(190 days)
The ComPreSs™ Distal Femoral Replacement System is indicated for tumors of the distal femur and revisions of oncologic distal femoral replacements.
The ComPreSs™ Distal Femoral Replacement components are intended for uncemented use.
The ComPreSs™ Distal Femoral Replacement is a metallic femoral segmental fixation stem intended to replace the distal part of the femur in cases of severe bone loss. The design of the ComPreSs™ stem allows a compressive load to be applied at the prosthetic implant-bone interface at the time of device insertion. This is accomplished through a spring system built into the stem.
The provided documentation describes the ComPreSs™ Distal Femoral Replacement, a medical device. Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength/Safety: Device addresses all failure mechanisms. | Non-Clinical Testing: "Testing also addressed all failure mechanisms for the device, and was found to be strong enough to begin the clinical study." |
| Stress Shielding: Device produces less stress shielding than standard cemented implants. | Non-Clinical Testing: "Results of mechanical testing showed that the ComPreSs™ Distal Femoral Replacement produces less stress shielding than a standard cemented implant." |
| Clinical Equivalence: Clinically substantially equivalent to similar knee prostheses for similar indications. | Clinical Results: "The clinical results determined that the ComPreSs™ Distal Femoral Replacement is substantially equivalent to similar knee prostheses implanted for similar indications." |
| Substantial Equivalence: Based on mechanical testing and clinical data, the device is substantially equivalent to the predicate device. | Summary: "Based on the results of mechanical testing and clinical data, the ComPreSs™ Distal Femoral Replacement is substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Testing also addressed all failure mechanisms for the device, and was found to be strong enough to begin the clinical study." and then refers to "The clinical results determined that the ComPreSs™ Distal Femoral Replacement is substantially equivalent..."
- Sample Size for Clinical Study (Test Set): The specific sample size for the clinical study is not provided in the given text.
- Data Provenance: The country of origin of the data is not specified. The text only mentions "clinical results." It is likely prospective, as it refers to a "clinical study" being initiated after mechanical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The text only mentions "clinical results" and "clinical data" without detailing how ground truth was established by experts.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
There is no mention of an MRMC comparative effectiveness study or any effect size of human readers improving with or without AI assistance. The device in question is a physical medical implant, not an AI-assisted diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
This question is not applicable as the device is a physical implant and not an algorithm.
7. The Type of Ground Truth Used
The type of ground truth used for the "clinical results" is not explicitly stated. Given it's a femoral replacement, the ground truth would likely be based on patient outcomes (e.g., pain reduction, range of motion, implant stability, absence of complications) as observed in the clinical study, compared to the outcomes of the predicate device. However, this is inferred, not explicitly stated.
8. The Sample Size for the Training Set
This information is not provided. The text refers to "clinical results" but does not distinguish between a training set and a test set for this device type. Given it's a medical implant, training sets in the context of biological data or machine learning are not typically relevant here; the "training" would be more akin to in-vitro or in-vivo testing to optimize the design, which isn't detailed with sample sizes in this summary.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is largely not applicable in the conventional sense for a physical medical implant. The design and testing would involve engineering principles and mechanical testing to establish performance parameters, rather than "ground truth" derived from patient data for a training set in the way one would for an algorithm.
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.