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The Modified Omniwave Endovascular System is indicated for use in the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature and for removal of thrombi from the peripheral vasculature.

The Modified Omniwave Endovascular System is comprised of two major components: (1) the sterile, single use Kit, and (2) the multi-use Generator.

The provided text is a 510(k) premarket notification summary for the Modified Omniwave Endovascular System. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria based on performance studies.

Therefore, the document does not contain the detailed information requested regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Instead, the document states:

• Substantial Equivalence: The Modified Omniwave Endovascular System is substantially equivalent to the predicate device, Omniwave Endovascular System (K071762), in terms of device classifications, intended use, indications for use, target population, product design, materials, packaging, labeling, sterilization, and product performance.
• Support of Substantial Equivalence: "Product testing has demonstrated that the applicant device is substantially equivalent to the predicate devices." This implies that testing was conducted to show the new device performs similarly to the predicate, but the specific acceptance criteria and results are not detailed in this summary.

Conclusion:

Based on the provided document, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them because this information is not present in the 510(k) summary, which focuses on demonstrating substantial equivalence rather than reporting detailed performance study outcomes against a predefined set of acceptance criteria.

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The Omniwave Endovascular System is indicated for use in the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature and for removal of thrombi from the peripheral vasculature.

The Omniwave Endovascular System is comprised of two major components: (1) the sterile, single use Kit, and (2) the multi-use Generator.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for the OmniWave Endovascular System, stating that it is substantially equivalent to predicate devices. It describes the device, its intended use, and lists predicate devices, but does not include details on specific device performance metrics or a study designed to test against acceptance criteria.

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The Omnisonics Resolution® Endovascular System is intended for use in the treatment of thrombosed synthetic dialysis access grafts.

The Resolution Endovascular System is a portable ultrasound energy system for the treatment of thrombosed synthetic dialysis access grafts. The System is comprised of two major components: (1) the sterile, single use Resolution Therapeutic Kit, and (2) the multi-use Generator. Required accessories include the Resolution Delivery Catheter and a commercially available hemostasis valve.

The provided text is a 510(k) summary for the OmniSonics Resolution® Endovascular System. This document asserts substantial equivalence to a predicate device rather than presenting a study proving acceptance criteria for a new device's performance. Therefore, detailed information on acceptance criteria and a specific study proving those criteria are not available in this text.

However, based on the information provided, we can infer some aspects relevant to your request, especially regarding the claim of "substantial equivalence" and the types of testing typically involved in such a submission.

Here's an attempt to answer your questions based on the provided FDA documents. Please note that many details are not explicitly stated in this summary and would typically be found in the full 510(k) submission, which is not provided.

Based on the provided 510(k) Summary (K052428) for the Resolution Endovascular System:

The document states that the Resolution Endovascular System is substantially equivalent to the predicate device, the Resolution® Thrombectomy System – K041705. It does not present a de novo study with specific acceptance criteria and performance data for a new device but rather relies on the equivalence to a previously cleared device. Therefore, a table of acceptance criteria and reported device performance specific to a new study is not provided in these documents.

The core of this submission is the assertion: "The technological characteristics of the applicant device are substantially equivalent to the predicate device with respect to device classification, intended use, indication for use, target population, product design, materials, packaging, labeling, sterilization and product performance."

The "Support of Substantial Equivalence" section mentions: "product performance testing has demonstrated that the applicant device is substantially equivalent to the predicate device." However, no specific details about this "product performance testing" (e.g., criteria, results, methodology, sample sizes) are included in this summary.

Here's an attempt to answer your numbered questions based on the limited information:

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

• Not explicitly provided. The 510(k) summary does not contain a table of acceptance criteria or reported device performance for a new study. Instead, it asserts "substantial equivalence" to a predicate device based on unspecified "product performance testing." To gain market clearance via a 510(k), the new device must perform at least as well as the predicate device, meaning its performance would meet the unstated acceptance criteria established for the predicate device.

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

• Not explicitly provided. The 510(k) summary does not mention specific sample sizes for any test set or the provenance of data. Substantial equivalence typically relies on bench testing, material characterization, and potentially animal or limited human factor studies, but no details are given here.

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

• Not applicable/Not explicitly provided. This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, diagnostic devices). The Resolution Endovascular System is an interventional device for treating thrombosed grafts, and the "product performance testing" would likely involve engineering and functional assessments rather than expert-derived ground truth.

4. Adjudication method for the test set:

• Not applicable/Not explicitly provided. Adjudication methods are usually for clinical trials involving human review of outcomes or data, which is not detailed in this 510(k) summary.

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. The device is an Endovascular System (medical device for treatment), not primarily a diagnostic or AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant or mentioned.

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

• Not applicable. This question pertains to AI/algorithm performance. The Resolution Endovascular System is a physical medical device; there's no mention of an algorithm or AI component in this 510(k) summary.

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

• Not explicitly provided. For "product performance testing" of a physical device, ground truth would typically refer to established engineering standards, material specifications, and functional targets (e.g., clot removal efficiency, flow rates, durability) that are compared to the predicate device's known performance. No specific details are given.

8. The sample size for the training set:

• Not applicable/Not explicitly provided. "Training set" is typically used for machine learning models. As this is a physical medical device, not an AI/ML product, this concept does not apply in the context of this 510(k) summary.

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

• Not applicable/Not explicitly provided. See point 8.

In summary: The provided FDA 510(k) documents are for a medical device cleared through the substantial equivalence pathway. They assert that "product performance testing has demonstrated that the applicant device is substantially equivalent to the predicate device" but do not provide the detailed results, acceptance criteria, methodologies, or sample sizes of such testing. This information would typically be found in the full 510(k) submission, which is not included in the provided text.

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The Omnisonics Resolution® Thrombectomy System is intended for use in the treatment of thrombosed synthetic dialysis access grafts.

The Resolution Thrombectomy System is a portable acoustic energy system for the treatment of thrombosed synthetic dialysis access grafts. The system is comprised of three major components: (1) the disposable Resolution 360° Therapeutic Wire, (2) the reusable Handpiece/Cable Assembly, and (3) the multiuse Generator. Accessories include the Resolution Torque Wrench and Resolution Irrigation Tubing Set.

The provided text describes a 510(k) premarket notification for the OmniSonics Resolution® Thrombectomy System. This is a medical device, and 510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, the document does not provide the detailed information requested in your prompt regarding acceptance criteria, specific device performance numbers, sample sizes, expert qualifications, adjudication methods, or multi-reader multi-case studies.

However, based on the information provided, here's what can be extracted and inferred:

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

The document does not specify "acceptance criteria" as clear quantifiable metrics for the device's performance. Instead, it claims "substantial equivalence" to predicate devices. The "performance" is generally described as:

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

• Test set sample size: Not specified. The document only mentions "clinical studies" in a general sense.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

Not specified. The document does not detail how the results of the "clinical studies" were evaluated or by whom.

4. Adjudication method for the test set

Not specified.

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 thrombectomy system, not an AI-assisted diagnostic or imaging device. There is no mention of "human readers" or "AI assistance."

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

Not applicable. This is a physical medical device (thrombectomy system), not an algorithm or software. It is intended for use by a clinician.

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

Not explicitly stated. Given the nature of a thrombectomy system, "outcomes data" related to successful thrombus removal and patient recovery would be the most relevant ground truth in a clinical study.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

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

Not applicable.

Summary of what the document focuses on:

The document is a 510(k) summary, which aims to establish "substantial equivalence" to legally marketed predicate devices. It relies on:

• A comparison of technological characteristics (indications for use, sterilization methods, product design, materials, labeling, packaging, and principles of operation).
• General mention of "clinical studies" demonstrating equivalence in thrombus removal.
• "Mechanical bench testing, biocompatibility testing and in vivo animal testing" to support safety and equivalence.

It does not provide a detailed report of a clinical trial with specific performance metrics, sample sizes, or ground truth establishment methods typically associated with proving a device meets predefined acceptance criteria for novel performance claims.

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The intended use of the OmniSonics Ultrasonic Probes is the breakup and removal of soft tissues in Neurosurgery, GI and affiliated organ surgery, Urology, General surgery, Plastic and Reconstructive surgery, Orthopedic, GYN, Thoracic. The OmniSonics Ultrasonic Probes are used in conjunction with the OmniSonics Ultrasonic Surgical System.

The OmniSonics Ultrasonic Probes are designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths or other devices with lumens having an inside diameter larger than the outside diameter of the probe.

The OmniSonics Ultrasonic probes work in conjunction with the OmniSonics Ultrasonic Generator. The generator creates a specific electrical signal that is directed into the OmniSoncs ultrasonic handle. The signal is converted into an ultrasonic motion within the handle and this motion is transferred to the ultrasonic probe.

The ultrasonic energy in contact with the probe causes a specifically defined motion to occur on the probe shaft. The motion of the probe in contact with the tissue causes a localized cavitation, and immediate destruction of the tissue in contact with the probe. Cavitation is caused by the motion of the probe within water and in contact with tissue.

The motion of the probe causes the formation of microbubbles to be formed. The upstoke of the probe causes the formation of the bubble behind the probe, the downstroke causes the collapse of the bubble and a small localized shock wave. This focused wave formed at the tip of the probe causes a localized and focused shock wave to be formed which impinges upon the tissue and breaks off the most least tightly bound tissue layer. The action is limited to a specific contact area of the probe upon the tissue, and does not travel beyond these contact points.

The OmniSonics Ultrasonic Probes are constructed of titanium and are all specifically designed for use and operation with the OmniSonics Ultrasonic Surgical System.

The specifications of the proposed OmniSonics Ultrasonic Probes are the following:

Diameter Exterior: 1 mm - 10 mm
Diameter Interior: .5 mm - 8 mm
Length: 10 mm - 30 mm

The provided text is a 510(k) summary for the OmniSonics Ultrasonic Probes. This document focuses on demonstrating substantial equivalence to existing devices rather than presenting detailed performance studies against specific acceptance criteria for a novel device or AI algorithm.

Due to the nature of a 510(k) submission for a non-AI/software device from 1999, the information typically requested in your prompt regarding AI/software performance studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, and effect sizes) is not applicable and not present in this document.

The document does mention performance testing in a general sense, but not in the detailed, quantitative manner you're looking for an AI/software product.

Here's a breakdown of what information can be extracted and what cannot:

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

The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in the way one would for an AI/software device. Instead, it aims to demonstrate substantial equivalence to predicate devices. The "performance testing" section is very brief and general.

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 / Not provided. This 510(k) summary does not describe a clinical study with a test set of data as would be used for an AI/software device. The "performance testing" mentioned refers to non-clinical testing (biocompatibility, sterilization, electrical safety).

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. No clinical "test set" requiring expert ground truth is described.

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

• Not applicable / Not provided. No clinical "test set" and thus no adjudication method 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

• Not applicable / Not provided. This is a hardware device, not an AI or software product. No MRMC study was conducted or reported.

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

• Not applicable / Not provided. This is a hardware device.

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

• Not applicable / Not provided. No clinical ground truth is discussed in relation to "performance" in the context of an AI/software test. The "performance testing" refers to compliance with standards (IEC 60601) and material properties (biocompatibility, sterilization), which have their own established methods of verification, rather than clinical ground truth as you'd define it for an AI.

8. The sample size for the training set

• Not applicable / Not provided. This is a hardware device, not an AI/software product, so there is no "training set."

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

• Not applicable / Not provided. No training set exists for this hardware device.

Summary of Device-Specific Information from the Text:

• Device Name: OmniSonics Ultrasonic Probes
• Manufacturer: OmniSonics Medical Technologies, Inc.
• Intended Use: Breakup and removal of soft tissues in Neurosurgery, GI and affiliated organ surgery, Urology, General surgery, Plastic and Reconstructive surgery, Orthopedic, GYN, Thoracic. Used in conjunction with the OmniSonics Ultrasonic Surgical System.
• Predicate Devices: Sonokinetics SONOTOME System (K990572) and Valleylabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696) and CUSA EXCEL System (K981262).
• Principle of Operation: Converts electrical signal to ultrasonic motion via the handle, transferred to the probe. The motion causes localized cavitation and immediate tissue destruction due to microbubble formation, collapse, and localized shockwaves.
• Materials: Titanium.
• Specifications:
  • Diameter Exterior: 1 mm - 10 mm
  • Diameter Interior: 0.5 mm - 8 mm
  • Length: 10 mm - 30 mm
• Regulatory Class: II
• Product Code: LFL
• Date of Submission: October 23, 1999
• FDA Clearance Date: December 15, 1999 (K993628)

Conclusion:

This 510(k) submission for the OmniSonics Ultrasonic Probes is for a physical medical device (ultrasonic probes) and demonstrates "substantial equivalence" to existing, legally marketed predicate devices. It does not contain information related to AI/software performance studies, test sets, training sets, ground truth establishment, or expert reviews as these concepts are not relevant to this type of device and submission. The "performance testing" refers to standard compliance for safety and material properties.

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The OmniSonics Endoscopic Deflector is designed to assist in the placement and deflection of I he Onlinoomiss indoscopic Donector atheters and endoscopes used in surgical procedures in body cavities, hollow organs and canals.

The OmniSonics Endoscopic Deflector is designed to be introduced through natural body openings, surgical incisions and through introducers, needles, trocars, catheters, sheaths and other devices with lumens having an inside diameter larger than the outside diameter of the OmniSonics Endoscopic Deflector shaft selected. The OmniSonics Endoscopic Deflector is sold sterile and is intended for single patient use. The OmniSonics Endoscopic Deflector is indicated for the following applications:

Ureteroscopy Thoracoscopy Nasopharyngoscopy Sinuscopy General laparoscopy Urology Gynecology Bronchoscopy

The OmniSonics Endoscopic Deflector assists in the delivery of small diameter flexible; instruments, catheters, probes, and endoscopes. The device deflects these instruments to aid in the direction and delivery of the product to a specific surgical site that is not in line with the axis of the instrument. The purpose of the OmniSonics Endoscopic Deflector is to provide a means to deliver small diameter instruments to areas that would be difficult to access with a straight instrument.

The OmniSonics Endoscopic Deflector works in a similar fashion to steerable endoscopes. This instrument is different in that it only contains lumens for the introduction of ancillary instrumentation and does not possess an integral visualization system. The user must insert all of the additional capabilities desired through the OmniSonics Endoscopic Deflector central lumen.

Products that are capable of working with the OmniSonics Endoscopic Deflector are flexible, malleable or bendable and must be capable of obtaining a bend radius of 30 mm or less. They must also have an outer diameter compatible with the inner diameter of the unit selected. The actual deflection produced at the end of the device will depend upon the stiffiess of the inserted instrument.

The OmniSonics Deflector is constructed with the following major components:
Outer sheath tube: A rigid, stainless steel tube that provides rigidity for insertion into the body
Deflection tube: A flexible, polyurethane, kink resistant tube that bends when the deflection handle is activated.
Deflection wire: A stainless steel wire that pulls the tip of the deflection tube to cause deflection.
Deflection handle: An ABS handle that has mechanisms for rotation of the shaft, articulation of the deflection tube, movement of the inserted device in and out and sealing of the inserted device.

The provided text does not contain information about acceptance criteria or a study that proves the specified device (OmniSonics Endoscopic Deflector) meets them.

The document is a 510(k) premarket notification summary from the FDA, detailing the device's substantial equivalence to other legally marketed devices. It focuses on the device's intended use, description, and comparison to predicate devices, but lacks details on performance testing or clinical study results as they relate to acceptance criteria.

Specifically, the document states: "Performance Testing The OmniSonics Deflector conforms to IEC 60601-18 All materials used are biocompatable". This is a very high-level statement and does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study details, standalone performance, or type of ground truth for any test set.
3. Sample size or ground truth establishment for a training set.

The document's purpose is to establish substantial equivalence for market clearance, not necessarily to provide detailed performance study results against specific acceptance criteria.

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The OmniSonics Endoscopes are intended for visualization of body cavities, hollow organs, and canals. The OmniSonics Endoscopes are designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths or other devices with lumens having an inside diameter larger than the outside diameter of the endoscope. The OmniSonics Endoscopes are indicated for the following applications: Ureteroscopy, Bronshoscopy, Thoracoscopy, Nasopharyngoscopy, Sinuscopy, General laparoscopy, Urology, Gynecological.

The OmniSonics Endoscopes are fiber optic designed endoscopes offered in a variety of lengths, diameters and configurations for user convenience. The fiberoptic endoscope functions by light being transmitted from a standard external high intensity light source through illumination fibers to the distal tip of the scope. The image is transmitted via a fiber-imaging bundle to an eyepiece. The image is viewed directly or transmitted through a video camera to a monitor. The device is provided with a reusable coupler and is also compatible with other standard couplers currently marketed.

The provided text is a 510(k) premarket notification for the OmniSonics Flexible Fiber Optic Endoscope and Coupler. It is a submission to the FDA seeking approval to market a medical device, asserting its substantial equivalence to already legally marketed devices.

Based on the provided information, the device is not a diagnostic AI device and therefore does not have the types of acceptance criteria and studies typically associated with AI/ML-driven diagnostic tools.

Here's a breakdown of why and what information is available:

This device is a traditional medical instrument (fiber optic endoscope), not an AI/ML-driven diagnostic device. The 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices based on design, intended use, technological characteristics, and materials, rather than performance metrics for diagnostic accuracy.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable in this context.

Here's what can be extracted and inferred from the text regarding the device and its "testing":

1. Table of Acceptance Criteria and Reported Device Performance:

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 does not describe a clinical performance study with a test set of data for diagnostic accuracy. The "testing" mentioned refers to engineering compliance and material biocompatibility.

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

• Not applicable. No diagnostic "ground truth" was established as this is not a diagnostic device in the AI sense.

4. Adjudication method (e.g. 2+1, 3+1, none) 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:

• No. This is not an AI device, and therefore no MRMC study for AI assistance was performed.

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. The "ground truth" here is the established safety and performance requirements for endoscopes via standards (IEC 60601-2-18) and the established characteristics of predicate devices.

8. The sample size for the training set:

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

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

• Not applicable.

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