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The UD-1000 A/B Scanner is indicated for:

• Ultrasound imaging of the eye and orbit
• Producing axial measurements of the eye
• Imaging the intraocular anatomy and pathology of the eye
• Imaging the anterior segment of the eye
• Imaging the anterior angle for Glaucoma Management
• Imaging of other structures of the anterior chamber

This instrument is designed as an ophthalmic diagnostic instrument that performs both Amode and B-mode ultrasound. In B-mode, the instrument acquires an ultrasonic crosssectional image of echoes from ocular structures. The brightness of the various dots in the two-dimensional image depends on the intensity of the echo sources. In A-mode, the instrument provides a one-dimensional display of returning echoes. Positive waves indicate the location of ocular structures; the distances between spikes can be measured.

The B-scan probe transmits focused ultrasonic waves into the eyeball. The transducer oscillates back and forth, resulting in a two-dimensional cross-sectional image view of the ocular structures. The image represents a "slice" through the portion of eye that is being examined. The ultrasonic beam focus range is controlled by six annular oscillators that are arranged concentrically. Multiple images can be saved and played back at the most appropriate resolution.

The B-scan probe is used to indirectly measure axial length based on a linear sampling of the image of the eye. Although this measurement is less accurate than axial length measurement by A-scan biometry, it provides a useful approximation in patients unable to maintain a steady primary gaze or in eyes with dense cataract, detached retina or posterior staphyloma.

The A-scan probe emits a non-focused ultrasound beam that results in a one-dimensional representation of echoes returned from ocular structures through which the beam passes. Ocular abnormalitites may be identified and evaluated by assessing the location and amplitude of the spikes produced by various ocular tissues.

The instrument control panel is a touch panel with membrane switch, rotary encoder and foot switch.

The provided text states, "Performance Data: None. The specifications and indications for use of the UD-1000 A/B Scanner are the same or very similar to those of the claimed predicate devices. The UD-1000 has the same indications for use for which the claimed predicates have been cleared and has no additional indications for use. Because of this, performance data were not required."

Therefore, based on the provided input, no acceptance criteria or study demonstrating that the device meets acceptance criteria are described. The manufacturer asserted substantial equivalence to predicate devices, and as such, performance data, including details on acceptance criteria, test sets, ground truth establishment, or multi-reader multi-case studies, were not required.

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The AL-2000 is indicated for:

• The axial length measurement of the eye by ultrasonic means; .
• The implanted IOL power calculation, using the axial length measurement; .
• The miplained TOL power of thickness before, during and after corneal and refractive . Measurement of the corneal disease assessment; and for contact lens fitting.

The AL-2000 is an ultrasound instrument designed for measuring the axial length of the eye and the thickness of the cornea for ophthalmic use.
Ultrasound energy is emitted from the probe tip. The probe acts as both the transmitter and receiver of ultrasound energy. Some of the energy is reflected back toward the probe in the form of an echo. Measurement data can be calculated based on both the time it takes the echo to travel back to the probe from the eye and the preset converted velocity.
The instrument provides five types of standard IOL power calculations, which can be made immediately after measuring the axial length.
The instrument uses measured (or entered) axial length and entered corneal curvature, desired postoperative refraction and lens constant values to calculate IOL power.

The provided 510(k) summary for the AL-2000 Combined Biometer and Pachymeter states that performance data were not required because "The specifications and indications for use of the AL-2000 Combined Biometer and Pachymeter are the same or very similar to those of the claimed predicate devices. The specifications of the claimed predicates have been cleared and it has no additional indications for use."

Therefore, most of the information requested regarding acceptance criteria and study details is not available in this document. The device did not undergo a specific study to prove it met acceptance criteria, as its substantial equivalence was based on its similarity to existing cleared devices.

Here's a breakdown of the available and unavailable information:

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

   • Acceptance Criteria: Not explicitly stated as new criteria were not required due to substantial equivalence. The implied acceptance criterion is that the device's specifications and functionality match those of the predicate devices.
   • Reported Device Performance: Not reported, as no new performance data was generated or submitted.

   Acceptance Criteria

   Reported Device Performance

   Specifications (e.g., axial length measurement, corneal thickness measurement, IOL power calculation) and Indications for Use are "the same or very similar" to legally marketed predicate devices (Compuscan LT Biometric Ruler and IOL Calculator (K910956) and DGH-4000 A-Scan Pachymeter (K913067A)).

   The submission states, "The specifications of the AL-2000 are the same or very similar to those of the claimed predicates." and "The specifications and indications for use of the AL-2000 Combined Biometer and Pachymeter are the same or very similar to those of the claimed predicate devices. The specifications of the claimed predicates have been cleared and it has no additional indications for use." No new performance data was submitted.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • No test set was used for performance evaluation of the AL-2000 as per the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable, as no test set requiring ground truth was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable, as no test set requiring adjudication was used.

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 MRMC study was done, as this is not an AI-assisted device, and no performance study was conducted.

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

   • No standalone performance study was done. The device's performance relies on its mechanical and ultrasonic properties, which are considered to be equivalent to predicate devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not applicable, as no new performance data was generated for the AL-2000. The ground truth for the predicate devices' clearance would have been established at that time, but it's not detailed here.

8. The sample size for the training set

   • Not applicable, as this is not a machine learning or AI device that requires a training set.

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

   • Not applicable, as this is not a machine learning or AI device that requires a training set.

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