(58 days)
The Pegasus System is indicated for diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.
The Pegasus System is a portable, disposable, rigid, video camera enabled handheld probe paired with a wireless video receiver. It is powered by internal batteries encased in a plastic handpiece/handle. The distal tip of the stainless steel probe contains a camera and LED light source for visualization. The device is provided sterile and is intended for single patient use.
The provided text describes the 510(k) premarket notification for the "Pegasus System," an arthroscope. This submission focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and non-clinical performance data, rather than clinical efficacy. Therefore, much of the information typically found in acceptance criteria of an AI/ML medical device (e.g., performance metrics, expert adjudication, MRMC studies) is not applicable here.
The document explicitly states: "No clinical data were required or submitted in support of this submission."
Given this, I cannot provide the full detail for all requested points as they pertain to clinical performance studies, which were not conducted for this specific device clearance.
However, I can extract the information that is present:
1. Acceptance Criteria and Reported Device Performance
Since no clinical efficacy data was submitted, the "acceptance criteria" here refer to meeting established standards for medical device safety and non-clinical performance.
| Criterion | Reported Device Performance |
|---|---|
| Biocompatibility | Meets ISO 10993-1 and ISO 10993-7 |
| Electrical Safety | Meets IEC-60601-1 and EN-60601-1-2 (Electromagnetic Compatibility) |
| Sterilization | Meets ISO-11135 (Ethylene Oxide Sterilization) |
| Functional & Performance Requirements | Representative samples meet design requirements (details of specific functional tests not enumerated in this text) |
| Indications for Use Equivalence | Same as predicate device (K162475) |
| Technological Equivalence | Nearly identical to predicate (K162475), minor differences (probe diameter, video transmission method) do not affect safety/efficacy. |
| Safety and Effectiveness Issues | Does not raise any new safety or effectiveness issues. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data. For non-clinical performance testing (biocompatibility, electrical safety, sterilization), it states "representative samples of the device must meet." The exact sample sizes for these tests are not provided in this summary. Data provenance (country of origin, retrospective/prospective) is not applicable as this was non-clinical testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth in the context of clinical performance (e.g., disease detection) was not established using experts, as no clinical data was submitted.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study was not conducted as no clinical data was required or submitted. Therefore, there is no information on how human readers might improve with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is an arthroscope, a piece of hardware, not an AI algorithm requiring standalone performance evaluation.
7. The Type of Ground Truth Used
The "ground truth" for this submission was based on established industry standards for medical device safety and performance (e.g., ISO, IEC standards for biocompatibility, electrical safety, sterilization) and a comparison to a legally marketed predicate device (K162475). There was no clinical ground truth (e.g., expert consensus, pathology, outcomes data) as clinical data was not submitted.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no training set in the sense of machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable, as it's not an AI/ML device.
§ 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.