(176 days)
The Sphinx Jr. laser system is intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gasteroenterology, Arthroscopy, Discetomy Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
The Sphinx Jr. system is a surgical laser system operating at a wavelength of 2.1 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery and surgical applications in aqueous media and non aqueous medium. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece endoscopic surgical instrument or similar approved device. It consists of: Laser Console with Internal Computer Control Panel and Display Operating Software Fiber port Footswitch
The provided document describes a 510(k) Premarket Notification for the Sphinx Jr Laser system. This type of submission in the US regulatory process for medical devices asserts substantial equivalence to a previously legally marketed device (predicate device), rather than directly demonstrating safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria.
Therefore, the document does not contain a table of acceptance criteria nor a study proving the device meets said criteria in the traditional sense of a clinical trial. Instead, the core argument is that the Sphinx Jr Laser is substantially equivalent to existing predicate devices (Sphinx Family of Lasers K033437 and Lumenis - Versapulse K011703) because it shares the same intended use, indications for use, similar design features, and functional features.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent due to the nature of a 510(k) submission based on substantial equivalence:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated or defined in the document. For a 510(k) submission, acceptance is based on demonstrating substantial equivalence to a predicate device, not on meeting predefined performance thresholds in de novo clinical studies.
- Reported Device Performance: The document states, "Since the specification and performance of the Sphinx laser system and the predicate devices are the same, it is suggested that preclinical performance data is not required." This implies that the performance is considered to be equivalent to the predicate devices, rather than providing new, original performance data against specific criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. No "test set" in the context of a clinical performance study is described. The demonstration of equivalence relies on comparing the device's design, intended use, and functional specifications to those of the predicate devices.
- Data Provenance: Not applicable. No clinical data or performance data from human or animal subjects is described as being used to establish equivalence in this document.
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 mention of a "test set" requiring ground truth establishment by experts in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No "test set" and thus no adjudication method for it 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 device is a surgical laser system, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm-only device. It is a physical surgical laser system operated by medical professionals.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No ground truth is established in the context of a performance study for the Sphinx Jr Laser. Its safety and effectiveness are inferred by its substantial equivalence to previously cleared devices.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that would require a "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, no training set or ground truth for such a set is relevant to this device.
Summary of the Study and "Acceptance" for the Sphinx Jr Laser:
The "study" in this context is the 510(k) Premarket Notification (K132975) process itself, which aims to demonstrate substantial equivalence (SE) to predicate devices. The "acceptance criteria" are effectively the FDA's requirements for establishing SE.
The document states:
- "The Sphinx Jr systems with fiber optic delivery devices share the same intended use, indications for use, similar design features and functional features and therefore are substantially equivalent to the Sphinx Family of Lasers K033437 and Versapulse K011703."
- "All necessary Software and EMC testing was conducted on the proposed Sphinx Jr to support a determination of safety to the predicate devices." (This refers to non-clinical, engineering-level testing, not clinical performance).
- "Since the specification and performance of the Sphinx laser system and the predicate devices are the same, it is suggested that preclinical performance data is not required."
- Conclusion: "The Sphinx Jr Systems with fiber optic delivery devices was found to be safe and effective and therefore substantially equivalent to the predicate surgical laser systems and delivery devices."
The FDA's letter on March 18, 2014, confirms that they have "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This letter constitutes the "acceptance" that the device meets the regulatory requirements for market clearance via the 510(k) pathway, based on the argument of substantial equivalence.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. 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 § 878.9.