(123 days)
The Electric Drill System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone in Head & Neck / ENT (Otologic, Neurologic, Neurotologic, Sinus, Rhinologic, Nasopharyngeal / Laryngeal), Oral / Maxillofacial, and Plastic / Reconstructive / Aesthetic Surgical Procedures.
The electric drill system consists of a power console, footswitches, connection cables, irrigation / cooling tubing sets, a remote irrigation control unit, and assorted handpieces to drive various burs, blades, drills, rasps, and saw blades. The system can also function as an endoscope lens cleaning system.
This 510(k) summary (K081277) describes the Electric Drill System (XPS 4000 System, Midas Rex Legend Drill System, Integrated Power Console (IPC)) from Medtronic Xomed, Inc. This submission is for a surgical device, and as such, the acceptance criteria and study information provided are related to demonstrating substantial equivalence for engineering performance and intended use, rather than diagnostic accuracy metrics typically found for AI/ML devices.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies, formatted to address your specific points where applicable:
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative "acceptance criteria" in terms of specific performance thresholds (e.g., sensitivity, specificity, or error rates) as would be typical for AI/ML diagnostic devices. Instead, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices. The "acceptance criteria" are implied to be that the new device performs equivalently or comparably to the predicate devices in terms of its intended use and functional characteristics.
The table below summarizes the characteristics compared between the new device and the predicate devices, effectively serving as the "performance" report for demonstrating this equivalence.
Table 1: Acceptance Criteria (Implied Equivalence) and Reported Device Performance
| Characteristic | Implied Acceptance Criteria (Equivalent to Predicate) | New Device Performance (XPS 4000 System, Midas Rex Legend EHS System, Integrated Power Console) | Predicate Device 1 Performance (Medtronic Xomed XPS 3000 Electric System) | Predicate Device 2 Performance (Medtronic Powered Surgical Solutions (MPSS) Electric System) | Predicate Device 3 Performance (Linvatec Advantage Drive Electric System) |
|---|---|---|---|---|---|
| Indications for Use | Must be substantially equivalent or broader while maintaining safety and effectiveness. | Incision/cutting, removal, drilling, sawing of soft and hard tissue/bone in Head & Neck/ENT, Oral/Maxillofacial, Plastic/Reconstructive/Aesthetic Surgical Procedures. | Incision/removal of soft & hard tissue/bone in general otorhinolaryngology, head & neck, and otoneurological surgery. ( 詳細な適応症は別のセクションで記載) | Neurosurgical, Spine, Orthopedic Surgery, General Surgery, ENT, Maxillofacial, Craniofacial. | Cutting of soft tissue and bone in Arthroscopic, Foot, Hand, Medial Sternotomy, Neurosurgical, Orthopedic, Otlaryngological, Oral/Maxillofacial, Plastic/Reconstructive, and Spinal surgical procedures. |
| Handpieces Compatibility | Must be compatible with relevant handpiece types for intended use. | Drills, Microdebriders, Saws | Drills, Microdebriders | Drills | Drills, Microdebriders, Saws |
| Pumps used for | Must perform necessary pump functions (irrigation, cooling, etc.). | Irrigation, Motor Cooling, Scope Cleaning | Irrigation, Motor Cooling | Irrigation | Irrigation, Motor Cooling |
| Stim Guard Capable | Presence or absence of this safety feature. | Yes | Yes | No | No |
| Provided Sterile | Sterilization status. | No | No | No | No |
| Foot control | Presence of foot control. | Yes | Yes | Yes | Yes |
| Tubing sets | Presence of tubing sets. | Yes | Yes | Yes | Yes |
| Blade/bur/drill bit | Compatibility with relevant accessories. | Yes | Yes | Yes | Yes |
| Irrigation Remote | Presence or absence of irrigation remote. | Yes | No | No | Unknown |
| External Software Upgradable | Presence or absence of this feature. | Yes | No | No | No |
| Patient Contact (console/handpiece) | Whether console/handpiece contacts patient. | No | No | No | No |
| Patient Contact (tubing set (fluid path)) | Whether tubing set (fluid path) contacts patient. | Yes | Yes | Yes | Yes |
| Patient Contact (blade/bur/drill bit) | Whether blade/bur/drill bit contacts patient. | Yes | Yes | Yes | Yes |
Here's an assessment for the specific points you requested:
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A table of acceptance criteria and the reported device performance
- See the table above. The "acceptance criteria" is implicit in demonstrating substantial equivalence to the predicate devices across the listed characteristics. The "reported device performance" is the description of the new device's features and capabilities, which are directly compared to the predicates.
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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. This is a submission for a mechanical/electrical surgical device, not an AI/ML diagnostic device that relies on a "test set" of data. The "study" here is a demonstration of substantial equivalence through comparison of specifications, intended use, and likely bench testing (though detailed results of bench testing are not explicitly in this summary). There is no "data" in the sense of patient-derived images or clinical measurements that would require a sample size, provenance, or retrospective/prospective classification.
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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 explained above, there is no "ground truth" test set of clinical data for this type of device. The ground truth for a surgical drill system would be its functional performance against engineering specifications and its safety profile, which are assessed through engineering tests, risk analyses, and comparison to predicate devices, not expert consensus on data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No test set requiring expert adjudication is relevant for this device.
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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 is not an AI-assisted diagnostic device, so an MRMC study is not applicable. The device is a surgical tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical surgical device, not an algorithm. Its performance is inherent in its mechanical and electrical function under human control.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For a surgical drill system, the "ground truth" (or basis for verification and validation) is related to its engineering specifications, safety standards compliance, and functional performance in simulated and (potentially) animal/cadaveric models. This would include criteria like:
- Motor speed consistency and torque output.
- Thermal management (to prevent tissue damage).
- Vibration levels.
- Noise levels.
- Sterilization efficacy for reusable components.
- Biocompatibility of patient-contacting materials.
- Electrical safety.
- Mechanical integrity and durability.
- The "study" cited in the 510(k) is primarily a comparison to predicate devices to demonstrate substantial equivalence based on these functional and safety attributes, leading to the regulatory clearance.
- For a surgical drill system, the "ground truth" (or basis for verification and validation) is related to its engineering specifications, safety standards compliance, and functional performance in simulated and (potentially) animal/cadaveric models. This would include criteria like:
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The sample size for the training set
- N/A. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established
- N/A. This is not an AI/ML device that requires a training set or its associated ground truth establishment.
In summary, the provided document is a 510(k) summary for a Class II surgical device (electric drill/saw system). The "acceptance criteria" and "study" are focused on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technological characteristics, intended use, and functional performance, rather than the statistical performance metrics and data sets common in AI/ML device submissions.
§ 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.