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K Number
K961944
Device Name
LUNAR REPORT GENERATOR
Manufacturer
LUNAR CORP.
Date Cleared
1996-07-03

(44 days)

Product Code
KGI
Regulation Number
892.1170
Type
Traditional
Panel
Radiology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The LUNAR Report Generator is provided as a software accessory to Lunar Corporation DPX and EXPERT bone mineral densitometers. The Report Generator assists the physician in communicating densitometer results to the patient and the patient's referring physician.

Device Description

The LUNAR Report Generator is provided as a software accessory to Lunar Corporation DPX and EXPERT bone mineral densitometers. The Report Generator assists the physician in communicating densitometer results to the patient and the patient's referring physician. The reports are generated with data received from the densitometer and physician comments. The Report Generator includes a dedicated word processing program so the physician may add comments to the data provided. The densitometer data is not modified by the Report Generator. The report is used under the complete and absolute control of the physician. The report does not: interpret or advise the physician, diagnose osteoporosis, assign a level of risk for fracture based upon bone density, make treatment recommendations.

AI/ML Overview

Here's an analysis of the provided text regarding the LUNAR Report Generator, addressing your questions about acceptance criteria and study details:

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) Summary of Safety and Effectiveness for the LUNAR Report Generator, which is a software accessory for bone densitometers.

Based on the content, here's why the requested information isn't available and what can be inferred:

The core assertion of the document is that the LUNAR Report Generator is a safe device because it:

  • Does not perform automated analysis.
  • Does not modify densitometer data.
  • Operates under the complete control and supervision of the physician.
  • Does not interpret, advise, diagnose, assign fracture risk, or make treatment recommendations.

Essentially, the device is presented as a sophisticated reporting tool that facilitates the communication of existing densitometer data and physician comments, without adding any analytical or diagnostic capabilities of its own. Because of this limited scope, traditional performance studies with acceptance criteria (like accuracy, sensitivity, specificity, etc.) for diagnostic or analytical devices are not described or implied in this document.

Therefore, I cannot provide answers to the specific questions posed, as the document doesn't detail such a study or acceptance criteria. If this were a device with diagnostic or analytical capabilities, this information would typically be present in sections detailing clinical studies, software validation, or performance specifications.

Summary of missing information:

  1. A table of acceptance criteria and the reported device performance: Not provided. The device's "performance" is implicitly tied to its function as a reporting tool under physician supervision, not a diagnostic aid.
  2. Sample size used for the test set and the data provenance: Not applicable, as no performance study is described.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method for the test set: Not applicable.
  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 the device is not an AI-assisted diagnostic tool.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as the device's function is centered around human-in-the-loop reporting.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable, as the device does not use machine learning or require a training set in the conventional sense.
  9. How the ground truth for the training set was established: Not applicable.

§ 892.1170 Bone densitometer.

(a)
Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.