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The DePuv LPS is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:

• malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant . cell tumors, bone tumors) requiring extensive resection and replacement;
• patient conditions of noninflammatory degenerative joint disease . (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory ioint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement;
• revision cases for a failed previous prosthesis requiring extensive . resection and replacement;
• severe trauma requiring extensive resection and replacement. .

It is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.

The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only.

The porous-coated metaphyseal and diaphyseal sleeves are intended for either cemented or cementless applications.

The technological characteristics of the DePuy LPS Universal Technological Hinge Insert Assembly are similar to the predicate devices Characteristics: including design, performance and material type.

This is a 510(k) summary for a medical device (DePuy LPS Universal Hinge Insert Assembly) and does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document discusses:

• The device's intended use and classification.
• Its substantial equivalence to predicate devices based on design, performance, and material type, as demonstrated by pre-clinical data (not clinical study data).
• The FDA's decision to clear the device for market.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment. The provided text is a regulatory filing, not a scientific study report.

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The LPS Upper Extremity is intended for use in replacement of the proximal, mid-shaft or intercalary portion, distal and/or total humerus. This system is especially designed for cases that require extensive resection and restoration. Specific diagnostic indications for use include:

• Primary bone neoplasnms (e.g., osteosarcomas, chondrosarcomas, Ewing's sarcomas) requiring extensive resection(s) and replacement(s) of the proximal and/or distal humerus;
• Metastatic bone disease and pathologic fractures with extensive bone loss or where other forms of treatment such as internal fixation are inadequate;
• Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (JD), e.g., rheumatoid arthritis, requiring extensive resection and replacement of the proximal and/or distal humerus;
• Patients suffering from congential or acquired deformity, such as post-traumatic deformity and/or arthritis;
• Communited fractures of the proximal, distal and/or humeral shaft where forms of fixation are indadequate;
• Persistent humeral fracture non-union;
• Patients suffering from severe cuff tear arthropathy that does not respond to any conservative therapy or better alternative surgical treatment;
• Revision shoulder or elbow arthroplasty cases requiring extensive resection(s) and replacements of the proximal, distal or total humerus.
• Severe trauma requiring extensive resection and replacement.
  The LPS Upper Extremity components are for CEMENTED USE ONLY.

The LPS Upper Extremity components are designed for the replacement of the mid-shaft or intercalary portion of the humerus, proximal, distal and/or total humerus. Unlike primary shoulder and elbow systems, this system is used when the amount of resection and restoration is extreme (e.g. in oncology cases, end-stage revision). A total humeral replacement is possible in those cases where no part of the humerus can be salvaged.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance results, or any study conducted to prove the device meets specific criteria. The document is a 510(k) summary for the 'LPS Upper Extremity' device, which outlines its indications for use, device description, and substantial equivalence to previously cleared devices. It does not include details on clinical trials, performance testing, sample sizes, expert ground truth establishment, or any comparative effectiveness studies. Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving the device meets them based on the given information.

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The LPS Intercalary component is intended for use in primary and revision knee joint replacement and in oncology cases with the Limb Preservation System (LPS). The previously cleared indications for use for this system are the following:

The LPS is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:

• · malignant tumors (e.g., osteosarcoma, chondrosarcoma, giant cell tumors, bone tumors) requiring extensive resection and replacement;
• · patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement;
• · revision cases for a failed previous prosthesis requiring extensive resection and replacement;
• · severe trauma requiring extensive resection and replacement.

The LPS is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.

The distal femoral component, the tibial components, tibial stems, metaphyseal sleeves, and the non-porous coated straight and bowed stems are intended for cemented use only.

The intercalary component serves as a segmental component in the previously cleared Limb Preservation System (LPS, K003182). The dovetail intercalary component is a 3piece assembly 55 mm in length. The three pieces are comprised of a male segment, a female segment and a connecting pin. The male-female parts connect as a dovetail connection and locked with a pin screwed through both segments. The dovetail intercalary component is made of cobalt chrome.

The provided text is a 510(k) summary for a medical device called the "LPS Lower Extremity Dovetail Intercalary." This document is a regulatory submission to the FDA, primarily focused on establishing substantial equivalence to a previously cleared device. It does not describe a clinical study or performance testing with specific acceptance criteria that demonstrate the device meets those criteria.

Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, expert ground truth, adjudication, MRMC studies, or standalone performance studies cannot be extracted from this document, as they are not present.

The 510(k) summary explicitly states: "The substantial equivalence of the LPS Dovetail Intercalary is substantiated by its similarity in sterilization, packaging and indications for use to the LPS (K003182 cleared on June 27, 2001). The design and materials of the LPS Dovetail Intercalary have been modified from the existing LPS Intercalary component cleared in K003182, however DePuy believes this new component is substantially equivalent."

This indicates that the primary "study" or evidence for this device is a comparison to a predicate device (K003182) to demonstrate substantial equivalence, rather than a de novo clinical study with new performance criteria.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document does not describe specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity, mechanical strength thresholds) for the device itself, nor does it report device performance against such criteria. The focus is on substantial equivalence to a predicate device rather than de novo performance testing against new metrics.

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

• Cannot be provided. No test set or data provenance from a performance study is described.

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)

• Cannot be provided. No test set requiring expert-established ground truth is described.

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

• Cannot be provided. No test set requiring adjudication 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

• Cannot be provided. This device is a total knee prosthesis component, not an AI or imaging device, so an MRMC study is not relevant and not discussed.

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

• Cannot be provided. This device is a physical implant, not an algorithm. Standalone performance for an algorithm is not applicable.

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

• Cannot be provided. As no specific performance study is detailed, no ground truth type is mentioned.

8. The sample size for the training set

• Cannot be provided. This device is a physical implant, not a machine learning model, so there is no concept of a "training set."

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

• Cannot be provided. Not applicable (see point 8).

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The metaphyseal sleeve is intended for use in primary and revision knee joint replacement and in oncology cases. The metaphyseal sleeve is used to fill metaphyseal defects in the distal femur and joins a knee femoral component with an intramedullary stem. The sleeve may be used across several product lines: the Limb Preservation System (LPS), the S-ROM system, and the fixed platform portion of the P.F.C. Sigma system. The previously cleared indications for use for these systems:

The LPS is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:

• malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) . requiring extensive resection and replacement:
• · patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid drithritis, requiring extensive resection and replacement;
• · revision cases for a failed previous prosthesis requiring extensive resection and replacement;
• · severe trauma requiring extensive resection and replacement.

The LPS is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.

The metaphyseal sleeve, the distal femoral component, the tibial components, and the nonporous coated straight and bowed stems are intended for cemented use only.

The S-ROM Modular Total Knee System was cleared as the "NOILES Posterior Stabilized Knee."

The NOILES Posterior Stabilized Knee is indicated for use with PMMA bone cement in primary or revised cases in patients:

• who have reached skeletal maturity and .
• for whom the surgeon has decided to resect both cruciate ligaments or whose cruciate . ligaments are absent or incompetent due to the following conditions: rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, and arthritis secondary to a variety of diseases and anomalies, failure of a previous knee reconstruction procedure, trauma.

The P.F.C. Sigma Knee System is indicated for use as a total knee replacement for patients suffering from severe pain and disability due to permanent structural damage in the knee joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, or pseudogout.

This damage may also be a result of trauma or failed prior surgical intervention.

The P.F.C. Sigma Knee System is indicated for use with polymethylmethacrylate (PMMA) bone cement.

The metaphyseal sleeve is a component to the previously cleared Limb Preservation System (LPS). The titanium sleeve is used to fill metaphyseal defects in the distal femur and joins a knee femoral component with an intramedullary stem. The sleeve is cone-shaped, with an outer stepped anatomical taper to fill the metaphyseal region of the distal femur. All but the final four steps of the sleeve are porous coated. The sleeve ranges in size from 31 to 46mm, as measured at the widest (M/L width) portion of the sleeve.

Through the use of adapters, the sleeve is compatible on its proximal and distal ends with femoral stems and distal femoral components. The femoral stems and distal femoral components are from previously cleared DePuy knee systems such as the Limb Preservation System, the S-ROM® NOILES Total Knee System and the fixed platform of the P.F.C. Σ System.

On the distal end, the sleeves either mate directly with the posts on previously cleared femoral components (e.g., the S-ROM femoral) or, through the use of one of the two wrought cobalt chrome femoral to sleeve adapters, mate with previously cleared femoral components that do not have posts (e.g., the LPS femoral, the P.F.C. Σ TC3 or the P.F.C. Σ PS femoral). These adapters will be available in 3 offsets: +0, +5 and +10 millimeters.

On the proximal side, the sleeves mate with previously cleared stems, either directly (when using an S-ROM stem) or through the use of the titanium LPS P.F.C. Stem to Sleeve Adapter (when using a P.F.C. type fluted or cemented stem).

The provided document is a 510(k) summary for the LPS Metaphyseal Sleeve, a medical device. It describes the device, its indications for use, and establishes substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.

Regulatory documents like 510(k) summaries focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies against specific acceptance criteria. These types of performance studies are typically found in design validation documentation, which is not publicly available in a 510(k) summary.

Therefore, I cannot fulfill your request for the tables and information based on the provided text, as the necessary details are absent.

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The LPS is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:

• malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement;
• patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement;
• revision cases for a failed previous prosthesis requiring extensive resection and replacement;
• severe trauma requiring extensive resection and replacement.
  The LPS is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.
  The distal femoral component, the tibial components, and the non-porous coated straight and bowed stems are intended for cemented use only.

The LPS components are designed for the replacement of the mid-shaft portion of the femur. proximal, distal and/or total femur, and proximal tibia. Unlike primary hip and knee systems, this system is used when the amount of resection and restoration is extreme (e.g. in oncology cases, endstage revision). A total femoral replacement is possible in those cases where no part of the femur can be salvaged.

The provided text is a 510(k) Summary for a medical device called LPS (Total Knee Prosthesis/Femoral Stem Prosthesis). This document details the device's intended use, description, and its claim of substantial equivalence to previously cleared devices.

Crucially, this document is a 510(k) Summary for a device (a prosthetic implant), not an AI/ML-driven medical device or software product that would typically involve acceptance criteria and a study proving its performance in the manner requested.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, standalone performance, and training sets is not applicable to this type of medical device submission.

Here's an explanation based on the provided text, highlighting what is and isn't available:

1. Table of Acceptance Criteria and Reported Device Performance

• Not Applicable in the traditional sense for an AI/ML device. This document is for a physical orthopedic implant. Acceptance criteria for such devices typically revolve around mechanical testing, biocompatibility, sterilization validation, and conforming to relevant material standards. These are usually established through compliance with voluntary performance standards (as mentioned in section E) and internal company specifications, rather than clinical performance metrics like sensitivity, specificity, or AUC as seen in AI/ML products.
• Reported Device Performance: The document states that the substantial equivalence is based on:
  • Similarity in design, sterilization, and packaging to the LPS (K003182).
  • Similarity in materials (cobalt chrome) to the S-ROM Noiles Rotating Hinge Knee (K870730).
  • Similarity in indications for use to the Howmedica Global Modular Replacement System (GMRS) (K023087).

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

• Not Applicable. There is no "test set" in the context of an AI/ML algorithm being evaluated. The equivalence claim is based on comparison to existing, already-approved devices, along with what would typically be non-clinical performance data (e.g., mechanical tests) which are not detailed in this summary.

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

• Not Applicable. This is not a study requiring expert-established ground truth for an algorithm.

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 for a prosthetic implant, not an AI-assisted diagnostic tool.

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

• Not Applicable.

7. The type of ground truth used

• Not Applicable in the context of AI/ML. For a physical implant, "ground truth" might refer to established engineering principles, material science data, and clinical outcomes data from similar predicate devices, which are implicitly part of the substantial equivalence determination.

8. The sample size for the training set

• Not Applicable. There is no "training set" for a physical medical device.

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

• Not Applicable.

Summary of what can be gleaned from the document regarding "acceptance" for this specific device:

The "acceptance" in this context refers to the FDA's determination of substantial equivalence to legally marketed predicate devices. The "study" that proves this involves demonstrating:

• Design Similarity: The LPS is similar in design to the previously cleared LPS (K003182).
• Material Equivalence: The specified material (cobalt chrome) is similar to materials used in the S-ROM Noiles Rotating Hinge Knee (K870730).
• Indications for Use Alignment: The indications for use are similar to the Howmedica Global Modular Replacement System (GMRS) (K023087).
• Conformance with Standards: The determination was also based on "conformance with voluntary performance standards," which would involve non-clinical testing (e.g., mechanical strength, fatigue, wear) to ensure the device performs as expected for its intended use and materials. Specific criteria for these tests are not provided in this summary but would be part of the full 510(k) submission.

In essence, the "study" for this type of device is a comprehensive technical and comparative analysis against established benchmarks and predicate devices, rather than a clinical trial or algorithm performance evaluation.

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