K Number
K113273
Manufacturer
Date Cleared
2012-01-27

(81 days)

Product Code
Regulation Number
882.4800
Panel
NE
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SPOTLIGHT™ Access System and SPOTLIGHT™ PL are intended to provide the surgeon with minimally invasive surgical access to the spine by ensuring the placement/positioning of the port or retractor, down to the posterior and posterolateral bony spinal elements. These ports and retractors provide access to the spinal site which can be visualized using a microscope or loupes, and through which surgical instruments can be manipulated.

Device Description

The SPOTLIGHT™ PL is a modular three blade expandable retractor, with the option of lighted and non lighted blades, which provides access to the spine for minimally invasive procedures. A fiber optic Y cable is included for use with the retractor. The SPOTLIGHT™ PL also contains surgical instruments and cases that are considered exempt from premarket notification.

AI/ML Overview

The medical device in question is the SPOTLIGHT™ PL, a modular three-blade expandable retractor designed to provide minimally invasive surgical access to the spine. The primary performance data provided focuses on thermal testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Test SystemAcceptance CriteriaReported Device PerformanceConclusion
Thermal TestingMaximum surface temperature in IEC 60601-2-18 for medical equipment applied parts not exceededMaximum surface temperature not exceededPass

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a distinct "test set" in the context of an AI/algorithm-driven device, as this is a physical surgical retractor. The performance data is based on a single thermal test. No information is provided regarding data provenance (country of origin, retrospective/prospective) because the study is a physical test, not a data-driven one.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable. The ground truth for thermal testing of a physical device is established by objective physical measurements against a specific standard (IEC 60601-2-18) rather than expert consensus.

4. Adjudication Method for the Test Set:

Not applicable. As this is a physical thermal test against a standard, no adjudication method (like 2+1 or 3+1) is relevant. The outcome is a direct measurement compared to a defined limit.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This is a physical surgical device, not an AI or imaging-based device that would typically undergo an MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No. This is a physical surgical device, not an AI algorithm.

7. Type of Ground Truth Used:

The ground truth used for the thermal testing was the defined maximum surface temperature limit specified by the international standard IEC 60601-2-18 for medical equipment applied parts.

8. Sample Size for the Training Set:

Not applicable. This is a physical surgical device, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no AI algorithm or training set, this information is not provided.

§ 882.4800 Self-retaining retractor for neurosurgery.

(a)
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.(b)
Classification. Class II (performance standards).