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The HSW Arthroscope and accessories is a tubular endoscopic device with accessory devices which attach to the Arthroscope and is intended to examine and / or perform surgery on the interior of a joint. Arthroscopic minimal invasive procedures are performed in the hip, knee, shoulder, wrist (carpal tunnel syndrome), temporal-mandibular joint, ankle, elbow and feet (plantar fascia release).

The Henke Sass Wolf of America's Arthroscope is identical in terms of materials and modes of construction, optical performance and safety to Henke Sass Wolf of America's current Arthroscope and the Smith & Nephew Arthroscope. The only difference from the current Henke Sass Wolf of America's Arthroscope is the new intended use for hip surgery. This indication for use is already in place for the Smith & Nephew Arthroscope.

The arthroscope is a long tube containing a series of lenses. At the distal end, an objective lens captures the image of the object. A series of rod lenses relay the image along the length of the tube. At the proximal end, in the case of a direct view model, an ocular lens forms an image for viewing directly with the human eye. In the case of a videoarthroscope, a proximal coupling lens relays the image to a CCD (charged couple device used as an electronic video sensor chip).

Arthroscopes generally come in two diameters, 2.7mm and 4.0mm, although other sizes are sometimes offered. Larger size arthroscopes are used for general viewing. This is due to the preferable larger and brighter image achievable with larger diameter optical components. The small sizes are used where access to the surgical site is restricted.

Arthroscopes generally come in several "directions of view", 0°, 30°, 70°, 90° and 110°, though others are sometimes offered. The center axis of the field of view of the 0° scope is along the normal axis of the Arthroscope. The other "direction of view" instruments are referenced from the scope normal axis. The various "directions of view" permit or facilitate viewing of different parts of the relevant anatomy.

All arthroscopes also contain glass fibers for illumination of the surgical site.

Henke Sass Wolf Arthroscopes are provided in Autoclavable and Non-Autoclavable models.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Henke Sass Wolf Arthroscope.

Important Note: The provided document is a 510(k) submission for a medical device (Arthroscope). In this context, "acceptance criteria" and "studies" are typically focused on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing completely new performance benchmarks through extensive clinical trials. The criteria and studies revolve around proving that the new device is as safe and effective as its predicates. Therefore, some of the requested information (like specific performance metrics measured in a clinical study, effect sizes of human readers with AI, etc.) is generally not present in this type of submission.

Description of Acceptance Criteria and Supporting Study for Henke Sass Wolf Arthroscope

The Henke Sass Wolf Arthroscope's acceptance criteria and supporting "study" are primarily based on demonstrating substantial equivalence to predicate devices, namely the Henke Sass Wolf of America Laparoscope (K962075) and the Smith & Nephew, Inc. Arthroscope (K971253). The submission argues that the device's design, materials, manufacturing, optical performance, and safety are identical or highly similar, with the only significant change being an expanded intended use to include hip surgery, which is already an indicated use for one of the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• No specific "test set" in the conventional sense of a prospective clinical study with patient data is mentioned for device performance. The primary "testing" for substantial equivalence relies on comparing the device's specifications and characteristics to those of predicate devices already on the market.
• Data Provenance: The data provenance is based on the existing design, materials, and validated manufacturing processes of the manufacturer's own existing arthroscope line and the Smith & Nephew arthroscope (which is also manufactured by Henke Sass Wolf, GmbH). This is retrospective in the sense that it refers to established device characteristics and prior validation reports rather than a new prospective data collection specifically for this submission's comparison.

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

• Not Applicable. As this is a 510(k) submission for substantial equivalence based on design and material comparisons, rather than a clinical study evaluating diagnostic accuracy or treatment outcomes, there is no mention of external experts or a ground truth panel in the context of a test set. The "ground truth" implicitly lies with the established performance and safety of the predicate devices.

4. Adjudication Method for the Test Set

• Not Applicable. No test set requiring expert adjudication is described in the submission.

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

• No. An MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices to assess human reader performance with and without AI assistance, which is outside the scope of this arthroscope submission.

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

• Not Applicable. This device is an arthroscope, a physical medical instrument for direct visualization and surgical procedures, not an algorithm or software-controlled device. "Standalone" performance as described for AI algorithms is not relevant here. The submission explicitly states, "Device incorporates software? No."

7. The Type of Ground Truth Used

• The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate devices. The new device's characteristics (design, materials, optical performance, manufacturing methods) are compared against these known predicates to demonstrate that it is equally safe and effective for its expanded intended use.
• For the sterilization validation, the ground truth is established by AAMI/ISO Standards (e.g., SAL of 10-6), with a "worst case scenario" device (a 0° 10mm Operative Laparoscope) being used to validate the Sterrad 100S system.

8. The Sample Size for the Training Set

• Not Applicable. As it's a physical device and not an AI algorithm, there is no "training set" in the context of machine learning. The design and validation are based on engineering principles and regulatory standards rather than data-driven machine learning models.

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

• Not Applicable. (See point 8).

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The Henke Sass Wolf of America HSW Bariatric Laparoscope is intended to be used in general laparoscopic surgery. Laparoscopic surgery is a means of performing diagnostic and therapeutic surgical procedures intra-abdominally using equipment that minimizes surgical invasiveness. Rather than creating large incisions to gain access to surgical sites, surgeons view inside the body and operate by using instruments inserted through small skin punctures (inserted through the laparoscope or through another small incision). This includes, but is not limited to such uses as gallbladder and appendix removal, hernia repair, and examination of the abdominal cavity, appendix, gallbladder, and liver.

Bariatric laparoscopes are intended to be used to perform surgical procedures on morbidly obese segments of the patient population.

The Henke Sass Wolf of America's Bariatric Laparoscope is identical in terms of materials and modes of construction, optical performance and safety to Henke Sass Wolf GmbH HSW Laparoscopy Set - K941967 and the Stryker - K993045. This Bariatric version is longer (up to 550mm) so that it is capable of performing the same types of procedures on morbidly obese segments of the patient population.

Diameter: 5mm - 10mm
Length: 280mm to 550mm
Direction of View: 0, 30, 45 Degrees
Field of View: 75 Degrees
Shaft: 300 Series Stainless Steel
Body: Stainless Steel
Sidearm: Stainless Steel
Eyepiece: P.E.E.K.
Lenses: Glass or Sapphire

Adapters for connection to all conventional light-guides are supplied as standard.

The device is intended to be sterilized prior to use. The Bariatric Laparoscopes are designed to facilitate cleaning and disinfection as were the predicate devices. There is no difference in design and material that would impact the sterilization validation conducted for the HSW predicate device.

Instructions for cleaning and sterilization are included in the instructions for use. Sterilization and disinfection validation for predicate devices included EtO, Steris, and Sterrad is performed to assure an SAL of 10-6 per AAMI / ISO Standards.

The provided text is a 510(k) premarket notification for a medical device, specifically a bariatric laparoscope. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with detailed acceptance criteria and performance metrics in the way that a new, high-risk device might.

Therefore, much of the requested information about a study that proves the device meets acceptance criteria (e.g., sample sizes for test/training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable to this type of regulatory submission or the information presented in the document.

The document primarily states that the proposed device is substantially equivalent to existing predicate devices based on design, materials, manufacturing methods, and intended use. The "acceptance criteria" here are essentially the requirements for demonstrating substantial equivalence as per FDA regulations.

Here's an attempt to answer the questions based only on the provided text, while acknowledging the limitations for a 510(k) submission:

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

For a 510(k) submission, "acceptance criteria" are not typically stated as quantified performance targets but rather as demonstrating equivalence to predicate devices. The "performance" is implicitly deemed equivalent if the device meets the characteristics and testing mentioned.

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

Not applicable. This is a 510(k) submission for a medical device (laparoscope), not an AI/software device requiring a "test set" of clinical data for performance evaluation in the typical sense. The "testing" referred to是在工程和生物相容性层面上进行的物理和材料测试，而不是基于临床数据集的性能评估。

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. See point 2.

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

Not applicable. See point 2.

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 device is a physical surgical instrument (laparoscope), not an imaging AI diagnostic aid.

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

Not applicable. This device is a physical surgical instrument, not an algorithm.

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

Not applicable in the context of clinical performance data. The "ground truth" for this submission revolves around established engineering standards (e.g., ISO for biocompatibility, IEC for electrical safety, AAMI/ISO for sterilization) and the established characteristics and safety profile of the predicate devices.

8. The sample size for the training set

Not applicable. This device is a physical surgical instrument, not an AI/software device requiring a "training set."

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

Not applicable. See point 8.

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The HSW flexible nasopharyngoscope and accessories is a tubular endoscopic device and is intended to examine or treat the nasal cavity and nasal pharynx. This Nasopharyngoscope from HSW has been specially developed for use between the upper respiratory tracts of the nasal passage and the vocal chords, and may only be used for this purpose.

The HSW flexible nasopharyngoscope and accessories is a tubular endoscopic device.

This document is a 510(k) premarket notification letter from the FDA regarding a Nasopharyngoscope. It does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format of AI/ML device performance.

The document primarily focuses on:

• Regulatory clearance: The FDA's determination that the Henke Sass Wolf of America Nasopharyngoscope is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
• Device classification: Class II, product code EOB.
• Intended use: To examine or treat the nasal cavity and nasal pharynx, specifically between the upper respiratory tracts of the nasal passage and the vocal cords.

Therefore, I cannot provide the requested table and study details as they are not present in the provided text. This type of information is typically found in accompanying technical documentation or clinical study reports, which are not included here.

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Intended for use in Endoscopic Saphenous Vein harvesting procedures.

The Henke Sass Wolf Saphenous Vein Laparoscope is identical in terms of materials and modes of construction, optical performance and safety to the existing line of HSW 5mm Laparoscopes, differing only in working length and angle of view. The materials and basic design are identical. For the purpose of saphenous vein harvesting, a standard 5mm laparoscope is modified to extend the working length to 300mm. The laparoscope in used in conjunction with Ethicon's Endo-Surgery cannula system to provide a complete visualization system. These laparoscopes were designed to be inserted in the Ethicon sheath to help view the surgical area. To facilitate this, the laparoscope working length was modified. These laparoscopes are reusable and employed in conjunction with other cleared devices, to form a complete system.

This document is a 510(k) premarket notification for a medical device called the "Henke Sass Wolf Saphenous Vein Laparoscope." It's primarily focused on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria for an AI-powered device.

Therefore, many of the requested sections about AI-specific criteria, studies, and ground truth are not applicable to this document. I will extract the information that is present concerning safety and effectiveness testing.

Acceptance Criteria and Study for the Henke Sass Wolf Saphenous Vein Laparoscope

This submission is for a conventional medical device, a laparoscope, and not an AI-powered device. As such, the "acceptance criteria" and "device performance" are related to established safety and performance standards for such physical medical instruments, rather than AI model metrics. The study focuses on demonstrating compliance with these standards and substantial equivalence to existing devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in terms of a "test set" as would be used for AI/software. The testing mentioned (Electrical Safety, Electromedical System) would involve testing of physical device prototypes or production samples. The substantial equivalence argument relies on comparison to known predicate devices already on the market.
• Data Provenance: Not applicable in the context of data for an AI model.

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

This information is not applicable as this is a submission for a physical medical device, not an AI or diagnostic application that would require expert-established ground truth on a test set of data.

4. Adjudication Method for the Test Set

Not applicable.

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

No, this type of study is typically done for diagnostic imaging or AI systems where human reader performance is a key metric. This is a surgical instrument.

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

Not applicable, as this is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" here is compliance with established safety standards (EN 60601-1-1, EN 601-2-10) and physical attributes (materials, construction, optical performance, safety) matching a known, legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI or machine learning device.

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

Not applicable.

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The Henke Sass Wolf Hysterscopic Resectoscopes and Accessories are intended to enable the viewing and resection/coagulation of soft tissue encountered in but not limited to gynecologic, urologic diagnostic and surgical procedures.

The HENKE SASS WOLF Hysteroscopic Resectoscopes are intended to provide the physician with a means for endoscopic diagnostic and therapeutic surgical procedures. The HENKE SASS WOLF Resectoscopes and Accessories will include the Sheaths - to establish portals for visualization and surgical access and the electrode devices indicated for resection/coagulation for soft tissue and are intended for the use with the compatible resectoscopes.

The Resectoscopes and Accessories are indicated for use in diagnostic examination and therapeutic surgical procedures of but not limited Urological and Gynecological Fields. The surgical applications to: may include:

Tissue Cutting, removal, and dissection as required or encountered in but not limited to:

• Excision of intrauterine myomas
• Excision of intrauterine polyps
• Lysis of intrauterine adhesions
• . Incision of uterine septa

The HENKE-SASS, WOLF Hysteroscopic Resectoscopes and Accessories are reusable handheld instruments designed for a means of performing diagnostic and therapeutic procedures. The HENKE-SASS, WOLF Hysteroscopic Resectoscopes and Accessories (available in various lengths and Sizes) have the same operating principals and intended uses as many of the competitive hysteroscopic resectoscopes and accessories already in commercial distribution

This document is a 510(k) summary for a medical device (Hysteroscopic Resectoscope and Accessories), and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report with specific performance metrics.

Therefore, the information requested for a detailed study demonstrating acceptance criteria is not present in the provided text. The document relies on the "same operating principles and intended uses" and "identical material and design" as already marketed predicate devices to establish safety and efficacy.

Here's a breakdown of why each requested point cannot be answered from the provided text:

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

• Not available. The document does not specify quantitative acceptance criteria for device performance (e.g., specific thresholds for cutting efficacy, coagulation efficiency, or instrument durability). It states that the device is "same as the predicate devices" in function and "utilize material and design is identical to the predicate devices."

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

• Not available. There is no mention of a specific test set, clinical study, or data associated with direct performance evaluation of this new device. The "data" implicitly refers to the long-standing safety record and performance of the predicate devices.

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 / Not available. No ground truth establishment experts are mentioned because there's no specific test set or clinical data presented for this new device.

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

• Not applicable / Not available. No test set or adjudication process is mentioned.

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 device is a surgical instrument (Hysteroscopic Resectoscope), not an AI-powered diagnostic or imaging interpretation tool. Therefore, MRMC studies and AI assistance are not relevant to its function.

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

• Not applicable. This is a physical surgical instrument, not an algorithm.

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

• Not applicable / Not available for this specific device. The "ground truth" for demonstrating safety and efficacy indirectly relies on the established performance and safety record of the predicate devices in clinical use.

8. The sample size for the training set

• Not applicable. This is a physical surgical instrument, not a learning algorithm or AI.

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

• Not applicable. See point 8.

Summary of available information regarding safety and effectiveness:

The provided 510(k) summary establishes substantial equivalence based on the following:

• Identical Operating Principles and Intended Uses: "The HENKE SASS WOLF Resectoscope and Accessories have the same operating principals and intended uses as many of the competitive resectoscopes and accessories already in commercial distribution."
• Identical Material and Design: "The resectoscope and accessories utilize material and design is identical to the predicate devices (Manufactured by HENKE SASS WOLF on an OEM basis)."
• Predicate Devices: A list of several predicate hysteroscopic resectoscopes and accessories is provided, implying that the safety and efficacy of the new device are derived from the established safety and efficacy of these legally marketed devices.
• Manufacturing Standards: The device is manufactured according to cGMPs, ISO 9001/EN 46001, AAMI/ASTM standards, and EN/IEC 60601 Standards.

In essence, for a Class II device like this undergoing a 510(k) process, the "study that proves the device meets the acceptance criteria" is the demonstration of substantial equivalence to predicate devices, which are already accepted as safe and effective. No new, specific performance study with acceptance criteria is presented in this summary document.

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The Henke-Sass Wolf, Disposable Hypodermic Single Lumen Needle is Intended to be used for the purpose of injecting fluids into, or withdrawing fluids from parts of the body below the surface of the skin.

The HENKE -SASS , WOLF FINE-JECT® Disposable Needles are sterile hypodermic Single Lumen Needles, packaged individually for single patient use. The HENKE SASS WOLF Needles have the same operating principals and intended uses as the predicate devices already in commercial distribution

Below is the information regarding the acceptance criteria and the study for the submitted device, a Hypodermic Single Lumen Needle.

Device Name: Hypodermic Single Lumen Needle (Proprietary Name: FINE-JECT®)
Classification Name: Hypodermic Needle
Product Code: FMI
Regulation Number: 880.5570
Classification: Class II

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission for the Hypodermic Single Lumen Needle (FINE-JECT®) relies on demonstrating substantial equivalence to already marketed predicate devices rather than presenting specific quantitative performance data against predefined acceptance criteria for novel safety/efficacy endpoints. The "acceptance criteria" here are therefore generally understood as compliance with established manufacturing and quality standards, and the "reported device performance" is its adherence to these standards and functional equivalency to predicate devices.

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

This submission is a 510(k) Premarket Notification for a Class II medical device (Hypodermic Single Lumen Needle). For such submissions, especially for devices like hypodermic needles that rely on well-established technology, the primary evidence of "safety and efficacy" (or substantial equivalence) often comes from bench testing, material conformity, and adherence to recognized standards, rather than clinical trials with patient test sets.

• Sample Size for Test Set: Not explicitly stated in terms of a "test set" from a patient population. The safety and efficacy information presented is based on material composition, manufacturing processes, sterilization validation, and comparison to predicate devices. Performance is assessed against industry standards and the characteristics of existing devices.
• Data Provenance: The data provenance is primarily from bench testing, material certifications, and regulatory standards compliance documents. This type of data is generated during the manufacturing and quality assurance processes, not typically from a clinical patient population. The country of origin for manufacturing is Germany (HENKE-SASS, WOLF GmbH, D-78532 Tuttlingen Germany). The data is retrospective in the sense that it refers to established manufacturing practices, material specifications, and standardized testing procedures, rather than a prospective clinical trial.

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

Given the nature of a 510(k) for a hypodermic needle, "ground truth" is established through:

• Material Science Experts: To certify the quality and properties of the stainless steel (ISO 5832/1 and ASTM 899) and plastics.
• Sterilization Experts: To validate the ethylene oxide sterilization process against ISO 11135-1194 and EN 550.
• Quality Management/Regulatory Experts: To ensure compliance with cGMP, ISO 9001/EN 46001, AAMI, and ASTM standards.

The specific "number of experts" and their detailed qualifications (e.g., "radiologist with 10 years of experience") are not provided nor typically required for this type of 510(k) submission. Instead, the submission relies on the certification of the manufacturing facility (ISO Approved Facility) and adherence to international standards, which implicitly involve expert-validated methodologies and practices.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typical for studies involving human interpretation (e.g., medical imaging) to resolve discrepancies in expert opinions. For this device, which relies on physical characteristics and performance against objective standards:

• Adjudication Method: None in the context of expert review of subjective data.
• Instead, performance is determined by objective measurements, material specifications, and validation reports (e.g., sterilization cycle reports, material certificates of conformity) that meet predefined quantitative and qualitative standards. Deviations from these standards would constitute a failure to meet acceptance criteria, not a matter for expert adjudication.

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

• MRMC Study: No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is designed for evaluating diagnostic devices where human readers interpret medical data, often with and without AI assistance. This type of study is not applicable to a basic medical device like a hypodermic needle.
• The device's effectiveness is established by its functional equivalence to predicate devices and compliance with safety and performance standards relevant to its physical properties and intended use.

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

• Standalone Performance Study: Not applicable in the context of an algorithm.
• For a hypodermic needle, the "standalone performance" refers to the device's ability to function as intended (injecting/withdrawing fluids) and its associated safety aspects (sterility, material integrity, sharpness, break resistance, etc.). These performances are assessed through bench testing and compliance with specific ASTM/ISO standards relevant to needles, ensuring that the device itself performs its mechanical and biological functions without requiring human "interpretation" of data generated by the device itself.

7. The Type of Ground Truth Used

The "ground truth" for a device like a hypodermic needle is based on:

• Objective Standards and Specifications: Adherence to defined material compositions (e.g., AISI SUS 304, ISO 5832/1, ASTM 899 for stainless steel), manufacturing tolerances, and physical properties (e.g., needle sharpness, hub attachment strength).
• Validated Processes: Successful validation of sterilization processes according to ISO 11135-1194 and EN 550.
• Functional Equivalence: Confirmation that the device's operating principles and intended uses are the same as legally marketed predicate devices, implying comparable safety and efficacy profiles that have been historically accepted.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not involve an AI algorithm or machine learning components that require a "training set" of data.

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

• Training Set Ground Truth: Not applicable. As there is no AI/ML component, there's no training set or associated ground truth for a training set.

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The HENKE- SASS, WOLF Sinuscope is intended to provide the physician with a means of endoscopic diagnostic and therapeutic sinus surgical procedures. The HENKE-SASS WOLF of America Inc. Sinuscope Accessories include Sheaths - to establish surgical access and the removal of debris and body fluids from the surgical site and to provide irrigation of the site with a sterile solution such as saline water. The Sinuscope and accessories are indicated for use in, but not limited to such procedures as examination of sinus passages and cavities, removal of abnormal growths such as polyps and facio-plastic surgery.

The HENKE-SASS, WOLF Sinuscopes are reusable hand-held instruments designed for a means of performing diagnostic and therapeutic sinus procedures. The HENKE-SASS, WOLF Sinuscopes and accessories have the same operating principals and intended uses as many of the competitive sinuscopes and accessories already in commercial distribution

The provided text does not contain information about acceptance criteria or a study proving device performance using quantitative metrics. The document is a 510(k) summary for a Nasopharyngoscope and Accessories (Sinuscope) from HENKE-SASS, WOLF of America, Inc. It primarily focuses on demonstrating substantial equivalence to predicate devices, material composition, and intended use, rather than detailed performance study results with acceptance criteria.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be inferred or explicitly stated from the provided text:

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

• Acceptance Criteria: Not explicitly stated as quantitative performance metrics. The implicit acceptance criterion is "substantial equivalence" to predicate devices, meaning the device performs as safely and effectively for its intended use.
• Reported Device Performance: Not presented with quantitative metrics. The document states:
  • "The sinuscope itself is well recognized as being safe and effective for diagnostic and therapeutic sinus procedures."
  • "The HENKE SASS WOLF Sinuscopes and accessories have the same operating principals and intended uses as many of the competitive sinuscopes and accessories already in commercial distribution."
  • "The sinuscope material and design is identical to the predicate devices... In function, the sinuscopes and accessories are the same as the predicate devices."

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

• No specific test set or study data is mentioned that would allow reporting of sample size or data provenance. The submission relies on equivalence to existing devices.

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 as no specific test set or ground truth establishment process is described beyond the general understanding that sinuscopes are "well recognized as being safe and effective."

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

• Not applicable as no specific test set or adjudication process is described.

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 done, as this is a medical device (endoscope), not an AI-assisted diagnostic tool for "human readers."

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

• Not applicable, as this is an endoscope, not an algorithm.

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

• No explicit ground truth is mentioned in the context of a performance study. The "ground truth" for the device's safety and effectiveness appears to be established by the general clinical acceptance and regulatory history of similar predicate devices.

8. The sample size for the training set:

• Not applicable, as this is a physical medical device, not an AI model that requires a training set.

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

• Not applicable, for the same reason as above.

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