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This instrument is indicated for use during gynecologic laparoscopic murgical procedures, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Specific Indications for Use

• unexplained pelvic pain (acute, chronic) .
• infertility work-up ●
• tubal sterilization .
• unexplained primary or secondary amenorthea .
• diagnosis and/or treatment of ectopic pregnancy ●
• evaluation, diagnosis and/or treatment of small pelvic turnors, including ● myomata
• evaluation of congenital anomalies of the pelvic organs .
• retrieval of foreign bodies ●
• determination of the presence and extent of pelvic endometriosis .
• determination of the presence and extent of pelvic inflammatory disease ●
• laparoscopic assisted vaginal hysterectomy ◆
• evaluation of ovarian endocrinopathy ●
• visualization, diagnosis and/or treatment of perforate abdominal organs .

The KSEA MVM 3.3 mm Microendoscope is comprised of a video module, and a endoscope module. The endoscope module is a rigid, panoramic telescope which utilizes rod lens technology. The video module is an imaging device which connects to a camera control unit. The body contact portions of the KSEA MVM 3.3 mm Microendoscope 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 document is a 510(k) summary for the Karl Storz MVM 3.3 mm Microendoscope. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria.

Therefore, the information requested below cannot be fully extracted from the provided text, as it describes a clearance process based on substantial equivalence, not a performance study against predefined acceptance criteria for AI/diagnostic devices.

Here's an attempt to answer based on the available information and highlight what is missing:

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

No explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are provided in this 510(k) summary. The document states that "minor differences between the KSEA MVM 3.3 mm Microendoscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices." This implies that the device's performance is considered to be equivalent to the predicate devices, but no specific performance data is given.

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

Not applicable. This is not a performance study against a test set with clinical data.

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. No ground truth establishment for a test set is described.

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

Not applicable. No test set or adjudication method is described.

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 device is a video endoscope, not an AI-powered diagnostic tool. No MRMC study is mentioned.

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

Not applicable. This device is a video endoscope, not an algorithm.

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

Not applicable. No ground truth for a performance study is described. The "ground truth" in 510(k) for substantial equivalence often refers to the understanding and performance of the predicate devices.

8. The sample size for the training set

Not applicable. This document is not describing an AI/machine learning model where a training set would be used.

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

Not applicable. No training set or associated ground truth establishment is described.

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The KSEA MVM 3.3 mm Microendoscope is designed to be used by qualified surgeons and physicians for general endoscopic and laparoscopic surgical procedures.
This instrument is indicated for use during general endoscopic and laparoscopic surgical procedures, and, using additional accessories, to perform-variousdiagnostic and therapeutic procedures.

The KSEA MVM 3.3 mm Microendoscope is comprised of a video module, and a endoscope module. The endoscope module is a rigid, panoramic telescope which utilizes rod lens technology. The video module is an imaging device which connects to a camera control unit. The body contact portions of the KSEA MVM 3.3 mm Microendoscope 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 510(k) summary for the Karl Storz MVM 3.3 mm Microendoscope does not contain information about acceptance criteria or a study proving the device meets said criteria.

The document is a standard 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance criteria and associated studies for a novel or significantly modified device. The key elements discussed in the provided text are:

• Applicant and Device Identification: Karl Storz Endoscopy - America, Inc., MVM 3.3 mm Microendoscope.
• Indication: General endoscopic and laparoscopic surgical procedures.
• Device Description: Comprised of a video module and an endoscope module, made of surgical grade stainless steel.
• Substantial Equivalence: Claimed by virtue of same basic features, design, and intended uses as predicate devices. The minor differences are stated not to raise new issues of safety and effectiveness.
• Regulatory Status: Communication from FDA confirming substantial equivalence and allowing marketing.

Therefore, I cannot provide the requested table or answer the specific questions regarding acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.

Ask a specific question about this device