Search Results
Found 1 results
510(k) Data Aggregation
(63 days)
Neuroview® Instrument Holder (Model: 300-33) is intended for use in holding Neuro Navigational Neuroview Endoscopes in a desired position over the patient during diagnostic and therapeutic procedures.
The Neuroview Instrument Holder, Model 300-33, is a reusable, stainless steel accessory used to hold currently marketed Neuro Navigational Endoscopes. The holder consists of a rail clamp, adjustable stainless steel rods, toggle clamps, and an instrument clamp.
This Instrument Holder, as well as the predicate devices, includes a one-piece design that is completely stable when used to position an instrument. The arms contain adjustable stainless steel clamps and holders that will adapt to any operating room table and hold any Neuro Navigational Endoscope. The holder can be positioned over the patient and locked into place to facilitate accurate Endoscope manipulation and instrument passage. The Instrument Holder, as well as the predicates accessory devices, is sold non-sterile and autoclavable for rapid operating room preparation.
This Instrument Holder is intended to hold the Neuroview Endoscope in place. It has no direct contact with the patient. The only important performance aspect of the Instrument Holder is that it maintains its position once it has been positioned and tightened in place.
This document is a 510(k) premarket notification for a medical device called the "Neuroview® Instrument Holder (Model 300-33)." It is a re-correction of an earlier letter from 1999, indicating a substantial equivalence determination by the FDA.
Based on the provided text, there is no study described that "proves the device meets acceptance criteria" in the way a clinical trial or performance study would for an AI/algorithm-based device. This document is for a mechanical instrument holder and relies on demonstrating substantial equivalence to existing predicate devices. Therefore, many of the requested points are not applicable.
Here's an analysis based on the structure of your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity). Instead, the "performance" is implicitly demonstrated through a comparison of technological characteristics to predicate devices, showing that it functions similarly and is intended for the same use. The key "performance aspect" is highlighted: "The only important performance aspect of the Instrument Holder is that it maintains its position once it has been positioned and tightened in place."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Rigidly affix endoscopes | "Neuroview® Instrument Holder (Model 300-33) is intended for use in holding Neuro Navigational Neuroview Endoscopes in a desired position over the patient during diagnostic and therapeutic procedures." (Matches predicate intended use) |
| Made of materials widely used in similar instruments | "The Instrument Holder is composed of stainless steel materials that are widely used in other instrument and scope holders." (Table 1 shows stainless steel for Neuroview and predicates) |
| No direct contact with the patient or fluids | "None of the Neuroview Instrument Holder (Model 300-33) components have patient, blood, and/or fluid contact." |
| Capable of being mounted to a table | "Table Mounted" (Matches predicates in Table 1) |
| Adjustable | "Adjustable stainless steel rods," "toggle clamps." (Matches predicates in Table 1) |
| Sterilizable | "sold non-sterile and autoclavable for rapid operating room preparation." (Matches predicates in Table 1) |
| Maintains position when tightened (primary performance aspect) | "The only important performance aspect of the Instrument Holder is that it maintains its position once it has been positioned and tightened in place." (This is a statement of expected function, not a result of a specific test documented here. The substantial equivalence argument implies this is met because it's a fundamental requirement for such a device and similar to predicates.) "one-piece design that is completely stable when used to position an instrument." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a mechanical device, and the evaluation for 510(k) clearance is based on technological comparison to predicates, not on a "test set" of data in the context of an algorithm. There is no mention of country of origin for any data or retrospective/prospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no "test set" or "ground truth" to be established by experts for this type of mechanical device clearance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is described.
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
Not applicable. This is a mechanical instrument holder, not an AI or algorithm-based device. No MRMC study was done, and the concept of human reader improvement with AI assistance is entirely irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm, so a standalone performance study as described is irrelevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. No "ground truth" data of this type is used for this mechanical device. The "truth" in this context is that the device functions as intended (holding an endoscope in place) and is safe and effective because it is substantially equivalent to legally marketed predicate devices.
8. The sample size for the training set
Not applicable. There is no training set for a mechanical device like this.
9. How the ground truth for the training set was established
Not applicable. There is no training set or ground truth in this context.
Ask a specific question about this device
Page 1 of 1