a coronal slot which potentially reduces bending stiffness of the distal stem and thigh pain. The distal tip of the Precedent Revision Hip System is polished to a machined finish to provide ease of insertion during surgery.

This document is a 510(k) summary for the Precedent Revision Hip System, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study. Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or stated based on the document's content:

1. Table of acceptance criteria and reported device performance:

This document does not specify quantitative acceptance criteria or report specific performance metrics from a dedicated study. The focus is on demonstrating "substantial equivalence" to existing legally marketed devices, implying that its performance is considered acceptable if it is similar to those predicate devices.

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

No test set or associated data provenance is mentioned as this is a 510(k) for substantial equivalence, not a performance study as typically understood for new algorithms or AI.

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 for the test set:

Not applicable.

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 is a hip implant, not an AI-assisted diagnostic device.

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

Not applicable. This is a hip implant, not an algorithm.

7. The type of ground truth used:

Not applicable. The "ground truth" here is the long-standing clinical experience and performance of the predicate hip systems, which the Precedent Revision Hip System is attempting to be substantially equivalent to.

8. The sample size for the training set:

Not applicable. There is no mention of a training set as this is not an AI/algorithm development.

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

Not applicable.

Summary of what the document does provide:

• Device: Precedent Revision Hip System, a femoral hip prosthesis for revision total hip arthroplasty.
• Purpose of filing: 510(k) to demonstrate substantial equivalence to predicate devices.
• Predicate Devices:
  • Sentry Femoral Component: Howmedica Inc.
  • S-ROM® Femoral Prosthesis: Joint Medical Product Corporation.
  • Stability Hip Stem: Depuy Inc.
  • Wagner Revision Stem: Protek Inc.
• Indications for Use: Primarily for femoral bone deficiencies associated with failure of primary total or hemi-hip arthroplasties, and for cementless application in total hip arthroplasty for conditions like non-inflammatory degenerative joint disease, inflammatory joint disease, and revision of previously failed arthroplasty.
• Regulatory Conclusion: The FDA determined the device is substantially equivalent to marketed devices prior to May 28, 1976. This allows marketing subject to general controls provisions of the Act.

Ask a specific question about this device

The Revision Hip System stems are single use devices. The components are indicated for cemented and uncemented use for individuals undergoing primary and revision surgery where other treatments or devices have failed for rehabilitating hips damaged as a result of trauma, or noninflammatory degenerative joint disease (NID) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Indications also include inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection of the hip; and correction of deformity.

The Revision Hip System stems are single use devices. The components of the Revision Hip System have the same function as other hip systems designed for cemented and cementless fixation.

The provided text describes a medical device, the "Smith & Nephew Orthopaedics Revision Hip System," and its indications for use. However, it does not contain any information about acceptance criteria, device performance studies, or details regarding AI algorithms, ground truth, or expert involvement.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance, or provide details about studies, sample sizes, data provenance, expert qualifications, or AI-related aspects.

The text only states that "The engineering analyses of these devices was acceptable and the components of the Revision Hip System should perform as well as other hip systems." This is a very general statement and does not provide quantifiable acceptance criteria or study results.

Ask a specific question about this device

The PERFECTA® Revision Hip System is intended to be used in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

The PERFECTA® Revision Hip System is a monolithic design femoral component. The device is manufactured from titanium alloy (ASTM F-136) with a titanium alloy wire arc spray coating. The stem is available in two configurations: straight and bowed. All configurations have a calcar platform, from 2.0cm to 3.75cm. All sizes, except for 12mm x 190mm, have a coronal slot. The stem is designed to be press-fit or can be used with bone cement.

This document is a 510(k) summary for a medical device (PERFECTA® Revision Hip System), not a study report on device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be found in the provided text.

However, I can extract the limited information that is present:

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

The document does not provide a table of explicit acceptance criteria with numerical targets. Instead, it makes general statements about testing results.

2. Sample sized used for the test set and the data provenance

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective). This document describes pre-market testing, which would typically be conducted in a controlled lab environment rather than using clinical patient data at this stage.

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

• Not applicable/Not specified. The testing described appears to be mechanical and material testing, not human-read clinical data.

4. Adjudication method

• Not applicable/Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, an MRMC study was not done. This document describes mechanical and material testing, not clinical studies involving human readers and AI.

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

• Not applicable. This is a physical medical device, not a software algorithm.

7. The type of ground truth used

• The "ground truth" for the mechanical testing would be the physical properties and performance metrics measured in a laboratory setting (e.g., actual fatigue cycles to failure, actual weight loss during wear simulation).

8. The sample size for the training set

• Not applicable/Not specified. This document is about a physical device undergoing mechanical testing, not a machine learning model.

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

• Not applicable/Not specified.

Ask a specific question about this device