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The Storz DP4210 Venturi Economy Anterior Pack and DP5000 ASC Daypack are intended to be used as accessory devices with the Storz DAISY® (K854508), PREMIERE® (K894278, K921460 and K946227), Protege® (K921758 and K950114), and Millennium™ (K961310) Ophthalmic Microsurgical Systems. Both accessory packs facilitate use of Storz phaco handpieces (K935926) and Storz I/A handpieces (K951463) with the above referenced microsurgical systems in various anterior segment ophthalmic surgical procedures, e.g., phacoemulsification and residual cortical material removal following a planned Extracapsular Cataract Extraction.

The Storz DP4210 Venturi Economy Anterior Pack and DP5000 ASC Daypack are intended to be used as accessory devices with the Storz DAISY® (K854508), PREMIERE® (K894278, K921460 and K946227), Protege® (K921758 and K950114), and Millennium™ (K961310) Ophthalmic Microsurgical Systems. Both accessory packs facilitate use of Storz phaco handpieces (K935926) and Storz I/A handpieces (K951463) with the above referenced microsurgical systems in various anterior segment ophthalmic surgical procedures, e.g., phacoemulsification and residual cortical material removal following a planned Extracapsular Cataract Extraction.

The Storz DP4210 Venturi Economy Anterior Pack is provided non-sterile and contains reusable components consisting of an anterior collection cassette, I/A tubing set, and I/A test chambers. The Storz DP5000 ASC Daypack is provided sterile and contains both reusable and single use components. The DP5000 reusable items include an anterior collection cassette, I/A test chambers, needle wrench, and infusion sleeve. The DP5000 single use items include an I/A tube assembly and a BSS administration tube assembly.

This document is a 510(k) premarket notification for two ophthalmic accessory packs, the Storz DP4210 Venturi Economy Anterior Pack and the Storz DP5000 ASC Daypack. It focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a study with performance metrics.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided text because this type of 510(k) submission generally relies on demonstrating similarity to legally marketed devices, not on new clinical performance studies with defined acceptance criteria and statistical analysis as would be required for a novel device or a Premarket Approval (PMA) application.

Here's what can be extracted and what is missing based on the provided text:

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

• Not explicitly stated in the document. The document's purpose is to demonstrate substantial equivalence to predicate devices, not to present performance metrics against predefined acceptance criteria. The "performance" is implicitly deemed equivalent to the predicate devices if substantial equivalence is established.

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 is a 510(k) premarket notification for accessory packs, which typically does not involve a "test set" and performance data in the way a clinical study for a drug or novel device would. The assessment is based on comparing device characteristics and intended use to predicate devices. There is no mention of a clinical study or data provenance.

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 "ground truth" establishment by experts for a test set is mentioned, as this is not a performance study.

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

• Not applicable/Not provided. No adjudication method is mentioned.

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. MRMC studies are not relevant to this type of device and submission. There is no AI component mentioned.

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

• Not applicable/Not provided. This device does not involve algorithms or AI.

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

• Not applicable/Not provided. No ground truth determination is described.

8. The sample size for the training set

• Not applicable/Not provided. This device does not involve a "training set" in the context of machine learning or algorithms.

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

• Not applicable/Not provided. No training set or ground truth establishment relevant to this context is described.

Summary of what the document does provide in relation to regulatory acceptance:

The document outlines a process of demonstrating substantial equivalence to existing legally marketed predicate devices, which is the "acceptance criteria" for a 510(k) submission.

• Predicate Devices:
  • Storz DP4210 Venturi Economy Anterior Pack: Substantially equivalent to Storz DP4210 Universal I/A and Phaco Pack (K882240).
  • Storz DP5000 ASC Daypack: Substantially equivalent to Storz DP4210 Universal I/A and Phaco Pack (K882240) and Storz DP4310 Deluxe Phaco Pack (K955901).
• Method of "Proof": Device comparison charts (Pages 2-3) are used to highlight similarities in:
  • 510(k) reference (i.e., previous clearance)
  • Pack Name
  • Intended Use
  • Individual Pack Components
  • Anterior Collection Cassette design (for DP4210 comparison)
  • Reusable Components
  • Limited Reuse (number of times)
  • Pack Provided Sterile (Yes/No)
  • Pack Sterilization method (for DP5000 comparison)
• Result of "Study" (FDA Outcome): The FDA reviewed the 510(k) notification and determined the device (both packs) to be substantially equivalent for its stated indications for use (Page 4). This determination allows the device to be marketed.

This document serves as an example of a 510(k) submission where "acceptance criteria" and "study" are framed by the regulatory concept of substantial equivalence, rather than a clinical trial with specific performance endpoints.

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The Storz Millennium™ High Speed Vitrectomy System is a new device intended for removal of vitreous matter from the posterior vitreous cavity during ophthalmic vitrectomy surgery. The Storz high speed vitrectomy system consists of the Storz CX5800 module to be used with the Storz Millennium™ Microsurgical System, Storz CX5810 handpiece, and the Storz CX4804 sterile single use accessory pack.

The Storz Millennium™ High Speed Vitrectomy System is intended for the aspiration of vitreous matter from the eye during ophthalmic vitrectomy surgery. The system consists of the Storz CX5800 Millennium™ System High Speed Vitrectomy module used with the Storz Millennium™ Microsurgical System, Storz CX5810 High Speed Vitrectomy handpiece, and the Storz CX4804 High Speed Vitrectomy single use disposable pack.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting studies for the Storz Millennium™ High Speed Vitrectomy System:

Summary of Acceptance Criteria and Study Information:

This 510(k) submission, K980488 for the "Storz Millennium™ High Speed Vitrectomy System," is a premarket notification for a new device claiming substantial equivalence to existing predicate devices. It does not contain information about specific performance acceptance criteria for the new device as a standalone product, nor does it detail a study that directly proves specific numerical performance metrics.

Instead, the submission focuses on demonstrating substantial equivalence in design, materials, and intended use to already legally marketed predicate devices. The "performance" assessment is implied through the comparison of characteristics and specifications against these predicates. This is a common approach for 510(k) submissions, where the new device is not required to meet novel performance criteria but rather to demonstrate it is as safe and effective as a legally marketed device.

Therefore, the table below will reflect the comparison of characteristics rather than specific "acceptance criteria" and "reported device performance" in the traditional sense of a clinical or analytical study with defined endpoints.

1. Table of Acceptance Criteria and Reported Device "Performance" (as presented in the 510(k) for substantial equivalence):

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

• This 510(k) submission does not refer to a "test set" or a formal clinical study with human subjects designed to evaluate the performance of the new device.
• The data provenance is based on published information and specifications of legally marketed predicate devices, as maintained by the manufacturers and available to the FDA through previous 510(k) clearances (e.g., K961310, K961078, K961738). There is no mention of country of origin for specific "data," as it's a comparison of specifications.
• The approach is a retrospective comparison against existing predicate device characteristics, not a prospective study.

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

• Given that no "test set" or clinical study for the new device is described, no experts were used to establish ground truth in this context.
• The "ground truth" here is effectively the accepted specifications and intended uses of the predicate devices as cleared by the FDA.

4. Adjudication Method for the Test Set:

• Not applicable. No test set was described.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices to assess the impact of AI on human reader performance, which is not applicable to a vitrectomy system.

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

• Not applicable. The device is a surgical instrument and system; it is not an algorithm, and the concept of "standalone performance" for an algorithm does not apply.

7. The Type of Ground Truth Used:

• The "ground truth" for demonstrating substantial equivalence relies on the established specifications, intended uses, and safety/effectiveness profiles of the identified legally marketed predicate devices, as detailed in their respective 510(k) clearances. There is no external clinical ground truth (like pathology or outcomes data) directly generated for this new device's submission.

8. The Sample Size for the Training Set:

• Not applicable. This device is a vitrectomy system, not an AI or machine learning algorithm. Therefore, there is no "training set."

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

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

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The Storz Millennium™ Viscous Fluid System is intended for the injection and aspiration of viscous fluids into and out of the eye during posterior ophthalmic vitreoretinal surgery. The system is designed to inject and aspirate viscous fluids, such as silicone oil which act as a tamponade in fixating large retinal tears and detachments.

The Storz Millennium™ Viscous Fluid System is intended for the injection and aspiration of viscous fluids into and out of the eye during posterior ophthalmic vitreoretinal surgery. The system is designed to inject and aspirate viscous fluids, such as silicone oil which act as a tamponade in fixating large retinal tears and detachments. The Storz viscous fluid system consists of the Storz CX5700 Millennium™ Viscous Fluid System Module and the Storz CX5710 Viscous Fluid Injection Pack. The Storz CX5700 module is a self-contained pump system used as an individual module with the Storz Millennium™ Microsurgical System for the injection and aspiration of viscous fluids. The Storz CX5710 is the disposable accessory pack intended for single use to be used with the Storz viscous fluid module.

The provided text is a 510(k) premarket notification for the Storz Millennium™ Viscous Fluid System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the way a clinical trial or performance study report would for an AI/ML device.

Therefore, many of the requested points regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies are not applicable or cannot be extracted from this type of regulatory submission.

The document primarily relies on predicate comparison to establish substantial equivalence.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not define explicit "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) typically associated with AI/ML devices. Instead, the acceptance is based on demonstrating substantial equivalence to existing legally marketed predicate devices. The "performance" is implied by demonstrating similar design, intended use, and operational characteristics to these predicates.

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

This is a premarket notification for a medical device (a pump system for ophthalmic surgery), not an AI/ML diagnostic or prognostic tool. Therefore, there is no "test set" or "data provenance" in the context of evaluating algorithm performance on a dataset of patient cases. The evaluation is based on comparing the device's design and functional specifications to legally marketed predicate devices.

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

Not applicable. There is no "ground truth" establishment in the context of a dataset for an AI/ML device. The "truth" for this submission is based on the established safety and effectiveness of the predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. No test set or adjudication method as described for AI/ML performance evaluation.

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

No, this is not an AI/ML device requiring an MRMC study.

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

Not applicable. This is not an AI/ML algorithm. It's a medical pump system.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the regulatory acceptance and established safety/effectiveness of the predicate devices. The submission essentially argues that the new device is sufficiently similar to these predicates that it can be considered equally safe and effective.

8. The Sample Size for the Training Set:

Not applicable. As this is not an AI/ML device, there is no training set.

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

Not applicable. There is no training set or ground truth in the context of AI/ML for this device.

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The Storz MicroFlow Plus, MicroFlow Plus Angled, and Standard Angled Phacoemulsification Needles are accessories to a phacoemulsification handpiece, intended for use in the ultrasonic surgical removal of the cataractous crystalline lens.

A phaco needle is the cylindrical, metal tip which is connected to the distal end of a phaco handpiece. The needle is the component of a phaco system which, as driven by the ultrasonic handpiece, contacts and fragments the crystalline lens. Irrigation fluid flows between the external surface of the needle and the internal surface of an irrigation sleeve and into the eye. The emulsified lens material and irrigant are aspirated from the eye through the lumen of the phaco needle.

The provided document is a 510(k) summary for Storz MicroFlow Plus, Storz MicroFlow Plus Angled, and Storz Standard Angled Phacoemulsification Needles. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving that a device meets specific acceptance criteria through a clinical study. Therefore, the document does not contain information about acceptance criteria, a specific study proving the device meets them, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established in the context of a clinical performance study.

Instead, the document focuses on demonstrating substantial equivalence based on device characteristics, intended use, and materials compared to several predicate devices.

Here's a breakdown of why the requested information cannot be fully provided from this document:

1. A table of acceptance criteria and the reported device performance: This document does not establish new acceptance criteria. It compares the device's characteristics to those of predicate devices to establish substantial equivalence. The tables provided (on pages 2 and 3) are "Substantial Equivalence Charts" comparing device characteristics, not performance against pre-defined acceptance criteria.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or clinical data is presented for this 510(k) submission.

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): No ground truth established by experts is mentioned as this is not a study assessing diagnostic or clinical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there is no test set or clinical 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. The device is a phacoemulsification needle, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no ground truth was established for a performance study.

8. The sample size for the training set: Not applicable as there's no machine learning algorithm involved requiring a training set.

9. How the ground truth for the training set was established: Not applicable as there's no machine learning algorithm involved requiring a training set.

Summary based on the document:

The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. The "study" referenced in the prompt (if considering the 510(k) process as a form of "study" for regulatory clearance) is a comparison of device characteristics to existing, legally marketed devices.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the Substantial Equivalence Charts):

While not framed as "acceptance criteria" in the traditional sense of a clinical trial, the tables compare characteristics of the new devices to predicates. The "acceptance criteria" in this context are implicitly that the new devices share similar fundamental technological characteristics and intended use with the predicate devices, thereby demonstrating safety and effectiveness.

Study to Prove Acceptance Criteria:

The "study" is implicitly the submission of the comparison charts and other descriptive information to the FDA, which then determined substantial equivalence. No separate, formal clinical study or performance study is detailed in this 510(k) summary as proof against quantitative acceptance criteria for the new devices. The FDA's letter (pages 4-5) confirms the determination of substantial equivalence.

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The Storz E8010 ErgoTec™/Premiere® Adaptor is a new device accessory designed to adapt the Storz ErgoTecTM Vitreoretinal Instrument Tips to the Storz D7108 Microscissors Handpiece for general use in posterior segment vitreoretinal ophthalmic surgery.

The Storz E8010 ErgoTec™/Premiere® Adaptor is composed of stainless steel and serves to allow connection of the existing Storz D7108 Microscissors Handpiece to the existing Storz ErgoTecTM Vitreoretinal Instrument Tips. The adaptor features an anterior rotation knob which allows the tip to be adjusted into optimal alignment.

The provided document is a 510(k) summary for the Storz E8010 ErgoTec™/Premiere® Adaptor. This type of document is for a medical device regulatory submission and focuses on demonstrating substantial equivalence to a predicate device, not on presenting results of a study that establishes acceptance criteria for performance metrics in the way one might see for an AI/ML medical device.

Therefore, the information requested in your prompt (e.g., acceptance criteria, device performance metrics, sample sizes for test/training sets, expert ground truth, MRMC studies) is not applicable to this document as it describes a physical surgical instrument accessory, not a software-based or AI/ML device.

The document primarily provides:

• Device Description and Intended Use: The adaptor allows existing Storz ErgoTec™ Vitreoretinal Instrument Tips to be used with the Storz D7108 Microscissors Handpiece.
• Predicate Device: Storz D7108 Microscissors Handpiece (K960061), and Storz CX7100 and CX7150 Microscissors Handpieces (K961310).
• Predicate Comparison Table: This table compares the characteristics of the new device (Storz D7108 Microscissors HP with the new adaptor) to the predicate devices, highlighting similarities in intended use, materials, mechanism, and compatibility. The purpose of this comparison is to establish substantial equivalence for regulatory approval, not to demonstrate performance against specific numerical acceptance criteria.

To directly answer your prompt based on the provided text, but acknowledging the difference in device type:

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Implicit for a 510(k) submission): Substantial equivalence to predicate devices in terms of intended use, technological characteristics (materials, design, function), and safety/effectiveness. There are no explicit numerical performance criteria stated for this mechanical adaptor.
   • Reported Device Performance: The device performs its intended function of adapting the ErgoTec tips to the D7108 handpiece, allowing for cutting and manipulation of posterior intraocular tissue, similar to the predicate devices. The comparison chart asserts equivalency across numerous features (see provided table in the document).

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI/ML algorithm requiring a data test set. Its safety and effectiveness are established through comparison to a legally marketed predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML performance evaluation is not relevant here. The "ground truth" for a physical device like this is its physical properties, functionality, and established safety/effectiveness (or that of its predicate).

4. Adjudication method for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical instrument adaptor.

7. The type of ground truth used: Not applicable. For this type of device, the "ground truth" is typically engineering and materials testing, biocompatibility assessments (if new materials), and a demonstration of equivalent function to predicate devices, rather than a clinical "ground truth" for diagnostic accuracy.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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The Storz D7120 Phaco Handpiece Maintenance Kit and the Storz D7125 Needle Wrench are intended to be used as accessories to Storz DAISY® (K854508). Storz Protegé® (K921758 and K950114). and PREMIERE® (K894278, K921460, and K946227) Microsurgical Systems for use in performing phacoemulsification. The D7120 contains an assortment of tools useful in cleaning and maintaining the Phacoemulsification Hndpiece (K935926) and the D7125 is an individual tool used in the assembly and disassembly of the handpiece.

The Storz D7120 Phaco Handpiece Maintenance Kit and the Storz D7125 Needle Wrench are intended to be used as accessories to Storz DAISY® (K854508). Storz Protegé® (K921758 and K950114). and PREMIERE® (K894278, K921460, and K946227) Microsurgical Systems for use in performing phacoemulsification. The D7120 contains an assortment of tools useful in cleaning and maintaining the Phacoemulsification Hndpiece (K935926) and the D7125 is an individual tool used in the assembly and disassembly of the handpiece.

The provided text describes a 510(k) premarket notification for ophthalmic microsurgical system accessories (Storz D7120 Phaco Handpiece Maintenance Kit and Storz D7125 Needle Wrench). This is a submission for medical devices, but it does not contain information about acceptance criteria or a study proving device performance in the context of diagnostic accuracy, a common scenario for AI/ML devices.

The document's purpose is to demonstrate substantial equivalence of these accessories to predicate devices, not to present performance data against specific acceptance criteria for diagnostic output. It's a comparison of features and intended use, not a performance study as typically understood for AI-enabled diagnostic tools.

Therefore, I cannot provide the requested information from the provided text for the following reasons:

• No Acceptance Criteria or Performance Metrics: The document does not define specific acceptance criteria (e.g., sensitivity, specificity, AUC, accuracy thresholds) that the device needs to meet. It focuses on comparing device characteristics.
• No Performance Study: There is no mention of a study designed to evaluate the diagnostic or treatment performance of the device against a ground truth. The comparison chart focuses on "Intended Use," "Tools Recommended/Included," "Instrument Type," "Tools Provided Sterile?", and "Tools Commonly Available Or Available From Supplier?".
• Device Type: The devices described are maintenance tools (handpiece maintenance kit, needle wrench), which are accessories for ophthalmic microsurgical systems. They are not AI/ML-enabled diagnostic tools that would typically undergo studies with performance metrics like those requested.

In summary, the provided text is a 510(k) summary for accessories based on substantial equivalence, not a performance study for an AI/ML device that requires acceptance criteria and an evaluation of its diagnostic or predictive capabilities.

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The D7108 handpiece, as connected to the D7106 drive tube and detachable microscissors, is intended to be used with the Storz PREMIERE® or Storz DAISY™ Microsurgical Systems to cut intraocular tissue in the posterior segment of the eye during ophthalmic surgical procedures.

The Storz D7108 Microscissors Handpiece is a reusable, electrically powered, pneumatic handpiece that is used to operate a variety of detachable microscissors. A selected microscissors attachment screws on to the tip of the D7108 Microscissors Handpiece The D7108 handpiece attaches to the Storz D7106 Microscissors Drive Tube, which in turn connects to the Storz PREMIERE® or the Storz DAISY™ Ophthalmic Microsurgical System. As the "Scissors" function of the microsurgical system is activated, the piston inside the D7108 handpiece is driven forward and backward by air pressure, causing the blades of the attached microscissors to open and close rapidly. The handpiece also has a manual over-ride lever near the tip of the handpiece that allows the physician to manually operate the scissors without requiring external power.

This document is a 510(k) summary for medical devices, specifically for surgical scissors and related components. It does not contain information about acceptance criteria or a study proving device performance in the way you've requested (e.g., in terms of diagnostic accuracy, sensitivity, specificity, etc., which are typical for AI/diagnostic device evaluations).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for lower-risk devices. The evaluation here is about comparing physical characteristics, intended use, and operational functionality, not about measuring clinical performance against a ground truth.

Therefore, I cannot extract the information you've requested as it's not present in the provided text. The document is about:

• Device Description/Intended Use: Explaining what the Storz D7108 Microscissors Handpiece and D7106 Microscissors Drive Tube do (cut intraocular tissue).
• Predicate Device: Identifying a similar device already on the market (Escalon™ Trek Medical Vertical Automated Scissors).
• Predicate Comparison: Showing that the new device is "substantially equivalent" to the predicate device based on characteristics like intended use, components, compatible systems, and reusability.

If you are looking for evaluation criteria and studies related to diagnostic or AI-powered devices, you would need a different type of document, such as a clinical study report or a 510(k) summary for a device that makes a diagnostic claim or involves image analysis.

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The Storz device is intended to be used as an accessory to the Storz Microvit ® Vitrectomy Cutter to provide a snap-on grip extension for the cutter to facilitate manibulation of the instrument.

The Storz device is intended to be used as an accessory to the Storz Microvit ® Vitrectomy Cutter to provide a snap-on grip extension for the cutter to facilitate manibulation of the instrument. The D7116 does not affect the functioning of the cutter.

The provided text describes a 510(k) premarket notification for a medical device accessory from 1996. This submission is for an accessory (a grip extension) for an existing vitrectomy cutter.

For a device like this, the "acceptance criteria" and "study" described in your prompt (which relate to performance metrics like sensitivity, specificity, or improvement with AI) are not applicable. This is because:

• The device is an accessory: Its primary purpose is to improve ergonomics or handling, not to perform a diagnostic or therapeutic function itself that would require clinical performance metrics.
• The device description explicitly states it "does not affect the functioning of the cutter." This is a key point for an accessory – it maintains the safety and effectiveness of the primary device it attaches to.
• The regulatory submission is a 510(k): This pathway demonstrates substantial equivalence to a legally marketed predicate device. The focus is on comparing features and intended use, not necessarily presenting new clinical performance data in the way a novel diagnostic or AI device would.
• The time period (1996): AI-driven medical devices and the associated performance criteria and study designs you've listed (MRMC, standalone algorithm performance, detailed ground truth establishment for AI training sets) were not part of medical device regulation or technology at that time.

Instead of performance criteria, the submission focuses on substantial equivalence to a predicate device. The "Device Comparison Chart" serves as the "study" proving this substantial equivalence, showing that the accessory does not introduce new questions of safety or effectiveness compared to the existing device it extends.

Here's how to address your questions given this context:

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

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. This type of data (test set size, provenance) is relevant for clinical performance studies, not for demonstrating substantial equivalence of a simple accessory that does not alter the primary device's function. The "sample" here refers to the device characteristics compared, not patient data.

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

• Not Applicable. No "ground truth" in the sense of clinical truth (e.g., disease presence) was established or required for this accessory. The "truth" in this context is whether the characteristics of the accessory (grip, indication, impact on probe) align with the predicate device. This would have been determined by engineering assessment and regulatory review.

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

• Not Applicable. No clinical test set requiring adjudication was used.

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 relevant for an accessory from 1996, especially one that states it "does not affect the functioning of the cutter."

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

• No. This device is a mechanical accessory, not an algorithm.

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

• Not Applicable in the clinical sense. The "ground truth" for this submission is the documented characteristics and intended use of the legally marketed predicate device (Storz MVS-3201 Vitrectomy Probe Pack), against which the new accessory (D7116 Vitrectomy Probe With Extension) was compared for substantial equivalence.

8. The sample size for the training set

• Not Applicable. No training set was used or required for this type of device submission.

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

• Not Applicable. No training set was used.

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The Storz D4600 is intended to be used as an accessory to the Storz PREMIERE® (K894278, K921460, K946227) or Storz DAISY® (K854508) Microsurgical Systems for use in air and fluid exchange during posterior segment ophthalmic surgical procedures. The D4600 Air Exchange Line provides the initial pathway through which air generated by the microsurgical system is routed into the posterior chamber of the eye.

The Storz D4600 is intended to be used as an accessory to the Storz PREMIERE® (K894278, K921460, K946227) or Storz DAISY® (K854508) Microsurgical Systems for use in air and fluid exchange during posterior segment ophthalmic surgical procedures. The D4600 Air Exchange Line provides the initial pathway through which air generated by the microsurgical system is routed into the posterior chamber of the eye.

This document, K962131, is a 510(k) Premarket Notification for an ophthalmic surgical accessory pack. It aims to demonstrate substantial equivalence to existing predicate devices rather than proving a device meets specific performance acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria and a study proving those criteria cannot be found or inferred from the provided text.

Here's an breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, not on presenting specific performance acceptance criteria and test results against those criteria. The provided table in the "DEVICE COMPARISON CHART" ({1}) shows comparisons of device characteristics (intended use, recommended system, instructions, sterility, etc.), not performance metrics against acceptance criteria.

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

• Cannot be provided. No test set or clinical study is described. The comparison is feature-based against predicate devices.

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

• Cannot be provided. No ground truth establishment by experts is mentioned, as there is no described test set or clinical study.

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

• Cannot be provided. Not applicable as no test set or clinical study is described.

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

• Cannot be provided. No MRMC study or AI component is mentioned. This device is an ophthalmic surgical accessory pack.

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

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

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

• Cannot be provided. Not applicable as no ground truth is established for a performance study. The "ground truth" here is the characteristics of the predicate devices to which the new device is compared for substantial equivalence.

8. The sample size for the training set

• Cannot be provided. No training set is mentioned. This is a physical medical device, not an AI model.

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

• Cannot be provided. Not applicable as no training set is mentioned.

Summary regarding the provided document:

The K962131 document is a 510(k) submission for a medical device accessory. Its purpose is to demonstrate that the new device, the Storz D4600 Air Exchange Line Pack, is "substantially equivalent" to legally marketed predicate devices (existing Storz D4600 and Intek International TR-9006-11 Air Delivery Tubing System). This is achieved by comparing characteristics like intended use, recommended system compatibility, sterility, and packaging, as shown in the "DEVICE COMPARISON CHART" ({1}). This type of submission generally does not include extensive clinical studies with defined acceptance criteria for novel performance claims but rather focuses on demonstrating safety and effectiveness based on similarity to already cleared devices.

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The Storz DP5200 is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Microsurgical Systems as a pathway for delivery of irrigation fluid from the irrigation reservoir. to the surgical handpiece irrigation line, during ophthalmic surgical procedures.

The Storz DP5200 is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Microsurgical Systems as a pathway for delivery of irrigation fluid from the irrigation reservoir. to the surgical handpiece irrigation line, during ophthalmic surgical procedures.

The provided text is a 510(k) premarket notification for a medical device (Storz DP5200 Irrigation Administration Set Pack). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth is NOT available in this type of submission.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Not available. The document is a 510(k) submission, not a study report. It focuses on demonstrating substantial equivalence to existing predicate devices, meaning it aims to show the new device is as safe and effective as a legally marketed device, rather than proving performance against predefined quantitative acceptance criteria. The comparison chart provided only lists device characteristics, not performance metrics or acceptance criteria.

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

Not available. No test set or associated data is described, as this is a substantial equivalence submission.

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 available. No ground truth establishment or expert involvement for a test set is described.

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

Not available. No adjudication method is mentioned as there is no test set or study described in this context.

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 irrigation administration set, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study with AI assistance is irrelevant.

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

Not applicable. This device is a passive medical instrument, not an algorithm.

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

Not available. Ground truth is not discussed as no study requiring it is presented. The "proof" in a 510(k) relies on demonstrating the new device is identical or nearly identical in function and materials to existing approved devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device relying on a training set.

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

Not applicable. This is not an AI/ML device, so there is no training set or associated ground truth.

In summary: The provided document is a 510(k) summary, which aims to establish substantial equivalence to predicate devices. It does not contain information about studies designed to meet specific performance acceptance criteria for a novel device, nor does it involve AI or human readers. The 'proof' of safety and efficacy comes from demonstrating that the new device shares fundamental characteristics (intended use, materials, sterilization, etc.) with devices already deemed safe and effective by the FDA.

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