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The KSEA Rigid Culdoscope and Accessories is intended for use by qualified surgeons for viewing the organs within the peritoneal cavity, via a posterior vaginal fornix entry, using CO2 gas insufflation. This Culdoscope is not intended for trausvaginal hydrolaparoscopy (transflotation). This Culdoscope has the following diagnostic indications:

• Unexplained pelvic pain (acute, chronic)
• Menstrual abnormalities
• Infertility and sterility
• Indefinite pelvic mass
• Ectopic pregnancy
• Pelvic endometriosis
• Polycystic ovaries
• Pelvic inflammatory disease
• Pain mapping
• Congenital anomalies of the pelvic organs

The KSEA Culdoscope and Accessories are manual reusable surgical devices. The KSEA Culdoscope and Accessories are composed of a Forward-Oblique 300 Telescopes, Culdoscope Sheath and a sharp obturator. The body contact portions of the KSEA Culdoscope and Accessories are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

The provided text is a 510(k) Summary for a medical device (KSEA Culdoscope and Accessories). This type of document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) Summary like this typically does not include detailed studies with acceptance criteria and performance data in the way a clinical trial report or a performance validation study for an AI/software device would. The purpose of a 510(k) is to show equivalence, often based on comparison to existing devices and basic engineering/design specifications, rather than extensive clinical efficacy data.

Therefore, many of the requested points cannot be answered from the provided text because such information is not part of a standard 510(k) summary for this type of device (a manual, reusable surgical instrument).

Here's a breakdown of what can be inferred and what cannot:

1. A table of acceptance criteria and the reported device performance

• Not Applicable / Not Provided. The document describes a manual surgical instrument. Acceptance criteria for such a device would typically relate to manufacturing specifications (e.g., material compliance, dimensions, finish, sterilization compatibility, durability), rather than performance metrics like sensitivity, specificity, or improvement in diagnostic accuracy that would be relevant for an AI/software device. No specific acceptance criteria or quantitative performance data are presented in this 510(k) summary. The summary focuses on comparing its features and intended use to predicate devices to establish substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided. This 510(k) does not describe a "test set" in the context of performance validation data for an AI/software device. The submission is for a physical medical instrument.

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 Provided. Ground truth establishment is not relevant for this type of device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable / Not Provided. Adjudication methods are not relevant for this type of device submission.

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 / Not Provided. This is a manual surgical instrument, not an AI/software device. Therefore, no MRMC study, AI assistance, or effect size is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable / Not Provided. This is a manual surgical instrument, not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable / Not Provided. Ground truth is not a concept applied to the approval process for this type of device as presented in this 510(k) summary.

8. The sample size for the training set

• Not Applicable / Not Provided. There is no "training set" for a manual surgical instrument in this context.

9. How the ground truth for the training set was established

• Not Applicable / Not Provided. Ground truth for a training set is not relevant for this type of device submission.

Summary based on the Provided Text:

The provided document is a 510(k) premarket notification for a KSEA Culdoscope and Accessories, a manual, reusable surgical device. The intent of the submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to provide detailed clinical performance data or studies with acceptance criteria as one would find for an AI/software device.

The "study" referenced in a 510(k) of this nature is primarily the comparison of the device's design, materials, and intended use against a predicate device. The key assertion is that "The minor differences between the Karl Storz Culdoscope and Accessories and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices." This statement is the "proof" within the 510(k) framework that the device "meets" the safety and effectiveness requirements by demonstrating it's as safe and effective as a device already on the market.

Therefore, many of the questions related to AI/software performance validation are not applicable to this document or the device it describes.

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Circon's Rigid Culdoscopes and Accessories are intended for viewing pelvic organs endoscopically via a posterior vaginal fornix entry. Culdoscopy is indicated for: Unexplained pelvic pain (acute, chronic), Menstrual abnormalities, Infertility and sterility, Indefinite pelvic mass, Ectopic pregnancy, Pelvic endometriosis, Polycystic ovaries, Pelvic inflammatory disease, Pain mapping, Congenital anomalies of the pelvic organs.

CIRCON's Rigid Culdoscopes and Accessories are rod lens-type endoscopes which consist of imaging optics and fiber optic illumination fibers contained within a stainless steel sleeve. Light from a high intensity light source is transmitted to the scope by a fiber optic light guide that is detachably connected to a light post on the body of the scope. The light is carried by the illumination fibers to the target. A distal lens focuses an image of the target onto the rod lens train. The image is transmitted to the proximal end of the scope, where it is magnified and focused by an eyepiece ocular. The image may be viewed directly through the eyepiece, or the scope may be connected to a video system via a standard endoscopic video coupler.

The provided document is a 510(k) summary for the CIRCON Rigid Culdoscope and Accessories (K980972). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through clinical trials or performance studies with detailed statistical analysis.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement.

Here's why and what the document does provide:

• Acceptance Criteria and Reported Device Performance (1): This information is not present. The 510(k) process for this device relies on demonstrating that the new device is "substantially equivalent" to predicate devices already on the market prior to May 28, 1976. This typically involves comparing design, materials, intended use, and operating principles, rather than presenting new performance data against specific acceptance criteria.
• Sample Size for Test Set and Data Provenance (2): Not applicable, as no performance study data is presented.
• Number of Experts and Qualifications for Ground Truth (3): Not applicable, as no ground truth establishment for a test set is described.
• Adjudication Method (4): Not applicable.
• Multi-reader Multi-case (MRMC) Comparative Effectiveness Study (5): This is not a study type relevant to a 510(k) submission for a culdoscope in 1998, which is focused on physical and functional equivalence to existing devices. Therefore, no such study is described, nor is any effect size for human readers with or without AI assistance.
• Standalone Performance Study (6): No standalone performance study (algorithm only) is mentioned, as this device is a physical medical instrument, not an AI or software-only device.
• Type of Ground Truth Used (7): Not applicable, as no performance evaluations against a ground truth are described.
• Sample Size for Training Set (8): Not applicable, as no machine learning model or training set is involved.
• How Ground Truth for Training Set was Established (9): Not applicable.

What the document does provide in lieu of performance data:

The core of this 510(k) submission is the demonstration of substantial equivalence to predicate devices.

• Name of Device: Rigid Culdoscope and Accessories
• Intended Use: "CIRCON's Rigid Culdoscopes and Accessories are intended to be used for direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures. The system is introduced into the pelvic cavity through the posterior vaginal fornix."
• Indications for Use: Unexplained pelvic pain, menstrual abnormalities, infertility and sterility, indefinite pelvic mass, ectopic pregnancy, pelvic endometriosis, polycystic ovaries, pelvic inflammatory disease, pain mapping, congenital anomalies of the pelvic organs.
• Predicate Devices: ACMI's Decker Culdoscope and Decker Operating Culdoscope, Karl Storz Endoscopy America, Inc.'s Culdoscopes, and Richard Wolf Medical Instrument Corp.'s Fiber Light Culdoscopes. All were marketed prior to May 28, 1976.
• Comparison of Technical Characteristics: "CIRCON's scopes employ the same design considerations and operating principles as the legally marketed predicate devices, and each can be sterilized and reused. Any differences between these culdoscopes do not raise new questions regarding safety or effectiveness."

In summary, this document is a regulatory submission focused on demonstrating equivalence in design and intended use to pre-existing devices, rather than presenting a study proving performance against specific acceptance criteria.

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