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The Synergetics Disposable Speztler-Malis Standard Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue.

The Synergetics™ Disposable Spetzler™ Malis® Standard Bipolar Forceps are sterile single use devices for use in electrosurgery. The forceps are a bayonet style and include a cord at the proximal end which allows for connection to a Malis bipolar electrosurgical generator.

The provided document is a 510(k) Summary for a medical device (Synergetics™ Disposable Spetzler™ Malis® Standard Bipolar Forceps), a submission for regulatory clearance in the US. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria and performance metrics in the way one might for a novel diagnostic algorithm or drug.

Therefore, the information requested, particularly regarding "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how ground truth for training set was established," is not applicable in the context of this 510(k) submission. These questions are more relevant to studies for AI/ML-driven diagnostic devices or clinical trials for drugs.

However, I can extract the relevant information regarding the device's technical characteristics comparison and regulatory testing, which serves a similar purpose of demonstrating safety and effectiveness for substantial equivalence.

Here's a breakdown based on the provided text, addressing the closest equivalents to your questions:

Device: Synergetics™ Disposable Spetzler™ Malis® Standard Bipolar Forceps

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) substantial equivalence determination, "acceptance criteria" are generally interpreted as demonstrating equivalent functional and safety characteristics to a legally marketed predicate device. The "performance" is the new device exhibiting these equivalent characteristics through non-clinical testing.

Summary of Non-clinical Testing:
Bench testing and comparative performance testing were conducted to demonstrate substantial equivalence to the predicate device. This included relevant electrical safety testing to IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. The non-clinical testing indicated that the device performance is substantially equivalent to the predicate, and the slight differences (primarily the lack of irrigation feature) raise no new issues of safety and effectiveness.

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

• Sample Size: Not specified for individual tests. The document refers to "bench testing" and "comparative performance testing," implying physical testing of the device. The sample size for these engineering tests would typically be determined by internal quality standards and statistical power requirements for specific tests (e.g., tensile strength, insulation integrity) but is not detailed in this summary.
• Data Provenance: The document implies the data comes from internal testing conducted by Synergetics, Inc., related to the manufacturing and design verification of the new device and comparison to the predicate. This is prospective testing performed for regulatory submission. Country of origin not explicitly stated, but the applicant's address is O'Fallon, MO, USA.

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

• Not Applicable. This device is a physical electrosurgical tool, not an AI/ML diagnostic system or imaging device requiring expert interpretation for ground truth. "Ground truth" in this context would be engineering specifications and validated performance metrics (e.g., electrical resistance, material integrity).

4. Adjudication Method for the Test Set

• Not Applicable. See point 3. Tests would be based on objective measurements against engineering specifications and industry standards rather than expert 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

• Not Applicable. This is a surgical instrument, not an AI/ML diagnostic aid. No human reader or AI assistance is involved in its direct function.

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

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

7. The Type of Ground Truth Used

• For the "tests" performed (bench testing, comparative performance, electrical safety), the "ground truth" would be engineering specifications, industry standards (e.g., IEC 60601 series, ISO 11135, ISO 14971, ISO 11607-1), and the established performance characteristics of the legally marketed predicate device. The goal is to show the new device meets safety and performance standards and is substantially equivalent to the predicate.

8. The Sample Size for the Training Set

• Not Applicable. This is a hardware 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. See point 8.

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The Synergetics VersaVit is an ophthalmic microsurgical system that is indicated for posterior segment (i.e. vitreoretinal) ophthalmic surgery. The integrated light source is intended to illuminate the eye during vitreoretinal procedures.

The VersaVit is a compact, stand-alone, portable device with a pneumatic vitrector drive, aspiration, and illumination through an imbedded solid state LED light source.

The provided document is a 510(k) summary for the Synergetics VersaVit, a vitreous aspiration and cutting instrument. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria and device performance metrics.

Based on the information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format typically seen for clinical trials. Instead, it states that the device "has undergone testing and is in compliance with the applicable requirements of safety standards." and was "found to perform equivalently to the predicate device in a series of bench tests."

The "acceptance criteria" here are largely implied to be "substantially equivalent" or "functionally equivalent" to the predicate device for parameters where direct identical values are not present, or "compliant with applicable safety standards" for overall performance.

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

The document mentions "a series of bench tests" and "internal comparative bench testing" but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for these tests. This is typical for a 510(k) application relying on bench testing for equivalence, rather than clinical studies with human subjects.

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 because the submission primarily relies on bench testing and comparison to an existing predicate device rather than human-read image interpretation or diagnostic performance that would require expert-established ground truth.

4. Adjudication method for the test set:

Not applicable, as the document describes bench testing and not a study requiring adjudication of human interpretations or diagnoses.

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 document describes a medical device (vitreous aspiration and cutting instrument) and not an AI/CAD system for image interpretation or diagnosis. Therefore, an MRMC study related to human reader improvement with AI assistance would not be relevant.

6. 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 is a surgical instrument.

7. The type of ground truth used:

For bench testing, the "ground truth" would typically refer to established engineering specifications, performance standards, or known performance characteristics of the predicate device against which the subject device's performance is measured. The document states compliance with "applicable requirements of safety standards" and equivalence to the predicate device's performance.

8. The sample size for the training set:

Not applicable, as this is a medical device and not an AI/machine learning model that requires a training set.

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

Not applicable, as this is a medical device and not an AI/machine learning model.

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The Synergetics Disposable Directional Endo Ocular Laser Probe provides a mean for delivering endophotocoagulation during vitrectomy surgery.

The Synergetics™ Disposable Directional Endo Ocular Laser Probe is a sterile single use ophthalmic laser delivery device. The Laser Probe assembly includes a probe tip (distal end), a handpiece and a coupling means (proximal end) for connecting the Laser Probe to a commercially available laser source. Glass optic fiber protected by PVC tubing is provided between the handpiece and the coupling means. The probe tip, handpiece, tubing and coupling include a passageway for an optic fiber to transmit laser energy from the proximal end through the assembly to the distal end of the probe tip includes a rounded circumferential edge and smooth distal end surface to minimize tearing or snagging of tissue during insertion of the probe assembly through an incision at the sclera at pars plana.

The laser fibers work on the principle of total reflection. Laser energy is focused into the glass silica fiber at the proximal end of the probe and traverses the length of the fiber by means of total reflection. The fiber is able to contain the laser beam and funnels the laser through the proximal end through the assembly to the distal end of the laser probe.

The provided text describes a 510(k) submission for the Synergetics Disposable Directional Endo Ocular Laser Probe. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a new, complex AI/software-driven device.

Therefore, much of the requested information regarding AI device testing (sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, training set details) is not applicable to this type of traditional medical device submission.

Here's an analysis based on the information provided:

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

The "acceptance criteria" for this conventional device are primarily based on demonstrating substantial equivalence to a predicate device (Gamp and Associates Disposable Endoocular Laser Probe, K954307) across key technical characteristics and intended use. The "reported device performance" is the direct comparison of these characteristics.

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

The submission indicates "Bench testing, and comparative performance testing to the predicate device, was performed." This refers to physical, non-clinical tests on the device itself.

• Sample Size: Not explicitly stated, but typically involves a number of manufactured units of the device. This is not patient or image data.
• Data Provenance: Not applicable in the sense of patient data. The tests would have been performed by the manufacturer, Synergetics, Inc., likely at their facilities or a contracted testing lab.

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. This is not a diagnostic AI device requiring expert-established ground truth from medical images or patient data. The "ground truth" here would be the physical properties and performance measurements of the device itself (e.g., laser power output, sterility, packaging integrity).

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

Not applicable, as this is not a diagnostic AI device or clinical study involving expert interpretation with 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

Not applicable. This is a traditional surgical device, not an AI software.

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

Not applicable. This is a traditional surgical device, not an AI algorithm.

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

The "ground truth" for this device's performance would be established through a series of engineering and physical measurements against predefined specifications and industry standards, as well as comparison to the predicate device's known characteristics. Examples include:

• Laser power transmission efficiency
• Fiber integrity and durability
• Sterility (validated to AAMI/ISO 11135)
• Packaging integrity (validated to ISO 11607-1:2006)
• Biocompatibility (if applicable, though not explicitly detailed here)
• Mechanical strength and component integrity

8. The sample size for the training set

Not applicable. This is a traditional hardware medical device, not an AI model requiring a training set.

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

Not applicable.

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The Synergetics Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps are single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue.

The Synergetics Disposable Spetzler Malis Irrigating Bipolar Forceps is a sterile single use device. It consists of dual inlet irrigating pathways that run along side of the forceps from the proximal end the distal end. This allows the surgeon to view the surgical field without obstruction allowing the fluid to irrigate through the irrigation module through the forceps.

This document is a 510(k) summary for the Synergetics Disposable Spetzler Malis Dual Irrigating Bipolar Forceps and details its substantial equivalence to a predicate device. It primarily focuses on comparing technical characteristics and non-clinical testing.

Here's an analysis based on your requested information, acknowledging that this type of regulatory submission often doesn't contain detailed study breakdowns in the same way a clinical trial publication would:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable table format for various performance metrics with corresponding numerical results. Instead, it relies on demonstrating substantial equivalence to a predicate device through comparison of technical characteristics and non-clinical testing.

The implicit acceptance criteria are that the new device performs comparably to the predicate device and meets relevant safety standards.

The "study" to prove the device meets these (mostly implicit) acceptance criteria is a sum of:

• Bench testing: Performed to compare the new device's performance to the predicate device.
• Comparative performance testing: Against the predicate device.
• Electrical safety testing: Conducted according to IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
• Risk Management: Implemented in compliance with ISO 14971.
• Sterilization Validation: In accordance with AAMI/ISO 11135.
• Packaging Validation: In accordance with ISO 11607-1:2006.

The conclusion from these tests is that "The non-clinical testing indicates the device performance is substantially equivalent to the predicate and the slight differences raise no new issues of safety and effectiveness."

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

• Sample Size: The document does not specify a quantitative sample size (e.g., number of units tested) for the bench or comparative performance testing. Typically, regulatory submissions for devices like this demonstrate equivalence through a sufficient number of tests to establish reliability and consistent performance rather than large clinical trial-style sample sizes for a 'test set.'
• Data Provenance: The studies are non-clinical (bench testing) and were conducted by Synergetics, Inc. (the applicant). The country of origin for the data is implicitly the United States, where the company is based. The data is prospective in the sense that the tests were specifically performed to support this 510(k) submission.

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

Not applicable. This is a non-clinical device summary. "Ground truth" in the context of expert consensus or pathology is typically associated with diagnostic or prognostic devices, not electrosurgical tools where performance is assessed through engineering and safety standards. The "truth" here is established by adherence to technical specifications and validated performance against a known device.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is non-clinical testing against technical standards and a predicate device, not involving human interpretation or adjudication in the sense of a clinical or image-based study.

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 an electrosurgical tool, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study with human readers and AI assistance is entirely outside the scope of this submission.

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

Not applicable. This is a hardware electrosurgical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating the device's performance is based on:

• Engineering specifications and design attributes: For technical characteristics like design, materials, and connectors.
• International Standards: Compliance with IEC 60601 series for electrical safety and ISO standards for packaging and sterilization.
• Predicate Device Performance: The functional performance of the new device is considered "true" or acceptable if it is comparable to the legally marketed predicate device (K080187) during bench and comparative testing.

8. The Sample Size for the Training Set

Not applicable. There is no AI component or machine learning model for which a "training set" would be used.

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

Not applicable, as there is no training set.

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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 RF Multi-Lesion Generator, in combination with the Stryker RF Electrodes and Cannulae are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. Examples include, but are not limited to: Facette Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.

The Stryker RF Multi-Lesion Generator in combination with a Smith & Nephew SPINECATH™ & Acutherm™ catheters are intended for coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.

The Stryker RF Multi Lesion Generator will be used in conjunction with Stryker RF Electrodes and Cannula for ablation and coagulation of soft tissue. The generator applies temperature controlled radio frequency RF energy into targeted tissue via an electrode probe, resulting in cellular necrosis. In the case of interventional pain applications, pain relief is achieved by creating defined lesions on pain-conducting nerve fibers or tissue. In addition, the Stryker RF Multi-Lesion Generator allows multiple areas to be targeted and treated concurrently. By treating multiple areas concurrently, overall procedure time can be reduced while maintaining thermal treatments each equivalent to an individual treatment

The Stryker RF Multi-lesion System is a bipolar and monopolar, high frequency electrosurgical system. The System consists of the following components: a RF generator, footswitch hand controller, monopolar and bipolar electrodes, cannulae, neutral electrodes, coaxial bipolar electrodes and cannula, parallel bipolar adapter, connecting cables, and intradiscal cable,

Here's a summary of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific acceptance criteria or quantitative performance metrics for the Stryker RF Multi-lesion Generator. The basis for clearance is a demonstration of "substantial equivalence" to predicate devices.

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

The provided document does not mention a test set, sample size for testing, or data provenance (e.g., country of origin, retrospective/prospective). The submission relies on a comparison to predicate devices rather than a new clinical study with a specific test cohort.

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

Not applicable, as a specific test set requiring expert-established ground truth is not described in the document.

4. Adjudication Method for the Test Set:

Not applicable, as a specific test set requiring adjudication is not described in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention an MRMC comparative effectiveness study. The clearance is based on substantial equivalence, not on demonstrating an improvement in human reader performance with or without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

This is not applicable as the device is a radiofrequency lesion generator, a hardware device, not an algorithm or AI.

7. Type of Ground Truth Used:

Not applicable, as a specific test set requiring ground truth is not described in the document. The basis for clearance is "comparison to the predicate devices" for safety and effectiveness.

8. Sample Size for the Training Set:

This is not applicable as the device is a hardware product, not an AI/ML algorithm that requires a training set.

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

This is not applicable for the same reason as above – the device is not an AI/ML algorithm.

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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.

Ask a specific question about this device

Ask a specific question about this device