(413 days)
Integra™ Jarit® Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecologic surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument for grasping, dissecting and/or other manipulation of soft tissue is determined to be appropriate by the surgeon. For those instruments with electrosurgical capability, current can be used for coagulation and/or cutting as determined necessary and appropriate by the surgeon.
Integra™ Jarit® Take-Apart Endoscopic Instruments easily separate into three components - insert, shaft, and handle. Inserts include graspers, dissectors, scissors, biopsy forceps and specialized spoon forceps. Inserts connect to either a 5mm or 10mm diameter shaft with lengths of 350mm or 425mm; inserts and shaft connect to monopolar handles which are available with/without rotation or ratchets. The reusable devices are packaged non-sterile and are steam sterilizable.
The provided text describes the Integra™ Jarit® Take-Apart Endoscopic Instruments and summarizes performance data to demonstrate substantial equivalence to predicate devices, rather than a study testing against specific acceptance criteria for a new AI/software device. The information requested (multi-reader multi-case study, standalone performance, ground truth establishment for training, etc.) is typically associated with AI/ML-driven medical devices, which this submission is not.
Therefore, the response below is based on the performance testing reported for this physical medical device (endoscopic instruments) and will interpret "acceptance criteria" as meeting the "Pass" result for each test performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Testing Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Manual Cleaning Validation (Spore Log Reduction) per AAMI TIR30:2003. | "Pass" (specific reduction not provided) | Pass |
| Mechanical Cleaning Validation (Spore Log Reduction) per AAMI TIR30:2003. | "Pass" (specific reduction not provided) | Pass |
| Manual Cleaning Validation (Protein Analyses) per AAMI TIR30:2003. | "Pass" (specific protein level not provided) | Pass |
| Mechanical Cleaning Validation (Protein Analyses) per AAMI TIR30:2003. | "Pass" (specific protein level not provided) | Pass |
| Pre-Vacuum (wrapped) Steam Sterilization Validation per ISO at 132°C with an Exposure Time of 4 minutes and a Minimum Drying Time of 20 minutes. | "Pass" (sterility assurance level not provided) | Pass |
| Biocompatibility Testing for both PEEK and PPSU materials according to ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation & Sensitization) | "Pass" (specific criteria from ISO standards applied) | Pass |
| Electromagnetic Compatibility & Safety Testing per IEC-60601-2-2:09.2007 according to manufacture's rated voltage 3,000 VB and tested frequency of 450 kHz. | "Pass" (specific criteria from IEC standard applied) | Pass |
| Load validation of intended use during surgery. | "Pass" (specific criteria not provided) | Pass |
| Mechanical Endurance Test | "Pass" (specific criteria not provided) | Pass |
| Reprocessing Test - 100 Autoclave Cycles per DIN EN 285 at 134°C with an exposure time of 5 minutes. | "Pass" (specific criteria from DIN EN standard applied) | Pass |
| Corrosion Resistance Testing for all Metal parts according to Boiling Test DIN EN ISO 13402. | "Pass" (specific criteria from DIN/ISO standard applied) | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (e.g., number of instruments, number of cycles) for each validation or test. The testing appears to be conducted in a laboratory setting to demonstrate compliance with various standards (e.g., AAMI, ISO, IEC, DIN EN) for reprocessing, biocompatibility, electrical safety, and mechanical endurance. The data provenance is not explicitly stated as retrospective or prospective in the context of clinical studies but rather as laboratory testing results. The country of origin of the data is not specified beyond the manufacturer being Integra York PA, Inc., USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is typically relevant for studies involving human interpretation or subjective assessment with expert consensus. For the described validation and performance tests of a physical medical device (endoscopic instruments), "ground truth" is established by adherence to recognized international technical standards and laboratory testing protocols. The document does not specify human experts for establishing "ground truth" in this context.
4. Adjudication method for the test set
Not applicable. This concept (e.g. 2+1, 3+1) is typically used for clinical review of medical images or data where human experts review and adjudicate discrepancies, commonly found in AI/ML performance studies. Here, performance is evaluated against defined technical standards and test methods.
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
Not applicable. This is a premarket notification (510(k)) for a physical medical device (endoscopic instruments), not an AI/ML-driven software device. Therefore, no MRMC study or AI assistance evaluation was performed or is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this device is a physical medical instrument, not a software algorithm.
7. The type of ground truth used
For the various performance tests (cleaning, sterilization, biocompatibility, electrical safety, mechanical endurance, corrosion resistance), the "ground truth" is defined by the specific, objective criteria outlined within the cited national and international standards (e.g., AAMI TIR30:2003, ISO 10993, IEC-60601-2-2, DIN EN 285, DIN EN ISO 13402). For example, for sterilization, the ground truth would be achieving a specified Sterility Assurance Level (SAL), and for cleaning, a specified reduction in microbial load or protein residue, as per the standard. There is no mention of expert consensus, pathology, or outcomes data as a primary ground truth in this context.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device. Therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML model, this question is not relevant to the provided submission.
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).