(189 days)
AlphaScope Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. AlphaScope Hysteroscope is used with Hysteroscope Sheaths to provide access to the uterine cavity during diagnostic and operative hysteroscopic procedures.
AlphaScope Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. AlphaScope Hysteroscope is used with Hysteroscope Sheaths to provide access to the uterine cavity during diagnostic and operative hysteroscopic procedures. The use of AlphaScope Hysteroscope is restricted for the use of endoscopic surgeons and qualified assistants. AlphaScope Hysteroscopes are re-useable, they can be sterilized by 134 C Degrees Steam Autoclave.
The provided text describes the regulatory clearance for the AlphaScope Hysteroscope, a medical device. However, it does not include information about specific acceptance criteria, a study proving the device meets those criteria, or any of the detailed performance metrics asked for in the prompt. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed new clinical or non-clinical performance studies with acceptance criteria.
The key statement regarding performance is: "Based on the equivalence in design and materials to predicate devices, performance testing was not warranted. The device meets the same criteria and is as effective and safe as SE devices." This indicates that no new performance studies were conducted to define specific acceptance criteria for this particular device.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for a performance study, as this information is not present in the provided text.
Based on the provided document, here's what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot provide. The document states that performance testing was not warranted due to equivalence with predicate devices. Therefore, specific acceptance criteria and detailed performance metrics for this new device are not reported. The device is deemed to meet the "same criteria" and be "as effective and safe" as existing, substantially equivalent (SE) devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot provide. No test set for performance evaluation is described.
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)
- Cannot provide. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot provide. No test set or adjudication process 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
- Cannot provide. No MRMC study is mentioned. This is a purely mechanical device, not an AI-driven one.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot provide. This is a purely mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot provide. No ground truth for performance evaluation is described.
8. The sample size for the training set
- Cannot provide. There is no mention of a training set, as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established
- Cannot provide. There is no mention of a training set or its ground truth.
Summary based on the provided document:
The AlphaScope Hysteroscope received 510(k) clearance based on its substantial equivalence to legally marketed predicate devices, specifically the MicroSpan Gold Hysteroscope (K972426) and Alpha Hysteroscope, Rod Lenses (K012869).
The basis for this substantial equivalence claim relies on:
- Identical intended use.
- Similar materials (primarily surgical grade stainless steel, with verification of biocompatibility).
- Similar basic design, with slight modifications (design, diameter, material) that were determined not to "adversely affect the safety and effectiveness."
- Conformity with European Norms and directives (CE-marked) and relevant international standards (ISO, EN, ASTM, AAMI, ANSI, IEC).
- Validation of reprocessing and sterilization protocols by Nelson Lap.
- Market observation of a rigid AlphaScope Hysteroscope (2.7 mm diameter) which "has shown that the used materials are not effect the safety of the patients."
Crucially, the document explicitly states: "Based on the equivalence in design and materials to predicate devices, performance testing was not warranted. The device meets the same criteria and is as effective and safe as SE devices." Therefore, no new, specific acceptance criteria or performance studies for this device are detailed in this 510(k) summary.
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. 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 § 884.9.