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510(k) Data Aggregation
(140 days)
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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document | Not provided in the document |
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:
- 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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(262 days)
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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(85 days)
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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(83 days)
The Storz DP5100 surgical accessory pack contains a single collection cassette. This component is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Ophthalmic Microsurgical Systems as a reservoir for aspirated fluid and tissue collected during anterior segment ophthalmic surgical procedures.
The Storz DP5100 surgical accessory pack contains a single collection cassette. This component is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460 and K946227) Ophthalmic Microsurgical Systems as a reservoir for aspirated fluid and tissue collected during anterior segment ophthalmic surgical procedures.
This document is a 510(k) summary for a medical device (Storz DP5100 Anterior Collection Cassette Pack) and does not contain information about studies related to device performance against specific acceptance criteria in the way you've described (e.g., accuracy, sensitivity, specificity for an AI/diagnostic device).
The context of this document is a regulatory submission demonstrating substantial equivalence to existing predicate devices, rather than a clinical performance study with predefined acceptance criteria for a diagnostic or AI-driven medical device.
Therefore, I cannot provide the requested information for acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader studies because these details are not present in the provided text.
The document primarily focuses on:
- Device Description and Intended Use: What the device is and what it's for.
- Predicate Device Comparison: Showing how the new device is "substantially equivalent" to already-cleared devices, primarily through comparing physical characteristics, materials, sterilization, and intended use.
This comparison chart (provided in your input) is the "study" that proves the device meets the "acceptance criteria" of being substantially equivalent to predicate devices. The "acceptance criteria" here are met by demonstrating that the modified device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicates.
In summary, none of the specific points you asked for regarding acceptance criteria for device performance, sample sizes, ground truth, or MRMC studies are applicable to this type of 510(k) submission document.
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(90 days)
The STORZ DP4310 surgical accessory pack contains an auxiliary drape (K934445), a Mayo arm drape, an irrigation administration tube assembly, a collection cassette (K953078), and an irrigation/aspiration (I/A) tube assembly. Other components included are a pair of IIA test chambers, a pair of infusion sleeves, a tube stopper, a male Luer cap, and a needle wrench. These components are to be used in conjunction with the STORZ Protegé (K921758 and K950114), PREMIERE® (K894278, K921460, and K946227) or DAISY® (K854508) Microsurgical Systems in the performance of phacoemulsification.
Phacoemulsification involves the ultrasonic disintegration of the opacified crystalline lens (cataract) from the eye. This process is accomplished by means of an electronically driven ultrasonic handpiece which 1) emulsifies the lens; 2) facilitates the irrigation of the anterior chamber; and 3) facilitates the aspiration of the emulsified lens material and irrigant from the eye. The Storz DP4310 Pack provides the accessories necessary to enable use of the Storz Phacoemulsification Handpieces (K935926) with the above Storz microsurgical systems.
The STORZ DP4310 surgical accessory pack contains an auxiliary drape (K934445), a Mayo arm drape, an irrigation administration tube assembly, a collection cassette (K953078), and an irrigation/aspiration (I/A) tube assembly. Other components included are a pair of IIA test chambers, a pair of infusion sleeves, a tube stopper, a male Luer cap, and a needle wrench. These components are to be used in conjunction with the STORZ Protegé (K921758 and K950114), PREMIERE® (K894278, K921460, and K946227) or DAISY® (K854508) Microsurgical Systems in the performance of phacoemulsification.
This document describes a 510(k) premarket notification for a medical device accessory pack and does not include information about acceptance criteria, device performance, or a study demonstrating the device meets such criteria in the way a clinical trial or algorithm validation would.
Therefore, I cannot fulfill your request for the specific information points you've outlined. The document primarily focuses on establishing substantial equivalence to a predicate device, which is a regulatory pathway for low-risk devices.
Here's a breakdown of why I cannot extract the requested information based on the provided text:
- Acceptance Criteria and Reported Device Performance: This document does not describe specific performance metrics (e.g., accuracy, sensitivity, specificity) for the device itself or any acceptance criteria related to these. It's an accessory pack for a surgical system, and its "performance" is implicitly tied to its ability to facilitate the function of the main phacoemulsification systems. The comparison chart focuses on design and labeling rather than performance data.
- Study Details (Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone): The document does not describe a study in the context of evaluating the performance or diagnostic capabilities of the device in a clinical or analytical setting. It's a regulatory submission for substantial equivalence based on comparing design and intended use with a previously cleared device. There's no mention of a test set, training set, ground truth, experts, or any of the other study-related metrics you requested.
The provided text is a 510(k) summary, which is a regulatory document to demonstrate that a new medical device is at least as safe and effective as a legally marketed predicate device. This is achieved by comparing the new device to the predicate device, focusing on similarities in intended use, technology, and performance, rather than conducting a full-scale clinical performance study in the way AI or diagnostic devices might be evaluated.
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