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The QUANTEL MEDICAL Compact TOUCH Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including:

• Visualization of the interior of the eye and the orbit by A and B scans.
• Axial Length measurement of the eye by ultrasonic means.
• Implanted IOL power calculation, using the Axial Length measurement.
• Measurement of corneal thickness by ultrasonic means.

The Compact TOUCH is an ultrasonic system designed for ophthalmic use. It combines A and B type scans for diagnostic imaging of the eye. The system is composed of a main console controlled by a touch screen. It consists of three probes which plug into the main console; the B-scan probe, the A-scan probe, and a Pachymetry probe.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Compact TOUCH Ophthalmic Ultrasound System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria with quantifiable metrics (e.g., accuracy, precision values) for the device's performance. Instead, it relies on a claim of "substantial equivalence" to predicate devices.

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

• Sample Size: Not specified.
• Data Provenance: Not specified. The study described is "Laboratory testing," which suggests it was likely performed in a controlled environment, but the origin of any data used for comparison (if any beyond predicate device specifications) is not mentioned. It is not possible to determine if it was retrospective or prospective.

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

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The submission states "No Clinical testing is required," meaning there was no human-based evaluation of diagnostic output that would necessitate an adjudication process.

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

• MRMC Study: No. The document explicitly states "No Clinical testing is required." Therefore, no assessment of human reader improvement with or without AI assistance was conducted.

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

• Standalone Study: Yes, in a way. The "Laboratory testing" was performed to verify that the device met design specifications and was substantially equivalent to predicate devices. This type of testing would assess the device's performance directly against established specifications or the performance of other devices, without human-in-the-loop diagnostic interpretation. However, the exact methodology for this testing is not detailed beyond referencing a guidance document.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this submission appears to be based on the design specifications of the Compact TOUCH and the established performance of the predicate devices. The device's components (probes) are explicitly stated to be "identical" to those used in the predicate devices, implying that their performance characteristics are known and accepted.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This device is an ultrasound system and its probes, not an algorithm that undergoes machine learning training in the context commonly understood today (e.g., AI with neural networks). The "training" in this context would refer to the engineering and validation processes that led to the design specifications of the device and its probes, which are stated to be identical to previously cleared devices.

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

• Ground Truth Establishment: Not applicable in the context of machine learning training data. For a hardware device like this, the "ground truth" for its design and manufacturing would be established through engineering specifications, previous validation studies for the predicate devices, and adherence to relevant industry standards and guidance documents (e.g., "Information for manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound systems and Transducers"). The claim of "identical" probes to predicate devices means the extensive testing and validation performed for those original devices serve as the foundation for the current device's performance claims.

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The ProLite III TM Pulsed Light System with the HR handpiece (containing a 630-1100 nm, 630-990 nm, or 750 - 1100 nm filter) is intended for the removal of unwanted hair in all Fitzpatrick skin types.

The ProLite III TM Pulsed Light System with the PR handpiece (containing a 530-1100 nm, 550-1100 nm, or 580-1100 nm filter) is intended for the treatment of benign pigmented lesions and the removal of tattoos, the treatment of vascular lesions, and the treatment of shallow veins, telangiectasia, facial hemangiomas, and rosacea vascular lesions.

The ProLite III IPL is a device designed for dermatological use. It produces an intense light pulse within the wavelengths of 450 to 2000 nanometers, which is tailored to specific indications by a bandpass filter. The system is composed of a Tower which encloses the power supply and cooling system and a Handpiece which contains the flash lamp, filter and waveguide. The device is controlled by a touchscreen graphic user interface.

This 510(k) summary does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological similarities and equivalent physical output characteristics.

Therefore, I cannot populate the requested tables and information based on the provided text.

Here's a breakdown of why the requested information is absent from this document:

• No Performance Data for Acceptance Criteria: The document describes the device's technical specifications (e.g., wavelength range, fluence, pulse duration) and its intended uses. However, it does not specify quantitative performance metrics (like efficacy rates, accuracy, precision, or safety outcomes) that would serve as acceptance criteria for a new clinical or performance study.
• No Study Details: The submission relies on "substantial equivalence" to previously cleared predicate devices (ProLite K021304 and Dermalux K010618) rather than presenting new clinical or performance study data for the ProLite III. The core argument is that because the new device uses similar technology and has equivalent output characteristics, its risks and benefits are comparable to those already established for the predicates.
• No Mention of Training or Test Sets: Since no new performance study is detailed, there's no discussion of sample sizes for test sets, training sets, data provenance, ground truth establishment methods, or expert involvement.
• No MRMC or Standalone Study: The document does not describe either a multi-reader multi-case comparative effectiveness study or a standalone algorithm performance study. These types of studies are typically conducted for AI/software devices or when demonstrating new performance claims that go beyond established equivalence.

In summary, the provided 510(k) summary is a "traditional" 510(k) submission that leverages substantial equivalence to predicate devices, rather than a submission that presents novel performance data against specific acceptance criteria.

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