(149 days)
The Celeris System (reusable power pack and Disposable Sinus Debrider) is intended for cutting, debriding, and removal of thin bone and soft tissue in general ENT and Sinus/Rhinology procedures and applications would include:
· FESS (Functional Endoscopic Sinus Surgery) – Including Endoscopic approaches for: Polypectomy, Sphenoidectomy, Maxillary Antrostomy, Uncinectomy, Frontal Sinusotomy
· Turbinate Reduction / Turbinoplasty, including sub-mucosal resection.
The Celeris DSD handpiece is a single-use disposable debrider handle and blade permanently combined with a built-in motor that plugs into a reusable power pack that contains a power supply for motor control. The power pack is also part of the subject system. The power supply is able to auto-adapt to any voltage via the universal power cord connection. Motor control requires software on a controller board inside the power pack.
The handpiece incorporates a rotatable blade and attached RF cable for bipolar models. The blades are either standard, bipolar, or malleable. The bipolar function requires a separate electrosurgical generator (not part of this system), connected via a cable. The cutting performance is equivalent to the current Gyrus ACMI predicate models.
A trigger style button on the DSD handle, or analog footswitch (sold separately) connected to the power pack, activates the blade oscillation and a standard electrosurgical unit footswitch (sold separately) powers the binolar effect for bipolar blades. The electrosurgical generator and footswitch alone will control the RF energy delivery.
A nosecone on the DSD handpiece allows the blade cutting window to rotate left or right. The blades are offered in 2mm and 4mm variants, either straight or malleable, and standard or bipolar. The malleable blade angle is flexible, and the design allows the blade to be bent with the provided bending fixture up to 60° at the user's discretion.
A standard suction tube (sold separately) is attached to the DSD handpiece proximal suction port and a clip attaches the tubing to the power cable. The handpiece power cable plugs directly into the power pack. The non-sterile power pack plugs into a standard power outlet and only provides power to the connected DSD handpiece. When the handpiece is activated power is sent to the motor which oscillates a gear which in turn oscillates the inner blade. For bipolar models, the energy lead from the cable is connected directly to the blade and energy is provided by the separate electrosurgical generator footswitch. For bipolar models, insulation around the cutting window limits energy delivery to the surgical site.
The provided document is an FDA 510(k) summary for the Gyrus ACMI Celeris Disposable Sinus Debrider. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to a predicate device.
However, the document does not describe a study involving an AI/algorithm model that processes data (like images) to provide diagnostic or prognostic information. Instead, it describes a physical medical device used for surgical procedures. Therefore, many of the requested criteria related to AI/algorithm performance, ground truth, expert review, sample size for test/training sets, and MRMC studies are not applicable to this submission.
Based on the information provided for this physical surgical device, here's an attempt to address the applicable parts of your request:
Acceptance Criteria and Device Performance (Based on the provided document for a physical surgical device):
The document details various non-clinical and preclinical tests to demonstrate the device's safety, effectiveness, and substantial equivalence to existing predicate devices. The "acceptance criteria" for a physical device like this are typically derived from recognized standards, performance requirements, and comparisons to predicate devices. The "reported device performance" indicates that the device met these criteria.
While not presented in a formal table with specific quantitative thresholds as one might expect for an AI model, the document implies the following acceptance criteria were met:
Table 1: Acceptance Criteria and Reported Device Performance (Adapted for a Physical Surgical Device)
| Acceptance Criterion (Type of Test) | Description of Test | Reported Device Performance |
|---|---|---|
| Electrical Safety & EMC | Adherence to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2 standards. | Basic safety and performance testing performed in accordance with standards. |
| Mechanical & Functional Performance | Evaluation against predicate devices to ensure similar operation and performance. | Verification and comparison bench studies conducted; performance comparable to predicate. |
| Stability/Shelf Life | Accelerated aging and real-time aging studies to confirm functionality over time. | Device maintains functionality and meets specifications over its stated shelf-life. |
| Preclinical (Tissue Performance) | Ex vivo bovine tissue tests (thermal margin/impact, coagulation, microscopic measurements) | Performs substantially equivalent to predicate devices in usability, cutting, coagulation, and tissue removal. |
| Biocompatibility | Testing to ISO 10993-1, 10993-5, 10993-7, 10993-10. | Full GLP biocompatibility testing on file; supporting data for cytotoxicity, sensitization, and acute systemic toxicity. |
| Sterility | Validation of ETO sterilization cycle. | Validated cycle to provide a sterility assurance level of 10^-6. |
| Packaging Integrity | Testing to ISO 11607-1, ASTM F88/F88M, ASTM F1886. | Implied as part of overall stability/sterility validation. |
| Software Validation | Software development and validation per concern level and guidance (IEC 62304). | Completed per the level of concern and guidance. |
| Risk Analysis | Performed in accordance with ISO 14971. | Carried out; design verification sample sizes and tests identified. |
Here's an assessment of the other points, noting their applicability to a physical device rather than an AI/algorithm:
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify exact sample sizes for each non-clinical or preclinical test (e.g., how many units were tested for electrical safety, or how many tissue samples were used for performance evaluation). It mentions "representative samples" for stability testing.
- Data Provenance: The tests are described as "non-clinical" and "preclinical," involving bench testing and ex vivo bovine tissue. There is no mention of human clinical data or patient data being used for these performance tests. Therefore, concepts like "country of origin" or "retrospective/prospective" studies for patient data are not applicable to the described performance testing.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is highly relevant for AI/algorithm performance where "ground truth" often comes from expert adjudication of medical images or data.
- For this physical surgical device, "ground truth" for performance is typically established by physical measurements, adherence to engineering specifications, and established biological responses in ex vivo models. There is no mention of expert consensus establishing a "ground truth" as would be done for an AI diagnostic tool. Qualifications would be standard engineering and biological testing expertise.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable in the context of testing a physical device's mechanical, electrical, or tissue interaction properties. Adjudication methods are typically for evaluating subjective interpretations, such as expert consensus on medical image findings.
-
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. This is designed for AI assistance in diagnostic tasks. The Celeris system is a surgical tool, not a diagnostic aid for human readers. No MRMC study was performed or needed for this type of device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device itself is a tool that requires human operation; it doesn't have a standalone algorithm that performs a task without human interaction in the way an AI diagnostic algorithm would. The "software" mentioned is for motor control within the power pack, not a standalone diagnostic algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this physical device, the "ground truth" for its described performance tests are:
- Electrical/Safety: Adherence to established international electrical safety standards.
- Mechanical/Functional: Engineering specifications, comparative performance to predicate devices' known characteristics, and objective measurements of mechanical output (e.g., cutting performance).
- Biocompatibility: Results of standardized biological tests (cytotoxicity, sensitization, etc.) as per ISO 10993 series.
- Sterility: Validation of sterilization protocols to achieve specific sterility assurance levels.
- Preclinical (Tissue): Objective measurements on ex vivo bovine tissue and visual comparisons (e.g., thermal impact, coagulation).
- For this physical device, the "ground truth" for its described performance tests are:
-
The sample size for the training set:
- Not applicable. As this is not an AI/machine learning device, there is no "training set."
-
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI model.
In summary, the provided document describes the regulatory submission for a traditional surgical device. Therefore, the questions related to AI/algorithm performance, training data, ground truth establishment by experts, and MRMC studies are not relevant to this specific device submission. The device's substantial equivalence and safety/effectiveness were demonstrated through engineering bench tests, preclinical ex vivo studies, and adherence to recognized performance and safety standards.
§ 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.