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The Schoelly Cystoscopes/Hysteroscopes and Accessories with additional Optical Grasping Forceps (51-0575a) and Optical Scissor (51-0576a) are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the use of the devices include the visualization and manipulation of anatomy as the surgeon deems appropriate. The Schoelly Cystoscopes/Hysteroscopes and Accessories with additional Optical Grasping Forceps (51-0575a) and Optical Scissor (51-0576a) are intended to be used in general urological and gynecological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.

The Schoelly Cystoscope/Hysteroscope and Accessories comprise several models of rigid endoscopes as well as rigid endoscopic sheaths, obturators, and instrument bridges; the currently marketed system also includes a flexible grasping forceps. This Premarket Notification adds two rigid cystoscope/hysteroscope accessories (optical scissors and optical grasping forceps), both of which have been designed and are intended for use with the currently marketed Schoelly 4mm rigid cystoscope/hysteroscope and 20Fr sheath cleared in K150158. There are no changes to any of the other system components or accessories, nor are there any changes to the Schoelly Cystoscope/Hysteroscope and Accessories indications for use. The optical scissors and optical grasping forceps accessories both consist of a rigid shaft with an inner lumen that accommodates the 4mm Schoelly Cystoscope/Hysteroscope. The outer diameter and the working length of both accessories are 4.6mm and 266mm, respectively. During application, the scissor or the forceps can be attached to the cystoscope via a simple mechanical locking located at the very proximal portion of the devices. The scissor or grasper is then inserted through a 20Fr Schoelly Cystoscope/Hysteroscope Sheath while being connected to the Schoelly Cystoscope/Hysteroscope. Another mechanical locking mechanism allows the user to lock all three coaxial components (scope, scissor/grasper accessory, and sheath) together. The scissor and grasper accessories incorporate a control handle. Operation of the control handle actuates the distal tip double action jaws via a pull wire mechanism. The optical scissor and grasper accessories are made entirely of stainless steel. The accessories are reusable instruments that are supplied nonsterile.

The provided text is a 510(k) premarket notification for a medical device. It describes the acceptance criteria for a new device and its accessories (optical grasping forceps and optical scissors) and states that testing was performed to confirm substantial equivalence to a predicate device. However, it does not provide the detailed results of a study to prove the device meets those acceptance criteria in the format requested, particularly for AI/machine learning aspects.

The document discusses non-clinical performance testing. It indicates that the device has met "pre-determined acceptance criteria" but does not define these criteria numerically or provide the raw or summarized performance data against them. There is no mention of AI or machine learning in this submission.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's what can be extracted and what cannot:

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

The document mentions that "Design verification and validation activities included the following: Physical/functional/bench testing (cutting performance, gripping performance, ease of movement, visibility in the endoscope image)..." and later concludes that the device "meet all the pre-determined acceptance criteria of the testing performed to confirm substantial equivalence." However, the specific acceptance criteria (e.g., "cutting performance must be >= X cycles," or "grip strength must be >= Y N") and the actual measured device performance against these criteria are not provided in this document.

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

This information is not provided in the document. The document refers to "testing performed" but does not elaborate on the sample sizes for physical/functional/bench testing, biocompatibility, or reprocessing validation.

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)

This is not applicable as the document describes a physical medical device (cystoscopes/hysteroscopes and accessories) and refers to non-clinical performance testing, not studies involving human interpretation or AI using ground truth established by experts.

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

This is not applicable as the document describes a physical medical device and non-clinical performance testing, not studies involving human interpretation or AI.

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

This is not applicable. The document describes a physical medical device; there is no mention of AI or human readers.

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

This is not applicable. The document describes a physical medical device; there is no mention of an algorithm or AI.

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

This is not applicable. The document describes non-clinical performance testing of a physical medical device. The "ground truth" would be the engineering specifications and test standards for physical attributes like cutting force, grip strength, material properties, and reprocessing efficacy.

8. The sample size for the training set

This is not applicable. The document describes a physical medical device and non-clinical testing, not an AI or machine learning model that requires a training set.

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

This is not applicable. See point 8.

Summary of available information from the document:

Here's a table based on the limited information that can be inferred regarding performance criteria and the claim of meeting them, acknowledging the absence of specific numerical acceptance criteria and performance data:

Conclusion: The provided document is a 510(k) summary for a traditional medical device (cystoscopes/hysteroscopes and accessories) and details the types of non-clinical tests performed to demonstrate substantial equivalence to a predicate device. It explicitly states that the device "meet all the pre-determined acceptance criteria" but does not provide the specific numerical acceptance criteria or the study results/data that would allow for a detailed fulfillment of your request regarding device performance against acceptance criteria. Crucially, it does not involve AI/machine learning, human readers, or structured ground truth beyond standard engineering/biocompatibility testing.

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The Schoelly Cystoscopes Hysteroscopes and Accessories are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the devices include the visualization and manipulation of anatomy as the surgeon deems appropriate. The Schoelly Cystoscopes and Accessories are intended to be used in general urological and gynecological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.

The proposed Schoelly Cystoscopes/Hysteroscopes and Accessories comprise several models of rigid endoscopes as well as endoscopic sheaths, obturators, instrument bridges and grasping forceps. The devices are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the use of the devices include the visualization and manipulation of anatomy as the surgeon deems appropriate. The Schoelly Cystoscopes/Hysteroscopes and Accessories are intended to be used in general urological and gynecological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.

Endoscopes (Cystoscopes/Hysteroscopes):
The endoscopes described in this submission are rigid reusable endoscopes for visualization of the operating site during cvstoscopic and hysteroscopic minimally invasive procedures in conjunction with a commercially available light source, video camera, monitor, and printer.

Light that is created by an external light source is transmitted from the endoscope's light guide connector through the endoscope itself to the tip via a fiber optic system. Images are transferred the other way back through a rigid lens system.

Technical parameters of the Schoelly Cystoscopes/Hysteroscopes that characterize the optical view are the Direction of View (0°-70°) and the Field of View (70°-85°). The image can be displayed by a camera/monitor system which can be connected to the endoscope eyepiece. Models of the Schoelly Cystoscopes/Hysteroscopes differ in diameter and length of the insertion tube (2.9mm; 4mm / 300mm - 365mm). None of the endoscope models have a working channel.

Like other currently marketed rigid cystoscopes and hysteroscopes, all endoscope models have outer surfaces mainly made from metal (Phynox cobalt-nickelchromium stainless steel alloy, 304 stainless steel) and incorporate fiber optics for light transmission and rigid lenses for image transmission.

Some Schoelly endoscope models have already been cleared for marketing by FDA (K060899) for the same general intended use but with a different material of the insertion tube and a different bonding material used for the fixation of the plan glass at the endoscope's distal end. Accessories do not have a prior 510(k) clearance.

Sheath:
The endoscopic sheaths included in this submission are rigid reusable instruments with an inner lumen and mainly made from stainless steel; the sheath serves as the most outer part of the whole device setup in cystoscopic or hysteroscopic procedures. The proximal end of the endoscopic sheath has two irrigation ports with integral stopcocks for the introduction and the egress of irrigation media. The distal end of the sheath is cut away in a fenestration to permit the use of working instruments and endoscopes with a Direction of View of more than 0°. Opposite to the fenestration, the sheath is bevelled to facilitate its introduction into natural body orifices (transurethral/transvaginal). The outer diameter of the sheaths in this submission ranges from 17Fr - 25Fr, which are standard sizes used in cystoscopic or hysteroscopic procedures in adults. The sheaths can be used with all endoscopes models, obturators and bridges that are included in this submission.

Obturator:
The obturators included in this submission are rigid reusable instruments with (visual obturators) or without (blind obturators) an inner lumen and mainly made from stainless steel. During application, the obturator can be attached to the endoscopic sheath; it fills the space inside the sheath to provide a smooth surface. The visual obturator has an inner channel that accommodates the endoscope and allows the sheath to be introduced under direct vision. The overall length of the obturator used in conjunction with the sheath complies with the working length of the endoscope.

Bridges:
This submission includes standard endoscope bridges, which are rigid reusable instruments with an inner lumen and mainly made from stainless steel. The evaluation bridges without any accessory port allow the connection of the endoscope to the endoscopic sheath; the single horn bridges include an accessory port with stopcock to allow the insertion of instruments through the inner lumen of the sheath. Both types of bridges are available in a range of lengths for use with the full range of endoscope working lengths.

Grasping forceps:
As with standard endoscopic grasping forceps, the one described in this submission is a flexible forceps solely made from stainless steel and designed for grasping tissue and/or retrieving foreign bodies under endoscopic visualization. It consists of a flexible shaft and a manual proximal control handle. Operation of the proximal control handle actuates the distal tip grasping jaws. The outer diameter and the working length of the grasping forceps comprised in this submission are 7Fr and 400 mm, respectively. The grasping forceps can be introduced into the instrument bridge and moved forward through the inner lumen of the sheath towards the tip.

The Schoelly Cystoscopes/Hysteroscopes and Accessories are delivered in a nonsterile condition and will have CE mark.

The provided document describes Schoelly Cystoscopes/Hysteroscopes and Accessories, which are medical devices intended for endoscopic diagnostic and therapeutic surgical procedures. The document focuses on establishing substantial equivalence to legally marketed predicate devices through non-clinical performance testing.

Here's an analysis of the acceptance criteria and study information provided:

1. Acceptance Criteria and Reported Device Performance:

The document states that the "Performance data demonstrated that the Schoelly Cystoscopes/Hysteroscopes and Accessories have met pre-determined acceptance criteria and are substantially equivalent to predicate devices. The devices are as safe, as effective, and perform as well as or better than the predicate devices."

The specific acceptance criteria are not explicitly detailed in a pass/fail format within the provided text. Instead, the document lists various performance tests and implies that meeting the standards referenced is the acceptance criteria. The reported device performance is that it met these criteria.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in terms of patient data or images. The testing described is non-clinical performance testing on the device itself.

• Sample Size for Test Set: Not applicable in the context of patient data. The number of physical devices or components subjected to each non-clinical test is not specified, but it's implied that sufficient samples were used to meet the requirements of the listed standards.
• Data Provenance: Not applicable in the context of patient data. All testing is non-clinical, likely conducted in a laboratory setting. The manufacturer, Schoelly Fiberoptic GmbH, is based in Germany.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not applicable as the described testing is non-clinical performance and not an assessment of diagnostic performance against a ground truth established by medical experts for patient data.

4. Adjudication Method for the Test Set:

This information is not applicable as the described testing is non-clinical performance and not an assessment of diagnostic performance against a ground truth established by medical experts for patient data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance testing of the device's physical and optical characteristics, sterilization, and biocompatibility, not its effectiveness in a clinical diagnostic setting with human readers.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This information is not applicable. The device is a rigid endoscope and accessories, not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used:

This information is not applicable as the described testing is non-clinical performance (e.g., optical properties, reprocessing efficacy, material biocompatibility), which uses established engineering and biological standards as the "ground truth" for performance.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a physical medical instrument, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as the device is a physical medical instrument, not a machine learning algorithm.

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