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The Synergetics Sterile Adjustable Gas Pressured Infusion Tube Set is intended to deliver forced humidified air or fluid to the eye during ophthalmic surgery.

The Synergetics AGPI Tubing set is a PVC tubing set intended to deliver forced humidified air or fluid to the eye during ophthalmic surgery. The tubing set consists of a three channel IV spike, for insertion into a bottle of Balanced Salt Solution. The three way spike is designed to deliver air from an air supply unit through the solution; while the dual PVC tubing also administers humidified air (clear lumen) and saline (green stripe lumen); this dual PVC tubing has a three-way stopcock for proper connection.

This document describes the Synergetics Adjustable Gas Pressured Infusion (AGPI) Tube Set, a device intended to deliver forced humidified air or fluid to the eye during ophthalmic surgery. The document is primarily a 510(k) submission, focusing on establishing substantial equivalence to predicate devices, rather than a clinical study report with detailed acceptance criteria and performance metrics in the context of diagnostic accuracy or clinical outcomes.

Therefore, many of the requested sections regarding acceptance criteria, study design, sample sizes for test and training sets, expert qualifications, and ground truth establishment cannot be fully addressed from the provided text, as this information is typically found in performance studies, which are not detailed here. The submission focuses on technical and safety aspects for regulatory approval.

However, I can extract the available relevant information about the device and its compliance.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity) in the sense of a clinical or analytical performance study. Instead, it focuses on demonstrating substantial equivalence to predicate devices by comparing technical characteristics and adherence to regulatory standards.

The primary "acceptance criteria" can be inferred as meeting the technical characteristics and safety/sterilization standards demonstrated by predicate devices and relevant ISO standards.

Study Information (Based on available text)

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

   • The document does not describe a "test set" in the context of a clinical performance study with a sample size for human subjects or case data. The "test set" here refers to the device itself being evaluated against technical and regulatory standards.
   • Data provenance is primarily through comparison with existing predicate devices (Peregrine Wet Set, Alcon VGFI Tube Set) and established international standards (ISO 11607-1:2006, AAMI/ISO 11135, ISO 14971, BS EN 13485:2003). This is therefore "retrospective" analysis of existing regulatory and technical standards and comparison to previously approved devices.

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

   • Not applicable in this context. The "ground truth" for this type of submission is adherence to predefined technical specifications and regulatory standards, rather than expert-derived diagnoses or interpretations. The FDA reviewers (e.g., in the Ophthalmic Panel) represent regulatory expertise.

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

   • Not applicable. There's no clinical "test set" requiring adjudication of results. The adjudication process would be the regulatory review conducted by the FDA.

4. 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 medical accessory (tubing set), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or is relevant.

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

   • Not applicable. This is not an algorithmic device.

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

   • The "ground truth" for this 510(k) submission relates to technical specifications, safety, and performance as defined by engineering standards, manufacturing controls, and the established characteristics of predicate devices. For example, the ground truth for sterilization is adherence to AAMI/ISO 11135, and for packaging, it's ISO 11607-1:2006.

7. The sample size for the training set:

   • Not applicable. There is no concept of a "training set" for this type of medical device submission. The device is not learning from data.

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

   • Not applicable.

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The Stryker Intradiscal RF Generator is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The Stryker Intradiscal RF Generator will be used with the previously cleared Stryker RF Intradiscal Adapter and catheters such as Smith & Nephew Spinecath™ & Acutherm™ catheters.

The Stryker Intradiscal RF Generator when used with the separately cleared Stryker RF Intradiscal Adapter and the separately cleared Smith & Nephew SPINECATH™ Intradiscal Catheter (K993967) ACUTHERM ™ Decompression Catheter is is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.

The provided documentation, K063489, is a 510(k) Summary for the Stryker Intradiscal RF Generator, submitted in 2007. It establishes substantial equivalence to a predicate device, the Smith & Nephew ElectroThermal 20S Spine Generator (K033981), rather than presenting a study with specific acceptance criteria and performance data for the Stryker device itself.

Therefore, many of the requested details regarding a study proving acceptance criteria are not directly available in this document. The submission asserts equivalence based on intended use, technological characteristics, operating principles, and similar performance characteristics.

Here’s an analysis based on the provided text, indicating what is not present in the document due to its nature as a 510(k) summary relying on predicate equivalence:

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 510(k) submission does not describe a new clinical or performance study with a test set for the Stryker Intradiscal RF Generator. It relies on the substantial equivalence to a previously cleared device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Applicable. No test set or ground truth establishment by experts is described for this submission.

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

• Not Applicable. No test set or 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. The device is a radiofrequency generator, not an AI-based diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant and not present in this document.

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

• Not Applicable. The device is a physical medical instrument (RF generator), not an algorithm or AI system. Its performance is evaluated through its physical and electrical characteristics, and its safety relies on its design and manufacturing.

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

• Not Applicable. As no specific performance study for this device is detailed, no ground truth data type is mentioned. The submission relies on the predicate device's established safety and effectiveness.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device, so the concept of a "training set" is not relevant.

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

• Not Applicable. As above, this is not an AI/machine learning device.

Summary of the K063489 Submission:

The K063489 submission for the Stryker Intradiscal RF Generator establishes substantial equivalence to the Smith & Nephew ElectroThermal 20S Spine Generator (K033981). This means that instead of conducting new performance studies, the applicant demonstrated that their device shares the same intended use, technological characteristics, operating principles, and similar performance characteristics as a device already legally marketed. Therefore, the detailed information typically found in a clinical or performance study (such as acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies) is not provided in this 510(k) summary for the Stryker device itself. The FDA cleared the device based on this comparative assessment.

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The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery and to provide photocoagulation when used with the appropriate commercially available laser light source and probe.

The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery and to provide photocoagulation when used with the appropriate commercially available laser light source and probe.

Acceptance Criteria and Study Details for Synergetics Synerlight FiberOptic Lightsource

The provided document describes the 510(k) summary and FDA clearance letter for the Synergetics Synerlight FiberOptic Lightsource. This submission is for substantial equivalence to a predicate device, K964005.

Based on the provided information, there are no explicit acceptance criteria or detailed study results demonstrating device performance against such criteria in the manner typically expected for AI/ML-based medical devices.

Instead, the submission relies on the concept of substantial equivalence to a predicate device already on the market. This means the device is considered safe and effective because it is as safe and effective as a legally marketed device, and does not raise different questions of safety and effectiveness.

Here’s a breakdown of the information that is available and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not provide specific, measurable acceptance criteria in terms of clinical or technical performance parameters for the device itself (e.g., minimum lumen output, color temperature range, specific photocoagulation effectiveness). The primary "acceptance criterion" from an FDA 510(k) perspective is demonstrated substantial equivalence to a legally marketed predicate device. The "reported device performance" is a general statement of meeting this substantial equivalence.

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

• Sample Size for Test Set: Not applicable/not provided. This type of information is typically associated with studies involving data analysis, such as image analysis for AI devices. The submission for a fiberoptic light source would not involve a "test set" of patient data in this manner.
• Data Provenance: Not applicable/not provided. The submission focuses on the performance characteristics of the hardware device itself, likely through engineering and functional testing, rather than analysis of patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable/not provided. Ground truth establishment with experts is relevant for diagnostic devices that interpret clinical data. For a fiberoptic light source, the "ground truth" would be objective measurement of its physical properties and functionality.

4. Adjudication Method for the Test Set

• Not applicable/not provided. This typically refers to resolving discrepancies in expert interpretations, which is not relevant for a hardware device like a light source.

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

• No, an MRMC comparative effectiveness study was not done. MRMC studies are used to assess the impact of a diagnostic tool (often AI-assisted) on human reader performance, usually in interpreting medical images or data. This is not relevant for a light source.
• Effect Size of Human Readers with vs. without AI assistance: Not applicable.

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

• Not applicable. This device is a hardware component and does not operate as a standalone algorithm. Its function is to illuminate, and potentially provide photocoagulation when used with a laser.

7. The Type of Ground Truth Used

• Implicit Ground Truth: For a fiberoptic light source, the "ground truth" would implicitly be based on established engineering standards for light output, spectral characteristics, safety (e.g., heat generation, electrical safety), and compatibility with other surgical equipment. These would be objectively measured and compared to the predicate device.
• The document does not specify the exact technical parameters or standards used for comparison, but states unequivocally that "Testing demonstrated that the subject device is substantially equivalent to the predicate device."

8. The Sample Size for the Training Set

• Not applicable. This device is a hardware product, not an AI/ML algorithm that requires a training set of data.

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

• Not applicable. As there is no training set, there is no ground truth for it to be established.

Summary of Approach for This Device:

The Synergetics Synerlight FiberOptic Lightsource gained FDA clearance through the 510(k) pathway by demonstrating substantial equivalence to an existing predicate device (K964005). The "study" mentioned, "Testing demonstrated that the subject device is substantially equivalent to the predicate device," refers to internal engineering and functional testing. This testing would have assessed that the new device has similar technological characteristics (e.g., light output, spectral range, safety features, intended use, materials) or, if different, that those differences do not raise new questions of safety and effectiveness.

The documentation does not contain the detailed performance metrics, clinical study designs, or expert review processes that would be typical for more complex diagnostic or AI-driven devices.

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Synergetics Sonotome™ Ultrasonic Aspirator Tips are intended for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g.: bone) tissue is desirable, including: Neurosurgery, Gastrointestinal and Affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery, Thoracoscopic Surgery.

Synergetics Sonotome™ Ultrasonic Aspirator Tips are accessories that are attached to the handpiece of an ultrasonic surgical aspirator system manufactured by another company. The tip, which simply transmits power from the system handpiece, is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissues while preserving vessels, ducts and other delicate structures. The main features on the Synergetics Sonotome™ Ultrasonic Aspirator Tips are: A variety of tip diameters, shapes and lengths are available for specific surgical applications. Curved tips are bent so as to provide clear visualization of the surgical site, unobstructed by the handpiece. Individually packaged, sterile tips can be replaced without the need for resterilization of the handpiece. Preaspiration holes in the tips minimize clogging and keep the tip clear of debris.

This document is a 510(k) Premarket Notification summary for the Synergetics Sonotome™ Ultrasonic Aspirator Tips. It specifies the device's intended use, materials, and a comparison to a predicate device.

However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document states: "Validation and verification of the Ultrasonic Aspirator Tips will be accomplished through a combination of analysis and testing. This process will include a Risk Analysis and a mechanical performance test on prototype units."

This indicates that a mechanical performance test was planned or conducted, but no details about the acceptance criteria, the results of the test, or the study methodology are provided in the extracted text.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Information about an MRMC comparative effectiveness study or its effect size.
• Information about a standalone performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

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The Synergetics Inc., Mode Scrambled LindoOto Laser Probe provides a means of delivering photocoagulation during otologic surgery. Indications include, but are not limited to treatment of stapes related disorders to be treated with stapedectorny by means of photocoagulation. This device transmits laser energy to target tissuc, thereby causing photocoagulation. Spot size can be varied by altering the distance between the tissuc and the probe tip.

Mode Scrambled EndoOto Laser Probe

The provided document is a 510(k) clearance letter from the FDA for a medical device (Mode Scrambled EndoOto Laser Probe) from 1999. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding specific acceptance criteria for device performance, nor does it describe a study proving the device meets such criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new performance studies with pre-defined acceptance criteria and statistical analyses as might be seen for novel devices or in the de novo pathway today.

Therefore, I cannot provide the requested information based on the given text.

To be explicit about the missing information:

1. Table of acceptance criteria and reported device performance: Not present.
2. Sample size used for the test set and data provenance: Not present. The document refers to "indications for use stated in the enclosure" and implicitly relies on the safety and effectiveness of the predicate device.
3. Number of experts used to establish ground truth and qualifications: Not present.
4. Adjudication method for the test set: Not present.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not present. This type of study is more common for diagnostic imaging devices and AI/ML-enabled devices, which is not the case for this laser probe.
6. Standalone performance study (algorithm only): Not applicable as this is a physical medical device, not an algorithm.
7. Type of ground truth used: Not present.
8. Sample size for the training set: Not applicable and not present.
9. How ground truth for the training set was established: Not applicable and not present.

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The SYNERGETICS VERITAS... Non-Stick Bipolar Forceps is a reusable instrument designed for bipolar coagulation during surgical procedures. It is designed for use with most available bipolar electrosurgical units, and will provide a means of transmitting and applying cauterization to captured tissue and small bleeding vessels, thereby causing coagulation and hemostasis

The SYNERGETICS VERITAS... Non-Stick Bipolar Forceps is a reusable instrument designed for bipolar coagulation during surgical procedures.

I am sorry but this document does not contain the information you are looking for. This document is a letter from the FDA to Synergetics, Inc. regarding the clearance of their Veritas Bipolar, Insulated, 0.5MM TIP device (Model N301-005) for marketing. It states that the device has been found substantially equivalent to legally marketed predicate devices.

The document includes:

• Regulatory Class: II
• Product Code: GEI
• Intended Use: The SYNERGETICS VERITAS Non-Stick Bipolar Forceps is a reusable instrument designed for bipolar coagulation during surgical procedures, specifically for transmitting and applying cauterization to captured tissue and small bleeding vessels, thereby causing coagulation and hemostasis.

However, it does not contain any information regarding acceptance criteria, study details, device performance metrics, sample sizes, ground truth establishment, or expert adjudication as typically found in a clinical study report or performance evaluation.

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The Synergetics Fiber Optic light Source is indicated for use during anterior and posterior vitreoretinal surgery to illuminate the eye.

The Synergetics lightsource is a stand alone arc-lamp based lightsource that incorporates a standard connector mount used by most endoilluminators. It has a brightness control, accessory filter control and lamp life timer display.

Here's an analysis of the provided text regarding the Synergetics, Inc. Synerlight Fiber Optic Lightsource, focusing on acceptance criteria and the study proving its performance.

It's important to note that this document is a 510(k) submission, which primarily aims to demonstrate substantial equivalence to a predicate device, rather than a clinical study establishing novel safety and effectiveness. Therefore, some of the requested information, particularly regarding formal acceptance criteria with specific thresholds, detailed study designs, and human reader performance comparisons, is not explicitly present in the provided text. The "study" described herein is a comparison between the new device and a predicate device.

Acceptance Criteria and Device Performance

The acceptance criteria for the Synergetics Synerlight Fiber Optic Lightsource are implicitly derived from its comparison to the predicate device, the Dutch Ophthalmic, USA Xenon Illumination System (D.O.R.C.). The core acceptance criterion is substantial equivalence in intended use, safety, and effectiveness. The reported device performance is measured against that of the predicate device across various parameters.

Table of Acceptance Criteria and Reported Device Performance

Study Details (Substantial Equivalence Comparison)

The "study" presented here is a comparison against a predicate device to establish substantial equivalence under the 510(k) pathway, not a traditional clinical trial or performance study with acceptance criteria in the sense of predefined statistical thresholds for device accuracy or efficacy.

1. Sample Size used for the test set and the data provenance:

   • Test Set: No explicit "test set" in the sense of patient data is used. The comparison is between the Synergetics Synerlight Fiber Optic Lightsource (new device) and the D.O.R.C. Xenon Illumination System (predicate device).
   • Data Provenance: The data appears to be a mix of manufacturer specifications (for both devices) and internal testing conducted by Tayman Medical (for D.O.R.C.'s visible light output) and Synergetics (for its own device's power output and IR output). It is a retrospective analysis and comparison of device specifications and internal lab measurements. The country of origin of the data is not specified beyond the manufacturers' locations (USA for Tayman Medical/Synergetics, and USA for D.O.R.C.).

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

   • This type of expert evaluation is not mentioned or relevant for a 510(k) substantial equivalence submission, which relies on objective device specifications and comparative measurements rather than expert clinical judgment on individual cases.

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

   • Not applicable. There is no expert adjudication of imaging or clinical findings. The comparison is based on technical specifications and measured output.

4. 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 light source for surgery, not an AI or imaging diagnostic tool. An MRMC study is not relevant here.

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

   • Not applicable. This is not an AI algorithm. The device's "standalone" performance is described through its technical specifications and measured outputs as compared to the predicate.

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

   • The "ground truth" for this submission is the technical specifications and measured performance of the predicate device, as stated in its own documentation or measured by the applicant, and established industry standards for medical device safety (e.g., phototoxicity concerns regarding UV and IR light). The goal is to show the new device is as safe and effective, or safer/more effective where justified and controlled (e.g., reduced UV/IR output, higher controlled visible light).

7. The sample size for the training set:

   • Not applicable. This device is not developed using machine learning, so there is no concept of a "training set."

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

   • Not applicable for the same reason as above.

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