(71 days)
The ComPreSs® Distal Femoral Replacement System is intended for:
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
- Tumor resections
- Revision of previously failed total joint arthroplasty
- Trauma
The ComPreSs® Distal Femoral Replacement components are intended for uncemented use only.
The ComPreSs® Distal 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.
The provided text describes a 510(k) submission for the ComPreSs® Distal Femoral Replacement System. This document focuses on establishing substantial equivalence to predicate devices for a medical implant, rather than reporting on a study demonstrating device performance against specific acceptance criteria in the way a diagnostic or AI device study would.
Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, etc.) are not applicable or not present in this type of submission.
Here's why and what information can be extracted:
1. A table of acceptance criteria and the reported device performance
The submission does not present acceptance criteria and performance data in the typical sense for a diagnostic device. Instead, it demonstrates substantial equivalence for the ComPreSs® Distal Femoral Replacement System to legally marketed predicate devices. The "performance" here is defined by meeting the same safety and effectiveness profiles as the predicates.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Equivalence of Tapers: Tapers incorporated into these components are substantially equivalent to those in predicate devices. | Mechanical testing was done on the tapers. This testing, along with engineering justification, indicated that the tapers incorporated into these components are substantially equivalent to the tapers used in the predicate devices. |
| Hydroxyapatite Coating Effect on Device Strength: Addition of Hydroxyapatite coating does not weaken the devices. | The Hydroxyapatite coating on the Hydroxyapatite coated spindles was previously tested with porous coating, and the testing concluded that the addition of Hydroxyapatite coating did not weaken the devices tested. |
| Material Equivalence (Hydroxyapatite coated spindles): Identical in material, function, design, and sizing as predicate spindles. | The Hydroxyapatite coated spindles are identical in material, function, design, and sizing as the predicate spindles. The only change is the addition of Hydroxyapatite coating. |
| Material Equivalence (Taper Adapters): Made of the same material, with the same taper geometries as predicate tapers. | The ComPreSs / OSS / Finn® Taper Adapters are made of the same material, with the same taper geometries as the predicate OSS tapers, the ComPreSs® Distal Femoral Replacement tapers, or the Finn® tapers included in the predicate ComPreSs® Distal Femoral Replacement. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. The "test set" here refers to mechanical testing of components, not a clinical data set. The document does not specify the number of components tested for mechanical equivalence.
- Data Provenance: Not applicable. This refers to engineering and laboratory testing rather than clinical data from patients.
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" in this context would typically refer to clinical diagnosis or outcome, which is not part of this 510(k) submission. The evaluation is based on mechanical testing and engineering justification by presumably qualified engineers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication is irrelevant for mechanical testing of device components.
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 surgical implant, not a diagnostic or AI-assisted device. MRMC studies are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" used for demonstrating substantial equivalence is based on accepted engineering principles, mechanical testing standards, and comparison to the design and materials of predicate devices. There is no clinical "ground truth" generated as part of this submission, as clinical testing was not required.
8. The sample size for the training set
Not applicable. This is not an AI/ML device; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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.