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The FlexLite™ Camera is indicated for use for endoscopic visualization in the surgical area of the cervical, thoracic, or lumbar spine during diagnostic or interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.

The Spine View FlexLite™ Camera is a flexible, reusable arthroscope designed for endoscopic visualization during diagnostic or interventional spinal procedures with access to the target area established through a surgical opening. The device includes fiber-optic illumination bundles with an integrated LED light source in the handle and a distal tip CCD image sensor with associated electronics. The camera is offered to support NTSC and PAL video formats. The FlexLite™ Camera is designed for use with the commercially available Vision-Sciences DPU-5050 Video Processor Unit (K102733, K072073) for image display and transfer. The FlexLite™ Camera contains neither software nor firmware. The FlexLite™ Camera is provided non-sterile to the customer and must be cleaned and sterilized by the user prior to each use.

This document describes the 510(k) submission for the Spine View FlexLite™ Camera, an arthroscope for endoscopic visualization during spinal procedures. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a dedicated table with corresponding performance metrics. Instead, it lists various non-clinical tests conducted and makes a general statement about their outcome.

2. Sample Size for Test Set and Data Provenance

• Sample Size: The document does not specify the sample size for individual tests. It only states that "non-clinical testing was conducted."
• Data Provenance: The data is generated from non-clinical testing, meaning it's likely laboratory-based and simulated, rather than human subject data. The country of origin for the data is not explicitly stated but is implied to be within the US, given the submission to the FDA. The data is prospective in the sense that it was specifically generated for this submission to validate the device.

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

• This information is not applicable to this submission. The tests described are primarily engineering and performance-based (e.g., dimensional, electrical safety, sterilization validation). These tests do not typically involve human experts establishing a "ground truth" in the way a diagnostic AI would require for image interpretation. The "ground truth" for these tests would be the established engineering specifications, standards, and validated protocols.

4. Adjudication Method for the Test Set

• This information is not applicable to this submission. Since no human expert interpretation or diagnostic classification is involved in the described non-clinical testing, there is no need for an adjudication method.

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

• No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic AI devices, not for a medical device like an arthroscope where the primary function is visualization. The FlexLite™ Camera itself does not contain AI or provide diagnostic interpretations.

6. Standalone Performance Study (Algorithm Only)

• No, a standalone (algorithm only) performance study was not done. This device is a physical camera for endoscopy and does not have an AI algorithm or software that operates independently to perform a diagnostic or therapeutic function. The document explicitly states, "The FlexLite™ Camera contains neither software nor firmware."

7. Type of Ground Truth Used

• The "ground truth" for the non-clinical tests conducted would be the established engineering specifications, recognized industry standards, and validated test protocols. For example, for biocompatibility, the ground truth would be the pass/fail criteria defined by ISO 10993 series standards. For electrical safety, it would be the requirements of relevant IEC standards (e.g., IEC 60601).

8. Sample Size for the Training Set

• This information is not applicable as this device does not involve machine learning or AI algorithms that require a "training set."

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

• This information is not applicable as there is no training set for this device.

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