(18 days)
DSM as part of a standard x-ray mammography unit is part of a stereotactic lesion localization system that has the application of localizing, and then giving a physician the capability of performing fine needle aspiration or core biopsy of lesions determined to be suspicious through prior mammographic examination.
DSM is comprised of a workstation, monitor, trackball, keyboard, computer and digital image receptor.
This document is a 510(k) premarket notification for a medical device called the Lorad Digital Spot Mammography System (DSM). It details the device's characteristics and compares them to a previously cleared predicate device.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state "acceptance criteria" in the typical sense of quantitative thresholds for performance metrics. Instead, the "acceptance" for this 510(k) seems to be based on demonstrating substantial equivalence to a predicate device.
The tables within the document compare the specifications of the new DSM to the predicate DSM (K030666). The acceptance is implicitly that the new device's specifications are "Same" or functionally equivalent to the predicate, with the primary new feature being DICOM capabilities.
| Feature / Acceptance Criteria (Implicit) | Reported Device Performance (New DSM) |
|---|---|
| Intended Use (Same as K030666) | "...application of localizing, and then giving a physician the capability of performing fine needle aspiration or core biopsy of lesions determined to be suspicious through prior mammographic examination." (Same as predicate) |
| General Configuration (Same as K030666) | Described as "workstation, monitor, trackball, keyboard, computer and digital image receptor." (Same as predicate) |
| Principles of Operation (Same as K030666) | Uses a Charge-Coupled Device (CCD) for image capture. (Same as predicate) |
| Operating Parameters (Similar to K030666) |
- Tissue Imaging Area: 5.0 cm x 5.0 cm
- Operator control of Image contrast & luminance: Choice of 512 or 1024 pixel resolution
- Monitor: Large 18 in. high resolution, gray scale flat screen monitor
- Near Real-Time Image Display: 512 Mode - approx. 4 seconds; 1024 Mode - approx 8 seconds
- Image Device: Charge-Coupled Device (CCD)
- Display Area: 18 in. diagonal (minimum) 160° viewing angle (minimum)
- Computer Microprocessor: Intel CPU
- Archive Media: DVD + R/RW, CD - R/RW
- Operating System: Only recognizes disks, DVD/CD formatted with DOS, Windows 9X/NT/2000
- User Controls: Power, Brightness, Contrast, Picture Tilt, Height Vertical Position, Horizontal Position
- Approvals: UL 1950, FCC-A, DHHS, CSA-950, IEC 950 | All "Same" as predicate (K030666) |
| Added Functionality | DICOM Query/Retrieval Operations | This is the significant change from the predicate, and its functionality is listed as "Same" for DICOM capabilities. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not contain information about a specific "test set" for performance evaluation in the context of clinical accuracy or diagnostic efficacy. This 510(k) seems to be primarily focused on demonstrating substantial equivalence in physical and functional specifications to a predicate device, rather than new clinical validation. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since there is no mention of a clinical test set or performance study to evaluate diagnostic accuracy, there is no information about experts used to establish ground truth.
4. Adjudication Method for the Test Set
Given the absence of a clinical test set for performance evaluation, there is no information about an adjudication method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done or is not reported in this document. The purpose of this 510(k) is to modify an existing device and demonstrate substantial equivalence, not to conduct a new clinical effectiveness study comparing human readers with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Based on the document, no standalone algorithm performance study was done or is reported. The device described (Digital Spot Mammography System) is a hardware and software system used by a physician for localization and biopsy procedures. It's an imaging and guidance tool, not an AI diagnostic algorithm operating independently.
7. The Type of Ground Truth Used
As no clinical performance study is described, there is no information on the type of ground truth used. The "ground truth" for this 510(k) process is the predicate device's established performance and safety, to which the new device is compared in terms of its specifications.
8. The Sample Size for the Training Set
No information is provided regarding a training set. This document describes a medical imaging device's hardware and software specifications for a 510(k) submission, not the development or validation of an AI algorithm which would typically involve training sets.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, there is no information on how ground truth for a training set was established.
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.