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510(k) Data Aggregation
(148 days)
MEDISISS Reprocessed ENT Ablation Wands (Coblators) are indicated for coagulation, ablation, resection, of soft tissue and hemostasis of blood vessels in otoloaryngology (ENT) procedures including: tonsillectomy/adenoidectomy and soft tissue reduction.
The device is a high frequency, bipolar ablation wand with suction capability that contains an integrated electrical cable and integrated saline delivery system.
The provided text is a 510(k) notification for MEDISISS Reprocessed ENT Ablation Wands (Coblators). This document is for a medical device (an ablation wand) and not for an AI/ML powered medical device. Therefore, the information requested such as "acceptance criteria and the study that proves the device meets the acceptance criteria", "sample size used for the test set and the data provenance", "number of experts used to establish the ground truth", "adjudication method", "multi reader multi case (MRMC) comparative effectiveness study", "standalone (i.e. algorithm only without human-in-the-loop performance)", "type of ground truth used", "sample size for the training set", and "how the ground truth for the training set was established" are not applicable to this document. These questions are typically relevant for discussing studies related to the performance of AI/ML algorithms.
The document focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and performance specifications for regulatory clearance, rather than presenting a study with acceptance criteria in the manner requested for an AI/ML device.
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(101 days)
The SISS Inc. (d.b.a. MediSISS) Reprocessed electrosurgical instruments have applications in a variety of minimally invasive surgical procedures to manipulate and manage internal soft tissue by grasping, cutting, and/or to facilitate coagulation, transection, resection, mobilization, and dissections of tissue.
Reprocessed Electrosurgical Instruments may consist of hand-manipulated devices with electrocautery capability and with or without rotation capability. The handpiece handles are connected to the distal end-effector by a narrow-diameter insulated barrel or shaft. The distal end of the device consists of a variety of distal end configurations including: dissectors (straight or curved), graspers, scissors (curved, hooked, or metzenbaum), shears, and cutting or dissecting forceps. The devices may be monopolar, bipolar, or tripolar. The devices are designed to be inserted through an appropriately sized trocar sleeve or cannula. If the instrument has a scissor or jaw end-effector these are opened and closed using the handles. The device's insulated shaft may be designed to (depending on the device model and type) be rotated (up to 360°) either direction (using a knob on the handle.) The jaws of some models may be rotated by manipulating controls on the handpiece. Grasper and clamp models may have manipulating jaws operated at the handpiece to lock and hold tissue.
The provided text describes a 510(k) premarket notification for reprocessed electrosurgical instruments. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive clinical efficacy studies with specific acceptance criteria as would be found for novel devices or AI/software as a medical device (SaMD).
Therefore, many of the requested categories for acceptance criteria and study details are not applicable (N/A) in this context, as the focus is on process validation and demonstrating that the reprocessed device performs identically to its original counterpart.
Here's the breakdown based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Equivalence | The reprocessed devices undergo mechanical testing to demonstrate that "the parts do not change in function" and that they have "appropriate functional characteristics." The manufacturer states "The technological characteristics of the reprocessed electrosurgical devices are the same as those of the legally marketed predicate devices." |
| Cleaning Validation | "Process validation testing was done to validate the cleaning procedures." Cleaning validations "demonstrate that the devices are equivalent and continue to be safe and effective for their intended use." |
| Sterilization Validation | "Process validation testing was done to validate the sterilization procedures." Sterilization validations "demonstrate that the devices are equivalent and continue to be safe and effective for their intended use." Compliance with ANSI/AAMI/ISO 11135-1994 (Ethylene Oxide Sterilization) and ANSI/AAMI/ISO 10993-7:1995 (Ethylene oxide sterilization residuals) is stated. |
| Packaging Validation | "Process validation testing was done to validate... the device's packaging." Packaging validations "demonstrate that the devices are equivalent and continue to be safe and effective for their intended use." |
| Biocompatibility | "Biocompatibility testing (or certification of the replacement insulation material)" is mentioned as part of the demonstrations for safety and effectiveness. Compliance with ANSI/AAMI/ISO 10993-1: 1997 (Biological Evaluation of Medical Devices Part 1) is stated. |
| Visual/Mechanical testing | "100 % visual and mechanical testing of all products prior to packaging, labeling, and sterilization" is part of the manufacturing process. "Visual and functional testing of all products produced" is also mentioned. Visual/mechanical testing "demonstrate that the devices are equivalent and continue to be safe and effective for their intended use." |
| Materials & Design | "Both the reprocessed devices(s) and the predicate device(s) have the same materials and product design." |
| Indications for Use | "The intended use... of the reprocessed devices do not differ from the legally marketed predicate device(s)." The uses are for "manipulate and manage internal soft tissue by grasping, cutting, and/or to facilitate coagulation, transection, resection, mobilization, and dissections of tissue" in minimally invasive surgical procedures. |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: The document mentions "Representative samples of reprocessed electrosurgical instruments underwent bench testing." However, a specific numerical sample size for the test set is not provided.
- Data Provenance: The testing appears to be internal "bench testing" conducted by SISS Inc. (d.b.a. MediSISS) in the US, as part of their manufacturing and re-processing validation. It is prospective as it's part of a manufacturing validation process.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This type of study (demonstrating substantial equivalence for reprocessed medical devices) does not typically involve expert review for ground truth in the same way an AI/CADe system would. The ground truth here is derived from objective measurements against established specifications for electrosurgical instrument function, cleaning, and sterilization.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are typically relevant for subjective assessments or discrepancy resolution in clinical trials or expert-labeled datasets. This premarket notification relies on objective bench testing and compliance with standards.
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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 a reprocessed medical device, not an AI/CADe system. No human reader studies or AI assistance are involved.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a reprocessed medical device, not an algorithm or AI system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is based on objective performance specifications and compliance with recognized standards (e.g., ISO for sterilization and biocompatibility) for electrosurgical instruments, along with visual and mechanical factory acceptance testing. The "truth" is that the reprocessed device functions identically and safely (e.g., cleaned, sterile, biocompatible) to the original predicate device.
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The sample size for the training set:
- N/A. This device does not involve machine learning or AI, so there is no "training set." The reprocessing "process validation" itself is akin to a training phase in a manufacturing context, ensuring the process consistently yields acceptable products.
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How the ground truth for the training set was established:
- N/A. As there is no AI training set, this is not applicable. The "ground truth" for the reprocessing process validation was established by adherence to industry standards and internal quality control specifications for device functionality, cleanliness, and sterility, verified through scientific methodologies like sterilization validation protocols.
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