(14 days)
The Diego Powered Dissector and Drill System's intended use is the cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures.
Sinus applications would embody:
- ethmoidectory/sphenoethmoidectomy .
- polypectomy .
- septoplasty and .
- procedures such as .
- antrostomy ●
- endoscopic DCR .
- frontal sinus drill-out .
- frontal sinus trephination and irrigation ●
- septal spurs removal .
- trans-spehnoidal procedures .
Nasopharyngeal/laryngeal procedures would comprise:
- adenoidectomy .
- laryngeal lesion de-bulking .
- laryngeal polypectomy .
- tracheal procedures ●
- tonsillectomy .
Head & Neck procedures would encompass:
- soft tissue shaving .
- rhinoplasty (narrowing of the bony vault and revision of the bony pyramid) .
- minopial of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular . regions of the face
- acoustic neuroma removal .
Otology procedures would include:
- mastoidectomy ●
- mastoidotomy. .
The Diego Powered Dissector and Drill System is an Electrical Surgical Drill/Shaver. It consists of a console with a separate footswitch and integrated irrigation pump. It supports 4 handpieces (Diego, Stapes, and Viper Straight and Angled). The console is controlled by an 8-bit Microprocessor. The handpieces have suction capability for the Shaver Handpiece and no suction for the Drill Handpiece. Irrigation capability is present with the exception of the Stapes Drill Handpiece. The chucking mechanism varies by handpiece type. The system is sterilizable by Autoclave or EO.
The provided text is a 510(k) premarket notification for the Diego™ Powered Dissector and Drill System. It focuses on demonstrating substantial equivalence to a predicate device (Turbo 7000 System) rather than presenting a study to prove acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria and performance studies for an AI/algorithm-based device is not applicable to this document.
However, I can extract the relevant information where available and explicitly state when information is not provided.
Acceptance Criteria and Device Performance
The "acceptance criteria" for this type of device (a powered surgical instrument) are typically met by demonstrating substantial equivalence to a legally marketed predicate device and compliance with recognized safety standards. The document primarily focuses on the latter.
| Acceptance Criterion (Compliance Standard) | Reported Device Performance (Compliance) |
|---|---|
| UL 2601-1 (including Australian deviations) | Designed to meet |
| CSA 22.2 No. 601 | Designed to meet |
| IEC 601-1-1 (EN 60601-1) | Designed to meet |
| IEC 601-1-2 (EN 60601-1-2) | Designed to meet |
| IEC 601-1-4 (EN 60601-1-2) | Designed to meet |
| IEC 61000-4-2 | Designed to meet |
| IEC 61000-4-3 | Designed to meet |
| IEC 61000-4-4 | Designed to meet |
| IEC 61000-4-5 | Designed to meet |
| IEC 529 | Designed to meet |
| ISO 10993-1 | Designed to meet |
| EN 55011. Class B | Designed to meet |
The primary "study" that proves the device meets the acceptance criteria is the demonstration of substantial equivalence to the predicate device (Turbo 7000 System) and compliance with the listed safety standards. The document asserts that the "Diego Powered Dissector and Drill system has the same technological characteristics, power modality and mode of operation as the predicate device" and that the "difference of the processors that control the units should not affect the safety or effectiveness of the device."
Additional Information (Not Applicable or Not Provided for this Device Type)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not provided. This is a traditional mechanical/electrical medical device, not an AI/algorithm-based one that would typically require a test set of data for performance evaluation in the context of this question. The assessment is based on design specifications, compliance with standards, and comparison to a predicate device.
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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):
- Not applicable/Not provided. Ground truth in the context of AI/algorithm performance is not relevant here.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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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:
- Not applicable/Not provided. This is not an AI-assisted diagnostic or interpretative device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not provided. The "ground truth" for this device's safety and effectiveness implicitly relies on established engineering principles, material science, and the safety track record of the predicate device.
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The sample size for the training set:
- Not applicable/Not provided. This is not an AI/machine learning device.
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How the ground truth for the training set was established:
- Not applicable/Not provided.
Summary of what the document does provide:
- Intended Use & Indications for Use: Clearly defined and found substantially equivalent to the predicate.
- Technological Characteristics Comparison: A detailed table comparing the Diego system to the Turbo 7000 system, showing similarities and minor differences (e.g., processor type, specific handpieces supported, operating speeds for sinus surgery). The submitter argues these differences do not affect safety or effectiveness.
- Compliance with Standards: A list of international and national safety and performance standards the device is designed to meet.
- Regulatory Conclusion: The FDA's finding of substantial equivalence based on the provided information, classifying it as a Class II device.
§ 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.