(169 days)
The OsteoGram 2000 is indicated for use in estimating bone mineral density (BMD). The estimate of BMD and t-score may be used as an aid to the physician in determining fracture risk, and for monitoring changes in bone mass over time.
The use of the currently marketed device involves exposures and processing of ordinary x-rays of the hand and scanning and analysis of those x-rays at a central processing lab. The present 510(k) is for a modification to the device, one that would allow the analysis of the x-rays at the same hospital or clinic where the x-rays were taken using off-the-shelf scanner and computer equipment. The proposed device is basically a change in software to provide user help and enhanced records keeping capability.
Here's an analysis of the provided text regarding the OsteoGram® 2000, addressing your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the OsteoGram® 2000. It generally claims "performs as well as the currently marketed device" and that "The precision and accuracy of the naïve operators and central lab operators were almost identical."
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly defined with numerical thresholds. The core criteria is "performs as well as the currently marketed device." The "performance characteristics may not be sufficiently precise to assure equivalence" implies a need to demonstrate non-inferiority or equivalence to the predicate device. | "The results of this testing demonstrate that the modified OsteoGram 2000 performs as well as the currently marketed device." |
| "Precision and accuracy" | "The precision and accuracy of the naïve operators and central lab operators were almost identical." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states "scanning and analysis of several patient x-rays." This indicates a very small, unspecified number, which is insufficient for rigorous statistical testing. It does not provide an exact count.
- Data Provenance: The document does not specify the country of origin. It does not explicitly state whether the data was retrospective or prospective, but the phrasing "several patient x-rays" suggests these were existing (retrospectively gathered) x-rays used for evaluation, rather than a new prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document refers to "naïve operators and central lab operators" performing the scanning and analysis. It does not specify:
- The number of either "naïve" or "central lab" operators.
- Their qualifications (e.g., radiologist, years of experience). The term "naïve operators" suggests less experienced users, while "central lab operators" implies experienced individuals, but no specific professional credentials are given.
4. Adjudication Method for the Test Set
The document does not mention an adjudication method (such as 2+1, 3+1, or none) for establishing ground truth or resolving discrepancies in readings. It seems to compare the device's output to that of the predicate device or a "central lab" without a formal adjudication process described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study compared performance between "naïve operators" and "central lab operators" using the new system and the predicate, but it does not detail an MRMC design to quantify human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document describes the device as a "change in software" and mentions "the analysis software has been mounted is a lows the OsteoGram x-improved patient revorus managers managers they are made." The testing involved "scanning and analysis... by both naïve operators and central lab operators," indicating a human-in-the-loop scenario. Therefore, a standalone (algorithm only) performance study was not explicitly described. The comparison is between the new device (with human operators) and the predicate device (also with human operators).
7. The Type of Ground Truth Used
The ground truth is implicitly established by the "currently marketed device" or the "central lab operators." The study compares the performance of the new device against the performance of the predicate device (or the standard practice of central lab analysis with the predicate). It does not explicitly state an independent, gold-standard ground truth like pathology or specific clinical outcomes. The goal was to demonstrate equivalence to the established method.
8. The Sample Size for the Training Set
The document does not provide any information about a training set since it focuses on a software modification to an existing device rather than the development of a new AI model from scratch that requires separate training. The "software" changes described are related to "user help and enhanced records keeping capability" and deployment, rather than a deep learning or machine learning algorithm requiring extensive training data in the modern sense.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (see point 8), there is no information on how ground truth for a training set was established.
§ 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.