(83 days)
The Spine View Minimally Invasive Surgical (MIS) Decompression System is indicated for use to facilitate access and visualization in the surgical area of the cervical, thoracic, or lumbar spine and is accessorized with surgical tools for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.
The Minimally Invasive Surgical (MIS) Decompression System is a collection of arthroscopic surgical accessories provided sterile (irradiated) and intended for single-use only. As a group, the accessories are provided to facilitate delivery of an endoscope and other instruments to the targeted treatment site. The addition of a new accessory, the enCise Bone Cutter, as an additional surgical tool to facilitate removal of soft and hard (bone) tissue during interventional spinal procedures. The new component will be offered in two configurations: one compatible with flexible endoscopes, and the second compatible with rigid endoscopes. Two additional enVue Cannula models are also being introduced for compatibility with rigid endoscopes: Long and Standard Jaw. Introduction of the new enCise Bone Cutter and additional configurations of the already cleared enVue Cannula do not affect the intended use or alter the fundamental scientific technology of the system.
The additional accessories being proposed in the modified MIS Decompression System are listed below:
- . enCise Bone Cutter: a tubular sheath with a mechanical "chisel" tip feature designed to cut soft and hard (cartilaginous, bone) tissue during spinal procedures. The enCise Bone Cutter is offered in two configurations (one compatible with flexible endoscopes, and the second compatible with rigid endoscopes).
- enVue Cannula, Standard and Long Jaw: configurations for use with rigid . endoscopes. The working end of the accessories is identical to the previously cleared enVue Cannulas. The only difference is in the handle, which is modified to accommodate rigid endoscopes (up to 5.9 mm OD; 205 mm working length).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Spine View, Inc. Minimally Invasive Surgical (MIS) Decompression System:
Based on the provided 510(k) Summary (K121548), the device in question is a minimally invasive surgical system, and the filing primarily focuses on demonstrating substantial equivalence to predicate devices for specific new accessories (enCise Bone Cutter, and new enVue Cannula configurations). This type of submission generally relies on non-clinical performance data to show that the new components perform as intended and do not raise new questions of safety or effectiveness compared to legally marketed devices. It is not a study about the performance of an AI/ML algorithm. Therefore, many of the requested categories regarding AI-specific studies, ground truth establishment, expert consensus, and reader studies are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria in terms of specific thresholds for performance metrics. Instead, it refers to validation against "product specifications and external standard requirements" and aims to demonstrate "substantial equivalence" to predicate devices. The "reported device performance" is summarized as the successful completion of various non-clinical tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Device functions according to stated intended use | "The above testing confirmed that the Spine View Minimally Invasive Surgical (MIS). Decompression System performs according to the stated intended use." |
| All data falls within product specifications | "All data fell well within product specifications..." |
| All data falls within external standard requirements | "...and external standard requirements." |
| Maintains substantial equivalence to predicate devices | "Results of non-clinical testing demonstrated that the Spine View Minimally Invasive Surgical (MIS) Decompression System is substantially equivalent to the predicate devices for its intended use." |
| Performance of specific non-clinical tests is satisfactory | Successful completion of: Device to Device Compatibility, Joint Integrity, Tip Rotation, Tip Robustness, Handle/Joint Integrity, Jaw & Trigger Force, Jaw Cycle Integrity, Jaw Activation, Biocompatibility, Design Validation, Packaging, Sterility Testing. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable as the submission describes non-clinical performance testing of mechanical components, not an AI/ML algorithm or a study with a "test set" of patient data. The tests would likely involve prototypes or production units of the device components. There is no mention of country of origin of data or retrospective/prospective in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The ground truth for this type of medical device submission is typically established through engineering specifications, material science standards, and established biocompatibility principles, performed by qualified engineers and scientists. There are no "patient cases" or an "AI test set" requiring clinical expert consensus for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable. There is no "test set" in the context of clinical data requiring adjudication.
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
This information is not applicable. No AI/ML algorithm is involved in this device submission. This is a special 510(k) for mechanical surgical instruments.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. No AI/ML algorithm is involved in this device submission.
7. The type of ground truth used
For the non-clinical performance data, the "ground truth" is based on:
- Engineering specifications and design requirements: Each test would have a pre-defined performance envelope or target.
- External standards: Relevant ISO standards, ASTM standards, or other industry benchmarks for material properties, sterility, biocompatibility, and mechanical performance.
- Predicate device characteristics: To demonstrate substantial equivalence, the performance of the new device is compared against the known performance and characteristics of the predicate devices.
8. The sample size for the training set
This information is not applicable. There is no AI/ML algorithm and therefore no "training set" of data in this submission.
9. How the ground truth for the training set was established
This information is not applicable. There is no AI/ML algorithm and therefore no "training set." The ground truth for the design and testing of the mechanical device is established through engineering principles, material science, and regulatory standards as described in point 7.
§ 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.