(33 days)
The Smith & Nephew VideoArthroscopes/ENT Endoscopes is indicated to provide illumination and visualization in diagnostic and operative arthroscopic procedures, endoscopic examination and treatment of the nasal cavities and nasal pharynx.
In addition, the Smith & Nephew 4 mm diameter rigid VideoArthroscopes/ENT Endoscopes are indicated to provide illumination and visualization in the removal of loose bodies and soft tissue within the hip joint as size/length appropriate
The Smith & Nephew VideoArthroscope is a reusable VideoArthroscope. The proposed device is available in a variety if diameters, lengths, and with direction of view ranging from 0° to 110° and incorporates a mechanical focus mechanism.
The provided 510(k) summary for the Smith & Nephew VideoArthroscope (K043395) describes a re-submission for a device that is substantially equivalent to a previously cleared predicate device (K971253). This type of submission relies on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate device.
Key takeaway regarding acceptance criteria and studies:
The 510(k) summary does not contain specific acceptance criteria or detailed study results proving the device meets those criteria. Instead, it makes a general statement that:
"All verification and validation data demonstrates that the device is safe and effective and performs as intended." (Section H. Summary Performance Data)
This is common for 510(k) submissions, especially for devices demonstrating substantial equivalence to a legally marketed predicate device with a similar design and intended use. The FDA determines substantial equivalence based on the provided information, which often includes engineering specifications, manufacturing controls, and bench testing, rather than extensive clinical trials or specific performance metrics listed as "acceptance criteria."
Therefore, most of the information requested in your prompt regarding acceptance criteria, sample sizes, ground truth, expert qualifications, and specific study types (MRMC, standalone) cannot be extracted from this document.
Here's an attempt to answer the questions based on the available information, noting where data is absent:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in 510(k) summary. | "All verification and validation data demonstrates that the device is safe and effective and performs as intended." (General statement, no specific metrics provided) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The data likely refers to internal testing conducted by Smith & Nephew, Inc., Endoscopy Division (Andover, MA, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as no specific test set or ground truth establishment by experts is detailed in this 510(k) summary. Performance data likely refers to bench testing and engineering validation.
4. Adjudication method for the test set
- Not applicable as no specific test set requiring expert adjudication is detailed.
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
- No. This device is a VideoArthroscope (an optical instrument), not an AI-powered diagnostic system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is an optical instrument for direct human visualization, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of an optical instrument's performance validation as described here. The "performance" likely refers to technical specifications like illumination, visualization clarity, field of view, mechanical focus function, durability, and biocompatibility, validated through engineering tests against internal specifications, rather than clinical ground truth like pathology.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
In summary:
This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device. For devices of this nature (optical instruments), the "study that proves the device meets acceptance criteria" typically involves internal design verification and validation testing (e.g., optical performance, mechanical integrity, sterilization effectiveness, biocompatibility, electrical safety) rather than clinical studies with human "readers" or AI algorithms. The document makes a blanket statement that this testing was performed and found acceptable, without detailing the specific criteria or results.
§ 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.