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The 1-650 Mammography System is intended to produce radiographic images of the breast. Its specific intended use is for screening and diagnostic mammography. Screening mammography involves the production of images for initial examination for breast cancer diagnosis. Diagnostic mammography includes the production of magnified images for more thorough examination of areas of the breast determined suspicious through screening mammography, special views, spot compression views, and the production of images used by a physician in preparation for biopsy.

The Lorad I-650 mammography system is based on Lorad's currently marketed D-550 (K934870) and Elite (K973631) Dedicated Mammographic Systems. The mechanical packaging is similar to the D-550, while the electronics are similar to the Elite. The Lorad I-650 is a standalone mammography device, mounted on a base to be permanently mounted in position. The unit is AC powered, and must be connected to a 220 VAC/50-60 Hertz (nominal) line to operate. The standalone unit has two major assemblies: The C-arm and the Gantry. The C-arm, which contains the x-ray tube, an image receptor support, compression device, a beam limiting device, switches that actuate the C-arm functions, and sensors for detecting installed accessories and making radiation measurements, is attached to the front (patient side) of the Gantry. The C-arm frame is constructed of two vertical steel rails, which are precision machined to accept the components which it supports. Molded plastic covers enclose the x-ray tube, which is purchased from OEM manufacturers, and the beam limiting device, while aluminum covers enclose the sides, back, top and bottom of the C-arm framework. The C-arm is attached by a locking pivot mechanism to the Gantry. The pivot allows the C-arm to be manually rotated about its axis. The pivot mechanism is attached to the Gantry via a vertically moving carriage. This carriage is capable of movement in the vertical direction, driven by an AC motor and a drive screw mounted to the base of the Gantry. The pivoting action of the C-arm is locked by an electromagnetic brake attached to the vertical carriage, which, in its unactuated condition, prevents rotation. The brake must be electrically actuated to release the C-arm for movement. The Gantry is constructed of a welded steel frame, to which the electrical assemblies and components of the unit are mounted. The operator control is mounted on the side panel of the Gantry, or may be mounted remotely. The input power and input circuit breaker are located on the lower rear panel of the Gantry.

This document describes the Lorad I-650 Mammography System. Here's an analysis of the provided text for acceptance criteria and the study proving it:

Key Takeaway: This document is a 510(k) summary for a mammography system. The "acceptance criteria" are primarily regulatory and performance specifications for the device itself, rather than acceptance criteria for an AI algorithm. The "study" described is a series of bench tests to verify these specifications, not a clinical trial involving human readers or AI performance.

Acceptance Criteria and Device Performance (Table)

The document outlines numerous specifications for the Lorad I-650 Mammography System, which serve as its acceptance criteria. The "reported device performance" are the results from the non-clinical testing.

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The Lite Touch Erbium Laser Treatment System is intended for the coagulation, vaporization, ablation, or cutting of soft tissue in dermatology and plastic surgery, including aesthetic surgery and resurfacing.

The Lite Touch Erbium Laser is an Erbium:YAG laser which emits its energy at 2.94um.

This document, K974460, is a 510(k) summary for the Lite Touch Erbium Laser Treatment System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria.

Therefore, the following information is largely not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided because no performance data was deemed required for this 510(k) submission. The submission states, "None. The specifications and intended uses of the Lite Touch Erbium Laser Treatment System are the same or very similar (substantially equivalent) to those of the claimed predicate devices. There are no significant differences between the devices under conditions of intended use. Because of this, performance data were not required."

2. Sample size used for the test set and the data provenance: Not applicable, as no performance study was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance study was conducted.

4. Adjudication method for the test set: Not applicable, as no performance study was conducted.

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: Not applicable. This device is a laser system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a laser system, not an algorithm.

7. The type of ground truth used: Not applicable, as no performance study was conducted.

8. The sample size for the training set: Not applicable, as no machine learning algorithm or training set is mentioned for this device.

9. How the ground truth for the training set was established: Not applicable, as no machine learning algorithm or training set is mentioned for this device.

Key takeaway from the document:

The regulatory strategy for the Lite Touch Erbium Laser Treatment System was to demonstrate substantial equivalence to already legally marketed predicate devices (Schwartz Electro-Optics, Inc. TriLase 2940 Erbium Laser, and Continuum Biomedical, Inc., Multilite Erbium Laser and CB Erbium 2.94™ Systems). This approach meant that a new de novo performance study with specific acceptance criteria was not required by the FDA. The submission focused on comparing the specifications and intended uses of the new device to those of the predicate devices.

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The Lorad M-Ille Mammography System is intended to produce radiographic images of the breast. Its specific intended use is screening and diagnostic mammography. Screening mammography involves the production of images for initial examination for breast cancer diagnosis. Diagnostic mammography includes the production of magnified images for more thorough examination of areas of the breast determined suspicious through screening mammography, special views, spot compression views, and the production of images used by a physician in preparation for biopsy.

Screening and diagnostic mammography, including magnification studies, special views, spot compression views, as well as images used by a physician in preparing for a biopsy.

The Lorad M-IIIe mammoqraphy system is based on Lorad's currently marketed M-III, with changes to add features of Lorad's M-IV. The mechanical package, layout and basic electrical design of the M-III are used, but the x-ray tube of the M-IV, as well as the M-IV user interface and several M-IV software feature algorithms are incorporated. The changes made to the M-III to create the M-IIIe are summarized in the table below.

The Lorad M-Ille is a stand alone mammography device, mounted on a base with casters which allow positioning in the room where it is installed. A foot-operated mechanical lock prevents movement during clinical use of the device. The unit is AC powered, and must be connected to a 220 VAC/50-60 hertz (nominal) line to operate.

The standalone unit has two major assemblies: the C-arm and the Control Console. An M-Ille configuration tree, identifying the major components and subassemblies that comprise the M-IIIe, is provided in Attachment 1. The C-arm, which contains an x-ray tube, an image receptor support, compression device, a beam limiting device, switches that actuate the C-arm functions, and sensors for detecting installed accessories and making radiation measurements, is attached to the front (patient side) of the machine. The C-arm frame is constructed of two vertical steel rails, which are precision machined to accept the components which it supports. Molded plastic covers enclose the x-ray tube, which is purchased from OEM manufacturers, and the beam limiting device, while aluminum covers enclose the sides, back, top and bottom of the C-arm framework. The bottom panel of the C-arm is spring loaded and attached to a safety switch which disables C-arm vertical movement downward should it contact an object, such as a wheelchair.

The C-arm is attached by a locking pivot mechanism to the Control Console. The pivot allows the C-arm to be manually rotated about its central axis. The pivot mechanism is attached to the control console via a vertically moving carriage. This carriage is screw mounted to the base of the Control Console. The pivoting action of the C-arm is locked by an electromagnetic brake attached to the vertical carriage which, in its actuated condition, prevents rotation. The brake is de-actuated to release the C-arm for movement. The Control Console is constructed of a welded steel frame, to which the electrical assemblies and components of the unit are mounted. At the top of the Control Console, an operator station, consisting of a keyboard, a panel of individual pushbuttons and a Liquid Crystal Display (LCD) are mounted. Steel and aluminum panels enclose the Control Console. At the rear of the Control Console, opposite the operator station, there is a input power connector and input circuit breaker.

The M-IIIe is equipped with accessories necessary in the performance of mammography. Bucky grid accessories, containing either conventional linear or air-interspaced High Transmission Cellular grids, and a motor system to move the grid during exposure, are provided to reduce the effects of scattered radiation on the image. Compression plates to accommodate different sized patients and different mammographic applications are supplied and are interchangeable by the operator. A magnification table is provided, which provides a means to obtain geometrically enlarged views of suspicious areas of the breast. Footswitches are provided that operate (1) the C-arm vertical position function, to place the breast platform appropriately to the patient's height, and (2) the compression function, allowing the operator to use both hands to position the patient while applying and releasing breast compression position the patient while applying and releasing breast compression.

The M-IIIe is capable of use with Lorad's StereoLoc II Breast Biopsy system which was separately cleared by FDA. Use of the M-IIIe with the StereoLoc does not alter the operation of the M-IIIe.

Here's an analysis of the provided text regarding the Lorad M-IIIE Mammography System's acceptance criteria and study data:

It's important to note that this document describes an X-ray mammography machine, not an AI/CAD (Computer-Aided Detection) device. Therefore, many of the typical acceptance criteria and study designs associated with AI devices (like standalone performance, multi-reader multi-case studies, and ground truth establishment by experts for AI training) are not applicable here. The "algorithms" mentioned refer to internal device control logic, not AI for diagnosis.

The acceptance criteria are primarily technical specifications and performance measurements for an imaging device, ensuring it produces high-quality images and operates safely and effectively.

Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample size used for the test set and the data provenance:

   • Focal Spot Measurement: 2 tests for large focal spot, 2 tests for small focal spot. (Presumably internal lab data, USA, prospective for this device).
   • Line Pair Evaluation: 2 tests for large focal spot, 2 tests for small focal spot. (Presumably internal lab data, USA, prospective for this device).
   • Object Phantom Tests: 2 phantom films were used. (Presumably internal lab data, USA, prospective for this device).
   • AEC Tracking: Tests performed using breast equivalent phantom materials from 2 to 8 cm. (Number of exposures not specified, but implied to be sufficient for evaluating consistency across the range. Presumably internal lab data, USA, prospective).
   • Stereotactic Localization: Tests performed with a single simulated lesion (1mm diameter) positioned at a known 3D point (X=10mm, Y=20mm, Z=30mm) for 3 different configurations (DSM 512 mode, DSM 1024 mode, Film). The number of repetitions for each configuration is not explicitly stated but implies single assessments for each, measuring the "localized" vs "set" position. (Presumably internal lab data, USA, prospective).

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

   • Object Phantom Tests: "three readers for each of two phantom films readers" were used to score the images. Their qualifications are not explicitly stated, but it's implied they are qualified to interpret mammography phantom images according to ACR procedures (likely radiologists or medical physicists specializing in mammography QA).
   • Other tests: For technical measurements like focal spot size, line pair resolution, AEC optical density, and stereotactic localization accuracy, the "ground truth" is based on precise physical measurements using calibrated equipment (e.g., star patterns, line pair phantoms, known phantom thicknesses, known target positions). Human experts were not needed to establish this type of ground truth.

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

   • Object Phantom Tests: "The phantom images were scored according to standard ACR procedure, using three readers for each of two phantom films readers. The results are averaged summarized below." This implies a form of consensus or averaging, not a specific adjudication method like 2+1.
   • Other tests: Not applicable as ground truth is a physical measurement.

4. 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 document describes a mammography X-ray machine, not an AI/CAD device. Therefore, no MRMC comparative effectiveness study involving AI assistance for human readers was performed or applicable.

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

   • No. This is a hardware mammography machine. Standalone performance for an AI algorithm is not applicable here. The "software feature algorithms" mentioned are for internal device control (e.g., Auto-Filter, Auto-Time, Auto-kV) and not for diagnostic image analysis.

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

   • Objective Physical Measurements: For most tests (focal spot, line pair, AEC tracking, stereotactic accuracy), the "ground truth" is derived from objective physical measurements using phantoms or calibrated instruments, compared against established technical standards (NEMA, ACR, IEC, 21 CFR).
   • Phantom Scoring by Multiple Readers: For the object phantom tests, the "ground truth" for the phantom image quality score is an average score from three readers, indicating agreement against standardized phantom criteria (ACR/MQSA).

7. The sample size for the training set:

   • Not applicable. This document is about a hardware device approval, not an AI model. There is no "training set" in the context of machine learning. The device's internal control algorithms are designed and programmed, not trained on data in a ML sense.

8. How the ground truth for the training set was established:

   • Not applicable. As above, no training set for an AI model.

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