(87 days)
Reprocessed endoscopic trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecological or other minimally invasive surgical procedures. Trocars are single patient used devices.
AMI intends to market Surgical Trocars that have been reprocessed. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready. AMI is a third party reprocessor. If all protocol parameters are met, AMI will reprocess each disposable trocar up to two times. Trocars are sold new by the original manufacture to the hospital uses the trocars, collects them and ships them to AMI for reprocessing. Trocars are reprocessed by AMI as described in our reprocessing protocol Control Document Number 40005 and returned to the hospital to be reused. Trocars that do not meet the AMI protocol are rejected. Rejection may occur during the first reprocessing (in which the trocar is not reprocessed at all) or second reprocessing.
The provided text describes a 510(k) submission for reprocessed disposable trocars by Adven Medical, Inc. (AMI). It focuses on establishing substantial equivalence to new disposable trocars and the reprocessing protocol. However, the document does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and the specifics of a study proving device performance against those criteria.
Specifically, the document states: "AMI has performed numerous tests to validate its reprocessing protocol." but does not elaborate on:
- The specific acceptance criteria used for these tests.
- The reported performance statistics from these tests.
- The sample size, data provenance, number of experts, adjudication methods, or ground truth details for these tests.
- Any information regarding MRMC studies or standalone algorithm performance.
Therefore, many sections of your request cannot be fulfilled with the provided text. I will provide the information that is available.
Acceptance Criteria and Study for Reprocessed Disposable Trocars
Based on the provided text, the primary "acceptance criteria" for the reprocessed trocars hinge on demonstrating that they remain "safe and effective for its intended use" after reprocessing, are "able to withstand the necessary cleaning and sterilization process," and that "the physical characteristics or quality of the device will not be adversely effected." The foundational study mentioned is the validation of AMI's reprocessing protocol.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance (Implied from 510(k) Clearance) |
|---|---|---|
| Safety and Effectiveness | Device remains "safe and effective for its intended use" after reprocessing. | The FDA's 510(k) clearance (K013987) indicates that the "device is substantially equivalent" to legally marketed predicate devices, implying that AMI successfully demonstrated the reprocessed trocars meet the same safety and effectiveness standards as new, single-use trocars. |
| Physical Characteristics/Quality | "The physical characteristics or quality of the device will not be adversely affected" by reprocessing. | FDA clearance for marketing suggests that physical characteristics and quality were maintained to a degree comparable to the original, new device, supporting the "substantially equivalent" determination. |
| Reprocessing Durability | Device is "able to withstand the necessary cleaning and sterilization process." Each trocar can be reprocessed "up to two times." | The approval of the reprocessing protocol (Control Document Number 40005) and the statement that AMI "will reprocess each disposable trocar up to two times" indicates that testing confirmed the device's ability to endure the specified reprocessing steps while maintaining functionality and integrity for the stated number of cycles. Trocars not meeting the protocol are "rejected." |
| Substantial Equivalence to Predicate Device | The reprocessed device is "substantially equivalent" to predicate devices currently on the market for single use, in terms of indications for use and technological characteristics. Reprocessed trocars provide "a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures." | The FDA's 510(k) clearance explicitly states the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This is the core finding of the FDA. The predicate devices are identified as trocars sold by original manufacturers and cleared for single use (KAB, KBG, KCI, FBQ, FBM, GCJ, DRC). This equivalence extends to the stated "Indications For Use." |
2. Sample size used for the test set and the data provenance:
- The document states: "AMI has performed numerous tests to validate its reprocessing protocol." However, it does not specify the sample size for these tests.
- Data Provenance: The origin of the data (e.g., country of origin, retrospective or prospective) is not specified in the provided text. It can be inferred that the testing would have been conducted primarily in the USA, as AMI is a US-based company submitting to the US FDA. The nature (retrospective/prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The validation tests mentioned likely refer to engineering and biocompatibility testing rather than expert-based clinical ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
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 MRMC study information is provided. This type of study is not relevant to the validation of a reprocessed surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This concept is not applicable as the device is a physical surgical instrument, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a reprocessed surgical instrument, the "ground truth" for the validation tests would likely involve a combination of:
- Functional Testing: Demonstrating the device continues to perform its intended mechanical function (e.g., proper insertion, seal integrity, port function) after reprocessing.
- Material Integrity Testing: Ensuring no degradation of materials, corrosion, or structural compromise.
- Cleaning Efficacy/Sterilization Validation: Demonstrating successful removal of bioburden and successful sterilization, typically through laboratory methods (e.g., protein residue tests, sterility tests).
- Biocompatibility Testing: Ensuring reprocessed devices remain biocompatible.
- Specific details on how these were established are not provided, beyond the general statement of "numerous tests".
8. The sample size for the training set:
- This concept is not applicable as the device is a physical surgical instrument, not an AI algorithm.
9. How the ground truth for the training set was established:
- This concept is not applicable as the device is a physical surgical instrument, not an AI algorithm.
§ 874.4420 Ear, nose, and throat manual surgical instrument.
(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.