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This device is used by an ophthalmic surgeon to extend the irrigation/aspiration syringe by use of the tubing extension set away from the cannula allowing better control of irrigation/aspiration during the ophthalmic surgical procedure. This also allows the surgeons assistant to perform the irrigation/aspiration process if needed.

The Hurricane Medical tubing extension set consists of a length of silicone tubing with huer taper hubs (one male and one female) attached to both ends.

The provided text describes a medical device, the "Tubing Extension Set" by Hurricane Medical, and its regulatory clearance as substantially equivalent to existing devices. However, it does not include information about acceptance criteria or a study proving the device meets specific performance criteria in the way one would typically describe for a software-based medical device (e.g., an AI algorithm).

The document is a 510(k) premarket notification summary and an FDA clearance letter. It focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a detailed performance study with quantitative acceptance criteria for a novel device.

Therefore, for almost all the requested information, the answer will be "Not applicable" or "Information not provided in the given text."

Here's a breakdown of why based on your request:

1. A table of acceptance criteria and the 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 / Information not provided. This document does not describe a clinical or performance study with a "test set" in the context of an AI/algorithm-driven device. The "study" mentioned is a review of existing literature and the physical properties of the device components.

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 / Information not provided. No "ground truth" was established by experts for a test set in the context of this 510(k) submission. Reference is made to historical uses described by "Emery et. al." and "Jaffe et. al." in ophthalmic surgery literature.

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

• Not applicable / Information not provided. 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 / Information not provided. This device is a physical tubing extension set, not an AI algorithm. Therefore, an MRMC study related to AI assistance is irrelevant.

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

• Not applicable / Information not provided. This is a physical medical device, not an algorithm.

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

• Not applicable / Information not provided. The "truth" in this submission relies on established surgical practices using similar tubing, the physical and material properties of the tubing, and sterility validation for a physical product. Not a "ground truth" as typically defined for AI performance studies.

8. The sample size for the training set

• Not applicable / Information not provided. This is a physical medical device, not an AI algorithm requiring a training set.

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

• Not applicable / Information not provided. This is a physical medical device.

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Irrigation and Aspiration of fluids during Ophthalmic phacoemulsification procedures.

Med-Logics, Inc., Administration Set (UT 3004)
Med-Logics, Inc., Drainage Bag (UT 3002)
Med-Logics, Inc., Universal Tubing Set (UT 3000)

The provided document is a 510(k) premarket notification letter from the FDA regarding Med-Logics, Inc.'s Administration Set, Drainage Bag, and Universal Tubing. This document is a regulatory letter approving a medical device based on its substantial equivalence to pre-existing devices. It does not contain information about acceptance criteria or study results in the context of device performance, algorithm evaluation, or clinical trials which are typically found in design validation reports or clinical study summaries.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory approval rather than technical performance data or study methodologies.

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This product is indicated for use with the Alcon Series 20,000 Legacy Phacoemulsifier. It may be utilized in phaco procedures in which either combined or segregated automated irrigation and aspiration is deemed appropriate.

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This looks like a 510(k) clearance letter for the "Surgin Kit" and "Ophthalmic Kit." The document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA did not require clinical trials or performance studies demonstrating specific acceptance criteria for the Surgin Kit, because substantial equivalence typically relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or different characteristics that do not raise new questions of safety and effectiveness.

Therefore, for your request, I cannot provide the following information from the given document:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: Not provided, as performance studies were not a requirement for this specific 510(k) clearance based on substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method: Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not provided.
6. If a standalone performance study was done: Not provided.
7. The type of ground truth used: Not provided.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

The document is purely a regulatory clearance letter based on substantial equivalence to a predicate device, and thus does not contain the detailed performance data or study design information that your questions are asking for.

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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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For use in cataract surgery to irrigate and aspirate cataract material.

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I apologize, but this document contains general regulatory correspondence from the FDA regarding a 510(k) submission for a medical device called "ML-Disposable Pak." It explicitly states that this is an "Indications For Use Statement" for a device used in cataract surgery to irrigate and aspirate cataract material.

This document DOES NOT contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or any of the other specific items you've requested.

Therefore, I cannot provide the requested table and information based on the text provided.

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