(95 days)
The OSSEODUO is a drill and shaver system that has been designed for drilling and shaping bone and for the resection of soft and hard tissues as part of surgical operations in the areas of otorhinolaryngology, otoneurology, maxillofacial surgery, and head and neck surgery.
The shaver handpiece S80 or S120 is designed for cutting and removal of soft and hard tissue in the fields of:
- Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty)
- Endoscopic dacryocystorhinostomy (DCR)
- Nasopharyngeal and laryngeal prodedures (such as adenoidectomy, polypectomy, tonsillectomy)
- Head and neck surgery( such as acoustic-neuroma removal, tumor removal, rhinoplasty, adipose tissue removal, plastic, reconstructive and aesthetic surgery)
The micromotor 80K combines with different drill and micro saw handpieces and is intended for cutting, drilling, shaping and sawing bone as part of various surgical procedures in the areas of ENT and head and neck surgery such as otoneurology, otorhinolaryngology and maxillofacial surgery (facial plastic, reconstructive and aesthetic surgery).
The OSSEODUO Shaver and Drill System consists of a control unit, a footswitch, connection cables, a shaver handpiece (also named microdebrider or microresector) to drive various shaver blades, a drill motor and assorted handpieces to drive various burs, drills, rasps and micro saw.
The control unit consists of a closed box with, on its main side, an LCD display screen and various function keys allowing the device to be adjusted according to the planned operation. On the right-hand side of the control unit are the connectors for the shaver handpiece S80 and for the micromotor 80K, while the pedal is connected on the rear panel. A peristaltic pump for irrigation and cooling is mounted on the rear panel which also contains the main power-up switch and the fuse holder.
The shaver handpiece includes a micromotor, a gear set, a coupling system for shaver blades and connections for irrigation. Through the control unit it can operate in oscillating modus (reversing after a user-defined number of turns in each direction) or in continuous CW and CCW rotation. Its made of stainless steel and autoclavable. The shaver handpiece is available in two version: the S80 being the basic model and the 5120 with higher rotation speed (up to 12'000 rpm in continuous rotation) and the ability to orient the shaver blade during operation without releasing the chucking mechanism.
The micromotor 80K has an ISO 3964 type E standard coupling which connects to a broad range of different handpieces, such as drill, contra-angle, saw, etc. Through the control unit it can achieve speeds of up to 80'000 rpm. All outer surfaces are made of stainless steel and the motor is autoclavable.
The footswitch allow a smooth progressive and continuous command of the shaver or drill speed. It is IPX8 waterproof.
The provided 510(k) summary for the OSSEODUO Shaver and Drill System describes non-clinical performance assessments rather than a typical study comparing a device's performance against defined acceptance criteria using a test set and ground truth in the way one might evaluate AI/ML systems.
Instead, this submission focuses on demonstrating substantial equivalence to predicate devices through a comparison of technical features and informal non-clinical trials. The "acceptance criteria" here are implicitly achieving similar performance to the predicate devices in the specific tests conducted.
Here is an analysis based on the provided text, structured to address your points as much as possible within the context of this medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Implied by Predicate Performance) | Reported OSSEODUO Performance |
|---|---|---|
| Non-Clinical Performance | ||
| Tissue Removal Rate (Oyster-flesh + eggshell) | Similar rate to Medtronic XPS 3000 (K041523) and Gyrus Diego (K020594) | Confirmed "similar rate of tissue removal (grams per minute) to the two reference systems." |
| Tissue Removal Rate (Scallops flesh) | Similar rate to Medtronic XPS 3000 (K041523) and Gyrus Diego (K020594) | Confirmed "similar rate of tissue removal (grams per minute) to the two reference systems." |
| Water Aspiration | Equivalent results to Medtronic XPS 3000 (K041523) and Gyrus Diego (K020594) with the same vacuum system | Confirmed "equivalent results" with the same vacuum system. |
| Frequency of Clogging | Not definitively quantifiable due to high variability in predicate devices (comparison difficult) | Results "vary widely randomly from one measure to the other even with the same system so that comparison between systems are difficult." |
| Post-Market Surveillance (Qualitative Feedback) | ||
| Cutting Performance (Shaver Blades) | Favorable comparison to competitor products (implied effectiveness) | Surgeons' reports "confirm the effectiveness and safety" of the system, addressing cutting performance compared to competition. |
| Suction/Aspiration Capability (Shaver Mode) | Satisfactory performance (implied effectiveness) | Surgeons' reports "confirm the effectiveness and safety" of the system, addressing suction/aspiration capability. |
| Bone Drilling (40,000 rpm) | Favorable comparison to competitor products (implied effectiveness) | Surgeons' reports "confirm the effectiveness and safety" of the system, addressing drilling of bone at 40,000 rpm compared to competition. |
2. Sample Size for Test Set and Data Provenance
- Sample Size: Not explicitly stated in numerical terms for the non-clinical trials. However, the description implies multiple trials were conducted for each test (oyster-flesh/eggshell, scallops flesh, water aspiration). For post-market surveillance, feedback was gathered from "different ENT Surgeons from Italy, Switzerland and China."
- Data Provenance:
- Non-Clinical Trials: Performed by the manufacturer (Bien-Air Surgery SA). The location of these trials is not specified but is presumably Switzerland, where the device was made.
- Post-Market Surveillance: Retrospective collection of feedback (qualitative) from "different ENT Surgeons from Italy, Switzerland and China" after the device had been CE-marked and marketed in Europe since October 2007.
3. Number of Experts and Qualifications for Ground Truth
- Non-Clinical Trials: No mention of external experts establishing ground truth for these trials. The "ground truth" was based on direct observation and measurement of physical parameters (weight removed, aspiration frequency) by the testing personnel, comparing directly to the predicate devices.
- Post-Market Surveillance: "Different ENT Surgeons" provided feedback. Their number is not specified beyond "different," nor are their specific qualifications (e.g., years of experience), though their role as "ENT Surgeons" implies clinical expertise relevant to the device's use. They served as the "experts" providing real-world feedback.
4. Adjudication Method for Test Set
- No formal adjudication method (like 2+1 or 3+1 consensus) is described for either the non-clinical trials or the post-market surveillance.
- In the non-clinical trials, direct measurements were taken and compared.
- For post-market feedback, it appears to be a collection of individual surgeon opinions/experiences, rather than a consensus-driven adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed in the context of this 510(k) submission. This type of study is more common for diagnostic devices (e.g., imaging AI) where human readers interpret results. This submission pertains to a surgical tool, and the "effectiveness" is assessed by physical performance metrics and qualitative surgeon feedback.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- Yes, the non-clinical trials can be considered a form of "standalone" performance assessment in that they evaluated the device's functional capabilities (tissue removal, aspiration) directly, independent of a specific surgeon's technique or interaction in a clinical setting. The device's operation was tested in a controlled environment to simulate its intended function.
7. Type of Ground Truth Used
- Non-Clinical Trials: The ground truth was essentially physical measurements and direct comparison of performance metrics (tissue removal rate, aspiration rate) against the performance of physically existing predicate devices.
- Post-Market Surveillance: The ground truth was based on expert clinical opinion/feedback from ENT surgeons regarding the device's real-world performance (cutting, suction, drilling effectiveness and safety).
8. Sample Size for the Training Set
- Not applicable. This device is a mechanical surgical tool, not an AI/ML algorithm. Therefore, there is no "training set" in the computational sense. The device's design and engineering would be refined through traditional R&D processes, prototypes, and testing rather than machine learning training.
9. How Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for this type of device.
Summary of the Study:
The "study" described in the 510(k) submission is a two-pronged approach to demonstrate substantial equivalence:
- Non-Clinical Performance Assessment: This involved performing laboratory-based trials using simulated tissues (oyster-flesh/eggshell, scallops flesh) and water aspiration tests. The goal was to compare physical performance metrics (tissue removal rate, aspiration results) of the OSSEODUO system directly against two legally marketed predicate devices (Medtronic XPS 3000 and Gyrus Diego). The conclusion was that the OSSEODUO system has a "similar rate of tissue removal" and "equivalent results" for aspiration, with clogging frequency being too variable for meaningful comparison.
- Post-Market Surveillance Feedback: This involved collecting qualitative feedback from "different ENT Surgeons from Italy, Switzerland and China" who had used the OSSEODUO system after its CE-marking in Europe (October 2007). This feedback addressed aspects like cutting performance, suction/aspiration capabilities, and bone drilling, with surgeons reporting confirmation of the system's effectiveness and safety.
Together, these assessments aimed to confirm that the OSSEODUO system is "substantially as safe and effective as the predicate devices," which is the core requirement for 510(k) clearance.
§ 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.