(13 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, single-use device and is packaged inside a Tyvek/Mylar peel pouch, which is standard packaging material for Applied's products. The packaged product is then placed in an outer product shelf pack. The Applied Medical disposable Specimen Retrieval System will be sterilized using Cobalt 60 Gamma Radiation, AAMI/ISO Guideline for Radiation Sterilization will be utilized to provide a Sterility Assurance Level of 106.
This document is a 510(k) Summary for a medical device called the "Specimen Retrieval System" by Applied Medical Resources Corporation. It describes the device's intended use and indicates that it has been found to be "substantially equivalent" to predicate devices.
Based on the provided text, a detailed study proving the device meets acceptance criteria in the way you've described for AI/diagnostic devices is not available or applicable. The document focuses on regulatory clearance for a physical medical device, not a diagnostic algorithm.
Here's a breakdown of why many of your questions cannot be answered from this document, and what limited information is available:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The primary acceptance criterion mentioned is for biocompatibility: "The Specimen Retrieval System has been found non-irritant when tested in accordance with ISO 10993, Part I: Biological Evaluation of Medical Devices."
- Reported Device Performance:
- Biocompatibility: Non-irritant (per ISO 10993, Part I).
- Sterilization: Will be sterilized using Cobalt 60 Gamma Radiation, meeting AAMI/ISO Guideline for Radiation Sterilization to provide a Sterility Assurance Level of 10⁻⁶.
- Clinical Utility: Stated to be equivalent to predicate devices in "design methodology, principle of operation and clinical utility," and introduces "no new safety or effectiveness issues." This is a regulatory statement for substantial equivalence, not a performance metric from a clinical study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document does not describe a "test set" in the context of diagnostic performance data. The ISO 10993 testing would involve specific biological samples, but the size or provenance of these are not detailed here.
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 / Not provided. This device is a physical tool; there is no "ground truth" to be established by clinical experts in the manner you're describing for a diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided.
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. This is a physical specimen retrieval system, not an AI or diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done.
- No. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The "ground truth" for this device relates to its physical and biological properties (e.g., sterility, biocompatibility, structural integrity for its intended use), which are confirmed through engineering and biological testing, not clinical "ground truth" as you'd define for a diagnostic.
8. The sample size for the training set.
- Not applicable / Not provided. There is no "training set" for this type of device.
9. How the ground truth for the training set was established.
- Not applicable / Not provided.
Summary of what the document does provide regarding device evaluation:
The evaluation described in this document is for a Class II medical device (Endoscope and accessories, Product Code: GCJ) seeking 510(k) clearance based on substantial equivalence to existing predicate devices.
The "study" that proves the device meets the acceptance criteria primarily consists of:
- Biocompatibility Testing: According to ISO 10993, Part I, demonstrating the device is non-irritant. (The scope and "sample size" for this specific test are not given).
- Sterilization Validation: A commitment to use Cobalt 60 Gamma Radiation and adhere to AAMI/ISO Guideline for Radiation Sterilization to achieve a Sterility Assurance Level of 10⁻⁶. This implies that sterilization validation studies (which involve a specific "sample size" of devices and test organisms) would have been performed or are planned, but the details are not in this summary.
- Comparison to Predicate Devices: The core of 510(k) clearance is demonstrating that the new device is "substantially equivalent" in design, principle of operation, and clinical utility, and introduces "no new safety or effectiveness issues." This is a regulatory comparison rather than a separate clinical study with specific performance metrics.
In essence, this document is a regulatory submission for a physical medical device, not a performance study for a diagnostic or AI-driven system, hence the lack of information pertaining to many of your questions.
§ 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.