(23 days)
The intended use of the Progeny JB-70 Intra Oral X-Ray System is to act as a diagnostic source for radiographic dental imaging.
The Progeny, Inc. JB-70 Intraoral Dental X-Ray System is an extraoral source of x-rays for intraoral radiographs in dental diagnostic radiography. The Progeny, Inc. JB-70 Intraoral Dental X-Ray System consists of the following main components: X-ray tubehead, Rotating yoke for tubehead mounting, Articulation arm, Horizontal extension arm, Electronic control unit, Wall mount, 8 inch cone. Optional Components: 12 inch cone, 8 ft. coil cord with exposure switch. The Power supply is regulated to provide a fixed 70 kVp at a fixed tube current of 8 mA. Predefined exposure times may be selected via the operator control panel. The range of exposure times is 0.05 to 1.65 seconds.
The provided text is a 510(k) summary for the Progeny JB-70 Intraoral X-Ray System. It explicitly states that the device's safety and effectiveness are demonstrated by "Performance testing and verification to meet product specifications." However, the document does not detail specific acceptance criteria or the study that proves the device meets those criteria, nor does it provide the type of outcomes data that would typically be used to assess the clinical effectiveness of a medical device against a ground truth.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Gendex Gx-770 and Gendex 765DC) based on shared indications for use, materials, design, and operational/functional features. It lists a comparison table of technical characteristics between the devices.
Therefore, most of the requested information cannot be extracted from this document. I will provide the information that is present and explicitly state what is not available.
1. Table of Acceptance Criteria and Reported Device Performance
Not available. The document states that performance testing and verification were done to meet product specifications, but it does not specify what those product specifications (acceptance criteria) were, nor does it report the results of such performance testing in a quantifiable manner (e.g., specific metrics for image quality, radiation dose, diagnostic accuracy, etc.). The "Comparison Table" provided focuses on design characteristics (kVp, mA, field size, etc.) rather than performance metrics against acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not available. There is no mention of a clinical test set, sample size, or data provenance (country of origin, retrospective/prospective). The assessment appears to be based on technical comparison and a general statement of performance testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable/Not available. Since no clinical test set or ground truth establishment is mentioned, there is no information about experts or their qualifications.
4. Adjudication Method
Not applicable/Not available. No clinical study or ground truth adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not available. The document does not describe an MRMC study or any assessment of human reader improvement with or without AI assistance. The device is an X-ray system, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not available. The device is an X-ray system, not an algorithm. There is no mention of an algorithm-only performance study.
7. Type of Ground Truth Used
Not available. No clinical study involving ground truth (e.g., expert consensus, pathology, or outcomes data) is described for product performance evaluation. The safety and effectiveness are established via performance testing to product specifications and substantial equivalence to predicate devices.
8. Sample Size for the Training Set
Not available. The document does not describe a training set, as it's not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not available. As there is no training set mentioned, there is no information on how its ground truth would have been established.
Summary of available information related to performance:
The document states:
- "Safety and effectiveness is demonstrated by: Performance testing and verification to meet product specifications."
- "Software testing to validate software design and performance."
- "Hazard analysis and risk level assessment."
- "Same indications for use as predicate devices."
The core argument for safety and effectiveness, beyond internal performance testing (details not provided), rests on substantial equivalence to two predicate devices:
The comparison table highlights similarities in key technical characteristics between the JB-70 and its predicates:
| Characteristic | Gx 770 | Gendex 765 | Progeny JB-70 |
|---|---|---|---|
| Fixed Kv | 70 kVp | 65 kVp | 70 kVp |
| Fixed mA | 7.0 mA | 7.5 mA | 8.0 mA |
| Operator Technique | |||
| Selection | Exposure | ||
| Duration Only | Exposure | ||
| Duration Only | Exposure | ||
| Duration Only | |||
| Suspension | Articulated Arm | Articulated Arm | Articulated Arm |
| X-Ray Field Size | 6.5 cm diameter | 6.0 cm diameter | 6.5 cm diameter |
| Focal Distance | 8 in. cone | ||
| 12 in. cone | 8 in. cone | 8 in. cone | |
| 12 in. cone | |||
| Operator Exposure | |||
| Control | Deadman | ||
| Switch | Deadman | ||
| Switch | Deadman | ||
| Switch |
The conclusion states that the JB-70 is "substantially equivalent to the predicate devices" because it "shares the same indications for use, materials, design, operational and functional features." This implies that the performance is expected to be similar because the device is technically comparable to already cleared devices, rather than through a direct demonstration of clinical performance against specific acceptance criteria in a clinical study.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.