(269 days)
Treatment of malignant pleural effusion by insufflation of medical grade talc following drainage of pleural fluid.
NOVATECH® TALCAIR™ is a powder blower comprised of an insufflation cannula, an insufflation bulb and its connecting pieces (a coupling, and a luer connector). The coupling, which is made of polypropylene, is used to attach the device to a vial. The device is a sterile, single use medical device which is sterilized by gamma sterilization. The coupling will be inserted into the glass vial. The cannula, made of polyethylene, is attached to the exit of the coupling. The insufflation bulb has two valves and a tube. The bulb and the tube are made of Soft-PVC. The luer connector, made of radiation grade polycarbonate, is attached to the tube of the insufflation bulb. The luer connector is to be attached to the coupling. When ready for use, the coupling is to be firmly pressed onto the vial until the coupling "clicks" on the vial top. Attach the balloon to the coupling with the luer connector. For administration, the cannula is introduced into the body cavity and pulverization is started. The medical device is intended for the administration of medical grade talc via thoracoscopy. The device is intended to treat patients with malignant pleural effusion.
The provided document is a 510(k) summary for the Novatech® Talcair™ device, which is a powder blower used for the administration of medical grade talc to treat malignant pleural effusion. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a stand-alone study with acceptance criteria and device performance as typically understood for diagnostic AI/ML devices.
Therefore, much of the requested information regarding acceptance criteria, sample sizes for test and training sets, expert involvement, and ground truth establishment, which are standard for AI/ML device studies, is not present in this regulatory submission. This submission does not describe a clinical study of an AI/ML device.
However, based on the provided text, I can extract information related to the device's technical performance and comparison with its predicate.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with corresponding "reported device performance" in the typical sense of a clinical study for a diagnostic device. Instead, it details benchmark performance tests comparing the Novatech® Talcair™ to its predicate device. The implicit acceptance criterion for these tests is "equal or better performance" than the predicate.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Novatech® Talcair™) |
|---|---|---|
| Benchmark Performance Tests | Equal or better performance than the KARL STORZ ENDOSCOPY POWDER BLOWER | Equal or better performance than the predicate device |
| Ejection volume in relation to flow | Equal or better than predicate | Equal or better performance for talc distribution against the predicate device |
| Distribution pattern of sprayed talc | Equal or better than predicate | Equal or better performance for spray coverage pattern against the predicate device |
| Pressure and volume changes (safety) | Equal or better than predicate (specifically pressure safety) | Equal or better performance for pressure safety against the predicate device |
| Yield of dosage | Equal or better than predicate | Equal or better performance for yield of dosage against the predicate device |
| Biocompatibility Testing | Compliance with EN ISO 10993-1, EN ISO 10993-5, EN ISO 10993-10, EN ISO 10993-11, EN ISO 10993-18, EN ISO 10993-12 | All risks were evaluated according to the mentioned standards, and relevant tests were performed. Deemed not relevant/applicable for other serious risks. |
| Sterile Barrier Test | Maintain sterile barrier after transport simulation (according to ISTA procedure 2A) | Passed; can be assumed that the product can be provided sterile to the end-user |
| Seal Strength | According to EN 868-10 | Tests performed and passed |
| Dye Penetration Leakage | According to ASTM F1929-12 | Tests performed and passed |
| Shelf Life | Confirmed for 5 years | Two test reports support a 5-year shelf life |
| Sterilization Assurance Level (SAL) | 10^-6 | Achieved with Gamma Radiation at 15 kGy |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes benchmark performance tests and biocompatibility testing of the device itself, not a clinical study involving patient data. The "test sets" refer to the physical devices or materials used in laboratory/engineering tests, not patient data.
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)
This information is not applicable as this is not a study assessing AI/ML diagnostic performance. The "ground truth" here relates to the objective measurements of the device's physical performance characteristics, which would be established through engineering and laboratory testing protocols, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are relevant for studies where human expert disagreement on interpretation needs to be resolved to establish ground truth for a diagnostic task. This document concerns a physical medical device's performance characteristics.
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 MRMC study was done, as this submission is for a physical medical device (powder blower), not an AI/ML diagnostic software. Therefore, there is no information on human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a physical medical instrument, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is based on objective engineering measurements and standardized test methods for physical and biological properties. For example:
- Benchmark Performance Tests: Quantitative measurements of ejection volume, observation of talc distribution patterns, and pressure monitoring.
- Biocompatibility Testing: Laboratory assay results aligned with ISO 10993 standards.
- Sterile Barrier Testing: Physical tests like seal strength (EN 868-10) and dye penetration (ASTM F1929-12) with defined pass/fail criteria.
- Sterilization: Validation of a specific Sterility Assurance Level through microbiological testing and dosimetry.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not an AI/ML device study.
9. How the ground truth for the training set was established
This information is not applicable. There is no "training set" or "ground truth for a training set" in the context of this device submission.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.