(90 days)
The KSEA Culdocentesis Set are intended for use by qualified surgeons or physicians in the collection of peritoneal fluid.
The KSEA Culdocentesis Set are manual reusable surgical devices (with two single-use disposable components). The KSEA Culdocentesis Set provides a high success rate in the collection of peritoneal fluid, while minimizing the problems of conventional culdocentesis. The body contact materials are surgical grade stainless steel, PTFE, and polyurethane. The non-body contact materials of the Culdocentesis Set are silicone, polyolefin, and PVC.
This submission (K962881) describes a manual surgical device (Culdocentesis Set), not an AI/ML-driven device or diagnostic software. Therefore, the questions related to AI/ML performance, ground truth, expert review, sample sizes for training/test sets, and multi-reader studies are not applicable.
The 510(k) summary focuses on establishing substantial equivalence to predicate devices for a physical medical instrument.
Here's a breakdown based on the provided text, indicating why most of your requested information is not present for this type of submission:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
| Information Category | Response |
|---|---|
| 1. Table of Acceptance Criteria & Reported Performance | Not Applicable (N/A) as defined for AI/ML. For physical devices like this, "acceptance criteria" and "performance" are typically addressed through comparison to a predicate device, demonstrating similar features, design, and intended use as safe and effective. The 510(k) summary states: "The KSEA Culdocentesis Set provides a high success rate in the collection of peritoneal fluid, while minimizing the problems of conventional culdocentesis." However, specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) or predefined acceptance thresholds are not provided in this summary. |
| 2. Sample size and data provenance (test set) | N/A. This is a manual surgical device. There is no "test set" of data in the context of an AI/ML algorithm evaluation. |
| 3. Number of experts and qualifications (ground truth) | N/A. Ground truth for AI/ML is not relevant for a manual surgical instrument. |
| 4. Adjudication method (test set) | N/A. Not applicable to a manual surgical instrument. |
| 5. Multi-Reader Multi-Case (MRMC) comparative study | N/A. Not applicable to a manual surgical instrument. |
| 6. Standalone (algorithm only) performance study | N/A. Not applicable as this is not an algorithm. |
| 7. Type of ground truth used | N/A. Not applicable to a manual surgical instrument. |
| 8. Sample size for the training set | N/A. Not applicable, as there is no AI/ML model to train. |
| 9. How ground truth for training set was established | N/A. Not applicable, as there is no AI/ML model to train. |
Summary of Device Performance (from the document):
The device "provides a high success rate in the collection of peritoneal fluid, while minimizing the problems of conventional culdocentesis."
Proof of Meeting Acceptance Criteria (as per 510(k) submission for manual devices):
The primary "proof" in this 510(k) summary is the demonstration of Substantial Equivalence to legally marketed predicate devices. The submission asserts:
- "The KSEA Culdocentesis for collection of peritoneal fluid are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar."
- "The minor differences in design and dimensions between the K.SEA Culdocentesis Set and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices."
This means the device is considered to meet "acceptance criteria" (i.e., being safe and effective for its intended use) because it is essentially the same as other devices already on the market that have been deemed safe and effective.
§ 884.1640 Culdoscope and accessories.
(a)
Identification. A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used through an operating channel, scope preheaters, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for culdoscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such culdoscope accessory instruments include: lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable) scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.