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510(k) Data Aggregation
(71 days)
COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM
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.
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(190 days)
COMPRESS DISTAL FEMORAL REPLACEMENT
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.
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