(39 days)
Cortical bone screws (alone) Intramedullary nails as locking bolts Screws with plates Where extra purchase in far cortex is required
The device is a nut with a 10mm hex. This nut is made from a composite of a UHMW Polyethylene nut with a built-in Titanium washer. The washer will aid in fixation in osteoporotic bone by helping to distribute the load against the bone.
Here's an analysis of the provided text regarding the DePuy ACE Composite Locking Nut, focusing on acceptance criteria and supporting studies:
It appears the provided document is a 510(k) summary for a medical device (DePuy ACE Composite Locking Nut). This type of document is for demonstrating substantial equivalence to a previously cleared device, not typically for reporting detailed performance against acceptance criteria from a comprehensive clinical trial with human subjects. Therefore, much of the requested information (like MRMC studies, multi-reader performance, expert ground truth for imaging, and large training sets) is not applicable to this type of submission.
The "study" referenced is a mechanical performance test to demonstrate a specific physical characteristic of the new device compared to its predicate devices, rather than a clinical study of diagnostic accuracy or comparative effectiveness in humans.
Here's the breakdown of what can be extracted from the provided text according to your request categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The nut can be applied without rounding the nut due to the ultimate torque being significantly higher than the insertion torque, allowing surgeons to clearly identify seating against the bone prior to accidental over-torque. | Testing has shown that the ultimate torque is approximately 10 times that of the insertion torque. (This ratio "10 times" implies sufficient margin to prevent over-torque and rounding during normal surgical use and is the performance criterion). |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not explicitly stated. The text refers to "Testing," suggesting a certain number of units were tested to determine the ultimate and insertion torque values.
- Data Provenance: The study was conducted by DePuy ACE Medical Company. No specific country of origin for the data is mentioned beyond the company's location in El Segundo, CA, USA. This was a retrospective engineering test on manufactured devices, not derived from patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. The ground truth for this engineering test was the direct measurement of torque values. It did not involve expert interpretation of images or clinical outcomes.
4. Adjudication Method for the Test Set
- Not applicable. The "test set" here refers to the physical devices undergoing torque testing. There was no human interpretation or adjudication process involved in measuring a physical property.
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
- No, an MRMC comparative effectiveness study was not done. This is a 510(k) for a mechanical device component, not an AI-powered diagnostic tool. The document does not mention any AI component or human reader studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a mechanical device. There is no algorithm or standalone performance being evaluated.
7. The Type of Ground Truth Used
- The ground truth was direct objective measurement of physical properties: ultimate torque and insertion torque.
8. The Sample Size for the Training Set
- Not applicable. There was no "training set" as this is not a machine learning or AI-driven device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there was no training set (see #8), no ground truth for a training set was established.
Summary of the "Study" (Test Report ET 63-001):
The only "study" mentioned in this 510(k) summary is "Test Report ET 63-001". This appears to be an internal engineering test conducted by DePuy ACE Medical Company.
- Purpose: To demonstrate that the DePuy ACE Composite Locking Nut allows for adequate fixation without accidental over-torque during application.
- Methodology: Measuring the ultimate torque (the torque at which the nut mechanically fails or rounds) and the insertion torque (the torque typically applied during surgical seating).
- Finding: The ultimate torque was found to be approximately 10 times that of the insertion torque.
- Conclusion: This 10x ratio is considered sufficient to allow surgeons to clearly identify when the nut is seated against the bone before accidental over-torque or rounding occurs. This finding directly supports the device's substantial equivalence and safe use.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.