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This instrument has been designed to be used with an Olympus Light Source, documentation equipment, display monitor, suction pump, Endo-Therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra and kidney.

The subject device, the XCYF-TP3 is basically identical to the predicate device (XCYF-1T3) which is the flexible endoscope for use in the bladder, urethra and kidney. Subject device may be used with three different Light source as follow, · A rechargeable powered Miniature Light source, or, · A battery powered Miniature Light source as predicate device, XENF-DP, or, · Light guide cable as predicate device, XENF-DP. In conclusion, this subject device is technically the same as the predicate device, which we describe in the table above.

The provided text is a 510(k) summary for the Olympus XCYF-TP3 Cystofiberscope/Nephrofiberscope. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria as would be found in a clinical trial report for a novel device. As such, the information you've requested regarding acceptance criteria and performance studies is not explicitly detailed in the provided document in the format you expect for a new, AI-enabled medical device.

However, I can extract information related to the demonstration of substantial equivalence, which is the core of this 510(k) submission.

Here's an interpretation based on the provided text, addressing your questions where possible:

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

The document does not provide a table of acceptance criteria and reported device performance in the form of specific quantitative metrics for sensitivity, specificity, accuracy, etc., as would be seen for an AI-enabled diagnostic device. Instead, the "acceptance criteria" for a 510(k) submission are based on demonstrating substantial equivalence to a predicate device. The "performance" is implicitly deemed acceptable if it's shown to be equivalent in terms of intended use, technological characteristics, and safety and effectiveness.

Here's how we can frame it based on the document:

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

The document states, "Therefore, the clinical data is not necessary for its evaluation of safety and efficacy." This indicates that no dedicated clinical test set or study was required or performed to demonstrate performance for this 510(k) submission, as substantial equivalence was established through technical and design comparisons to the predicate device.

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)

Since no separate clinical data or test set was generated for this 510(k), no experts were used to establish ground truth in the context of a new performance study. The "ground truth" for substantial equivalence rests on the predicate device's established safety and effectiveness.

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

As no specific test set was generated or analyzed for performance, no adjudication method was applied.

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 MRMC study was conducted, nor is this device an AI-assisted diagnostic tool. It is a traditional endoscope.

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

Not applicable, as this is a physical medical device (an endoscope), not a standalone algorithm.

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

The "ground truth" for this 510(k) approval rests on the established safety and effectiveness of the legally marketed predicate device (Olympus XCYF-1T3). This implies that the predicate device's performance was previously demonstrated or accepted, likely through a combination of design validation, materials testing, and potentially prior clinical use or previous 510(k) submissions that established its safety and effectiveness.

8. The sample size for the training set

Not applicable. This device is an endoscope, not an AI model, and therefore does not have a "training set" in the machine learning sense.

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

Not applicable. See point 8.

In summary, the provided document is a 510(k) notification for a physical medical device (an endoscope), not an AI/ML-powered diagnostic tool. Therefore, it focuses on demonstrating substantial equivalence to a predicate device through technical comparisons, rather than presenting a performance study with acceptance criteria, test sets, or ground truth establishment as would be done for a novel, data-driven device.

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The SpectraScience™ Reusable Biopsy Forceps are designed specifically to provide adjunctive illumination while collecting tissue endoscopically for bistological examination. The instruments are intended for endoscopic gastrointestinal and urologic biopsy and should not be used for any purpose other than their intended function.

The current biopsy forceps design has not changed during its long course of past clinical utility. The standard hinged design utilizes cup-shaped jaws to bite or pinch off tissue with minimal complications while providing a viable tissue sample. The cup-shaped jaws also serve to hold the biopsy sample within the forceps until the tissue can be transferred to a biopsy container. The proposed SpectraScience™ Reusable Biopsy Forceps uses the most basic of standard design. The mechanism of action of the SpectraScience™ design is identical to predicate devices in that the same standard mechanical design, materials and sizes are utilized. Using essentially identical mechanisms of action and materials results in identical clinical performance. The SpectraSciences design employs an adjunctive technological characteristic. The SpectraScience design incorporates an optical illumination fiber. The optical illumination fiber is intended to provide the endoscopist with additional light from a different angle compared to the endoscope's light source. In various anatomies under certain circumstances, the endoscope's light angle may not reveal critical structural contours which should be considered before a biopsy is performed. The intent of the SpectraSciences device is to enhance visualization and thus result in more accurate and precise identification and location of the tissue to be sampled.

The document provided is a 510(k) Notification for SpectraScience™ Reusable Biopsy Forceps, dated September 17, 1997. It describes the device, its intended use, and its substantial equivalence to predicate devices. The notification emphasizes the addition of an optical illumination fiber as an "adjunctive technological characteristic" to enhance visualization during endoscopic biopsy without changing the core mechanism of action.

Based on the provided information, here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not describe a test set or any specific clinical studies involving human subjects or collected data from a particular country. The approval is based on a claim of substantial equivalence to predicate devices, supported by bench testing and material specifications, not clinical trial data.

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

This information is not applicable as there was no test set or expert-established ground truth described in the submission. The assessment relies on a comparison to existing, already-approved medical devices.

4. Adjudication Method for the Test Set:

This information is not applicable as there was no test set described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

No MRMC comparative effectiveness study was described. The device's enhancement is qualitative (improved visualization) rather than a quantitative measure of performance that would typically be assessed in an MRMC study.

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

This information is not applicable. This device is a physical medical instrument, not an AI algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is the established safety and effectiveness of the predicate devices and the accepted principles of medical device engineering and biocompatibility. For the enhanced visualization feature, the ground truth is the historical and accepted safety and utility of fiberoptic illumination in medical devices.

8. The Sample Size for the Training Set:

This information is not applicable as there is no mention of a training set for an AI algorithm.

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

This information is not applicable as there is no mention of a training set for an AI algorithm.

Summary of the Study and Device Proof:

The SpectraScience™ Reusable Biopsy Forceps gained clearance through a 510(k) submission, demonstrating substantial equivalence to existing predicate devices. The "study" described is primarily based on engineering analysis, material scientific data, and historical precedent. The manufacturer asserts that the new device shares the same fundamental design, materials, and mechanism of action as previously approved biopsy forceps. The key addition, an optical illumination fiber, is justified by its long history of safe and effective use in other medical contexts, and the claim is made that it enhances visualization without altering the core function or safety of the biopsy procedure. Therefore, the proof of meeting acceptance criteria is largely through comparison to established medical device standards and the known performance of predicate devices, rather than a novel clinical study with a specific test or training set.

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The auxiliary instruments for ureteroscopes and uretero-renoscopes are used for preliminary procedures in the ureter and kidney, as well as for procedures in the urethra and bladder.
Flexible and rigid auxiliary instruments can be used in connection with single or double instrument ports.
Various diagnostic and therapeutic procedures can be performed, for example:

• transurethral extraction of uretero calculi
• biopsy for tumor diagnostics
• removal of foreign bodies, e.g. ureteral stents
  The interventions are carried out by trained and experienced surgeons who consider the general condition and the anatomic specialties of the patient in their diagnosis.
  The forceps are used for endoscopically controlled grasping and obtaining tissue specimens for diagnosis. Both flexible and rigid forceps are available.
  The stone extractors (graspers) are used to grasp stones or stone calculi and extract them out of urological tract. The stone extractor is also used to immobilize the calculus while disintegrating the stone.
  The stone extractors are intended for minimally invasive, diagnostic and therapeutic interventions. They are used e.g. in conjunction with ureteroscopes and uretero-renoscopes.
  Various electrodes are used for controlling bleeding and for removing or destruction of tissue by use of unipolar high-frequency current under endoscopic view.
  The bougies are used for the atraumatic distention of tubular organs. The flexible hollow dilators can be inserted over a guide wire, for example into the renal pelvis.
  The bougies are intended for minimally invasive, diagnostic and therapeutic interventions.

The submitted auxiliary instruments for URS are accessories for the ureterrenoscopy. These are rigid or flexible biopsy, grasping, and foreign body forceps, stone extractors, unipolar electrodes for high frequency applications, and bougies.

The provided K971315 submission describes auxiliary instruments for ureteroscopes and uretero-renoscopes. It is a 510(k) premarket notification for traditional medical devices rather than an AI/ML-enabled device, thus the standard acceptance criteria for AI devices and associated studies are not directly applicable.

However, I can extract the performance data and the methods used to demonstrate substantial equivalence for these instruments.

Here's an interpretation based on the provided text:

Acceptance Criteria and Reported Device Performance

The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical and sterilization testing to ensure the new design maintains safety and efficacy.

Study Details (Interpreted for traditional device testing)

1. Sample size used for the test set and the data provenance:

   • The document does not explicitly state the sample sizes (number of instruments tested) for the mechanical load tests or sterilization tests.
   • Data Provenance: The tests were "performed by Richard Wolf," indicating internal company testing. The country of origin for the data is implicitly the USA, where the company is located. The study is prospective in the sense that the tests were conducted specifically for this submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as this is not an AI/ML-enabled device requiring expert ground truth for classification or detection. The "ground truth" here is the objective measurement of mechanical failure or functional performance.
   • The "experts" involved would be the engineers and technicians conducting the mechanical and sterilization testing, presumably qualified in those fields.

3. Adjudication method for the test set:

   • Not applicable for this type of mechanical/sterilization testing. Performance is measured against engineering specifications or established protocols rather than expert consensus on diagnostic outcomes.

4. 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/ML-enabled device.

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

   • Not applicable. This is not an AI/ML-enabled device. The performance tests evaluate the physical device's integrity and function, not an algorithm.

6. The type of ground truth used:

   • For mechanical tests: "Ground truth" is the objective state of the device (intact vs. broken, functional vs. non-functional) under specified load conditions.
   • For sterilization tests: "Ground truth" is the objective state of the device's functional performance after sterilization.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML-enabled device and does not involve training data.

8. How the ground truth for the training set was established:

   • Not applicable.

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The Injecto Flush was designed to give a more practial and consistsnt way of flushing out reusable biopsy forcepts and canulated instruments.

The Injecto Flush was designed to give a more practial and consistsnt way of flushing out reusable biopsy forcepts and canulated instruments. The Injecto Flush was also designed to have no effect on on the break down of instrumentation nor any possibility of cross contamination. The Injecto Flush is a one time disposable, but totally recyclable flushing unit.

I apologize, but the provided text "DEC 30 1996 SUMMARY The Injecto Flush was designed to give a more practical and consistent way of flushing out reusable biopsy forceps and cannulated instruments... 9" is a product description for a medical device called "Injecto Flush" and doesn't contain any information about a study, acceptance criteria, device performance, sample sizes, expert qualifications, or any of the other specific details requested in your prompt.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

To answer your request, I would need a text that describes a study evaluating the Injecto Flush device, including details about its performance, the methodology of the study, and the criteria used to deem it successful.

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The SpectraScience Biopsy Forceps are designed specifically to provide adjunctive illumination while collecting tissue endoscopically for histologic examination. The instruments are intended for endoscopic gastrointestinal and urologic biopsy and should not be used for any purpose other than their intended function.

The current design of biopsy forceps has not changed during its long course of past clinical utility. The standard hinged design utilizes cup-shaped jaws to bite or pinch off tissue with minimal complications while providing a viable tissue sample. The cup-shaped jaws also serve to hold the biopsy sample within the forceps until the tissue can be transferred to a biopsy container. The proposed SpectraScience biopsy forceps uses the most basic of standard designs in that no teeth or spikes will be employed in the design. The mechanism of action of the SpectraScience design is identical to predicate devices in that the same standard mechanical design, materials and sizes are utilized. Using identical mechanisms of action and materials results in identical clinical performance. The SpectraScience design employs a different technological characteristic. The SpectraScience design incorporates a fiberoptic illumination fiber. The illumination fiber is intended to provide the endoscopist with adjunctive light directed at the tissue biopsy site in addition to the endoscope's light source.

This 510(k) summary describes a medical device, the SpectraScience Biopsy Forceps, for which the manufacturer is seeking clearance through a substantial equivalence pathway. As such, the document primarily focuses on establishing that the new device is as safe and effective as a legally marketed predicate device, rather than providing a detailed study proving performance against acceptance criteria in the way a novel device might.

Therefore, many of the typical elements of an AI/ML device study (like sample size for test sets, ground truth establishment, or human reader studies) are not present in this summary. The manufacturer's argument for substantial equivalence relies on the device sharing fundamental design, materials, and mechanisms with existing devices, with the addition of a fiberoptic illumination feature.

Here's an analysis based on the provided text, addressing the requested points where information is available or inferable:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size (Test Set): Not applicable in the context of this 510(k) summary. This submission relies on demonstrating substantial equivalence to a predicate device through engineering and material comparisons, not a clinical trial with a "test set" of patient data for performance evaluation in the typical sense.
• Data Provenance: Not applicable. The "data" here primarily refers to engineering specifications, material certifications, and a comparison to the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. There is no "ground truth" derived from expert consensus on a test set of cases as this is not an AI/ML device requiring clinical validation against ground truth.

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

• Not applicable. No test set requiring adjudication in this context.

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. This is not an AI/ML device, and no MRMC study was conducted or mentioned. The device's enhancement is a physical illumination feature, not an AI assistance tool.

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

• Not applicable. This is not an algorithm, so a standalone performance study as described would not be relevant.

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

• Not applicable. The "ground truth" equivalent would be established engineering standards, material properties, and the known performance of the predicate device. The claim of "identical clinical performance" is based on having "identical mechanisms of action and materials," implying that if the fundamental physical aspects are identical, the outcome (tissue sampling) will be identical.

8. The sample size for the training set:

• Not applicable. This summary is not about an AI/ML device that requires a training set.

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

• Not applicable. No training set is involved.

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