(115 days)
The SpineVu Endoscopic Spine System (SESS™) and SpineVu MiniScope are indicated for use for endoscopic access and visualization in the surgical area of the cervical, thoracic, or lumbar spine and are accessorized with surgical and coagulation tools for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.
The SESS kit is a collection of arthroscopic surgical accessories, including a bipolar RF electrosurgical accessory. The Spine Vu MiniScope is an arthroscope.
The provided text is related to a 510(k) Premarket Notification for the "SpineVu Endoscopic Spine System (SESS)" and "SpineVu MiniScope." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a comparative study with a ground truth, as would typically be described for AI/ML device evaluations.
Therefore, many of the requested elements (acceptance criteria table, sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or cannot be extracted from this type of regulatory submission. This document describes a medical device, not a software or AI device that would have performance metrics like sensitivity, specificity, or AUC against a ground truth.
However, I can extract information about the types of testing performed to support the substantial equivalence claim.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
Note: This 510(k) submission focuses on demonstrating substantial equivalence of a physical medical device (endoscopic spine system) to previously cleared predicate devices, rather than establishing performance against specific acceptance criteria for an AI/ML algorithm or software as commonly described in device performance studies for AI. Therefore, the response will focus on the types of evidence provided to support the substantial equivalence claim.
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, as typically found in AI/ML device studies, is not present in this document. Instead, the submission relies on demonstrating substantial equivalence based on intended use, design, and certain testing types.
| Category | Description of "Acceptance" / Evidence | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993 standards. | "Biocompatibility data demonstrates that the device is in compliance with ISO 10993." |
| Bench Testing | Compliance with pertinent standards, medical community expectations, and product labeling. | "Bench testing has demonstrated that the device is in compliance with pertinent standards, the medical communities expectations, and the product labeling." |
| Cadaver Testing | Device can be used as intended in humans. | "Cadaver testing demonstrated that the device can be used as intended in humans." |
| Substantial Equivalence | Device is substantially equivalent to predicate devices in intended use and design, raising no new safety or efficacy issues. | The document concludes "SpineView concludes that the SESS is substantially equivalent to the predicate arthroscopic surgical kits," and "Spine View concludes that the SpineVu MiniScope is substantially equivalent to the predicate arthroscopes." It further states, "The testing described below demonstrates that the differences in the devices do not raise any unresolved issues of safety or efficacy." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) as it's not an AI/ML performance study with a 'test set' of data.
- Data Provenance:
- Biocompatibility data and bench testing are laboratory-based.
- Cadaver testing involves human cadavers. Specific country of origin is not mentioned.
- The studies described are for regulatory submission to the FDA, implying they were conducted to support this submission. They are not framed as "retrospective" or "prospective" clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable. This submission focuses on the safety and effectiveness of a physical medical device through substantial equivalence, not on the performance of a software or AI algorithm requiring expert-established ground truth. Expert involvement would be in the design, testing, and regulatory review process, but not for "ground truth" calibration for a test set.
4. Adjudication Method
- Not applicable. No adjudication method is described as this is not an AI/ML performance study requiring expert consensus on data labels.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC comparative effectiveness study is not mentioned or implied because this is a physical medical device, not an AI/ML interpretive or diagnostic aid. The "effectiveness" is primarily demonstrated through the intended use and lack of new safety/efficacy concerns compared to predicates.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. The device is a physical endoscopic spine system, not an algorithm.
7. Type of Ground Truth Used
- Not applicable in the AI/ML sense of labeled data. The "truth" for this submission revolves around:
- Compliance with established standards (ISO 10993 for biocompatibility)
- Functional performance against engineering specifications and clinical expectations (bench testing)
- Feasibility of intended use (cadaver testing)
- Equivalence to predicate devices (demonstrated through comparative analysis of intended use, technology, materials, and safety/performance data).
8. Sample Size for the Training Set
- Not applicable. The device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI/ML training set, there is no ground truth establishment process for it.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.