(65 days)
The Apex Universal Drive System is utilized for shaving of soft tissue and bone during otolaryngological and reconstructive surgery. The drive system is reusable.
The Apex Universal Drive system contains a drive console, micro handpiece, blades/burrs/routers and foot switches.
The forward/reverse speed is being increased to reduce the incidence of bur chatter. The oscillation speed is being modified to increase the rate of resection.
The modification will take place within the drive console power unit software. A computer chip will be upgraded to allow the handpiece to run at a higher maximum rpm in forward/reverse and oscillate mode.
The provided text is a 510(k) Summary of Safety and Effectiveness for a medical device called the "Apex™ Universal Drive System." This document is a regulatory submission to the FDA, and it describes modifications made to an existing device and compares it to predicate devices.
It does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the way a clinical trial or performance study would typically be described.
Instead, this document focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the primary requirement for a 510(k) submission. The "testing" mentioned is to prove the safety and effectiveness of the modified device in comparison to the predicates, ensuring it doesn't raise new questions of safety or effectiveness.
Therefore, I cannot fulfill your request for specific acceptance criteria or the details of a study structured around proving those criteria, as the document does not provide this information.
However, I can extract information regarding device performance from the provided text and explain what type of "acceptance" is implied by this regulatory submission.
Implied "Acceptance Criteria" and Reported Device Performance (from the perspective of a 510(k) submission for substantial equivalence):
The implied "acceptance criteria" for a 510(k) submission like this are that the modified device is substantially equivalent to predicate devices and that the modifications do not introduce new questions of safety or effectiveness. The "device performance" in this context primarily refers to the operating specifications that are being modified and compared to predicates.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Apex™ Universal Drive System - NEW PRODUCT) |
|---|---|
| Safety and Effectiveness: The modified device (Apex™ Universal Drive System) must be safe and effective for its intended use, and the modifications should not raise new questions of safety or effectiveness when compared to the original device and predicate devices. This is demonstrated by showing that the new specifications are within the range or similar to the specifications of legally marketed predicate devices. | Micro Handpiece Speed: |
| Maximum Forward/Reverse: 5,000 rpm | |
| Maximum Oscillate: 2,500 rpm |
Rationale for change: "The forward/reverse speed is being increased to reduce the incidence of bur chatter. The oscillation speed is being modified to increase the rate of resection." (This implies the new performance is "better" or addresses a specific functional improvement while maintaining safety). |
| Substantial Equivalence in Design, Function, and Intended Use: The modified device should be substantially equivalent to predicate devices in its design, function, and intended use. This is demonstrated through a comparative analysis. | Design: Drive console, micro handpiece, blades/burrs/routers, foot switches. Modification is a software upgrade (computer chip) to allow for higher maximum RPMs.
Function: Utilized for shaving soft tissue and bone.
Intended Use: Otolaryngological and reconstructive surgery. |
Now, addressing the specific points of your request based on the absence of this information in the provided document:
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A table of acceptance criteria and the reported device performance
- See table above. Specific, quantifiable acceptance criteria with pass/fail thresholds for clinical performance (e.g., sensibility, specificity, accuracy against a gold standard) are not present in this document. The "performance" described is hardware specification, not clinical outcome.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. The document does not describe a clinical "test set" in the sense of patient data. It refers to "Testing has been done to prove safety and effectiveness of the devices" but provides no details on what was tested, sample size (e.g., how many devices or units), or data provenance. This likely refers to in-vitro or bench testing of the device's mechanical and electrical properties.
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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)
- N/A. As there is no described clinical "test set" with patient data requiring expert consensus for ground truth, this information is not applicable.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not applicable, as there is no described clinical test set requiring adjudication.
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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
- N/A. This document predates the widespread use of AI in medical devices and describes a surgical drive system. An MRMC AI study is completely irrelevant to this device and document.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a hardware device (surgical drive system), not an algorithm or AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. For this type of device and submission, the "ground truth" for safety and effectiveness is largely based on engineering principles, component specifications, and comparison to the known safety and effectiveness of predicate devices. There's no mention of pathology or outcomes data in the context of a new study for this specific 510(k). The "ground truth" for the new device's performance would be its measured RPMs, stability, etc., compared against design specifications and predicate performance.
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The sample size for the training set
- N/A. This is a hardware device submission, not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established
- N/A. Not applicable.
In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence for a hardware modification, not a clinical study on diagnostic accuracy or AI performance. Therefore, most of your requested information is not present or applicable.
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.