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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.

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.

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:

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.

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

The SPOTLIGHT™ Access System consists of a series of dilators and tubular retractors with and without integrated light source of various lengths and diameters designed to provide minimally invasive surgical access to the spine. The SPOTLIGHT™ Access System also contains Class I manual surgical instruments and cases that are considered exempt from premarket notification.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SPOTLIGHT™ Access System:

This document describes a 510(k) premarket notification for a medical device, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy trials. Therefore, the "study" described here is primarily a series of engineering and biocompatibility tests designed to show the new device performs similarly to or better than the predicate.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state sample sizes for each test in numerical terms (e.g., "n=X units"). However, for tests like "Static Torque Testing on Fixed Handle Connection," it states "All samples met the acceptance criteria," implying a sample was tested. For animal studies (e.g., Guinea Pig Maximization, USP Systemic Injection Test, USP Rabbit Pyrogen Test), it refers to "animals" but does not give a specific number.

• Sample Size: Not explicitly quantified in numerical terms for most tests. General phrasing "All samples" or "None of the animals" is used.
• Data Provenance: The document does not specify the country of origin of the data. Given it's a submission to the U.S. Food and Drug Administration, it's likely conducted in compliance with US or internationally recognized standards (e.g., ASTM, USP). The studies appear to be retrospective in the sense that they are conducted on manufactured devices or materials to demonstrate compliance.

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

N/A. This type of submission (510(k) for a surgical access system) relies on engineering and biocompatibility testing against established standards, not expert clinical interpretation of results. Therefore, no "medical experts" were used to establish ground truth in the way one would for diagnostic imaging. The "ground truth" is defined by the technical specifications and biological standards (e.g., USP standards) themselves.

4. Adjudication Method for the Test Set

N/A. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies involving human interpretation or subjective assessments. The tests presented here are objective, quantitative, or qualitative assessments against predefined scientific/engineering criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No. A MRMC comparative effectiveness study is designed to assess the performance of diagnostic devices often with human interpretation. This document pertains to a surgical access system where efficacy is demonstrated through mechanical and biological safety testing, not diagnostic accuracy.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done

N/A. The "SPOTLIGHT™ Access System" is a physical surgical device, not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of AI does not apply. The tests described are for the physical device itself.

7. The Type of Ground Truth Used

The ground truth for these tests is based on established scientific and engineering standards and specifications.

• Engineering Specifications: For tests like Compressive Force and Static Torque, the "ground truth" is the predefined mechanical performance requirement, often derived from predicate device performance.
• Biological Standards: For biocompatibility tests (e.g., Cytotoxicity, Pyrogenicity, Implantation), the "ground truth" is defined by widely accepted standards, particularly those published by the United States Pharmacopeia (USP) and relevant ISO standards (though not explicitly listed, USP often aligns with ISO for biological evaluations). These standards define what constitutes "non-toxic," "non-irritating," etc.

8. The Sample Size for the Training Set

N/A. This device is not an AI/ML algorithm, so there is no concept of a "training set" in the context of model development. The manufacturing processes and material selection might be informed by historical data, but not in the sense of a machine learning training set.

9. How the Ground Truth for the Training Set was Established

N/A. As there is no AI/ML training set, this question is not applicable.

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