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The asap multiscope is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as arthroplasty, nucleotomy, discectomy, and foraminotomy.

The asap multiscope is a rigid or semiflex-type multi-channel endoscope provided with a rod lens system to transmit light and images, a working channel and one or two irrigation channel(s) and stopcocks. The body consists of an outer and an inner tube of surgical steel. The light-carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod lens system, the working channel and the irrigation/suction channel(s). The eyepiece and light post are adaptable to standard endoscopic cameras and light systems. The endoscope is intended for use with standard working sheaths (cannulas) for minimally invasive access. Accessories include working sheaths, spinal needles, guide wire, dilators, trephine, hammers, trocars, forceps, and rongeurs, as well as cleaning brushes, a rubber sealing cap, spare O-rings, and a protection sheath.

Here's an analysis of the provided text regarding the acceptance criteria and study for the asap multiscope device:

This 510(k) summary for the asap multiscope is a Substantial Equivalence (SE) premarket notification. This means the manufacturer is asserting their device is as safe and effective as existing legally marketed predicate devices, rather than demonstrating novel performance against pre-defined criteria. Therefore, the information you're requesting regarding acceptance criteria, specific performance metrics, and detailed study parameters (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, and human reader studies) is typically not provided in this type of submission, as it's not required for a SE determination.

The core of the submission revolves around demonstrating that the asap multiscope is substantially equivalent to its predicate devices (Joimax Tessys Multiscope, Arthro Kinetics Endoscopic Spine System, and maxMorespine Endoscope).

Here's an attempt to address your points based on the provided text, highlighting where information is absent or inferred due to the nature of a 510(k) SE submission:

Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence Claim)

Since this is a Substantial Equivalence submission, the "acceptance criteria" are generally that the device performs at least as well as and has no significant differences in safety or effectiveness compared to the predicate devices. The "reported device performance" is essentially that it meets this standard.

Here's a breakdown of the specific points you requested, with indications of what is and isn't available in this 510(k) summary:

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

   • See the table above. The "acceptance criteria" for a 510(k) SE typically revolve around demonstrating equivalency to known safe and effective predicate devices, rather than meeting specific quantifiable performance thresholds for clinical accuracy or efficacy.

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

   • Not provided. This type of detail is not required or typically included in a 510(k) SE submission for a device like an endoscope, where the primary demonstration is mechanical and material equivalence and adherence to recognized safety standards. The "performance data" mentioned refers to testing against safety standards and validation of sterilization, not clinical performance with a specific patient dataset.

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 provided. Since there's no clinical "test set" in the sense of patient data being evaluated for diagnostic or therapeutic accuracy, there's no ground truth established by experts in this context. The "truth" being established is that the device meets engineering specifications and safety standards and is comparable to predicates.

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

   • Not applicable/Not provided. As with point 3, there's no clinical test set requiring adjudication.

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, not done. This device is an endoscope, a visualization and access tool, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI improvement effect size are irrelevant.

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

   • No, not applicable. This device is a manual, physical tool; it does not involve any algorithms.

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

   • The "ground truth" for this device's performance is its adherence to engineering specifications, material biocompatibility, and validated sterilization processes, and its equivalence to legally marketed predicate devices. This is established through bench testing and documentation of material properties and manufacturing processes, not clinical outcomes or expert consensus on patient data.

8. The sample size for the training set:

   • Not applicable/Not provided. There is no "training set" as this is not an AI/ML device.

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

   • Not applicable/Not provided. There is no "training set."

In summary:

This 510(k) notification for the asap multiscope is a prime example of a Substantial Equivalence (SE) submission for a traditional medical device (an endoscope). The "study" mentioned primarily refers to:

• Engineering and material testing to ensure the device meets its own specifications (which are asserted to be similar to predicates).
• Biocompatibility testing of materials (by stating they are "identical to those of the predicate devices").
• Validation of cleaning and sterilization processes.
• Compliance with recognized industry safety standards (IEC 60601-2-18).

The crucial point is that for a 510(k) of this nature, the manufacturer does not perform independent clinical studies to demonstrate new safety or effectiveness. Instead, they demonstrate that their device is substantially equivalent to existing devices that have already been deemed safe and effective by the FDA. Therefore, detailed clinical performance metrics, sample sizes for patient data, expert reviews, or AI-related study details are not part of this type of submission.

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The asap ENT endoscope is intended to provide the physician with a means for direct viewing of the nasal cavity and nasal pharynx by providing illumination and visualization of these regions during various diagnostic and therapeutic procedures.

The asap ENT endoscope is reusable.

The asap ENT endoscope is of the rigid type with a new generation of compact objectives and a newly developed rod-lens system.

The basic design of the asap ENT endoscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.

This document is a 510(k) summary for a Sinuscope device and focuses on establishing substantial equivalence to a predicate device rather than presenting a study related to acceptance criteria for a new, breakthrough AI-driven medical device. Therefore, much of the requested information regarding AI device studies cannot be found or inferred from the provided text.

Here is the information that can be extracted or inferred based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

There is no explicit table of acceptance criteria with reported device performance in the context of a new efficacy study for this device. The document primarily focuses on demonstrating substantial equivalence to a predicate device.

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

Not applicable. This document describes a traditional medical device (sinuscope) being reviewed for substantial equivalence, not an AI/ML device undergoing performance testing with a specific test set of data. Therefore, there is no test set of patient data, nor is there data provenance in the context of an AI study.

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

Not applicable. As described in point 2, there is no test set of data requiring expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable. As described in point 2, there is no test set of data requiring an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

Not applicable. Ground truth for an AI device is not relevant here. The "ground truth" in this 510(k) context is the established safety and effectiveness of the predicate device (Sinuscope K981751), which the current device aims to be substantially equivalent to by meeting similar specifications and performance.

8. The Sample Size for the Training Set

Not applicable. This document is not describing an AI model, and therefore, there is no training set.

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

Not applicable. As described in point 8, there is no training set for which ground truth would need to be established.

Summary of the Study (as described in the document):

The "study" described in this 510(k) pertains to demonstrating substantial equivalence to an already legally marketed predicate device (Sinuscope, K981751). The core of this demonstration relies on:

• Comparison of specifications and intended use: The document states that the specifications and intended use of the new asap ENT endoscope are "the same" as the predicate.
• Comparison of design and conditions of intended use: It states "no significant differences."
• Material comparison: The device is constructed of materials of "the same specifications" as the predicate to ensure biocompatibility and conforms to applicable ISO standards.
• Sterilization validation: The ability to repeatedly adequately sterilize the device was "confirmed by validation protocol."

This is a traditional medical device submission, not a study involving AI/ML performance. The "acceptance criteria" are compliance with relevant voluntary standards and demonstrating that the device is as safe and effective as the predicate, based on design, materials, and validated processes (like sterilization).

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Hysteroscope: Provides illumination and visualization of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

Gynecologic Laparoscope: Used to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.

The asap hysteroscope and gynecologic laparoscope (herinafter: asap endoscope) is a rigid type endoscope with a new generation of compact objectives and a newly developed rod-lens system.

The basic design of the asap endoscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.

Here's an analysis of the provided text regarding the asap endoscope's acceptance criteria and studies:

Assessment: The provided document is a 510(k) summary for a medical device (Hysteroscope and Gynecologic Laparoscope). For this type of submission, the primary focus is demonstrating substantial equivalence to existing predicate devices, rather than conducting new clinical trials to prove efficacy or performance against specific numerical acceptance criteria. Therefore, most of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test sets, expert-established ground truth, MRMC studies, or standalone algorithm performance, is not present in this document.

Summary of Device Acceptance and Study Information:

Reported Performance: The document states that the asap endoscope's specifications and intended use are the same as the predicate devices. It is constructed of materials of the same specifications to ensure biocompatibility and conforms to applicable ISO standards. The ability to repeatedly adequately sterilize the devices has been confirmed by validation protocol. |
| 2. Sample Size for Test Set & Data Provenance | Not applicable. This document does not describe a "test set" in the context of a clinical performance study with patient data. The evaluation is based on a comparison to predicate devices and adherence to standards. |
| 3. Number of Experts & Qualifications for Ground Truth | Not applicable. Ground truth for clinical performance was not established by experts for a new study, as the submission relies on equivalence to devices with established safety and effectiveness. |
| 4. Adjudication Method for Test Set | Not applicable. No test set requiring adjudication of findings is described. |
| 5. MRMC Comparative Effectiveness Study | Not applicable. This is not an AI-assisted device, and no MRMC study is mentioned. |
| 6. Standalone Algorithm Performance Study | Not applicable. This is a physical medical device (endoscope), not a software algorithm. |
| 7. Type of Ground Truth Used | The "ground truth" implicitly used for this type of submission is the established safety and effectiveness of the legally marketed predicate devices, as determined by prior FDA approvals or marketing. The new device is deemed safe and effective if it can demonstrate substantial equivalence to these predicates. |
| 8. Sample Size for Training Set | Not applicable. This is a physical medical device, not an AI/ML system requiring a training set. |
| 9. How Ground Truth for Training Set was Established | Not applicable. |

Explanation of the 510(k) Process in this Context:

The 510(k) pathway is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device). This is called "substantial equivalence." The document's purpose is to show that the asap endoscope is substantially equivalent to the Baho and Galileo hysteroscopes and gynecologic laparoscopes.

The "study" described in the document is essentially a comparison study against predicate devices and adherence to recognized standards.

• Design Comparison: The "basic design of the asap endoscope is similar to those legally available for sale in the U.S.A."
• Materials Comparison: "constructed of materials of the same specifications as the predicate devices to ensure biocompatibility."
• Intended Use Comparison: The "indications for use" are explicitly stated to be "Like the predicate device" and "used to illuminate and visualize... for the purpose of performing diagnostic and surgical procedures."
• Compliance with Standards: The device "comply[s] with applicable portions of voluntary standards IEC 60601-2-18, DIN 58105, part 1 and 2, DIN 17442 (medical steel), as well as applicable portions of DIN 980." This demonstrates adherence to recognized safety and performance benchmarks.
• Sterilization Validation: "The ability to repeatedly adequately sterilize the devices has been confirmed by validation protocol." This is a crucial safety aspect for reusable devices.

This 510(k) summary does not involve a clinical trial with a "test set" of patients or data, nor does it involve AI algorithms with "training sets" or expert adjudications of performance. The acceptance is based on demonstrating that the new device is fundamentally the same as devices already on the market that have been deemed safe and effective.

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The asap arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures of the knee, shoulder, wrlst (carpal tunnel syndrome), temporal-mandibular joint, ankle and elbow.

The asap arthroscope is reusable and has to be sterilized prior to each procedure by the user.

The intended use for the asap arthroscope is according to relevant medical indication by trained physicians only.

The asap arthroscope is a rigid type endoscope with a new generation of compact objectives and a newly developed rod-lens system.

The basic design of the asap arthroscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light quide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.

The provided document is a 510(k) summary for a medical device (asap arthroscope). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this type of regulatory submission for a simple arthroscope does not typically contain detailed studies with acceptance criteria, reported performance metrics, or information related to AI/algorithm performance, multi-reader multi-case studies, or specific ground truth establishment methods as you've requested.

The document's purpose is to demonstrate that the new arthroscope is "substantially equivalent" to already legally marketed devices, primarily by showing similar design, materials, indications for use, and compliance with relevant standards. It focuses on safety and effectiveness through equivalence, rather than new performance claims that would necessitate rigorous quantitative studies of diagnostic accuracy.

Therefore, most of the information you've requested cannot be extracted from this document based on the nature of the device (a reusable arthroscope, not an AI-powered diagnostic tool).

Here's an attempt to answer what can be inferred or directly stated, and where the information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document implies that the acceptance criteria are met if the asap arthroscope is "substantially equivalent" to the predicate device (AMO Arthroscope K962330) in terms of specifications, intended use, materials, and compliance with voluntary standards.
• Reported Device Performance: The document states that the "specifications and intended use of the asap arthroscope are the same to those of the claimed predicate devices. There are no significant differences between the asap arthroscope and the claimed predicates in design or conditions of intended use." It also mentions successful validation of the ability to repeatedly sterilize the device.

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

• Information Not Provided: This type of information (sample size, data provenance for specific tests) is not typically detailed in a 510(k) for a basic arthroscope. The review is based on bench testing, material equivalence, and standard compliance, not clinical diagnostic performance studies on patient data.

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)

• Information Not Provided: Ground truth as described (e.g., for diagnostic accuracy) is not relevant or applicable to this device and its 510(k) submission.

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

• Information Not Provided: Adjudication methods are not relevant for the type of evaluation performed for this device.

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

• Information Not Provided & Not Applicable: This is a rigid arthroscope, not an AI-powered diagnostic device. MRMC studies or AI assistance are not relevant.

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

• Information Not Provided & Not Applicable: This is a rigid arthroscope, not an algorithm.

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

• Information Not Provided & Not Applicable (in the requested context): The "ground truth" for this device relates to engineering specifications, material properties, and functionality, verified through bench testing and compliance with standards, rather than clinical diagnostic outcomes or expert consensus on medical images/data.

8. The sample size for the training set

• Information Not Provided & Not Applicable: There is no "training set" as this is not an AI/machine learning device.

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

• Information Not Provided & Not Applicable: As above, no training set. The "ground truth" for the device's properties is established by engineering principles, material science, and regulatory standards.

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Like the predicate devices, the asap endoscope is used to visualize the body cavities, hollow organs and canals during diagnostic and, in conjunction with additional instruments, therapeutic procedures.

The asap endoscope is a rigid type endoscope with a new generation of compact objectives and a newly developed rod-lens system.

The basic design of the asap endoscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.

This 510(k) submission for the Asap Endoscope describes a substantial equivalence determination rather than a study with specific acceptance criteria and performance metrics for a novel device. Therefore, a table of acceptance criteria and reported device performance, information regarding sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, and details on training sets for AI models are not applicable to this document. These would be relevant for devices that utilize AI or have new performance claims requiring specific clinical studies.

The provided document primarily focuses on establishing substantial equivalence to previously cleared predicate devices based on design, materials, and intended use.

Here's an analysis of the information that is available in the document, framed by the spirit of your request:

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

• Acceptance Criteria (Implied by Substantial Equivalence): The primary "acceptance criterion" for this submission is that the asap endoscope must be "substantially equivalent" to its predicate devices in terms of safety and effectiveness. This is demonstrated by showing that its specifications, intended use, materials, and sterilization properties are comparable to those of the predicate devices.
• Reported Device Performance: The document states that "The specifications and intended use of the asap endoscope are the same to those of the claimed predicate devices." It also confirms that "The ability to repeatedly adequately sterilize the devices has been confirmed by validation protocol." These statements imply that the device performs equivalently to the predicates for its intended use and meets sterilization requirements.

An adapted table based on the document's content would look like this:

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 submission relies on a comparison to predicate devices, not on a clinical test set with human or synthetic data to evaluate new performance claims. The "test" in this context is primarily a comparison against existing device specifications and relevant standards. The sterilization validation would have involved a sample size of devices, but the specific numbers and provenance for that internal validation are not detailed 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)

• Not applicable. No expert review of a test set, as would be required for AI/imaging devices, is conducted or reported here.

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

• Not applicable. No adjudication process for a test set is conducted or reported here.

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 passive optical instrument, not an AI-assisted diagnostic tool.

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

• Not applicable. This device does not involve an algorithm.

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

• Not applicable / Implied: The "ground truth" for this type of submission is the established safety and effectiveness of the predicate devices based on their prior clearances and regulatory compliance. The "truth" is that the asap endoscope's fundamental characteristics (design, materials, intended use) are equivalent to those already accepted by regulatory bodies.

8. The sample size for the training set

• Not applicable. No AI/machine learning training set is involved.

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

• Not applicable. No AI/machine learning training set is involved.

In summary: The provided 510(k) summary is for a traditional medical device demonstrating substantial equivalence to predicates, not a device with complex performance claims typically associated with AI or advanced diagnostic capabilities that would require the extensive study details requested. The "study" done here is a detailed comparison of the new device to existing, cleared devices and adherence to relevant standards.

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