(262 days)
The TEMBO Embolic System is a gelatin agent intended for use in the embolization of hypervascular tumors and blood vessels to occlude blood flow in the peripheral vasculature.
The TEMBO Embolic System consists of biocompatible, dry resorbable particles of porcine gelatin in a 10 mL syringe with a non-vented luer lock cap. The TEMBO Embolic System is a gelatin agent and a sterile, single use, medical device intended for the embolization of hypervascular tumors and blood vessels to occlude blood flow in the peripheral vasculature. The TEMBO Embolic System particles are hydrated using commercially available contrast media or contrast mixed with saline. Once hydrated, the material is injected into the target blood vessel via a commercially available microcatheter for occlusion of target vasculature. The dry TEMBO Embolic System gelatin particles are between 85 µm.
The provided text describes the TEMBO Embolic System, but it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy.
The document is an FDA 510(k) clearance letter and a 510(k) Summary. This type of document focuses on demonstrating substantial equivalence to a predicate device through bench testing, biocompatibility, sterility, shelf-life, and limited animal studies. It does not typically include information about clinical studies with human participants that establish diagnostic performance metrics like sensitivity, specificity, or accuracy, as would be relevant for devices that provide diagnostic output or alter human reader performance.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance (in a clinical/diagnostic context).
- Sample size used for the test set and data provenance (for diagnostic performance).
- Number of experts used to establish ground truth and their qualifications (for diagnostic performance).
- Adjudication method (for diagnostic performance).
- MRMC comparative effectiveness study or its effect size.
- Standalone algorithm performance.
- Type of ground truth used (for diagnostic performance).
- Sample size for the training set (for an AI algorithm).
- How ground truth for the training set was established.
What the document does provide regarding performance and studies:
- Performance Data (Bench Testing and Functional Testing): The document lists several types of performance testing, including Visual Verification, Particle Size (Dry), Iodinated Contrast Media Chemical Compatibility, Delivery Ease, Embolic Persistence, Pepsin Digestion, pH of Hydrated Gelatin, Pot Life, Simulated Use Testing (Ability to Create an Embolization, Depth of Penetration, Minimal Non-target Embolization, Directed Delivery of Embolic Material, Embolic Material Withstands Confirmation Angiography, Embolic Delivery Through Microcatheter System, Ability to Start and Stop Embolic Delivery), and Compatibility with Female Luer Connections. It states, "All performance testing met predetermined specifications."
- Biocompatibility Testing: A comprehensive list of biocompatibility tests was successfully completed according to ISO 10993-1.
- Sterility: Sterilization via gamma radiation to a SAL of 10⁻⁶, with a validated bacterial endotoxins test.
- Shelf Life: Demonstrated for 6 months.
- Animal Testing:
- One study on 11 swine evaluated the acute embolization effect in renal arteries and systemic impact over 28 days, assessing target tissue embolization and non-target embolization/device migration.
- An additional study on 8 swine compared the embolic effect of TEMBO to EmboCube and Gel-Bead at 7 days.
Conclusion based on the provided text:
The TEMBO Embolic System is a vascular embolization device. The provided FDA submission documents demonstrate its substantial equivalence through mechanical, chemical, and biological testing, including animal studies, but do not involve any diagnostic or AI-related evaluation processes that would require acceptance criteria for reader performance, ground truth establishment by experts, or MRMC studies. The "acceptance criteria" referred to in the document pertain to engineering and biological specifications of the device itself ("predetermined specifications" for bench and functional testing).
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).