(119 days)
The AIM 200® OR Major Surgical Light is designed to provide the required illumination for surgeries, procedures, and examinations of patients. The AIM 2000 OR Major Surgical Light is to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms and all other health care facilities where the need for additional illumination exists.
The new AIM 200® OR is intended to be used in Acute care arena in operating theaters, emergency rooms, trauma centers, and endo-suites as well as in ASC's for endo-suites, plastic surgery, ophthalmology and orthopedic procedures. It is available in floor, wall, single ceiling and double ceiling models. The new AIM 200® OR combines the smart and versatile styling of the existing AIM 50® and AIM 100® with the increased luminance of a Major OR product. The AIM 200® OR uses proven AIM 100® optical modules at increased powers to yield illuminance of 90,000 Lux at 1 meter while meeting the D50/D10 light distribution ratio required by the IEC 60601-2-41 standard for Major Surgical Lighting.
The provided text describes a 510(k) premarket notification for a medical device, the AIM 200® OR Major Surgical Light, and its substantial equivalence to a predicate device, the AIM 100® Minor Surgery Light. The focus is on demonstrating that the new device is as safe and effective as the previously cleared device, rather than proving that it meets specific acceptance criteria through a clinical study involving AI or human readers.
Therefore, many of the requested categories in your prompt are not applicable to the information contained in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this medical device are based on compliance with harmonized standards. The performance is reported in comparison to the predicate device and the standards.
| Criterion | Acceptance (Standard) | Reported Device Performance (AIM 200® OR Major Surgical Light) |
|---|---|---|
| Illuminance | 90,000 Lux at 1 meter (required by IEC 60601-2-41 for Major Surgical Lighting) | 90,000 Lux at 1 meter |
| D50/D10 Light Distribution Ratio | Required by IEC 60601-2-41 for Major Surgical Lighting | Meets the D50/D10 light distribution ratio. |
| Safety and Performance Standards Compliance (General) | - UL 60601-1 (Issued 2003-04-25 Ed.:1 Rev:2006/04/26) |
- CSA C22.2#601.1 (Issue 1990/0101, Amendment 2 - February 1998, Update No. 2 (R2001))
- IEC 60601-2-41:2000 Ed:1 | Meets all requirements as defined in the above Safety and Performance standards. Issued an "Authorization to Mark" by Intertek. Performed as well as, or better than, the legally marketed predicate device (AIM 100™). |
| Intended Use (Scope) | To provide required illumination for surgeries, procedures, and examinations of patients in various healthcare facilities, including operating rooms. (Expanded from predicate's "Minor Surgery" to "Major Surgery"). | Designed to provide the required illumination for surgeries, procedures, and examinations of patients. To be used with various mounting configurations in operating rooms, examination rooms, emergency rooms, and all other healthcare facilities where additional illumination is needed. (Acknowledged modification from Minor to Major Surgery compared to predicate.) |
| Electrical Safety / EMC | IEC/UL 60601 / IEC 60601-1-2 / IEC 60601-2-41 / MDD 93/42/EEC / CAN/CSA C22.2 601-1 M90 | Complies with IEC/UL 60601 / IEC 60601-1-2 / IEC 60601-2-41 / MDD 93/42/EEC / CAN/CSA C22.2 601-1 M90. (This is implied by meeting "all requirements as defined in the above Safety and Performance standards" and the certifications listed in the comparison table are identical to the predicate.) |
| Physical/Operational Specifications (e.g., Color Temp, Light Field Diameter, etc.) | Equivalent to or better than predicate device (e.g., Color Temp: 3500K for predicate; Light Field Diameter: 25-30cm; Depth of Illumination: 119cm; Number of bulbs: 3; Light Sources: 35W IRC, 12V, bi-pin; Swivel Radius: 160cm max; Height Movement: 104cm vertical; Power: 116 Watts for predicate) | Color Temperature: 3700 K
Light Field Diameter: 25 – 30 cm (10 – 12 inches)
Depth of illumination: 119 cm (47 inches)
Number of bulbs: 3
Light Sources (Halogen): 35 W IRC, 12 volt, bi-pin
Rated life of Halogen Lamp: 1,400 hours (Predicate: 2,000 hours, this is a difference but not framed as a failure of acceptance, rather a characteristic of the higher illumination)
Swivel Radius of Lam Housing – Ceiling Mounted: 160 cm (63 inches) max.
Height Movement of Lamp Housing – Ceiling Mounted: 104 cm (41 inches) vertical movement
Power: 105 Watts |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission is for a surgical light, not an AI/software device that analyzes data. Therefore, there is no "test set" in the context of diagnostic performance or image analysis. The "testing" referred to is against electrical, safety, and performance standards for a physical medical device.
- Sample Size: Not applicable in the context of an AI/diagnostic study. The device (AIM 200® OR Major Surgical Light) was tested.
- Data Provenance: Not applicable. The testing was conducted by Underwriters Laboratory (UL) and completed by Intertek. These are certification bodies, and the testing is performed on the physical device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth, in the context of diagnostic imaging or AI, is not relevant here. The device's performance is measured against objective technical standards (e.g., lux levels, color temperature, safety standards).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no diagnostic "test set" or adjudication process.
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 is a physical surgical light, 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 a physical surgical light, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is defined by the technical specifications and requirements of the referenced international and national standards (e.g., IEC 60601-2-41 for surgical luminaries). Compliance is demonstrated through objective measurements and tests performed by accredited laboratories.
8. The sample size for the training set
Not applicable. This is a physical surgical light, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a device of this nature.
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.