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To acquire and display high resolution images of the anterior segment of the eye.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic (B-Mode)

The Model P60 UBM is a PC-based digital instrument that utilizes ultrasonic energy to generate various images of the eye. The pulser circuitry is designed to accept information from the user via a graphical user interface provided by the software. The pulser generates signals specific to the probe installed. The signal acquired from the transducer is translated into an image that is displayed on an LCD monitor.

The provided text describes a 510(k) Premarket Notification for the Paradigm Medical Model P60 UBM Ultrasonic Bio-Microscope. The information primarily focuses on the device's technical specifications, intended use, and substantial equivalence to a predicate device, rather than a clinical study evaluating its performance against specific acceptance criteria.

Therefore, it's not possible to populate all the requested fields as a clinical study with detailed performance metrics, ground truth establishment, or expert adjudication as typically seen for AI/ML devices is not present in this document.

However, based on the available information, here's what can be inferred:

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

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable. The document describes a technical safety compliance and substantial equivalence claim, not a clinical performance study with a test set of patient data.
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. There is no mention of establishing ground truth with experts for a test set in a clinical performance study.

4. Adjudication method for the test set

• Not applicable. No adjudication method is mentioned as there's no clinical test set being evaluated for performance against a ground truth.

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 device is an ultrasonic bio-microscope, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant and was not performed.

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

• Not applicable. This is a hardware device; no algorithm-only performance study would be relevant.

7. The type of ground truth used

• Not applicable in the context of clinical performance data. The "ground truth" for this submission appears to be regulatory standards (IEC60601-1) and the performance characteristics of a legally marketed predicate device (Paradigm Medical Model P45 Ultrasonic Bio-Microscope) for establishing substantial equivalence.

8. The sample size for the training set

• Not applicable. There is no mention of a training set as this is not an AI/ML device.

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

• Not applicable.

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Tonometry for Measuring and Recording Intraocular Pressures and Intraocular Pressure Pulse Amplitudes, Pulsatile Ocular Blood Flow, Pulsatile Ocular Blood Volume, Pulsatility Index Equivalent (PEQ).

The Paradigm Medical Industries, Inc. Blood Flow Analyzer (BFA) is an electronic pneumatic tonometer capable of measuring and recording the intraocular pressure. The pressure measurements are made at a rate of 200 times per second over a period of 5-15 seconds. Contact with the eye is by means of a sterilized single-use per patient probe having an integral membrane that isolates the cornea from the internal pneumatic operation of the BFA. The pulsatile ocular blood flow is derived from the intraocular pressure measurements acquired with the pneumatic tonometer using mathematical equations that link intraocular pressure to ocular volume change and volume flow.

The Blood Flow Analyzer (BFA) is an electronic pneumatic tonometer that measures and records intraocular pressure at a high frequency. It then derives pulsatile ocular blood flow from these measurements using mathematical equations. The device also calculates pulsatile ocular blood volume, pulse amplitude, and a pulsatility index equivalent (PEQ).

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) summary, details the device's capabilities and mentions studies related to its reproducibility and reliability. However, it does not explicitly state specific quantitative acceptance criteria for its performance metrics (Intraocular Pressure, Pulse Amplitudes, Pulsatile Ocular Blood Flow, Pulsatile Ocular Blood Volume, or Pulsatility Index Equivalent).

Instead, the document highlights claims of reproducibility and reliability for key measurements. The study primarily focused on establishing normative data for pulsatile ocular blood flow, rather than directly demonstrating performance against pre-defined acceptance thresholds for device accuracy or precision for a 510(k) submission.

Therefore, we can only infer the performance from the descriptions given:

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

• Test Set Description: The document describes a "Study Protocol for Normative Pulsatile Ocular Blood Flow." This study serves as the primary data used to support the device's characterization, particularly for the pulsatile ocular blood flow measurement.
• Sample Size: The overall sample size for the "Normative Pulsatile Ocular Blood Flow" study was 1502. Out of these, 777 subjects satisfied the inclusion criteria to be considered "normal."
• Data Provenance: The study was conducted at six optometric centers in the United Kingdom in 1995 and sponsored by OBF Labs (UK), Ltd. The data is retrospective in the context of this 510(k) submission, as it was collected in 1995 and presented in 2002.

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

The document states that the "normative data set was analyzed at Moorfields Eye Hospital, London," a renowned ophthalmic institution. However, it does not specify the exact number of experts involved in establishing the ground truth (i.e., defining "normal" or analyzing the data for the normative values). It also does not detail their specific qualifications (e.g., "radiologist with 10 years of experience").

The "normal" definition relied on a patient questionnaire with five negative answers, indicating:

• No family history of glaucoma.
• No significant ocular history (ocular diseases, treatments, or surgery).
• No use of ocular medications.
• No significant medical history (systemic hypertension, diabetes, or vascular disease).
• No use of systemic beta blockers.

This definition of "normal" serves as the ground truth for the normative data set.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method (e.g., 2+1, 3+1) for the test set. The determination of "normal" was based on a direct patient questionnaire. The analysis of the normative data set was performed at Moorfields Eye Hospital, suggesting expert review, but no multi-reader adjudication process is detailed.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described in the provided 510(k) summary. The document does not discuss human reader performance with or without AI assistance, as the device's function is automated measurement rather than an AI-assisted diagnostic read.

6. Standalone (Algorithm Only) Performance Study

The entire description of the device's function and the normative study effectively describes standalone performance. The "Blood Flow Analyzer (BFA)" is an instrument that takes measurements and performs calculations automatically to output values like intraocular pressure, pulsatile ocular blood flow, etc. The studies mentioned (reproducibility and reliability, normative data collection) are all assessments of the device's performance in this standalone capacity.

7. Type of Ground Truth Used

For the normative data study, the ground truth was established by expert-defined clinical criteria obtained through a patient questionnaire. This questionnaire defined what constituted a "normal" subject based on the absence of specific ocular or systemic conditions and medications. This is akin to using clinical state or healthy control definitions as the ground truth.

For the fundamental intraocular pressure measurements, the document mentions that "The pressure-volume relation was derived by analyzing the pressure responses to injections of volumes of fluid to living human eves measured by direct cannulation of the eye connected to a manometer." This implies an invasive, direct physiological measurement was used to establish the foundational relationship for the device's calculations.

8. Sample Size for the Training Set

The document does not explicitly describe a separate "training set" as would be common for machine learning algorithms. The device performs calculations based on established physiological principles and equations. The normative data collected from the 777 "normal" subjects and the reproducibility/reliability studies serve to characterize the device's performance and establish normal ranges, rather than train an AI model in the conventional sense.

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

Since there is no explicitly defined "training set" in the context of machine learning, this question is not directly applicable. However, the foundational "ground truth" for the device's core calculations (like the pressure-volume relation) was established via direct physiological measurements (direct cannulation of the eye connected to a manometer). For the "normative data," the ground truth for classification of "normal" was based on the patient questionnaire's clinical criteria.

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The QuiteTip™ I/A handpiece and tips are used in ophthalmic surgery to provide controlled aspiration of lens tissue while maintaining anterior chamber shape by replacing aspirated fluids with BSS.

I/A Handpiece and Tips

The provided text is a 510(k) premarket notification letter from the FDA to Paradigm Medical Industries, Inc., regarding their QuiteTip™ I/A Handpiece and Tips. This document indicates the device has been found substantially equivalent to a predicate device and can be marketed.

However, the letter does not contain any information about acceptance criteria, performance data, or studies that prove the device meets specific acceptance criteria. It is a regulatory approval letter based on substantial equivalence, not a detailed report of a device performance study.

Therefore, I cannot provide the requested information as it is not present in the given text.

To answer your request, I would need a document that describes the specific performance studies, their methodology, results, and acceptance criteria for the QuiteTip™ I/A Handpiece and Tips.

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The Paradigm Phaco Tip is intended to be used in conjunction with an ultrasonic handpiece for ophthalmic surgery to remove cataract tissue.

Not Found

This document is a 510(k) clearance letter from the FDA for a device called "Phacopak" (also referred to as "Phaco Tip"). It explicitly states that the device is substantially equivalent to legally marketed predicate devices.

However, this document DOES NOT contain any information regarding acceptance criteria, device performance, sample sizes for testing, ground truth establishment, expert qualifications, adjudication methods, or results from any studies (standalone or MRMC comparative effectiveness).

The letter is a regulatory approval document and focuses on the administrative aspects of substantial equivalence, not the detailed technical data that would be found in a study report.

Therefore, I cannot fulfill your request for the acceptance criteria and study details based on the provided text. The requested information is simply not present in these documents.

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The ACM Module is an accessory device incorporated in the aspiration line behind the handpiece to neutralize vacuum surge during phacoemulsification.

Not Found

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets any specific criteria. The document is a 510(k) clearance letter from the FDA for a device called "Automated Chamber Maintenance (ACM) Module," indicating that it is substantially equivalent to a previously marketed device. It provides regulatory information and contact details, but does not include details about performance studies, acceptance criteria, or ground truth establishment.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance study results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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A tonometer and acsessories are devices intended to measure intraocular pressure by applying a known force on the globe of the eye to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. We intend the device for use in the diagnosis of glaucoma.

A tonometer and accessories are devices intended to measure intraocular pressure by applying a known force on the globe of the eye to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. We intend the device for use in the diagnosis of glaucoma.

The Blood Flow Analyzer, manufactured by Paradigm Medical Industries, Inc., is a tonometer and accessories intended to measure intraocular pressure by applying a known force on the globe of the eye to measure intraocular tension by applanation (applying a small flat disk to the cornea). This device is intended for use in the diagnosis of glaucoma.

1. Acceptance Criteria and Reported Device Performance

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