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Reprocessed Phacoemulsification Tips are intended to emulsify and excise cataract tissues in ophthalmic microsurgical procedures. Reprocessed Phacoemulsification Tips are indicated for use to emulsify and excise cataract tissues in patients requiring eye surgery.

Phacoemulsification Tips are used to emulsify and excise cataract tissue in ophthalmic microsurgical procedures. When connected to the ultrasonic handpiece of a phacoemulsification system and activated, the Phacoemulsification Tip vibrates at an ultrasonic frequency that emulsifies cataract tissue. The extracted tissue is then aspirated away through the hollow tip. Irrigation of the eye with a saline solution compensates for the loss of volume in the eye when the cataract tissue is removed.

The present document describes the reprocessing of Phacoemulsification Tips. From the provided information, we could not extract the acceptance criteria and the comprehensive details of the study for the Phacoemulsification tips.

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

2. Sample size used for the test set and the data provenance: Not specified

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified

4. Adjudication method: Not specified

5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable based on the provided text. The document describes laboratory and bench testing, not a clinical study involving human readers.

6. Standalone performance: Standalone performance was conducted through bench and laboratory testing. The document states: "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Phacoemulsification Tips." The listed tests include: Biocompatibility, Validation of reprocessing, Sterilization Validation, Function test(s), Packaging Validation.

7. Type of ground truth used: For the performance data listed in point 6, the ground truth would be established by validated test methods and specifications relevant to each testing category (e.g., specific parameters for biocompatibility, sterility assurance levels for sterilization, defined functional parameters for function tests).

8. Sample size for the training set: Not applicable and not specified. The document describes a reprocessing procedure and validation, not a machine learning model that requires a training set.

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

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Reprocessed Phacoemulsification Tips are intended to emulsify and excise cataract tissues in ophthalmic microsurgical procedures.
Reprocessed Phacoemulsification Tips are indicated for use to emulsify and excise cataract tissues in patients requiring eye surgery.

Phacoemulsification Tips are used to emulsify and excise cataract tissue in ophthalmic microsurgical procedures. When connected to the ultrasonic handpiece of a phacoemulsification system and activated, the Phacoemulsification Tip vibrates at an ultrasonic frequency that emulsifies cataract tissue. The extracted tissue is then aspirated away through the hollow tip. Irrigation of the eye with a saline solution compensates for the loss of volume in the eye when the cataract tissue is removed.

Here's a breakdown of the acceptance criteria and study information for the Alliance Medical Corporation Reprocessed Phacoemulsification Tips, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Performance testing demonstrates that Reprocessed Phacoemulsification Tips perform as originally intended." This indicates that the device met the acceptance criteria for each of these categories.

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

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the bench and laboratory testing.

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

The provided text does not mention the use of experts to establish ground truth for the test set. The validation appears to be based on technical performance testing rather than expert-reviewed data.

4. Adjudication Method for the Test Set

The provided text does not mention any adjudication method for the test set.

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

The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The evaluation focuses on the reprocessed device's physical and functional equivalence to the predicate device, not on human reader performance.

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

The device described is a physical medical device (Phacoemulsification Tips), not an algorithm or AI system. Therefore, a standalone (algorithm only) performance study is not applicable and was not performed. The "standalone" performance here refers to the device's own functional performance, which was demonstrated through the listed performance tests.

7. Type of Ground Truth Used

The ground truth for the performance evaluation was based on technical specifications and functional output in comparison to the original, non-reprocessed predicate devices. This includes demonstrating:

• Biocompatibility
• Successful reprocessing
• Sterility
• Appropriate function
• Packaging integrity

8. Sample Size for the Training Set

The device is a reprocessed physical medical device, not an AI or machine learning model that would require a "training set." Therefore, the concept of a training set sample size is not applicable.

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

As explained above, there is no "training set" for this type of device. The performance evaluation relies on comparing the reprocessed devices to the established performance and specifications of the original predicate devices.

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The MediSISS™ Reprocessed Phacoemulsification Tips/Needles are intended to emulsify and excise cataract tissue in ophthalmic microsurgical procedures.

Reprocessed Phacoemulsification Tips/Needles are specifically designed to be used to emulcataractous lens material and remove it from the eye (phacoemulsification). Electric energy is generated in the Phacoemulsification System, delivered in a headpiece, and is finally converted to ultrasonic energy delivered through a hollow titanium needle or tip. Irrigation fluid is delivered to the eye via a combination of an irrigation sleeve over the handpiece tip. The emulsified lens material is aspirated out of the eye through the center of the headpiece /tip assembly. The headpieces are routinely used repeatedly in multiple surgical procedures, while the tips are marketed as single use only.

The provided text is a 510(k) clearance letter from the FDA regarding a reprocessed medical device, specifically MediSISS™ Reprocessed Phacoemulsification Tips/Needles. It does not describe an AI medical device or its performance criteria. Therefore, most of the requested information regarding AI device acceptance criteria, studies, sample sizes, expert involvement, and ground truth establishment is not applicable to this document.

However, based on the provided text, I can extract the following relevant details about the reprocessed medical device itself:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of numerical acceptance criteria for a new AI device or its performance. Instead, it focuses on demonstrating that the reprocessed devices are substantially equivalent to legally marketed predicate devices and meet certain established standards for reprocessing.

Study that Proves the Device Meets Acceptance Criteria:

The "study" described in the document is a validation submission for reprocessed single-use devices. It demonstrates substantial equivalence.

• Cleaning, sterilization, packaging validations, and visual/mechanical testing were performed to show that the reprocessed devices are equivalent to new devices and are safe and effective for their intended use.
• Process validation testing was specifically done to validate the cleaning and sterilization procedures, as well as the device's packaging.
• The conclusion states that the device meets the requirements of the stated standards and embodies technological characteristics identical to the predicate device, implying it is safe, effective, and performs as well as or better than the predicate device.

Information Not Applicable or Available from the Provided Text (for an AI device):

The following points are not directly addressed as the document concerns a reprocessed physical medical device, not an AI medical device:

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 for a reprocessed physical device. Validation involves testing of the reprocessed devices themselves, not a data set.
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. Ground truth for a reprocessed device would involve analytical and performance testing against established standards, not expert consensus on data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) 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, as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this reprocessed device centers on compliance with established reprocessing standards (cleaning, sterilization, material integrity, functional performance) and substantial equivalence to the original predicate devices. This is verified through laboratory testing and engineering analysis rather than clinical outcomes data or expert consensus on diagnostic interpretations.
8. The sample size for the training set: Not applicable, as this is not an AI device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

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As an accessory device of a compatible phacoemulsification system, the phaco needle is intended for the breaking up of a cataractous lens nucleus with simultaneous irrigation and aspiration of the emulsified fragments.

A phacoemulsification needle is a component of a phacoemulsification system that utilizes ultrasound to disrupt and extract a cataract through a small incision. Ultrasonic energy combined with the mechanical action of the vibrating tip applicator (phaco tip) is applied to the cataractous lens of the eye. The lens undergoes fragmentation and emusification and is rapidly removed from the eye by aspiration.

The phaco tip is a hollow titanium needle located centrally in a handpiece with is connected via an irrigation and/or aspiration line(s) to a console for powering and controlling the functions of the phaco system. The tip is piezoelectronically oscillated longitudinally at an ultrasonic frequency of about 40,000 hertz.

Vanguard receives previously used phaco needles (only) from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the devices; and returns them to the healthcare facility.

The provided document is a 510(k) summary for reprocessed phacoemulsification needles/tips by Vanguard Medical Concepts. It details their substantial equivalence to legally marketed predicate devices.

However, the document does not contain specific acceptance criteria, detailed study designs, or performance metrics presented in a quantitative manner (e.g., sensitivity, specificity, accuracy, precision, recall) that are typically associated with AI/ML device validation. It focuses on demonstrating that the reprocessed devices are functionally equivalent to new devices.

Therefore, I cannot extract the requested information (such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC study results, or standalone algorithm performance) because these details are not present in the provided text.

The document states:

• "Performance/functional testing demonstrate that the devices are equivalent and continue to be safe and effective for their intended use."
• "Cleaning, sterilization and packaging validations; and functional/performance demonstrates that the reprocessed devices perform as intended and are safe and effective."

This indicates that functional testing was performed for the reprocessed devices, but the specific acceptance criteria (e.g., maximum allowable deviation in ultrasonic frequency, aspiration rate, tip integrity) and the results against these criteria are not detailed in this summary. The information provided is high-level and focused on regulatory clearance for reprocessed medical devices, not the in-depth performance validation of an AI/ML algorithm.

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The intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.

The phaco tip is a component of the phacoemulsification system. The tip is attached to an ultrasonic transducer. When properly stimulated, the transducer lengthens and shortens, causing the tip to oscillate at a specific frequency usually between 27 to 64 kHz. Phacofragmentation of the cataractous lens is accomplished by the action of the phaco tip, a hollow needle located centrally in the device handpiece. When the device is used in the phacofragmentation mode both irrigation and aspiration occur simultaneously. The irrigating solution enters the eye via a collinear axial lumen, which encircles the phaco tip. The fragmentation process is the result of combined mechanical and ultrasonic action induced by the oscillating phaco tip. The cataractous lens and its fragments are disrupted by the phaco tip during the procedure and removed due to the pump suction at the phaco tip orifice. This submission is for the phaco tip only.

The provided document describes the FDA clearance for SterilMed, Inc.'s reprocessed phaco tips (K012579). The key information regarding acceptance criteria and the supporting study is found in the "Functional and Safety Testing" section and the comparison table.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with specific numerical thresholds. Instead, it broadly states that "Representative samples of phaco tips underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced."

However, we can infer some performance characteristics from the comparison table (Table 1: Comparison of Subject Devices' and Predicate Devices' Characteristics) which implicitly serve as acceptance criteria for reprocessing, aiming for substantial equivalence to predicate devices.

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

• Sample Size: The document mentions "Representative samples of phaco tips underwent bench testing." However, it does not specify the exact sample size used for the functional and safety testing.
• Data Provenance: The nature of reprocessing (SterilMed, Inc. reprocessing devices from OEMs like Alcon, Allergan, AMO, and OPTIKON) implies that the devices themselves are from various manufacturers. The testing was conducted by SterilMed, Inc., which is located in Minneapolis, MN, USA. The data would therefore be retrospective in the sense that the devices were initially manufactured and used, then reprocessed and tested. The testing itself is prospective in relation to the reprocessing process.

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

This document describes a 510(k) submission for a reprocessed medical device, focusing on functional and safety equivalence rather than diagnostic performance or interpretation. Therefore:

• No "ground truth" established by experts in the context of disease diagnosis or image interpretation.
• The "truth" is established by comparing the physical and functional characteristics of the reprocessed devices to those of new, legally marketed predicate devices, and demonstrating that reprocessing maintains safety and effectiveness. This is typically done through engineering and microbiology testing, not expert clinical review of test data.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of clinical outcomes or interpretations. The "adjudication" in this context would be the internal review and approval by SterilMed's R&D team and the FDA's regulatory review of the submitted data.

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

No. This is a 510(k) submission for a reprocessed medical device, not a diagnostic AI device requiring an MRMC study. There is no human reader component that would be "assisted by AI" in this context.

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

Yes, in a sense. The bench testing and process validation for the reprocessed phaco tips are standalone performance evaluations of the device itself and the reprocessing procedures. The performance is assessed based on predefined engineering and sterility parameters, without a human "in-the-loop" for interpretation or decision-making beyond operating the test equipment.

7. The Type of Ground Truth Used

The "ground truth" used for this submission is the established performance and safety characteristics of the original, new predicate devices (Alcon Limited Reuse Ultrasonic Tip, Tri-Star Ophthalmic Phaco Tip, Surgin High Efficiency Phaco Tip). SterilMed's reprocessed devices are deemed substantially equivalent if they meet these established benchmarks through functional, material, and sterility testing.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI algorithm development study, so there is no concept of a "training set" in the traditional sense. The "training" for the reprocessing procedures would have been done during the initial process development and validation, but this refers to process optimization, not a data-driven training set for an algorithm.

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

Not applicable, as there is no training set mentioned or implied for an AI algorithm. If "training set" were interpreted as the data used to validate the reprocessing process, then the ground truth for that validation would be the specifications and requirements for a safe and effective reprocessed device, derived from regulatory standards, material science, and the characteristics of the predicate devices.

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