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AlphaScope Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. AlphaScope Hysteroscope is used with Hysteroscope Sheaths to provide access to the uterine cavity during diagnostic and operative hysteroscopic procedures.

AlphaScope Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. AlphaScope Hysteroscope is used with Hysteroscope Sheaths to provide access to the uterine cavity during diagnostic and operative hysteroscopic procedures. The use of AlphaScope Hysteroscope is restricted for the use of endoscopic surgeons and qualified assistants. AlphaScope Hysteroscopes are re-useable, they can be sterilized by 134 C Degrees Steam Autoclave.

The provided text describes the regulatory clearance for the AlphaScope Hysteroscope, a medical device. However, it does not include information about specific acceptance criteria, a study proving the device meets those criteria, or any of the detailed performance metrics asked for in the prompt. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed new clinical or non-clinical performance studies with acceptance criteria.

The key statement regarding performance is: "Based on the equivalence in design and materials to predicate devices, performance testing was not warranted. The device meets the same criteria and is as effective and safe as SE devices." This indicates that no new performance studies were conducted to define specific acceptance criteria for this particular device.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for a performance study, as this information is not present in the provided text.

Based on the provided document, here's what can be inferred and what cannot:

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

• Cannot provide. The document states that performance testing was not warranted due to equivalence with predicate devices. Therefore, specific acceptance criteria and detailed performance metrics for this new device are not reported. The device is deemed to meet the "same criteria" and be "as effective and safe" as existing, substantially equivalent (SE) devices.

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

• Cannot provide. No test set for performance evaluation is described.

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)

• Cannot provide. No ground truth establishment for a test set is described.

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

• Cannot provide. No 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

• Cannot provide. No MRMC study is mentioned. This is a purely mechanical device, not an AI-driven one.

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

• Cannot provide. This is a purely mechanical device, not an algorithm.

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

• Cannot provide. No ground truth for performance evaluation is described.

8. The sample size for the training set

• Cannot provide. There is no mention of a training set, as this is not an AI/algorithm-based device.

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

• Cannot provide. There is no mention of a training set or its ground truth.

Summary based on the provided document:

The AlphaScope Hysteroscope received 510(k) clearance based on its substantial equivalence to legally marketed predicate devices, specifically the MicroSpan Gold Hysteroscope (K972426) and Alpha Hysteroscope, Rod Lenses (K012869).

The basis for this substantial equivalence claim relies on:

• Identical intended use.
• Similar materials (primarily surgical grade stainless steel, with verification of biocompatibility).
• Similar basic design, with slight modifications (design, diameter, material) that were determined not to "adversely affect the safety and effectiveness."
• Conformity with European Norms and directives (CE-marked) and relevant international standards (ISO, EN, ASTM, AAMI, ANSI, IEC).
• Validation of reprocessing and sterilization protocols by Nelson Lap.
• Market observation of a rigid AlphaScope Hysteroscope (2.7 mm diameter) which "has shown that the used materials are not effect the safety of the patients."

Crucially, the document explicitly states: "Based on the equivalence in design and materials to predicate devices, performance testing was not warranted. The device meets the same criteria and is as effective and safe as SE devices." Therefore, no new, specific acceptance criteria or performance studies for this device are detailed in this 510(k) summary.

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AlphaXenon Light 300W and 180W light source is used with an endoscope to provide illumination during endoscopic procedures.

AlphaXenon Light is a light generating device that when used with in conjunction with endoscopes to illuminate surgical site during Endoscopic procedures.

The provided text is a 510(k) summary for the AlphaXenon Light, a medical device. This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to existing devices, not on presenting novel clinical study data with acceptance criteria for device performance as would be expected for a new technology or diagnostic AI.

Therefore, the document does not contain information on:

• Acceptance criteria for device performance (beyond substantial equivalence to predicates).
• A "study that proves the device meets the acceptance criteria" in the sense of clinical performance or accuracy study.
• Sample sizes for test sets.
• Data provenance.
• Number of experts, their qualifications, or adjudication methods for ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for training sets.
• How ground truth for training sets was established.

The document primarily focuses on demonstrating that the AlphaXenon Light is substantially equivalent to legally marketed predicate devices.

Here's what the document does state regarding its compliance and equivalence:

1. Acceptance Criteria and Reported Device Performance:

The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to predicate devices already on the market. The reported "performance" is that the device is "similar in design, technology and intended use" and raises "no new questions of safety and effectiveness."

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

Not applicable. This is a light source, not a diagnostic AI or imaging device requiring a test set for performance evaluation in the usual sense. The submission likely relies on engineering and bench testing to demonstrate functionality and safety, but these details are not provided in this summary.

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

Not applicable for this type of device and submission.

4. Adjudication method for the test set:

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

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

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

Not applicable. This is a light source, its "ground truth" relates to functional specifications and safety, not diagnostic accuracy.

8. The sample size for the training set:

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable.

In summary, this 510(k) summary is for a basic medical device (light source) where the primary regulatory hurdle is demonstrating substantial equivalence to existing, legally marketed devices. It does not involve complex clinical performance studies or AI evaluation metrics as outlined in your request.

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Permanent GIMMI Aneurysm Clips (Yasargil) and vessel clips are intended for Permanent occlusion of blood vessels and cerebral aneurysms. Likewise, temporary permianent occlusion of blood vessel clips are intended for temporary occlusion Gilvilli Aneurysin Olips (Tabargi) and cerebral aneurysms. They are also intended to be applied exclusively with the corresponding Clip Appliers.

GIMMI Aneurysm Clips and their Clip Applying Forceps are used for the occlusion of aneurysms. "Mini" and "Standard" Clips can only be applied with the according Applying forceps; these forceps are labelled with "Mini" or "Standard". Clips are available in different sizes and shapes, to have the right size and shape due to the size and shape of the aneurysm.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the GIMMI Aneurysm Clips and Applying Forceps:

Executive Summary:

The provided document (K081640) is an Abbreviated 510(k) submission for the GIMMI Aneurysm Clips and Applying Forceps. This means that the manufacturer is demonstrating substantial equivalence to pre-existing, legally marketed devices (predicates) rather than providing extensive de novo performance data. Crucially, the document explicitly states that "performance testing was not warranted" due to the device's equivalence in design and materials to predicate devices and their long use history. Therefore, there is no detailed study described that establishes explicit acceptance criteria beyond regulatory standards and then proves the device meets those criteria through novel testing.

The "acceptance criteria" can be inferred as compliance with relevant industry standards, material specifications, and the demonstration of substantial equivalence to predicate devices in terms of intended use, performance attributes, materials, and basic design.

1. Table of Acceptance Criteria and Reported Device Performance

As performance testing was not warranted, explicit quantitative acceptance criteria for device performance (e.g., clip strength, fatigue, closure force) are not detailed in this submission. The "reported device performance" is primarily based on the demonstrated equivalence to predicate devices and material biocompatibility.

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

• Performance Testing: No dedicated test set in the traditional sense for evaluating device performance against new, quantitative acceptance criteria was used. The submission explicitly states, "Based on the equivalence in design and materials to predicate devices and their use since over 15 Years, performance testing was not warranted."
• MR Compatibility Test: A "non-clinical testing" was performed.
  • Sample Size: Not explicitly stated for the number of clips tested, but it refers to the "GIMMI Aneurysm Clip system."
  • Data Provenance: This was a prospective non-clinical test conducted internally (likely by GIMMI GmbH or a contracted lab) using a "SIEMENS MAGNETOM MAESTRO CLASS SYMPHONY MR scanner." Specific country of origin beyond "Germany" (GIMMI's location) for the testing facility is not provided.

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

This is not applicable as there was no "test set" requiring expert ground truth for evaluating novel performance. The FDA's substantial equivalence determination relies on comparing the device to existing predicate devices.

4. Adjudication Method for the Test Set

This is not applicable as there was no "test set" requiring adjudication of results against a ground truth.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study would compare human performance with and without AI assistance, which is irrelevant for this medical device submission, as it is a physical implant, not an AI diagnostic tool.

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

No, a standalone algorithm-only performance study was not done. This device is a physical implant, not an algorithm or AI.

7. The Type of Ground Truth Used

For the overall submission, the "ground truth" for demonstrating safety and effectiveness relies on:

• Predicate Device History and Regulatory Approval: The long-standing safe and effective use (over 15 years) and prior regulatory approvals of the identified predicate devices made of similar materials (Titanium, Phynox) and having similar intended uses and designs.
• Material Standards and Biocompatibility: Compliance with ISO 5832 for materials and historical evidence of biocompatibility.
• Non-Clinical Testing for MR Compatibility: For MR safety, the "ground truth" was established by the experimental results of temperature rise and movement measurements in a specified MR scanner.

8. The Sample Size for the Training Set

This is not applicable as this is a physical medical device submission, not a machine learning model. There is no concept of a "training set" in this context.

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

This is not applicable as there is no "training set" for this device.

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GIMMI ALPHA® Hysteroscopes and Accessories are intended to be used by qualified physicians to provide access, illumination and visualization of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. These generic devices are used to perform diagnostic and surgical procedures.

GIMMI ALPHA Hysteroscopes are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

Laparoscopic and obstetric-gynecologic accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. Some specialized instruments, such as the gynecologic fibroid screw and uterine tenaculum are one-piece.

The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue structures (grasping, cutting, dissecting, coagulating and suturing).

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Gimmi Alpha Hysteroscopes & Accessories:

Based on the provided 510(k) summary (K012869), the device is cleared based on substantial equivalence to predicate devices, rather than meeting specific quantifiable performance metrics through a clinical study with detailed acceptance criteria as one might expect for novel technology. This is a common approach for medical devices that are similar in design, materials, and intended use to products already on the market.

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not describe a clinical "test set" with human subjects or a specific data provenance in the way a clinical trial for a novel device would. The evaluation is based on engineering and material testing and a comparison to known predicate devices. The "Summary of Testing" states: "All materials used in the composition of GIMMI ALPHA Hysteroscopes and Accessories were subjected to performance and physical tests to evaluate safety, effectiveness, and reliability of the devices." No sample size or data provenance details like country of origin or retrospective/prospective nature are provided for these internal tests, as it's not a clinical study.

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

This information is not applicable to this 510(k) submission. There was no "test set" requiring expert ground truth establishment in the context of a clinical performance study. The evaluation focused on material properties, design similarity, and compliance with manufacturing standards.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

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 performed to evaluate reader performance (e.g., radiologists interpreting images) with and without AI assistance, which is not relevant for the type of device (hysteroscopes) being discussed here.

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

No, this is not an AI algorithm. It is a physical medical device (hysteroscopes and accessories). Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Predicate Device Performance: The safety, effectiveness, and performance of existing, legally marketed hysteroscopes serve as the primary reference point.
• Engineering Standards and Material Specifications: Compliance with established international and national standards (ISO/EN/ASTM/AAMI/ANSI/IEC) for medical devices, materials, manufacturing, and reprocessing.
• Biocompatibility Data: The historical biocompatibility of surgical grade stainless steel for human use.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. There is no AI training set.

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GIMMI ALPHA® Gastro-Urology and Laparoscopic Endoscopes, Endoscopic Accessories and GIMMI devices for minimally invasive gastrointestinal (GI), genitourinary (GU), and laparoscopic diagnostic and/or therapeutic indications are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/urologic and minimally invasive procedures.

GIMMI ALPHA Endoscopes are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

Laparoscopic and urological-gastroenterologic and related accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. Needle holders and other Class I devices included in the endoscopic catalogs may be onepiece. The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue structures (grasping, cutting, dissecting, coagulating and suturing).

Minimally Invasive Gl and GU Devices are design specific for short term use in diagnostic and/or therapeutic procedures

This document is a 510(k) premarket notification for the GIMMI ALPHA® Endoscopic Instruments & Accessories. It establishes substantial equivalence to various predicate devices and describes the general characteristics of the device. However, it does not contain a detailed study with specific acceptance criteria and performance results directly comparable to those criteria in a quantitative manner.

Instead, the document states general compliance and conformance without providing numerical performance metrics or detailed study designs.

Therefore, many of the requested sections regarding specific acceptance criteria, performance data, sample sizes, ground truth establishment, and expert involvement cannot be extracted from this document based on the provided text.

Here's what can be inferred and what cannot:

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

• Acceptance Criteria: Not explicitly stated with quantifiable thresholds in the provided text. The document broadly states "safety, effectiveness, and reliability."
• Reported Device Performance: Not reported numerically. The document states, "All results were in conformance with the cited harmonized device standards" and "The results of design validation raise no new issues of safety and effectiveness."

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

• Sample Size: Not specified.
• Data Provenance: Not specified, but likely from GIMMI GmbH's internal testing.

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

• This information is not provided as the document does not detail specific clinical or performance studies involving "ground truth" established by experts. The "ground truth" in this context would typically refer to definitive diagnoses or outcomes for a clinical study comparing the device's output to reality, which is not described.

4. Adjudication method for the test set

• Not applicable/not provided, as no expert-adjudicated test set 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

• This is not applicable. The device is described as "Endoscopic Instruments & Accessories" and devices "for minimally invasive GI, GU, and laparoscopic diagnostic and/or therapeutic indications." It is a physical medical device, not an AI-powered diagnostic tool, and therefore, an MRMC study with AI assistance is not relevant to this submission.

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

• This is not applicable as the device is a physical instrument, not a standalone algorithm.

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

• Not applicable/not specified for a clinical performance study involving "ground truth." The "performance and physical tests" would likely rely on engineering standards and measurements rather than medical ground truth.

8. The sample size for the training set

• Not applicable, as this is a physical medical device, not a machine learning algorithm requiring a "training set."

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

• Not applicable for the same reason as above.

Summary based on the provided text:

The document serves as a regulatory submission confirming that the GIMMI ALPHA® Endoscopic Instruments & Accessories are "substantially equivalent" to predicate devices. It states that:

• The devices have the same intended use.
• They are made of the same materials.
• They are produced to the same international and FDA-recognized standards.
• "All materials used... were subjected to performance and physical tests to evaluate safety, effectiveness, and reliability of the devices."
• "All results were in conformance with the cited harmonized device standards."
• "The results of design validation raise no new issues of safety and effectiveness."

However, it refrains from providing detailed study protocols, quantitative performance data, or specific acceptance criteria with reported numerical results. The substantiation relies on adherence to general standards and comparison to existing, cleared predicate devices rather than a new, detailed clinical performance study with defined acceptance criteria.

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GIMMI ALPHA Sinuscopes and Bronchoscopes are intended for use by qualified physicians to perform endoscopic diagnostic and therapeutic surgical procedures of the sinus and larynx/tracheobronchial tree respectively.

GIMMI ALPHA® Bronchoscopes are intended to provide qualified physicians with a means for performing endoscopic diagnostic and therapeutic surgical procedures of the larynx and tracheobronchial tree.

GIMMI ALPHA® Sinuscopes are intended to provide qualified physicians with a means for performing endoscopic diagnostic and therapeutic sinus surgical procedures.

GIMMI ALPHA Sinuscopes and Bronchoscopes are reusable, hand-held instruments designed for performing diagnostic and therapeutic sinus and bronchial procedures. The devices have the same operating principles and intended uses as many of the competitive sinuscopes and bronchoscopes already in commercial distribution.

The devices are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

The provided document is a 510(k) summary for the GIMMI ALPHA Sinuscopes and Bronchoscopes. Based on the information presented, a traditional clinical performance study with acceptance criteria and a detailed study design to prove the device meets those criteria was not conducted. Instead, the submission relies on demonstrating substantial equivalence to predicate devices.

Here's an breakdown based on your requested information, highlighting what was done according to this document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• No specific "test set" in the context of a clinical performance study was used. The submission relies on a comparison to predicate devices rather than a direct study on the GIMMI ALPHA devices in a clinical setting.
• Data provenance is therefore not applicable in the traditional sense, as no new clinical data was generated for this submission.

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

• Not applicable. No new clinical performance study was conducted that would require experts to establish ground truth for a test set. The assessment relied on regulatory evaluation of equivalence to existing predicate devices.

4. Adjudication method for the test set

• Not applicable. No clinical performance study was conducted.

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 a submission for an endoscopic device, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-related effectiveness assessment was not performed.

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

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

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

• The "ground truth" for the acceptance of this device implicitly relies on the proven safety and effectiveness of the identified predicate devices in clinical use. The assessment is based on the substantial equivalence of the GIMMI ALPHA devices to these predicates in terms of intended use, materials, operating principles, and compliance with recognized standards. No new ground truth specific to the GIMMI ALPHA devices was established through a clinical trial or expert review.

8. The sample size for the training set

• Not applicable. No training set was used, as this is not a machine learning or AI device.

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

• Not applicable.

In summary: The 510(k) submission for GIMMI ALPHA Sinuscopes and Bronchoscopes does not include a new clinical study with acceptance criteria and device performance evaluation in the typical sense. Instead, it demonstrates the device's safety and effectiveness by asserting substantial equivalence to legally marketed predicate devices, based on similarities in intended use, materials, design, and adherence to established industry standards. The FDA's clearance (K013731) indicates their agreement with this claim of substantial equivalence.

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