(257 days)
The ClearMedical Reprocessed Used, Disposable Endoscopic Scissors and Graspers have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transaction of tissue.
The Reprocessed SUD (Reprocessed Used, Disposable Endoscopic Scissors and Graspers) is a sterilized SUD. The reprocessed Endopath endoscopic instruments are sterile, single patient use instruments that have a rotating insulated shaft and are designed for use through appropriate surgical trocars. The rotation knob located on the handle rotates the shaft 360 degrees in either direction. Some instruments have a monopolar cautery connector extending from the top of the handle and can be used for electosurgery when properly attached to standard cautery cables and appropriate generators. Other instruments have rachet handles, which allow the instrument jaws to be locked in place. The instrument jaws or scissor blades are activated by compression and release of the ring handles. See instructions for complete mode of operation details. The Reprocessed SUD (Reprocessed Used, Disposable Endoscopic details. The Reprosesses Coasted using EtO sterilization.
The provided text is a 510(k) summary for a reprocessed medical device, the "Reprocessed Used, Disposable Endoscopic Scissors and Graspers." It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove meeting those criteria in the way a new device would.
Therefore, much of the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, ground truth establishment, adjudication methods, and MRMC studies is not present in this document. This document is a regulatory submission for substantial equivalence based on similarity to an existing device.
Here's an analysis of what can be extracted and what is missing:
Description of Acceptance Criteria and Study to Prove the Device Meets Them:
The document does not describe specific acceptance criteria and a detailed study designed to quantitatively prove the reprocessed device meets those criteria with performance metrics (e.g., accuracy, sensitivity, specificity, mechanical performance thresholds). Instead, the submission argues for substantial equivalence to a predicate device based on similar design, materials, intended use, and technological characteristics. The "study" here is implicitly the comparison made to the predicate device to satisfy the FDA's regulatory requirements for substantial equivalence.
1. A table of acceptance criteria and the reported device performance
- Not provided. The document does not contain a table of acceptance criteria or quantitative performance metrics for the reprocessed device. The submission relies on the concept that if the reprocessed device is substantially equivalent to a legally marketed predicate device, its performance is implicitly acceptable for its intended use.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document does not describe a "test set" in the context of performance evaluation with a specific sample size. The substantial equivalence argument is based on a comparison to a predicate device's characteristics, not an independent performance study on a separate dataset of reprocessed devices.
3. 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 specified. This type of information is pertinent to performance studies involving expert review (e.g., for image analysis algorithms). For a reprocessed surgical instrument, "ground truth" would typically relate to functional performance, sterility, and material integrity, which are assessed through engineering and quality control tests, not expert interpretation of data. The document does not detail such specific testing experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically used in clinical or imaging studies where multiple readers interpret data and discrepancies need to be resolved. This is not relevant to the type of substantial equivalence argument presented for a reprocessed surgical instrument.
5. 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
- No such study was done or reported. MRMC studies are relevant for evaluating the impact of AI or new diagnostic tools on human reader performance. This device is a surgical instrument, not an AI-powered diagnostic tool, so an MRMC study is inapplicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a manual surgical instrument. It does not operate as a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Implied Regulatory Ground Truth: The "ground truth" for this submission is the legally marketed predicate device (Ethicon Endoscopic Surgical Instruments, K930933). The substantial equivalence argument posits that the reprocessed device is functionally equivalent to this predicate, thus implicitly sharing its established "ground truth" performance and safety profile from its original approval. Specific, independent "ground truth" data for the reprocessed device's performance, as would be generated for a novel device, is not described.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device, so there is no training set in that context. The "training" for the reprocessed device would be in the quality control processes and procedures established for reprocessing, but this is not discussed in terms of a "training set" for statistical analysis.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary of available information from the document:
- Device Name: Reprocessed Used, Disposable Endoscopic Scissors and Graspers
- Predicate Device: Ethicon Endoscopic Surgical Instruments (K930933), cleared June 22, 2003.
- Basis for Equivalence: Similarities in intended use, material, design, performance, and physical characteristics to the predicate device.
- Reprocessing Method: Ethylene Oxide (EtO) sterilization.
- Intended Use: "indicated for use in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transaction of tissue."
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.