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The Mentor Absorbent Drape is used to absorb fluids during surgical procedures.

The Mentor Absorbent Drape measures 29 X 35 inches and is comprised of layered absorbent material between a permeable spunbond layer and a non-permeable layer. The device is packaged sterile for single use only.

Acceptance Criteria and Device Performance Study for Mentor Absorbent Drape

This summary details the acceptance criteria and the study proving the Mentor Absorbent Drape meets these criteria, based on the provided 510(k) summary (K973146).

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The provided document does not specify the exact sample sizes used for the absorbency and strength tests. It simply states that the "Mentor Absorbent Drape was tested."

The data provenance is internal to the manufacturer (Mentor Corporation), and the tests were likely conducted prospectively as part of the device development and regulatory submission process. There is no information regarding the country of origin of the data beyond the manufacturer's location in the USA.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish a "ground truth" for the absorbency or strength tests. These tests appear to be objective, quantitative measurements against predefined physical criteria rather than expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. The tests described are objective measurements, not subjective evaluations requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a surgical drape, and its performance is evaluated based on physical properties rather than diagnostic accuracy or human interpretation.

6. Standalone Performance Study

Yes, a standalone study was presented. The "Summary of Testing" describes the performance of the Mentor Absorbent Drape itself against the specified criteria for absorbency and strength. These tests were conducted on the device without human interaction being a variable in the performance measurement.

7. Type of Ground Truth Used

The ground truth used for these tests was objective, quantitative criteria for physical performance.

• For absorbency: A specific volume (100 cc) and area (per ft²) of saline solution, and the absence of liquid leakage.
• For strength: The absence of ripping, tearing, or separation under simulated clinical use conditions.

8. Sample Size for the Training Set

Not applicable. This device is a physical product (surgical drape), not an algorithm or AI model that requires a "training set" in the computational sense. The testing described focuses on the physical properties of the manufactured product.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device. The specifications for performance (e.g., 100 cc/ft² absorbency) would have been established through engineering design requirements, industry standards for surgical drapes, and potentially comparison to predicate devices, but not through a "ground truth" establishment process for a training set.

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The Mentor® Gemini™ Hemostatic Eraser™ is used to achieve episcleral and or intraocular hemostasis utilizing diathermy.

The MENTOR® GEMINI™ HEMOSTATIC ERASER™ is a hand-held bipolar probe used for coagulation which consists of (a) a handle and (b) a disposable tip (electrode). The handle transfers RF energy to the disposable tip via a unique electrical contact system located in the internal cavity of the handle. After a single use, the Tip is intended to be disposed of in a safe and cost effective manner. The handle is intended to be used 1-50 times before discarding.

This 510(k) summary explicitly states: "The determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical." This means the submission does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information from the provided text. The device's substantial equivalence was determined based on its similarity in indications, design, and features to a predicate device, not on specific performance data or clinical studies.

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The MENTOR TONO-PEN 3 is used to measure the intraocular pressure (IOP) during routine eye examination or when an increased IOP is suspected.

The MENTOR TONO-PEN 3 is a precision electronic tonometer which measures intraocular pressure [IOP]. The body of the instrument is specially designed to fit comfortably in the user's hand, facilitating fast and accurate measurements.

TONO-PEN 3 contains an elemental silicon strain gage which converts intraocular pressure to an electrical signal. The pen displays each valid reading on a liquid crystal display [LCD]. When four valid readings are obtained, a mean IOP reading and an indication of reliability are shown on the LCD. The TONO-PEN 3 has a molded plastic tip which must be covered by a latex protective membrane. MENTOR Ocu-Film Tip covers are recommended.

This submission explicitly states, "The determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical." Therefore, there is no information in the provided text to describe acceptance criteria or a study that proves the device meets them.

The sections requested in the prompt, such as acceptance criteria, reported device performance, sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and ground truth establishment for the training set, cannot be answered from the provided document.

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MENTOR® Advent™ A/B System is a dual function ultrasonic ophthalmic imaging system. The A-scan is used to measure the axial length of the eye. The system includes various programs for calculating the optical power of the IOL to be implanted during cataract surgery. Anterior chamber depth and lens thickness of the eye are also measured and displayed. The B-scan is used to image the internal structure of the eye including the opaque media and posterior pathology for the purpose of diagnosing pathological or traumatic conditions in the eve.

MENTOR® Advent™ A/B System is an easy to use ophthalmic ultrasonic system, offering capabilities and versatility for both A-scan and B-scan operations.

The A-Scan biometric unit of the Advent System has the following features: Operational modes - Automatic and Manual Probe alignment - LED fixation light and audio feedback Multiple eye categories - Normal, Aphakic, Cataractous, Dense Cataractous and Pseudophakic IOL calculations - programs include the latest in SRK, Holladay and Hoffer Q Patient storage - up to 16 patients, including right and left eye User interface - standard computer keyboard Display - 9" high resolution white phosphor CRT Accessories - printer, video output

The B-Scan imaging unit of the Advent System has the following features: Scanning - 50 degrees sector scan probe, allowing eye view from wide variety of angles

Normal mode - requires selection of parameters Windowed mode - allows user selectable scanning angle Controls - depth, gain, contrast and brightness Display - 9" high resolution white phosphor CRT User interface - standard computer keyboard

Accessories - camera, printer. VCR

MENTOR Advent™ System uses the following transducer operations and characteristics:

A-Scan: There is a single ultrasound mode where the transducer is pulsed at a repetition frequency of approximately 5 Hz. The transducer is a non-scanning crystal with a frequency of approximately 8 Mhz. This system uses the same ultrasound transducer as in the predicate device.

B-Scan: There are two ultrasound modes, Normal and Windowed. The transducer is a single crystal mechanical sector probe with a center frequency of 11 MHz. It is housed in an oil-filled sealed chamber. The transducer sweeps 8 frames/sec. Sweep angle is 50°, pulse repetition frequency is 5.5 KHz and there are 275 transmitted lines per scan. In the Windowed mode, the size and position of the user selected window affects the pulse rate and spacing of the pulse, and thus the radiated field. Ultrasonic power measurements reported later have been made in the worst case condition,

This 510(k) summary explicitly states that the determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical. Therefore, there is no study described in the provided text that proves the device meets any acceptance criteria.

Response based on provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission states, "The determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical."

2. Sample sized used for the test set and the data provenance: Not applicable as no performance study was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no performance study was conducted.

4. Adjudication method for the test set: Not applicable as no performance study was conducted.

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 described is an ophthalmic ultrasonic system, not an AI-assisted device. Additionally, no performance studies were conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as no performance study was conducted.

7. The type of ground truth used: Not applicable as no performance study was conducted.

8. The sample size for the training set: Not applicable. This is a medical device, not an AI/ML algorithm requiring a training set in the conventional sense. No performance studies were conducted.

9. How the ground truth for the training set was established: Not applicable. This is a medical device, not an AI/ML algorithm. No performance studies were conducted.

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