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The OES Elite Telescopes are indicated to provide the user with the means for visualizing diagnostic and therapeutic surgical procedures. The device is intended for use in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site.

The OES ELITE Telescopes are rigid endoscopes. An image relay system of rod lenses transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image. The OES ELITE Telescopes are delivered non-sterile. They are reusable and fully autoclavable. Before first and each subsequent use the device must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use. The OES ELITE Telescopes will be marketed as individual telescopes. The OES ELITE Telescopes are available in 4 mm diameters with four different directions of view (0°, 12°, 30°, 70°) each to allow use for various applications in accordance with the intended use as submitted with this 510(k). The OES ELITE Telescopes will be delivered with a protective tube WA2P400A which is subject to this 510(k) submission.

The provided document is a 510(k) Summary of Safety and Effectiveness for the Olympus OES ELITE Telescopes and Protective Tube. This document describes the device, its intended use, and its comparison to a predicate device, along with performance data.

However, it does not contain the specific details required to complete your request for acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is missing:

• Acceptance Criteria and Reported Device Performance Table: The document states that "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO-14971:2007" and "Performance tests were carried out to ensure that the system functions as intended and meets design specifications." It then lists various types of tests conducted (biocompatibility, electrical safety, thermal safety, optical/mechanical performance, shipping, service life, illumination system, design validation/usability). However, it does not provide a specific table of acceptance criteria metrics (e.g., minimum resolution, defined field of view, specific sterility assurance level) or the quantitative results from these tests against those criteria. It only broadly states that the tests were conducted and the device "comply[s] with the intended use."
• Sample size and data provenance for test set: The document mentions "Performance tests" and "design validation/usability tests" were conducted, but it does not specify the sample sizes used for these tests, nor does it detail the provenance of any data (e.g., country of origin, retrospective/prospective). Given the nature of an endoscope, the testing would likely involve bench testing and possibly some limited in-vivo or ex-vivo testing, but the details are absent.
• Number of experts and qualifications for ground truth: There is no mention of experts being used to establish a ground truth for a test set. The device is an endoscope for visualization, meaning its "performance" is more related to its physical build, optical quality, and safety/sterility, rather than an AI's diagnostic accuracy against a ground truth from experts.
• Adjudication method: Not applicable as there is no mention of expert review or a test set requiring adjudication in the context of diagnostic accuracy.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This type of study is typically for AI-assisted diagnostic tools comparing human performance with and without AI. The OES ELITE Telescope is an imaging device, not an AI diagnostic tool.
• Standalone (algorithm only) performance: Not applicable. This device is a manual endoscope, not an algorithm.
• Type of ground truth used: Not explicitly stated as "ground truth" in the diagnostic sense is not relevant for this device's type of performance testing (which focuses on physical and optical specifications, safety, and reusability). The "ground truth" would implicitly be the established engineering specifications and standards against which the device passed its tests.
• Sample size for training set: Not applicable. This is a physical medical device, not a machine learning algorithm.
• How ground truth for training set was established: Not applicable. This is a physical medical device, not a machine learning algorithm.

In summary, the provided text is a regulatory submission for a physical medical device (an endoscope) and not for an AI/ML-based diagnostic system. Therefore, the types of acceptance criteria, study designs, and data provenance details you are looking for, which are common for AI/ML devices, are not present.

The document primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to relevant safety and performance standards (like ISO 14971, ISO 10993, IEC 60601, and ISO 8600 series for endoscopes), which are crucial for physical medical devices.

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Endoservice Endoscopic Instruments & Accessories and Minimally Invasive GI and GU Devices are intended to be used by qualified physicians to provide access and visualization of internal structures such as bladder, urethra, kidneys, prostate and for manipulating soft tissue (grasping, cutting, coagulating, dissecting, and suturing).

Endoservice Endoscopic Instruments & Accessories are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions 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. The urological-gastroenterological accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue, body cavities, hollow organs and canals (grasping, cutting, dissecting, coagulating and suturing). The Endoservice Endoscopic Instruments & Accessories and Minimally Invasive gastrointestinal GI and genitourinary GU Devices contain different components such as Scissors, Forceps, Connections (inner Rod, Sheath insulated), Handles, Sheaths, Endoscopes, Cystoscopes, Resectoscopes, Urethrotomy, Retractor, Forceps, Scissors, Punches, Tubes, Trocars, Trocar Sleeves, Sheat, Needle holder, and Inserts. The device is made out of following materials: Body: steel 1.4301; plastic PPSU Handle: adhesive hysol-resin Lens: saphir

The provided text describes a 510(k) submission for Endoservice Endoscopic Instruments & Accessories and Minimally Invasive GI and GU Devices. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" here refer to demonstrating this substantial equivalence through various tests, primarily non-clinical, rather than specific performance metrics against a disease outcome.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are typically demonstrating equivalence in design, technical characteristics, intended use, indications for use, sterilization processes, and materials, as well as meeting established performance standards for safety and effectiveness.

• Tube: 3.5-12.5mm, 70-150cm
• Cystoscope, Resectoscope, Urethrotome: Length 298-310mm, Diameter 2.7mm, 2.8mm, 2.9mm, 4.0mm | Diameters & Lengths:
• Tube: 3.5-12.5mm, 40-105cm
• Laparoscope: Length 270-330mm, Diameter 5.0mm, 10mm, 11mm
• Cystoscope, Resectoscope, Urethrotome: Length 300mm, Diameter 4.0mm |
  | Materials | Steel 1.4301; plastic PPSU; adhesive hysol-resin; sapphire lens | Stainless Steel; Insulation material |
  | Components | Scissors, Forceps, Connections (inner Rod, Sheath insulated), Handles, Sheaths, Endoscopes, Cystoscopes, Resectoscopes, Urethrotomy, Retractor, Punches, Tube, Sheath, Needle holder, and Inserts. | Dismantable and Non-dismantable; Insulated and non-insulated; Forceps, Probes, Needle Holders, Clamps, Dissectors, Scissors, Knife, Hook, Knot Guide, Retractors, Divers and Blades. |
  | Intended Use & Indications for Use | Intended for qualified physicians to provide access and visualization of internal structures (e.g., bladder, urethra, kidneys, prostate) and manipulating soft tissue (grasping, cutting, coagulating, dissecting, and suturing). | Identical to GIMMI ALPHA® Instruments (implied by "identical to the predicate device...in terms of...intended use, indications for use"). |
  | Sterilization Processes | Identical to GIMMI ALPHA® Instruments (stated). Validation Tests of Sterilization, Disinfection and Cleaning (automatically) performed. | Follows predicate device's sterilization processes. |
  | Biocompatibility | Body contact portions composed of surgical grade stainless steel, "long history of biocompatibility." Cytotoxicity Test performed. | Implied by established predicate. |
  | Safety and Effectiveness (Non-clinical Performance) | Successfully tested according to ISO 8600, ISO 10993, ISO 11737, ISO 17665, ISO 15883, and ISO 14971. Bending Tests, Material Tests, Bench Tests, and Microbiological Test for determination of microorganisms performed. Conclusions: devices are as safe and as effective, and perform as well as or better than the legally marketed device, and do not raise new issues regarding safety and effectiveness. | Legally marketed predicate device. |

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

The document does not explicitly state the "sample size" in terms of number of devices or components used for each non-clinical test. It lists the types of tests conducted (Bending Tests, Material Tests, Bench Tests, Validation Tests of Sterilization, Disinfection and Cleaning, Cytotoxicity Test, Microbiological Test). The data provenance is implied to be from internal testing conducted by Endoservice Optical Instruments GmbH (a German company), and it is retrospective in the sense that these tests were performed and results compiled for the 510(k) submission.

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

This information is not provided in the document. For a non-clinical 510(k) submission for instruments like these, "ground truth" as it's typically understood in diagnostic AI studies (e.g., expert consensus on medical images) is not directly applicable. The "ground truth" here is adherence to engineering standards and safety tests, which are objective measurements rather than subjective expert interpretations.

4. Adjudication Method for the Test Set

This information is not provided and is not typically relevant for non-clinical testing of medical instruments. Adjudication methods (like 2+1 or 3+1) are usually found in clinical studies involving interpretation of data where disagreements among reviewers need resolution.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those using AI, where human performance with and without assistance is measured. This submission is for direct-use endoscopic instruments, not a diagnostic AI system.

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

No, a standalone (algorithm-only) performance study was not done. This is not an AI or algorithm-based device. The device itself is the instrument used by a human physician directly.

7. The Type of Ground Truth Used

The "ground truth" for this submission are the objective measurements and results from the non-clinical performance tests conforming to recognized international standards (e.g., ISO 8600, ISO 10993). This includes:

• Material properties: Verifying that materials meet specified compositions and strength.
• Dimensional accuracy: Ensuring diameters and lengths are within acceptable ranges.
• Biocompatibility: Results of cytotoxicity tests.
• Sterilization efficacy: Validation of cleaning and sterilization processes.
• Functional integrity: Results from bending and bench tests demonstrating durability and performance.
• Microbiological tests: Confirming absence of microorganisms where required.

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI/ML algorithm requiring a training set. This is a conventional medical instrument.

9. How the Ground Truth for the Training Set was Established

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

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ACMI® M4™ Series Telescopes are intended for use in patients requiring endoscopic evaluation or for surgical procedures of the urological or gynecological systems.

ACMI M4 Series Telescopes are optical devices that are used with endoscopic accessories in diagnostic and surgical procedures of the urological and gynecological systems.
ACMI M4 Telescopes are optical devices that are used along with endoscopic accessories for diagnostic and therapeutic procedures in urology and gynecology. They are designed to be inserted through an endoscopic device such as an ACMI cystourethroscope, hysteroscope, or resectoscope. M4 Telescopes are (4mm diameter, 31 cm long) rigid autoclavable optical instruments available in four directions of view: M4-0A, direct (0°), M4-12A, operative (12°), M4-30A, foroblique (30°), and M4-70A, lateral (70°), to assist the physician in visualization of the anatomy during diagnostic and surgical procedures.

The provided text is a 510(k) summary for the ACMI® M4™ Telescope. It indicates that the device is substantially equivalent to a predicate device (ACMI Resectoscope System and accessories, K890328/B) and does not describe a study involving acceptance criteria in the way one might for a novel AI/software-as-a-medical-device.

Therefore, the requested information elements related to such a study (sample size, data provenance, experts, adjudication, MRMC study, standalone performance, ground truth type, training set size, and training set ground truth establishment) are not applicable to this submission.

Here's an interpretation based on the provided document:

1. Table of acceptance criteria and the reported device performance:

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 510(k) relies on substantial equivalence to a predicate device rather than performance data from a specific test set.

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.

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

• Not applicable.

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 is not an AI/software device.

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

• Not applicable. This is not an AI/software device.

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

• Not applicable.

8. The sample size for the training set

• Not applicable.

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

• Not applicable.

Explanation:

The K031758 submission is a 510(k) Pre-market Notification for a medical device (telescopes for endoscopy) that establishes substantial equivalence to existing predicate devices. This regulatory pathway primarily focuses on demonstrating that the new device has the same intended use and similar technological characteristics as a legally marketed predicate, and that any differences do not raise new questions of safety or effectiveness.

It explicitly states: "The M4 Series designs utilize similar telescope technology (design, materials, and performance specifications) as in the predicate devices and, therefore, are substantially equivalent to the ACMI M2 and M3 series telescopes." and "The proposed modification in materials, design, and processing are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices."

Therefore, the submission does not detail a clinical study with specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy, nor does it refer to data from test sets, expert consensus, or training sets as would be common for AI/ML-based devices. The "acceptance criteria" in this context are implicitly met by demonstrating substantial equivalence according to FDA regulations.

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The endoscopes serve to visualize the inside of the patient via natural or surgically generated access.

For examination, diagnosis and/or therapy by personnel trained in the use of endoscopic instrumentation used in various medical disciplines, such as surgery, urology, gynecology, and ENT.

An endoscope with 1.9 mm and 2.7 mm diameter, typically used in endoscopy in infants and babies.

Here's a summary of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. The document explicitly states, "Clinical tests performed were not performed."
• Data Provenance: Not applicable, as no clinical tests were performed.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. No clinical tests were performed, hence no ground truth established by experts.

4. Adjudication Method for the Test Set

• Not applicable. No clinical tests were performed.

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

• No. The document explicitly states, "Clinical tests performed were not performed." Therefore, no MRMC study was conducted.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is an endoscope, a physical medical instrument, not a software algorithm.

7. Type of Ground Truth Used

• Not applicable. No clinical tests were performed to establish ground truth.

8. Sample Size for the Training Set

• Not applicable. This device is an endoscope, and the document focuses on its technological characteristics and equivalence to existing devices rather than a machine learning model requiring a training set.

9. How the Ground Truth for the Training Set was Established

• Not applicable. No training set was used.

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