(28 days)
MyoSure™ Single Use Seals are a component / accessory to the MyoSURE™ Rod Lens Hysteroscope and are used to prevent distension fluid leakage from the proximal ends of the MyoSure™ Rod Lens Hysteroscope and removable outflow channel.
The MyoSure™ Rod Lens Hysteroscope incorporates a 3 mm ID working channel and a proximal seal. Additionally, the MyoSure™ Rod Lens Hysteroscope utilizes a removable 3.0 mm OD outflow channel which also includes a seal to prevent distension fluid leakage from its proximal end. The seal also provides an insertion pathway for handheld instruments or cautery probes.
MyoSure™ Rod Lens Scope Seals are comprised of white-tinted silicone.
The provided text is for a 510(k) Pre-market Notification for a medical device called "MyoSure™ Single Use Seals". This type of document is used to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, and thus does not require a full Pre-Market Approval (PMA).
The key takeaway from this document is that the study performed here is NOT a study to prove a device meets acceptance criteria in the sense of demonstrating a certain level of clinical performance (e.g., diagnostic accuracy, sensitivity, specificity). Instead, it's a demonstration of substantial equivalence based on material, dimensional, and functional similarity to a previously cleared device.
Therefore, many of the questions asked in the prompt are not applicable to the type of information presented in this 510(k) submission.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 10993-1) | Meets the biocompatibility requirements of ISO 10993-1 Biological Evaluation of Medical Devices. |
| Bench Test Performance | Meets bench test performance requirements established by Interlace Medical, Inc. (Specific criteria are not detailed in this summary, but assumed to be related to preventing fluid leakage, which is its intended use). |
| Material (Silicone) | The modified seals are fabricated from silicone, equivalent to the predicate seals. |
| Dimensional Identity | The modified seals are dimensionally identical to the predicate seals. |
| Sterility Requirement | All seals are required to be sterile prior to being placed in the MyoSure™ Rod Lens Hysteroscope and outflow channel (implies that the seals themselves are sterile or sterilized before use, but doesn't specify if this is an "acceptance criteria" for the material of the seal itself). |
| Prevent Fluid Leakage (Intended Use) | Demonstrated to be equivalent in functional performance to the predicate seals, which are used to prevent distension fluid leakage. |
Study Details (Based on the provided 510(k) summary, which is a regulatory submission, not a detailed clinical study report)
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Sample size used for the test set and the data provenance:
- The document implies bench testing was performed. Specific sample sizes for bench testing are not provided.
- Data Provenance: Not explicitly stated as "country of origin." The company is Interlace Medical Inc., located in Framingham, MA, USA. The testing would have been conducted by them or a contracted laboratory. The testing appears to be retrospective in the sense that it's comparing a modified device to a previously approved predicate, but the bench tests themselves would be specific to the modified device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission describes bench testing and a comparison to a predicate device, not a study evaluating human interpretation or clinical outcomes against a defined ground truth established by experts.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method is mentioned as this is not a study assessing human reader performance.
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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 is a medical device (seals for a hysteroscope), not an AI diagnostic tool. Therefore, an MRMC study is not relevant or described.
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If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not applicable. This device is a physical component (seals). It does not involve an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bench Test Performance Requirements: The "ground truth" for the performance testing would be the pre-defined engineering specifications and performance limits for preventing fluid leakage, dimensional accuracy, and biocompatibility, as established by Interlace Medical, Inc. and relevant standards (ISO 10993-1). There is no "clinical ground truth" in the sense of pathology or outcomes.
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The sample size for the training set:
- Not applicable. This is not an AI/algorithm development, so there's no "training set."
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How the ground truth for the training set was established:
- Not applicable. (See point 7).
In summary, the K102686 submission is a 510(k) pre-market notification for a minor modification (seals) to an existing hysteroscope. The "study" described is primarily bench testing and a comparison of characteristics to demonstrate substantial equivalence to a predicate device, not a clinical trial or performance study against a complex ground truth involving human experts or AI algorithms.
§ 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.