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510(k) Data Aggregation
(31 days)
JOB CORPORATION
PORTA 100HF is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays.
PORTA 100HF is an X-ray unit which operates from AC100-120V/15A or AC200-240V/10A. The device consists of the control panel with the kV and mAs selectors (a rotary switch system) and display for radiographic operations, and the APR switch with 8 memory settings (kV/mAs) to store the exposure data. The device also consists of the X-ray tube, the collimator, power code, and the hand switch, comprising the mono-tank type of a portable X-ray unit. The unit utilizes a high frequency inverter designed to be mounted on a stand. The device can be used with conventional X-ray film or digital imaging media. The usual safety precautions regarding X-rays must be observed by the operator.
This is a 510(k) premarket notification for the PORTA 100HF, a portable general-purpose diagnostic X-ray unit. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the Mikasa X-Ray Co., LTD.'s MinXray HF100H+ (K052721).
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device through a comparison of physical and technical characteristics, and compliance with applicable safety and performance standards, rather than defining specific acceptance criteria for a novel performance claim.
The "Acceptance Criteria" here are implicitly successful demonstration of:
- Identical Intended Use: The new device shares the same intended use as the predicate.
- Similar Technical Characteristics: Key technical specifications fall within acceptable ranges compared to the predicate.
- Compliance with Safety Standards: The device meets relevant electrical, electromagnetic, and X-ray performance standards.
- Software Validation: The software functions as intended and meets its specifications.
The "Reported Device Performance" is the outcome of the nonclinical tests and characteristic comparisons.
| Acceptance Criteria (Implicit) | Reported Device Performance (PORTA 100HF) |
|---|---|
| Intended Use (Same as predicate) | Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays. (Same as predicate) |
| Physical Characteristics (Compared to predicate) | Size/weight: 160mmx161mmx291mm / 9.2Kgs (Smaller and lighter than predicate's 406mmx222mmx241mm / 18.6Kgs) |
| Energy Source: AC100-120V/15A or AC200-240V/10A (Slightly narrower voltage range than predicate's AC100-140V or AC200-260V, but within typical operating ranges) | |
| Mounting Method: Mounted to a commercially available portable stand (Similar to predicate) | |
| Technical Characteristics (Compared to predicate) | User Interface: Up and down Rotary switch for kV and mAs value with 7 segment LED (Different from predicate's pushbuttons/LED indicators) |
| Exposure times: 0.01-2.50 second, 32 steps (Predicate: 0.03-2.00 sec, 0.01 increments. Range overlaps) | |
| Exposure switch: Dual stage, deadman type with curled cable (Same as predicate) | |
| Controls: Software based (Same as predicate) | |
| Construction: Monobloc HF generator, Medical full bridge inverter system (Same as predicate) | |
| High Voltage Adjustment: High frequency inverter (Same as predicate) | |
| Line Voltage Adjustment: Automatic, dynamic (Same as predicate) | |
| Tube Potential (kV): 40-100kV (2kV step) (Same as predicate) | |
| kV step: 31 (Same as predicate) | |
| Tube current: 30mA (40-66kV), 20mA (68kV-100kV) (Predicate: 30mA (40-60kV), 25mA (62-80kV), 20mA (82-100kV). Some differences but generally comparable) | |
| X-ray tube: Toshiba D-124 (Predicate: Toshiba D-124S. Very similar, likely minor variant) | |
| Anode heat Storage: 20,000HU (Same as predicate) | |
| Focal Spot Size: 1.2mm (Same as predicate) | |
| mAs: 0.3mAs-50mAs (Predicate: 0.6-120mAs. Lower maximum mAs than predicate) | |
| Total Filtration: 2.5mm Al. eq. at 100kV (Predicate: 3.2mm Al equivalent. Lower filtration, which can affect dose/image quality, but likely acceptable for equivalence) | |
| Collimator: Complete with 30 sec. timer and cross indication line (Similar to predicate) | |
| Source to Skin Distance (SSD): 216mm (Predicate: 300mm. Shorter SSD, which affects beam divergence and dose distribution, but again, likely within acceptable safety limits for portable units) | |
| KvP: 100KvP (Same as predicate) | |
| Compliance with Safety Standards (as applicable) | Performance Standard: 21CFR 1020.30 & UL 2601-1 (Same as predicate for 21CFR 1020.30, and comparable UL standard) |
| Electrical Safety: IEC 60601-1:2005, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-1-2, CISPR11, IEC 60601-2-7, IEC 60601-2-54 (Demonstrates compliance with multiple relevant and updated safety standards, including some not explicitly listed for predicate but likely covered by its general IEC 60601-1 and IEC 60601-1-2) | |
| Software Validation | Software validation and verification testing was performed. (Result concluded positively for substantial equivalence) |
| Device Output (Compatibility with imaging media) | Conventional X-ray film or digital imaging media (Same as predicate) |
2. Sample size used for the test set and the data provenance:
The document describes nonclinical tests primarily focused on electrical safety, electromagnetic compatibility, and software validation. It does not refer to a clinical "test set" in terms of patient data or images. The "data provenance" would be from laboratory testing of the device itself, rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is an X-ray unit, not an AI or diagnostic imaging interpretation device. The "ground truth" for the nonclinical tests would be the established international and national standards (e.g., IEC, UL, CFR) for device safety and performance. Compliance is demonstrated through measurements and verification against these standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no clinical "test set" requiring expert adjudication.
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. This is an X-ray imaging device, 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 is hardware.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the nonclinical tests described are the various safety, electromagnetic compatibility, and X-ray performance standards (e.g., IEC 60601-1-2, CISPR11, IEC 60601-2-7, IEC 60601-2-54, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-1:2005, and UL2601-1, 21CFR 1020.30). The device's measured performance is compared against the specifications defined by these standards.
8. The sample size for the training set:
Not applicable. This is a hardware device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable for the same reason as above.
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