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The PacScan Plus is Sonomed's newest diagnostic ultrasound system which integrates a contact A-scan system, pachymeter, and analog thermal printer into a single unit for the convenient collection and retention of intraocular measurements. The system's principal application is to serve as an aid in the calculation of the associated IOL power for implanted lenses. As such, the PacScan Plus has been designed to capture key measurements such as axial length, anterior chamber depth and corneal thickness with both accuracy and precision.

The PacScan™ Plus is the latest generation ophthalmic biometry instrument introduced by industry leading Sonomed. The series consists of two different models: PacScan™ 300A+. This A-scan system allows for measuring the axial length 0 (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. PacScan™ 300AP+. This system seamlessly integrates the A-Scan and 0 Pachymeter capabilities into a single system. All systems utilize a high-resolution, color backlit touch screen liquid crystal display (LCD) by which the user can enter information and view data and calculations. Each system also includes a built-in thermal printer. The system is compact and lightweight thereby making the system extremely portable.

The provided 510(k) summary for the PacScan Plus device does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria.

Instead, the summary focuses on:

• Substantial Equivalence: It claims that the PacScan Plus is substantially equivalent to two predicate devices (Sonomed Inc.'s 4000P Pachymeter System and E-Z Scan 5500+ A-Scan / B-Scan System). This means the device's safety and effectiveness are based on its similarity to legally marketed devices, rather than on proving specific performance metrics against pre-defined acceptance criteria.
• Safety, EMC, and Performance Data (Pending/General): It states that "Electrical, mechanical, environments safety and performance testing according to standard IEC 60601-1 and IEC 60601-2-37are currently pending and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All tests results were satisfactory." This is a general statement about standard compliance for safety and electromagnetic compatibility, not about clinical performance or acceptance criteria for measurements like axial length or corneal thickness.
• Indications for Use: The device is intended to capture measurements like axial length, anterior chamber depth, and corneal thickness with accuracy and precision as an aid in IOL power calculation. However, no specific numerical thresholds or a study demonstrating this accuracy and precision are provided.

Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided document.

Based on the provided text, the following information is NOT available and therefore cannot be reported:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study details.
• Standalone (algorithm only) performance study details.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Conclusions from the document:

• Device Type: Diagnostic ultrasound system for ophthalmic biometry (A-scan and Pachymeter).
• Purpose: Measures axial length, anterior chamber depth, and lens thickness; calculates IOL power; measures corneal thickness.
• Basis for Clearance: Substantial equivalence to predicate devices (Sonomed 4000P Pachymeter System and Sonomed E-Z Scan 5500+ A-Scan / B-Scan System).
• Safety & Performance Testing: General compliance with IEC 60601-1, IEC 60601-2-37 (pending at the time of submission), and EN/IEC 60601-1-2(2001) for EMC. No specific clinical performance study details are given.

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