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510(k) Data Aggregation
(255 days)
ACCUTOME ULTRASOUND, INC.
The indications for use include measuring intraocular pressure for suspected glaucoma or when an increased intraocular pressure is suspected.
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The provided text does not contain information about acceptance criteria, device performance, or details of any studies conducted for the AccuPen device. The documents are limited to a 510(k) clearance letter and an Indications for Use statement. Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or other study-related details.
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(15 days)
ACCUTOME ULTRASOUND, INC.
The instrument is used for imaging the internal structure of the eye including the opaque media and posterior pathology for the purpose of diagnosing pathological or traumatic conditions in the eye.
The B-Scan Plus device is designed as an ultrasound B- Scan which uses pulsed echo ultrasound to image the internal structure of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulses, and provides graphic display of returning pulse echoes to image these structures.
Here's a breakdown of the acceptance criteria and study information for the B-Scan Plus device based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, resolution). Instead, the 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Advent A/B System K960765).
The device performance is described functionally rather than parametrically.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Ability to image internal structure of the eye using pulsed echo ultrasound. | "The B-Scan Plus device is designed as an ultrasound B-Scan which uses pulsed echo ultrasound to image the internal structure of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulses, and provides graphic display of returning pulse echoes to image these structures." |
| Functional equivalence to predicate device (Advent A/B System K960765). | The FDA determined the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This implies it meets the same functional and safety performance expectations. |
| Intended Use: Diagnosing pathological or traumatic conditions in the eye. | "The instrument is used for imaging the internal structure of the eye including the opaque media and posterior pathology for the purpose of diagnosing pathological or traumatic conditions in the eye." |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not contain information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided 510(k) summary does not contain information about experts used to establish ground truth or their qualifications. As there's no mention of a clinical test set in this document, this information would not be present.
4. Adjudication Method for the Test Set
The provided 510(k) summary does not contain information about an adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided 510(k) summary does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study would typically be conducted to evaluate the impact of an AI-assisted device on human reader performance, which doesn't seem to be the focus of this 510(k).
6. Standalone (Algorithm Only) Performance Study
The provided 510(k) summary does not describe a standalone (algorithm only) performance study. The device is a B-Scan ultrasound system, which inherently involves human operation and interpretation of images. The concept of a "standalone algorithm" doesn't directly apply in the same way as it would for, say, an AI-powered image analysis software.
7. Type of Ground Truth Used
Given the lack of a detailed performance study in the document, there's no explicit mention of the type of ground truth used. For a B-scan ultrasound system, ground truth in clinical validation would typically involve:
- Clinical Diagnosis: Based on a combination of patient history, physical examination, and other imaging modalities (e.g., MRI, CT, other specialized ophthalmic tests).
- Surgical Confirmation: If pathology is surgically removed.
- Histopathology: Microscopic examination of tissue samples.
- Expert Consensus: Agreement among multiple, highly qualified clinicians (ophthalmologists) on the diagnosis based on the full clinical picture.
8. Sample Size for the Training Set
The provided 510(k) summary does not mention a training set or its sample size. The B-Scan Plus is a traditional medical imaging device, not an AI/ML-driven device that typically requires a discrete training set in the same manner.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, the document does not describe how ground truth for a training set was established.
Summary of Study Information Gaps:
It's important to note that the provided document is a 510(k) summary, which often focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical trial data with detailed performance metrics. For devices like the B-Scan Plus, the primary means of demonstrating safety and effectiveness relied on showing that its technological characteristics and indications for use were similar to a legally marketed predicate device, and that any differences did not raise new questions of safety or effectiveness. Therefore, many of the detailed study parameters typically associated with AI/ML device submissions are not present here.
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(37 days)
ACCUTOME ULTRASOUND, INC.
The instrument is used for measuring the corneal thickness of the eye, and calculating a corrected intraocular pressure based on those measurements.
The AccuPach V device is designed as an ultrasound pachymeter which uses pulsed echo ultrasound to measure the corneal thickness of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulses, and provides a numeric display of returning pulse echoes to indicate the thickness of the cornea.
The provided 510(k) K042752 for the AccuPach V does not contain information about acceptance criteria or a study proving the device meets said criteria.
The 510(k) submission generally describes the device, its intended use, and claims substantial equivalence to a predicate device (Accutome Kremer Corneometer K810660). It mentions that the AccuPach V is an ultrasound pachymeter that measures corneal thickness of the eye using a 10.5 MHz A-Mode probe.
The document includes the FDA's clearance letter, which confirms substantial equivalence but does not detail performance specs or the studies conducted to establish them. It primarily focuses on regulatory compliance and administrative details.
Therefore, I cannot provide the requested information based on the provided text. The document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample size for test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Information about MRMC comparative effectiveness studies or effect sizes.
- Results of a standalone performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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