(15 days)
PHOT-X II MODEL 303 is a extraoral source dental radiographic x-ray unit. This unit works as a diagnostic purpose x-ray source for human teeth with the resultant image recorded on intraoral dental x-ray film or image receptor . The design, function and positioning of the x-ray unit is similar to most all other x-ray machines manufactured for this specific purpose over the past thirty years.
PHOT-X II, MODEL 303 dental x-ray contains; control box, wall mounting, adjustable support arm and x-ray generating tubehead. Package includes Operators Manual, Installation Manual and Warrantee.
The provided document is a 510(k) premarket notification for a dental X-ray device (PHOT-X II, MODEL 303). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness or diagnostic accuracy through a traditional clinical study with acceptance criteria for device performance. It's a regulatory filing, not an efficacy study report.
Therefore, many of the requested items related to clinical performance studies (such as acceptance criteria, sample size for test sets, ground truth establishment, expert qualifications, MRMC studies, or standalone performance) are not applicable in this context.
The document does not describe an acceptance criteria or a study that proves the device meets specific performance criteria in terms of diagnostic accuracy or clinical outcomes. Instead, it demonstrates that the new device has similar technical specifications and characteristics to previously cleared devices.
Here's the information that can be extracted from the document based on your request:
1. A table of acceptance criteria and the reported device performance
As this is a 510(k) submission focused on substantial equivalence based on technical specifications rather than diagnostic performance, explicit "acceptance criteria" and "reported device performance" in the typical sense of a clinical study are not provided. The comparison provided is between the new device and predicate devices on various electrical and radiation parameters. The "acceptance criteria" here is implicitly that the new device's specifications should be comparable to or within acceptable ranges of the predicate devices.
| Parameter | Predicate Device (MODEL 2001CP) (K874238) | Predicate Device (HELIODENT DS) (K960819) | Predicate Device (PROSTYLE INTRA) (K970975) | Proposed Device (MODEL 303) |
|---|---|---|---|---|
| X-RAY WAVE FORM | DC Constant wave | N/A | N/A | DC Constant wave |
| FILAMENT | Pre-heating system | N/A | N/A | Pre-heating system |
| CONTROL PANEL LOCATION | At arm mounting bracket | N/A | N/A | Separable from power board |
| PRE-HEATING TIME | Manually adjusted | N/A | N/A | Automatically adjusted |
| HIGH VOLTAGE GENERATOR | 75 kHz high frequency inverter | N/A | N/A | 80 kHz high frequency inverter |
| FILAMENT CIRCUIT | 50 kHz high frequency inverter | N/A | N/A | 25 kHz high frequency inverter |
| Focal Point Measurement | 0.8mm×0.8mm | 0.7mm×0.7mm | 0.7mm×0.7mm | 0.7mm×0.7mm |
| Rated tube potential | 60kV, 70kV | 60kV | 50,53,55,57,60,63,66,70 kV | 60kV, 70kV |
| Rated tube current | 10mA | 7mA | 8mA | 4mA, 7mA |
| Maximum rated tube potential | 70kV | 60kV | 70kV | 70kV |
| Rated line voltage | 120VAC | 100VAC-125VAC | 110VAC-115VAC | 120VAC |
| Line voltage range | 105VAC-130VAC | 90VAC-137.5VAC | 99VAC-126VAC | 108VAC-132VAC |
| Range of line voltage regulation | 2-5% | 2.5% | 10% | 2-5% |
| Rated line current | 14A at 70KV,10mA | N/A | N/A | 10.8A at 70KV,7mA |
| Maximum line current | 17A at 70KV,10mA | 11A | 9.0A | 12A at 70KV,7mA |
| Exposure time | 0.01-2.0sec., 27steps | 0.01-3.2sec., 23steps | 0.01-3.2sec., 23steps | 0.01-3.2sec., 23steps |
| Timer accuracy | ±10% or ±10msec, whichever is greater | ±10% | ±10% | ±5msec (below 0.1sec), ±10msec (0.1sec & up) |
| Inherent filtration | 1.3mmAl Equivalent | 0.55mmAl Equivalent | 1.0mmAl Equivalent at 70KV | 1.7mmAl Equivalent |
| Added filtration | 2.0mmAl | N/A | N/A | 0.3mmAl |
| Minimum filtration permanently in useful beam | 3.3mmAl Equivalent at 70KV | 2.0mmAl Equivalent | 2.0mmAl Equivalent at 70KV | 2.0mmAl Equivalent at 70kV |
| Nominal roentgen output (Regular cone) | 6.3mGy/s±40% (60kV,10mA) | 10mGy/s±30% | N/A | 5.4mGy/s±40% (60kV,4mA), 9.4mGy/s±40% (60kV,7mA) |
| Nominal roentgen output (Long cone) | 2.2mGy/s±40% (60kV,10mA), 2.9mGy/s±40% (70kV,10mA) | N/A | N/A | 2.4mGy/s±40% (60kV,4mA), 4.2mGy/s±40% (60kV,7mA), 3.1mGy/s±40% (70kV,4mA), 5.5mGy/s±40% (70kV,7mA) |
| Source to skin distance (Regular cone) | 203mm | 203mm | 200mm | 203mm |
| Source to skin distance (Long cone) | 350mm | 305mm | 300mm | 305mm |
| Leaking technique factor | 70kV/0.48mA | 0.12mA | N/A | 70kV/0.14mA |
| Duty cycle | 1:20 | 1:60 | 1:15 | 1:50 |
| Maximum deviation of tube potential and tube current | ±10kV,±5mA (0.01-0.05sec); ±5kV,±2mA (0.06-2.0sec) | ±6.0kV (tube potential), ±0.7mA (tube current) | ±2.0kV (tube potential), ±10% (tube current) | ±10kV,±2mA (below 0.1sec); ±5kV,±1mA (0.1sec & up) |
| Intended Use | For diagnostic purposes of teeth, jaw, oral structures | For diagnostic purposes of teeth, jaw, oral structures | N/A | For diagnostic purposes of teeth, jaw, oral structures |
2. Sample size used for the test set and the data provenance
Not applicable. This document is a 510(k) submission, not a study report. It focuses on comparing technical specifications of a new device to existing predicate devices. No test set of patient data is mentioned or used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No test set requiring expert ground truth is described in this regulatory filing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication is described.
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 dental X-ray unit, which is a hardware device for image acquisition, 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 relates to an AI algorithm's performance, which is not relevant for a dental X-ray hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. As no clinical performance study for diagnostic accuracy is presented, no ground truth is established or used. The "ground truth" in this context is the technical specifications and safety standards met by the predicate devices, against which the new device is compared for substantial equivalence.
8. The sample size for the training set
Not applicable. No machine learning or AI component is described, so there is no training set mentioned.
9. How the ground truth for the training set was established
Not applicable. No machine learning or AI component is described, so there is no training set or ground truth for it.
§ 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.