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510(k) Data Aggregation
(75 days)
The DISTALOCK™ Femoral Intramedullary Nail System is indicated for use in orthopedic intramedullary nailing procedures: midline femoral fractures, femoral fractures in multiple trauma patients, fractures in the morbidly obese patient, fractures in osteoporotic bone or malunions and nonunions.
The DISTALOCK™ Femoral Intramedullary (IM) Nail System permits an antegrade intramedullary approach for fixation of fractures of the femur. The DISTALOCK™ Femoral Intramedullary Nail is a closed section, cannulated, thick walled, mirror finished, curved intramedullary fixation device containing two proximal and two distal holes to accept locking screws which thread transversely though the proximal and distal third of the femur. The DISTALOCK™ Femoral IM Nail System includes the following components: DISTALOCK™ IM standard entry and trochanteric nails, locking screws and end caps made of titanium allov. The DISTALOCK™ Ancillary Instrumentation includes the DISTALOCK™ drill, the DISTALOCK™ Control System (which includes the control box, drill motor assembly and hand controller) and other disposable and reusable instruments.
The provided document is a 510(k) summary for the DISTALOCK™ Femoral Intramedullary Nail System, which is a medical device. This type of document is relevant for demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving a device meets those criteria in the way a diagnostic AI/ML device submission would.
Therefore, many of the requested categories (such as sample size, ground truth, expert qualifications, MRMC studies, standalone performance, and training set information) are not applicable to this type of device and submission.
However, I can extract the information that is present:
1. Table of Acceptance Criteria (Implicit) and Reported Device Performance
| Acceptance Criteria Category | Description | Reported Device Performance | Study Type |
|---|---|---|---|
| Biocompatibility | Selection of materials demonstrating appropriate levels of biocompatibility. | Achieved through selection of appropriate materials. | Biological Safety testing |
| Human Factors | Acceptable human factors features in device functioning and labeling. | Concluded as acceptable. | Human Factor Analysis |
| Performance & Safety | Device performs as intended, is safe, and is substantially equivalent to predicate device. | Bench testing and cadaver testing demonstrated performance and safety, confirming substantial equivalence. | Bench Testing, Cadaver Testing |
| Risk Assessment | No new risks or efficacy concerns compared to the predicate device. | Confirmed no new questions of safety or effectiveness. | Risk Assessment |
| Design Verification & Validation | Device system as modified is as safe as the predicate device. | Results demonstrate the modified device is as safe as the predicate. | Design Verification & Validation Testing |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a physical medical device (intramedullary nail), and the "test set" would refer to physical devices or cadavers, not a data set in the AI/ML sense. The document does not specify sample sizes for bench or cadaver testing. Data provenance such as country of origin or retrospective/prospective is not relevant in this context.
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. No "ground truth" using human experts in the context of diagnostic performance is described for this physical device. The testing involved engineering, material science, and possibly anatomical cadaver studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective interpretations of data, such as images, which is not the primary focus of this device's testing.
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 not an AI/ML diagnostic device, so MRMC studies and human reader improvement with AI are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context would be defined by engineering specifications, material science standards, and established biomechanical principles for orthopedic fixation. For cadaver testing, the "ground truth" would be the successful mechanical fixation of fractures as assessed by engineers or orthopedic experts in a controlled setting, potentially comparing against the predicate device's performance. The document doesn't explicitly detail the "type" of ground truth but implies it's based on engineering and biomechanical performance.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for this physical device.
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