(49 days)
The Socorro SMI Tunnel Release Device is intended for the minimally invasive examination, isolation and recession/incision of ligament, tendons, or fascia as in:
-Plantar Fasciotomy,
-Carpal Tunnel Release,
-Elbow Cubital Tunnel Release and
- -Gastrocnemius Tenotomy.
The SMI Tunnel Release Device is comprised of a hand piece with a tissue cutting probe which is used in conjunction with an endoscope camera and fiber optic illumination system. The device is supplied sterile and is for single use only.
The hand piece provides an actuation member for extending, retracting, and angularly rotating surgical blades which are attached to the distal end of the hand piece. Basic features of these probes are a retraction region and visualization that is nearly threehundred and sixty degrees (360°).
The visualization scope connects with the camera head and optic cables which provide the surgeon a clear and complete view of the surgical site on the overhead monitor.
The endoscope is used to illuminate and visualize the anatomy in or around the operative site. It allows the physician to directly visualize the actions of the probe during the procedure and to verify complete excision of the targeted tissue.
The provided text is a 510(k) summary for the Socorro SMI Tunnel Release Device. It describes the device, its intended use, and its substantial equivalence to a predicate device, supported by bench testing. However, it does not contain detailed acceptance criteria, specific quantitative performance metrics, or a description of a clinical study or even a detailed bench study that would typically include the elements requested in the prompt.
Therefore, many of the requested items cannot be extracted from the provided text. The document focuses on regulatory compliance through substantial equivalence, primarily based on design, materials, and bench testing, rather than a detailed performance study with specific acceptance criteria.
Below is a response attempting to address the prompt based only on the information available in the provided text. Where information is not present, it is explicitly stated.
Acceptance Criteria and Study Details for the Socorro SMI Tunnel Release Device
The provided 510(k) summary for the Socorro SMI Tunnel Release Device (K102219) concludes that the device is substantially equivalent to its predicate device based on intended use, technology, design, and materials, supported by bench testing. However, the document does not explicitly state specific quantitative acceptance criteria or provide a detailed report of the bench testing that demonstrates how these criteria were met.
Instead, the summary states a general conclusion: "Bench testing has demonstrated that the device is in compliance with international standards, the expectations of the medical community and the product labeling." This implies that the device's performance, as evaluated during bench testing, met the necessary standards and expectations to deem it safe and effective for its stated intended use and comparable to the predicate device.
Given the information, we can only infer the 'reported device performance' is that it does meet these implied standards.
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria (Inferred from "compliance with standards and expectations") | Reported Device Performance (Inferred) |
|---|---|
| Compliance with international standards | Device is in compliance with international standards. |
| Compliance with medical community expectations | Device is in compliance with the expectations of the medical community. |
| Compliance with product labeling | Device is in compliance with the product labeling. |
| Substantial equivalence to predicate device (K080133) in: | Demonstrated substantial equivalence to the A.M. Surgical Mountable Endoscopic Blade (K080133) in intended use, technology, design, and materials. |
| - Intended use | Achieved. |
| - Technology | Achieved. |
| - Design | Achieved. |
| - Materials | Achieved. |
| No unresolved safety or efficacy issues from device differences | The differences in the devices (primarily concerning sterility and single-use status) do not raise any unresolved issues of safety or efficacy. |
2. Sample size used for the test set and the data provenance:
The document mentions "Bench testing has demonstrated...", but does not provide details on the sample size used for this testing or the data provenance (e.g., country of origin, retrospective or prospective). This type of information is typically detailed in the full test report, which is not included in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not describe a study involving expert consensus or ground truth establishment in the context of human expert review. The evaluation relied on bench testing against established standards and predicate device comparison.
4. Adjudication method for the test set:
Not applicable, as no multi-expert review or adjudication process for a test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC or comparative effectiveness study involving human readers or AI assistance is described in this 510(k) summary. The device is a surgical tool, not an AI diagnostic or assistance system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical surgical tool and does not involve standalone algorithm performance.
7. The type of ground truth used:
For the bench testing, the "ground truth" implicitly refers to the established international standards, medical community expectations, and the performance characteristics of the predicate device. These serve as the benchmarks against which the new device's physical performance (e.g., cutting ability, structural integrity, retraction/rotation mechanisms) would have been validated.
8. The sample size for the training set:
Not applicable. This device is a surgical instrument evaluated through bench testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an algorithm.
§ 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.