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Indications:

1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
2. Tumor resections.
3. Revision of previously failed total joint arthroplasty
4. Trauma
   The Compress Segmental Femoral Replacement System components are intended for uncemented use only.

The ComPreSs® Segmental Femoral Replacement System consists of three main components, the anchor plug, the spindle assembly, and the intercalary segment. The Anchor Plug is embedded within the medullary canal, the Spindle Assembly attaches to the Anchor Plug and is compressed against the bone / implant interface at the osteotomy site. The Intercalary Segment attaches to the Spindle Assembly, and completes the Femoral Stem Component.
This system is intended for use in both the proximal and distal femur.

This document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it is a 510(k) summary for a medical device (ComPreSs® Segmental Femoral Replacement System) seeking substantial equivalence to legally marketed predicate devices.

The key points from the provided text are:

• Device: ComPreSs® Segmental Femoral Replacement System
• Applicant: Biomet Manufacturing Corp.
• Date: August 5, 2005 (with a correction letter dated April 23, 2009)
• Purpose of Submission: To demonstrate substantial equivalence to predicate devices, not to prove specific performance against acceptance criteria in a new study.
• Basis for Equivalence: The submission states that "All components of this system are identical in material, processing, function, and design to their respective predicate components."
• Non-clinical Testing: "The engineering rationale with the attached literature and mechanical test reports support the claim for substantial equivalence to the predicate devices." (No specific acceptance criteria or performance numbers are given here).
• Clinical Testing: "Clinical testing in support of the predicate Compress® Distal Femoral Replacement System is sufficient to ensure safety and efficacy. No further clinical testing is necessary to support the claim for substantial equivalence to the predicate devices." This explicitly states that no new clinical study was performed for this specific device to establish novel acceptance criteria.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, adjudication methods, or MRMC studies is not present in the provided text. The document focuses on demonstrating equivalence through comparison to existing, approved devices and their past testing, rather than presenting new performance data for the subject device against defined acceptance metrics.

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

• metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur;
• 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 of the proximal and/or distal femur;
• patients suffering from severe arthropathy of the hip and/or knee that does not respond to any conservative therapy or better alternative surgical treatment;
• revision cases requiring extensive resection(s) and replacements of the proximal, distal or total femur or proximal tibia.
  The distal femoral and tibial components, tibial stems and non-porous coated femoral stems are intended for cemented use only.

The Orthogenesis LPS components are designed to be implanted for the replacement of the mid-shaft or intercalary 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 of roovenon and renoration in those cases where no part of the femur can be salvaged.

The provided text describes a 510(k) summary for the Orthogenesis LPS System, a total femur/proximal tibial replacement prosthesis. This submission focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study demonstrating the device meets specific performance acceptance criteria.

The 510(k) process is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. It typically relies on comparing the new device to existing ones rather than extensive novel studies with acceptance criteria.

Therefore, the input does not contain the information required to answer the prompt in detail, as it pertains to a different type of regulatory submission. The requested information (acceptance criteria, specific study details, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is typically found in documentation for clinical trials or performance studies that aim to prove a device's performance against predefined metrics, which is not the primary purpose of a 510(k) summary.

However, based on the information available, I can report the following in relation to substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission, the "acceptance criteria" revolve around demonstrating substantial equivalence to predicate devices, rather than meeting specific quantifiable performance thresholds from a novel study.

2. Sample Size Used for the Test Set and Data Provenance
Not applicable for a 510(k) substantial equivalence submission in the context of a performance study. No separate "test set" in the sense of a clinical trial or algorithm validation dataset is described. The submission relies on comparison to existing, legally marketed devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This information is not part of a 510(k) summary where the primary assessment is regulatory review against predicate devices rather than expert-adjudicated ground truth data.

4. Adjudication Method for the Test Set
Not applicable. No "test set" requiring adjudication by experts is described in this 510(k) summary.

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 physical prosthesis, not an AI/software device. Therefore, no MRMC study involving human readers or AI assistance would be relevant or conducted for this type of product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical prosthesis, not an algorithm, so standalone performance in the context of AI is irrelevant.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.)
For a 510(k), the "ground truth" for demonstrating substantial equivalence is implicitly the established safety and effectiveness of the legally marketed predicate devices. The new device is deemed equivalent if it raises no new questions of safety and effectiveness and performs as well as or better than the predicate. Direct 'ground truth' from pathology or outcomes data specifically for the new device's own clinical study is typically not required for 510(k) clearance, though design verification and validation testing (e.g., mechanical testing) would occur.

8. The Sample Size for the Training Set
Not applicable. This pertains to AI/machine learning model development, which is not relevant for this physical medical device and its 510(k) submission.

9. How the ground truth for the training set was established
Not applicable. As above, this pertains to AI/machine learning model development.

Summary of the Study (510(k) Assessment for Substantial Equivalence):

The "study" presented here is a 510(k) premarket notification to the FDA. The objective was to demonstrate substantial equivalence of the Orthogenesis LPS System to several predicate devices already on the market.

• Predicate Devices:

  • S-ROM Noiles (references K896048, K905810, K924940)
  • Sulzer Orthopedics MOST™ System (K973087)
  • Wright Medical Segmented Orthopaedic System (SOS) (K933281)
  • Howemedica MRS (K972401 and K965164)

• Methodology: The determination of substantial equivalence was based on a detailed comparison of the new device's:

  • Indications for use
  • Design
  • Materials
  • Sterilization
  • Packaging
  • Performance testing (implied, not detailed, likely mechanical/biocompatibility testing to show similar performance characteristics to predicates)
  • Conformance with voluntary performance standards (not specified which ones).

• Conclusion of the 510(k): The FDA reviewed the submission and determined that the Orthogenesis LPS System is substantially equivalent to the referenced predicate devices, allowing it to be marketed. This determination was made on June 27, 2001.

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