(15 days)
The Applied Medical Specimen Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.
The Applied medical specimen Retrieval System is a disposable receptacle used to collect and extract tissue, organs and calculi during laparoscopic procedures. It consists of a flexible polymer bag and an introducer structure that fits through a trocar port. Extracorporeal activation of the introducer handle ejects the flexible bag which automatically opens in preparation for receipt of the specimen. The device is constructed of various polymers and stainless steel. It is packaged in a Tyvek/Mylar peel pouch and a product shelf pack. The shelf pack will be sterilized using gamma irradiation per AAMI/ISO guidelines. Sterility Assurance Level will be 10°.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Applied Medical Specimen Retrieval System (K100959):
Overall Assessment:
The provided document is a 510(k) summary for a medical device. For this type of submission, the "acceptance criteria" are not typically presented as quantitative performance metrics that the device must meet to be considered "accepted." Instead, the key acceptance criterion for a 510(k) is demonstrating substantial equivalence to a predicate device. This substantial equivalence is primarily shown through a comparison of technological characteristics and, crucially, through non-clinical testing that confirms the new device's safety and effectiveness compared to the predicate.
The "study" described is not a typical clinical trial or a performance study that generates specific statistical metrics like sensitivity, specificity, or accuracy that would be used to meet predefined quantitative acceptance criteria. Instead, it's a comparative non-clinical testing program designed to show that the new device performs similarly to the predicate.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for 510(k) Substantial Equivalence) | Reported Device Performance |
|---|---|
| Device must be suitable for use as a receptacle for the collection and extraction of tissue, organs, and calculi during general and laparoscopic surgical procedures. | Intended Use: "The Applied Medical specimen Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures." (Matches desired use) |
| Device functions as intended (collection and extraction of specimens). | Functional Testing: "Applied Medical created a dedicated test method designed to confirm safety and efficacy of the subject device relative to the predicate device of K060051. These tests focused on functionality... Test results for predicate and new device are essentially the same." (Demonstrated functionality similar to predicate) |
| Device is robust and durable for its intended use. | Robustness Testing: "Applied Medical created a dedicated test method designed to confirm safety and efficacy of the subject device relative to the predicate device of K060051. These tests focused on... robustness... Test results for predicate and new device are essentially the same." (Demonstrated robustness similar to predicate) |
| Specimen retrieval bag possesses adequate strength. | Bag Strength Testing: "Applied Medical created a dedicated test method designed to confirm safety and efficacy of the subject device relative to the predicate device of K060051. These tests focused on... bag strength. Test results for predicate and new device are essentially the same." (Demonstrated bag strength similar to predicate) |
| Device presents no new safety or effectiveness concerns compared to the predicate. | Overall Conclusion: "Applied's performance and functional testing demonstrated that the subject specimen retrieval system is substantially equivalent to the predicate device of K060051 and introduces no new safety and effectiveness issues." |
| Device is sterilized to appropriate standards. | Sterility Assurance Level: "Sterility Assurance Level will be 10⁻⁶." (Meets AAMI/ISO guidelines for gamma irradiation) |
| Device is constructed of appropriate materials and design for its intended use and is similar to the predicate. | Summary of Technological Characteristics: "Both predicate and subject device a tissue bag and a delivery system... Predicate and new device are constructed of the same materials and the design is similar except for a reduction in introducer tube diameter... The subject device bag also has a smaller volume." (Demonstrated similarity in materials and design, with justified differences as a "downsized version") |
Additional Information on the Testing ("Study")
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Sample size used for the test set and the data provenance:
- The document does not explicitly state the numerical sample size (e.g., number of test specimens, number of devices tested) for the functionality, robustness, and bag strength tests. It only refers to "test methods" and "test results."
- Data Provenance: The testing was conducted by Applied Medical. It is non-clinical/bench testing, not involving human subjects. The country of origin of the data is not specified but assumed to be the United States, given the company's location and FDA submission. It is by definition a prospective test of the newly manufactured 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 was a non-clinical, bench testing study. "Ground truth" in the clinical sense (e.g., expert diagnosis) is not relevant here. The ground truth for performance was established by engineering specifications and comparative testing against the predicate device.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As a non-clinical bench test, there was no expert adjudication process for establishing a "ground truth" outcome. Test results were likely directly measured against predetermined engineering criteria or predicate device 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:
- Not applicable. This device is a specimen retrieval system, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation. No MRMC study was conducted or relevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing, the "ground truth" was established by:
- Engineering specifications and design requirements: For functionality, robustness, and bag strength.
- Predicate device performance: The "ground truth" for acceptable performance was essentially defined by the performance characteristics of the legally marketed predicate device (K060051), as the goal was to demonstrate substantial equivalence.
- For the non-clinical testing, the "ground truth" was established by:
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of this device. This is a physical medical device, not a machine learning model.
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How the ground truth for the training set was established:
- Not applicable. As no training set was used.
§ 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.