(47 days)
The ATI-014A insulation and continuity testing system is a non-destructive, non-patient contacting, voltage insulation tester designed to test the insulation of electrosurgical instruments. The ATI-021 has the same indications for use for insulation testing, but does not include continuity testing.
The tester is a non-sterile multiple use handheld device operated by 9V battery. An embedded software (firmware) is used to program a microcontroller hardware platform, that interface the user's actions with visual and audible output signals. The tester is used pre-operating room by nurses in hospitals, for the purpose of verifying the insulation (for ATI-021 and ATI-014A) and continuity (for ATI-014A) of electrosurgical instruments. The tester is tested for functionality prior to each use.
The document provided is a 510(k) summary for the Jac-Cell Medic testers (models ATI-014A and ATI-021). It focuses on demonstrating substantial equivalence to a predicate device (ATI-014), rather than providing detailed acceptance criteria and a study report as typically seen for novel device performance claims.
Based on the information available, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative sense with defined thresholds and confidence intervals. Instead, it relies on demonstrating substantial equivalence to a predicate device. The performance is assessed by comparing technical characteristics.
| Category/Parameter | Specific Element of Comparison | Predicate Device (ATI-014) | Subject Device (ATI-014A) | Subject Device (ATI-021) | "Acceptance Criteria" (Implicit) | Reported Device Performance (as stated) |
|---|---|---|---|---|---|---|
| Indications for Use | Identical | Insulation/Continuity Testing | Insulation/Continuity Testing | Insulation Testing | Identical or covered | ATI-014A: Identical. ATI-021: Covered. |
| Target Population | Identical | Pre-operation nurses in Hospitals | Pre-operation nurses in Hospitals | Pre-operation nurses in Hospitals | Identical | Identical |
| Material/Flammability Rating | Enclosure | ABS Plastic/UL94-HB | ABS Plastic/UL94-V0 (flame retardant) | ABS Plastic / UL94-HB | Equivalent or better | ATI-014A: Better (V0 vs HB). ATI-021: Equivalent. |
| Energy Used | Battery Powered | Yes | Yes | Yes | Yes | Yes |
| Level | 9V | 9V | 9V | 9V | 9V | |
| Average current consumption | 30mA | 20mA | 20mA | Equivalent or better | Better (lower current). | |
| Battery life (continuous test) | 30 hrs. | 41 hrs. | 41 hrs. | Equivalent or better | Better (longer life). | |
| Protection | Shortcircuit | Shortcircuit | Shortcircuit | Shortcircuit | Shortcircuit | |
| Battery level discharge warning | at 7V | at 7V | at 6.75V | Equivalent or early warning | ATI-014A: Equivalent. ATI-021: Earlier warning. | |
| Energy Delivered | 1.5nF Capacitor discharge | not available | 5.88 mJoules | 5.88 mJoules | New information | 5.88 mJoules |
| Performance | Voltage Insulation and Electrical Continuity Tester | Voltage Insulation and Electrical Continuity Tester | Voltage Insulation and Electrical Continuity Tester | Voltage Insulation Tester | Equivalent functionality | ATI-014A: Equivalent. ATI-021: Equivalent for insulation. |
| HV Output (High Level) | 2800 V | 2800 V | 2800 V | 2800 V | 2800 V | |
| Tolerance | +/-2.5% | +/-2.5% | +/-2.5% | +/-2.5% | +/-2.5% | |
| HV Output (Low Level) | 1500V | 1500V | not applicable | 1500V | ATI-014A: 1500V. ATI-021: Not applicable. | |
| Tolerance | +/-2.5% | +/-2.5% | not applicable | +/-2.5% | ATI-014A: +/-2.5%. ATI-021: Not applicable. | |
| Continuity testing level | 10 Ohms | 10 Ohms | not applicable | 10 Ohms | ATI-014A: 10 Ohms. ATI-021: Not applicable. | |
| Tolerance | +/-20% | +/-10% | not applicable | Equivalent or better | ATI-014A: Better (+/-10%). ATI-021: Not applicable. | |
| Shortcircuit testing level | 150 Kohms | 150 Kohms | not applicable | 150 Kohms | ATI-014A: 150 Kohms. ATI-021: Not applicable. | |
| Tolerance | +/-20% | +/-10% | not applicable | Equivalent or better | ATI-014A: Better (+/-10%). ATI-021: Not applicable. | |
| Compatibility | Non-RoHS | Non-RoHS | RoHS | RoHS | Equivalent or better | Better (RoHS compliant). |
| Standards Met | Basic safety and Essential performance | IEC60601-1:1988 | ES60601-1:2005/(R02012 and A1:2012) | ES60601-1:2005/(R02012 and A1:2012) | Updated medical device safety standards | Meets updated standards (better). |
| EMC/EMI Conformity | EN60601-1-2:2001 | IEC60601-1-2:2007 FCC Part 15-Subpart B ICES-003 | IEC60601-1-2:2007 FCC Part 15-Subpart B ICES-003 | Updated EMC/EMI standards | Meets updated standards (better). | |
| Risk Analysis | ISO 14971:2007 | ISO 14971:2007 | Performed | Performed (new for subject devices). | ||
| Visual Signals | "Pass" for insulation testing | Green Light/Led | Green Light/Led | Green Light/Led | Green Light/Led | Green Light/Led |
| "Fault" for insulation testing | Red Light/Led | Red Light/Led | Red Light/Led | Red Light/Led | Red Light/Led | |
| "Good" for electrical resistance testing | Green Light/Led | Green Light/Led | not applicable | Green Light/Led | ATI-014A: Green Light/Led. ATI-021: Not applicable. | |
| "Fault" for electrical resistance testing | Red Light/Led | Red Light/Led | not applicable | Red Light/Led | ATI-014A: Red Light/Led. ATI-021: Not applicable. | |
| "Battery Level" warning | Red Light/Led | Orange Light/Led | Orange Light/Led | Indicator present, perhaps different color | Orange Light/Led (different from predicate). | |
| Audible Signals | On "Fault" detection | Yes | Yes | Yes | Yes | Yes |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a "sample size" for a performance study in the typical clinical or statistical sense. The assessment is based on bench testing of the subject devices (ATI-014A and ATI-021) against the characteristics of the predicate device (ATI-014). This implies testing of the manufactured device units themselves, not a dataset of patient cases.
- Data Provenance: The document only states "Bench testing confirms same performance to predicate device(s)." This indicates the testing was conducted internally by the manufacturer or a contracted lab. There is no mention of country of origin for data or whether it was retrospective or prospective, as these are not relevant for bench testing of device characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a bench test comparing device specifications and performance characteristics, not a diagnostic or AI-assisted interpretation of medical images/data requiring expert ground truth establishment. The "ground truth" here would be the known, objective specifications and performance of the predicate device and the measurement results from the subject devices.
4. Adjudication method for the test set
Not applicable. There was no need for adjudication as the testing involved objective measurements and comparisons of technical specifications and performance during bench testing, not subjective interpretations.
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 an electrosurgical instrument tester, not an AI-powered diagnostic tool, and therefore no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an instrument tester with embedded firmware, not an AI algorithm. Its performance is inherent to its design and functional testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this substantial equivalence claim is:
- Predicate Device Specifications: The known, documented technical characteristics and performance of the legally marketed predicate device (ATI-014).
- Engineering Measurements and Standards: The measurements obtained during bench testing of the subject devices (ATI-014A, ATI-021) compared against the predicate's performance and relevant industry standards (e.g., IEC, FCC).
8. The sample size for the training set
Not applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.