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The Henke-Sass, Wolf Resection Instruments are intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples of use of the product include the visualization and manipulation of anatomy, ablation, incision, coagulation, cauterization of minor bleedings, resection of tissue, vaporization and enucleation, and as the surgeon deems appropriate. The instruments are intended for use in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site. The system's use is intended for, but not limited to the following types of procedures:

• . Dilation of the urethra, and cold-slitting of urethral strictures
• . Trans-urethral incision and resection of the prostate
• . Trans-urethral removal of bladder tumor
• . Trans-cervical resection and ablation of the endometrium
• . Trans-cervical resection of fibroids

The Henke-Sass, Wolf Resection Instruments consist of various components that assemble into and/or work as a diagnostic and therapeutic resectoscopic system in urology and gynecology.
This submission is comprised of rigid working elements (resectoscopes), sheaths, obturators, electrodes (bipolar and monopolar), and HF cables. With the exception of the electrodes, the subject devices are provided non-sterile and reusable. The electrodes are provided sterile and are single-use.
Examples of use of the product include the visualization and manipulation of anatomy, biopsy, and as the surgeon deems appropriate.

This document is a 510(k) premarket notification for Henke-Sass, Wolf GmbH's HSW Resection Instruments. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a new AI-powered device meets specific performance acceptance criteria.

As such, there is no information in the provided text regarding acceptance criteria, AI device performance, sample sizes for AI test sets, expert adjudication methods, MRMC studies, standalone AI performance, ground truth establishment for AI, or training set details.

The document describes a traditional medical device (resection instruments) and the non-clinical testing performed to establish its safety and effectiveness. This testing includes:

• Bench Testing: Visual inspection, resection setup mechanical functionality, leakage test and flow measurement, and functional tests for monopolar and bipolar electrodes.
• Sterility and Shelf Life: EtO sterilization validation, package integrity testing, transport validation, and accelerated aging testing for sterile electrodes (5-year shelf life). Reprocessing validation for reusable instruments (manual and automated cleaning, steam sterilization to achieve 10^-6 sterility assurance level).
• Conformance to Standards: Electrical safety (IEC 60601-1, IEC 60601-2-2, IEC 60601-1-6, IEC 60601-2-18) and biocompatibility (ISO 10993-5 for cytotoxicity, ISO 10993-10 for sensitization and irritation).

Therefore, I cannot fulfill your request for the specific information points related to AI device acceptance criteria and study details. The provided document does not pertain to an AI/ML-powered medical device.

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a. Endoscopes: The Henke-Sass, Wolf Cystoscopes 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 the anatomy, as the surgeon deems appropriate. The Henke-Sass, Wolf Cystoscopes are intended to be used in general urological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.

b. Urology Instruments: The Henke-Sass, Wolf Urology Instruments in combination with endoscopes are intended to provide the user with the means for endoscopic visualization during examination, diagnosis and therapy of the lower urinary tract in conjunction with endoscopic accessories, or as the surgeon deems appropriate. The intended for use in urological procedures through the minimally invasive approach, by utilizing natural orifices to access the surgical site.

The Henke-Sass, Wolf Cystoscopes, Hysteroscopes and Accessories are composed of cystoscopes, hysteroscopes and cystoscopic accessories, which provide the user with the means for endoscopic diagnostic and therapeutic procedures. Examples of use of the product include the visualization and manipulation of anatomy, biopsy, and as the surgeon deems appropriate.

The provided text is a 510(k) Summary for the Henke-Sass, Wolf Cystoscopes, Hysteroscopes, and Accessories. It describes the device, its indications for use, and a comparison to a predicate device to establish substantial equivalence. The document is a regulatory submission to the FDA, not a study report that details acceptance criteria and the results of a specific clinical or technical study proving the device meets those criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC effectiveness studies cannot be fully extracted from this document because it does not contain such a study report.

However, based on the Non-Clinical Performance Data section, we can infer some aspects related to acceptance criteria and the nature of the "study" conducted.

Here's an attempt to answer based only on the provided text, with many fields explicitly stated as "Not applicable" or "Not provided" as the document does not present a detailed scientific evaluation report.

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

• Optical Performance: (Implicit: Clear visualization, light transmission suitable for endoscopic procedures.)
• Illumination Performance: (Implicit: Adequate light output for visualization, comparability to predicate's light source types like Xenon, LED.)
• Sterilization Efficacy: (Achieve Sterility Assurance Level (SAL) of 10^-6 after steam sterilization.) | - Working length: 269mm - 302mm (Meets or is comparable to predicate)
• Outer diameter: 2.7mm - 4.0mm (Meets or is comparable to predicate)
• Deflection: 0° - 70° (Meets or is comparable to predicate)
• Light Source: Xenon, LED (Comparable to predicate)
• Validated for manual and automated cleaning.
• Validated for steam sterilization to provide a sterility assurance of 10^-6. |
  | Safety & Risk Management | - Risk Analysis: (Implicit: Risks identified and mitigated in accordance with ISO 14971.) | - Risk analysis carried out in accordance with established in-house acceptance criteria based on ISO 14971. |
  | Regulatory Conformance | - Conformance to Recognized Standards and Guidances: (e.g., 510(k) submission guidance for Hysteroscopes and Gynecology Laparoscopes; IEC 60601-2-18, Sec. 201.11.1.2.2; ISO 8600-1, -3, -4, -5, -6.)
• Substantial Equivalence: (Implicit: Demonstrate equivalence in indications for use, technological characteristics, safety, and effectiveness to the identified predicate device K040390.) | - Demonstrates conformance with listed recognized standards and guidances.
• Concluded to be substantially equivalent to the predicate device (K040390) based on intended uses, technological characteristics, and non-clinical performance.
• Results show that the subject device has met pre-defined design and performance acceptance criteria. Results of all non-clinical testing support the safety and effectiveness of the subject devices. |
  | Cleaning Validation | (Implicit: Cleaning instructions must be effective in preparing the device for sterilization or reuse.) | - The cleaning instructions were validated. |

Explanation of the "Study":
The document refers to "Bench testing" and "Design verification testing" for evaluating mechanical, optical, and illumination performance, and validation for cleaning and sterilization procedures. This is a non-clinical performance study.

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

• Sample Size: Not provided. The document states "Bench testing was conducted" but doesn't specify the number of devices or components tested.
• Data Provenance: Not provided, but implicitly generated as part of the device development and validation by Henke-Sass, Wolf GmbH in Germany (company address provided). The testing is proprietary non-clinical data. It is prospective testing designed to validate the new 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)

• Not applicable. This was non-clinical bench testing, not an evaluation requiring expert clinical ground truth assessment for diagnosis. Performance was measured against engineering specifications and validated processes.

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

• Not applicable. This was non-clinical bench testing, not an evaluation requiring adjudication of human readings or interpretations.

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 document describes traditional medical devices (endoscopes and accessories), not AI software. Therefore, no MRMC study for AI assistance was performed or reported.

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

• Not applicable. This device is not an algorithm or AI.

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

• For functional performance (mechanical, optical, illumination): Ground truth was established by engineering specifications, recognized industry standards (e.g., ISO, IEC), and comparison to the characteristics of the legally marketed predicate device.
• For cleaning and sterilization: Ground truth was established by microbiological testing methods to demonstrate a Sterility Assurance Level (SAL) of 10^-6, adhering to relevant standards for reprocessing medical devices.

8. The sample size for the training set

• Not applicable. This is a traditional medical device, not an AI or machine learning model that requires a training set.

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

• Not applicable. As above, this is not an AI/ML device.

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The HSW NORM-JECT®- syringes are intended to be used to inject into, or withdraw fluids from the body. The 1 ml- syringe with a purple plunger, labeled with BOTOX® is exclusively produced for use with BOTOX® Cosmetic (onabotulinumtoxinA).

The purpose of this request is for marketing clearance of Henke-Sass, Wolf piston syringe because we have added a new purple-colored plunger for a new version of the syringe. The piston syringes covered by this submission will have the same performance as already marketed devices. The only difference will be the coloring of the plunger in adding a master batch to the original material.

The provided text describes a 510(k) submission for a piston syringe, focusing on demonstrating substantial equivalence to predicate devices rather than a study with acceptance criteria and device performance in the context of diagnostic accuracy or AI assistance.

Therefore, many of the requested elements for describing such a study (e.g., acceptance criteria for diagnostic performance, sample size for test sets with data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this document.

The document primarily focuses on bench testing and compliance with recognized standards to show that the new syringe, with a color change to its plunger, performs identically to existing, cleared devices.

Here's the information that can be extracted from the provided text, with the understanding that it pertains to a medical device clearance for a syringe rather than a diagnostic algorithm study:

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

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 submission references international ISO standards for testing but does not detail the specific sample sizes or provenance of data for each test. For a syringe, testing would typically involve a predefined number of units per lot to meet standard requirements, but these specifics are not included in this summary.

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 (syringe) and its compliance with engineering and biological safety standards, not a diagnostic device relying on expert interpretation for ground truth.

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

This is not applicable for the same reasons as above.

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 as this submission is for a physical syringe, not an AI-assisted diagnostic device or a study involving human readers.

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

This is not applicable as this submission is for a physical syringe, not an algorithm or AI device.

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

The "ground truth" for this device is based on compliance with established international standards (ISO standards) for material safety, physical performance, sterilization, and packaging, as well as demonstrating identical operating principles and intended uses to legally marketed predicate devices. There wouldn't be a "ground truth" in the diagnostic sense (like pathology or expert consensus).

8. The sample size for the training set

This is not applicable as this submission is for a physical syringe, not a machine learning or AI device that requires a training set.

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

This is not applicable for the same reasons as above.

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Ask a specific question about this device