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The Endosee System is used to permit viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic procedures The types of procedures where the Endosee System could offer visualization include:

• Abnormal bleeding
• Infertility and pregnancy wastage
• · Evaluation of abnormal hysterosalpingogram
• · Intrauterine foreign body
• · Amenorrhea
• · Pelvic pain
• · Directed biopsy
• Removal of fibroids and polyps
• · Transection of intrauterine adhesions
• · Transection of intrauterine septa

The Endosee System can also be used to permit viewing of the adult urinary bladder through a minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic and therapeutic procedures.

The Endosee System is a handheld, battery-operated, portable endoscope that consists of a reusable Display Module with an LCD touchscreen monitor and a sterile, single-use cannula. It is intended for use in viewing the adult cervical canal, uterine cavity, or female urinary tract, including the bladder, during diagnostic or therapeutic hysteroscopy or cystoscopy procedures in an operating room, outpatient, or office setting. The Cannula has a light source and camera at the distal end, which are used for visualization and to capture image and video of the diagnostic area. The image and video signals are electronically transferred from the Cannula to the Display module via an electrical connector and cable, and the LCD monitor is used for viewing. The Endosee is provided with a Docking Station that recharges the battery in the Display Module and allows the user to download images/video from the internal device memory to an external computer.

The Endosee System is a handheld, battery-operated, portable endoscope used for viewing the adult cervical canal, uterine cavity, or female urinary tract during diagnostic or therapeutic procedures. The device under review (K200038) is a modification of a previously cleared device (K190639), with the primary changes being to indirect patient-contacting materials and additional shielding on the cannula board.

Here's the information regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the numerical sample size for each specific non-clinical test conducted. However, it indicates tests were performed on "samples accelerated aged to 6-months per ASTM F1980-16." This implies that a sufficient number of devices were tested to draw statistically sound conclusions, in accordance with the specified standard.

The data provenance for the tests is entirely non-clinical bench testing. There is no mention of human patient data (retrospective or prospective) being used to evaluate the device's performance in this submission, as the submission focuses on demonstrating substantial equivalence through engineering and laboratory testing related to the physical changes.

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

Not applicable. This submission is for a medical device that does not involve algorithmic diagnostic or prognostic capabilities requiring expert interpretation for ground truth establishment. The ground truth for the non-clinical tests is based on established engineering and materials standards (e.g., ISO, ASTM, IEC).

4. Adjudication Method for the Test Set:

Not applicable. No expert adjudication method (e.g., 2+1, 3+1) was used as the evaluation was based on objective, quantifiable non-clinical test results against established engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This device is a physical medical instrument, not an AI or imaging diagnostic tool that would typically involve human readers interpreting cases.

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

Not applicable. The Endosee System is a physical endoscope, not an algorithm. Therefore, "standalone" performance in the context of AI algorithms is not relevant to this submission.

7. The Type of Ground Truth Used:

The ground truth used for proving the device meets the acceptance criteria is established engineering and materials standards, along with internal company specifications for performance. These include:

• ISO 11135:2014 (Sterilization)
• ISO 11737-1:2018 (Bioburden)
• ISO 10993 (Biocompatibility series: -5, -10, -7)
• ASTM F1980-16 (Accelerated Aging)
• ISTA 3A:2008 (Ship Testing)
• ASTM 2096-11 (Bubble Leak)
• ANSI/AAMI ES 60601-1:2005/(R)2012 (Electrical Safety)
• IEC 60601-2-18:2009 (Electrical Safety for Endoscopes)
• IEC 60601-1-2:2014 (EMC)
• IEC 60601-1-15 (Drop Test)
• IEC 60529:2004 (IPX2 Ingress Test)
• IEC 62304:2006 (Software Verification)

8. The Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI or machine learning model. There is no concept of a "training set" for the type of evaluation presented in this submission.

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

Not applicable. As there is no training set, there is no ground truth established for it in the context of this device.

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The Endosee System is used to permit viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic procedures. The types of procedures where the Endosee System could offer visualization include:

• · Abnormal bleeding
• · Infertility and pregnancy wastage
• · Evaluation of abnormal hysterosalpingogram
• · Intrauterine foreign body
• · Amenorrhea
• · Pelvic pain
• · Directed biopsy
• · Removal of fibroids and polyps
• · Transection of intrauterine adhesions
• · Transection of intrauterine septa

The Endosee System can also be used to permit viewing of the adult urinary bladder through a minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic and therapeutic procedures.

The Endosee System is a handheld, battery-operated, portable endoscope that consists of a reusable Display Module with an LCD touchscreen monitor and a sterile, single-use cannula. It is intended for use in viewing the adult cervical canal, uterine cavity, or female urinary tract, including the bladder, to perform diagnostic and therapeutic hysteroscopy or cystoscopy procedures in an operating room, outpatient, or office setting. The Cannula has a light source and camera at the distal end, which are used for visualization and to capture image and video of the diagnostic area. The image and video signals are electronically transferred from the Cannula to the Display module via an electrical connector and cable, and the LCD monitor is used for viewing. The Endosee is provided with a Docking Station that recharges the battery in the Display Module and allows the user to download images/video from the internal device memory to an external computer.

The Endosee® System is a handheld, battery-operated endoscope used for viewing the adult cervical canal, uterine cavity, or female urinary tract for diagnostic and therapeutic procedures.

Here's an analysis of the provided information regarding its acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal "acceptance criteria" with specific thresholds or metrics for the device's performance in a table format. However, it does describe the areas of non-clinical performance testing conducted to demonstrate substantial equivalence to its predicate device (K183020). The conclusion states that the results of the testing demonstrate that the subject Endosee System is substantially equivalent to the predicate. This implies that the device met the performance expectations in these tested areas to be considered substantially equivalent.

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

The document does not specify the sample size for the test set in the non-clinical performance testing. It also doesn't mention data provenance such as country of origin or whether the data was retrospective or prospective, as the testing described is non-clinical performance (bench testing) rather than clinical studies on patients.

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

This information is not applicable. The non-clinical performance testing described involved validating the device's design, functional aspects, and safety standards, not comparisons against expert interpretation of medical images or patient outcomes. Therefore, no medical experts were involved in establishing ground truth for this type of testing.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data by multiple readers, which is not the type of testing described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. The submission focuses on non-clinical performance testing to demonstrate substantial equivalence to a predicate device, not on comparing reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

No standalone (algorithm only) performance study was done. This device is a physical endoscope system, not an AI-powered diagnostic algorithm.

7. Type of Ground Truth Used:

For the non-clinical performance testing, the "ground truth" would be the engineering specifications, functional requirements, and safety standards (e.g., IEC 60601-2-18) against which the device's performance was measured. It is not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set:

This information is not applicable. There is no mention of a "training set" as this device is not an AI/ML algorithm that requires training data.

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

This information is not applicable, as there is no training set for this device.

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The Endosee System is used to permit viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic procedures. Generally recognized indications for diagnostic hysteroscopy include:

• Abnormal bleeding
• Infertility and pregnancy wastage
• Evaluation of abnormal hysterosalpingogram
• Intrauterine foreign body
• Amenorrhea
• Pelvic pain

The Endosee System can also be used to permit viewing of the adult urinary bladder through a minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic procedures.

The Endosee System is a handheld, battery-operated, portable endoscope that consists of a reusable display module with an LCD touchscreen monitor and a sterile, single-use cannula. It is intended for use in viewing the adult cervical canal, uterine cavity, or female urinary tract, including the bladder, to perform diagnostic hysteroscopy or cystoscopy procedures in an operating room, outpatient, or office setting. The cannula has a light source and camera at the distal end, which are used for visualization and to capture image and video of the diagnostic area. The image and video signals are electronically transferred from the cannula to the display module via an electrical connector and cable, and the LCD monitor is used for viewing. The Endosee is provided with a docking station that recharges the battery in the display module and allows the user to download images/video from the internal device memory to an external computer.

The provided text describes the Endosee® System, a medical device used for diagnostic hysteroscopy and cystoscopy. The document, an FDA 510(k) summary, focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria for performance, a standalone study, or an MRMC study related to AI.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not present in the provided text. The document primarily reports on non-clinical performance testing conducted to ensure safety and equivalence.

Here's a breakdown of the information that can be extracted and what cannot:

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

The document doesn't provide a table of acceptance criteria with corresponding performance metrics for diagnostic accuracy or clinical effectiveness. Instead, it lists various non-clinical engineering and safety tests performed. While these tests have internal acceptance criteria, they are not typically clinical performance metrics. The closest general "performance" reported are the specifications that match the predicate device, such as Field of View and Direction of View, which are design specifications rather than clinical performance outcomes.

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

The document does not describe a clinical test set or data provenance in terms of patient data. The "test set" refers to physical samples of the device components (cannulas, display modules) subjected to various engineering and safety tests. For example, for shelf-life testing, samples were "Aged to 6-months" but the number of samples is not specified. There is no information about country of origin for any clinical data as none was presented.

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 information is not applicable to the provided document. The "ground truth" in this context would typically refer to diagnostic accuracy established by expert clinicians (e.g., confirming the presence or absence of abnormalities in patient images). The provided document focuses on engineering and safety testing, not clinical diagnostic performance, and thus does not involve human experts establishing a clinical ground truth for a diagnostic test set.

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

This information is not applicable. Adjudication methods are used in clinical studies to resolve discrepancies among expert interpretations. The tests described are engineering and safety tests, which do not involve expert adjudication in this manner.

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

There is no mention of an MRMC comparative effectiveness study, nor is there any indication that the Endosee System incorporates AI or is intended for AI-assisted interpretation. The device is a direct visualization tool.

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

Not applicable. The Endosee System is a hardware device for direct visualization; it does not feature an algorithm that would operate in a "standalone" mode for diagnostic interpretation.

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

Not applicable. As noted above, since no clinical performance study focused on diagnostic accuracy is described, there's no mention of how clinical ground truth would be established. The "ground truth" for the engineering tests would be adherence to the specified technical standards and design requirements.

8. The sample size for the training set

Not applicable. The document does not describe any machine learning or algorithm development that would involve a "training set."

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

Not applicable, as there is no training set described.

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