(105 days)
The intended use of the Mondeal Endoscopic Tissue Recession and Release System is to endoscopically recess the gastrocnemius tendon or the plantar fascia ligament and to release the transverse carpal tunnel ligament.
Indications for use:
The Mondeal Endoscopic Tissue Release Recession and Release System is indicated for the following:
Endoscopic Gastrocnemius Tenotomy (EGT) - as a tool for tissue recession in patients with heel cord contracture (equinus) who fail to respond to a full course of non-surigcal treatment.
Endoscopic Plantar Fasciotomy (EPF) – as a tool for tissue recession in patients with plantar fasciitis who fail to respond to a full course of non-surgical treatment.
Carpal Tunnel Release (ECTR) - as a tool for tissue release in patients who fail to respond to non-surgical treatment of carpal tunnel syndrome.
The Mondeal Endoscopic Tissue Recession and Release System is a minimally invasive device for gaining exposure to perform Gastrocnemius Tenotomy, Plantar Fasciitis Recession, and Carpal Tunnel Release.
The system is comprised of the instruments required to perform the above mentioned maladies in conjunction with commercially available endoscopes. The instruments include an obturator, cannula, cannula locking mechanism, elevator, rasp, suction handle, and knife(s).
The system requires bi-portal incisions to pass the cannula from one side of the intended recession/resection to the other, allowing the knife to perform a complete and verified recession/release.
The cannula locking mechanism aids the surgeon in ensuring the cannula does not move while performing the procedure.
The knife is offered in two different designs. One design is for forward cutting (away from the surgeon), the other is for reverse cutting (towards the surgeon). The benefits of each design are dependent upon which procedure the device is used for and surgeon preference.
The provided text is a 510(k) summary for a medical device called the "Mondeal Endoscopic Tissue Recession and Release System." This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a clinical study with detailed acceptance criteria, performance metrics, and a study design to prove those criteria.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in the provided text. The document is a regulatory submission, not a clinical trial report.
Here's what can be extracted and what is explicitly not available based on your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document implies the acceptance criterion is substantial equivalence to predicate devices. It doesn't define specific numerical performance targets (e.g., sensitivity, specificity, accuracy) that a study would measure against. The criteria are related to design, materials, and intended use being similar to already cleared devices.
- Reported Device Performance: The document states: "The Mondeal Endoscopic Tissue Recession and Release System is shown to be safe and effective for the indications described in this submission." This is a general statement required for a 510(k) submission, based on comparison to predicate devices, but not performance data from a specific study against predefined numerical acceptance criteria.
| Acceptance Criterion (Implied) | Reported Device Performance (Implied) |
|---|---|
| Substantial Equivalence to Predicate Devices | "The Mondeal Endoscopic Tissue Recession and Release System is substantially equivalent to the Instratek and A.M. Surgical Endoscopic Tissue Recession and Release systems." |
| "The Mondeal Endoscopic Tissue Recession and Release System is shown to be safe and effective for the indications described in this submission." | |
| Safety | Shown to be safe with indications described. |
| Effectiveness | Shown to be effective for indications described. |
| Compliance with General Controls | Addressed by FDA clearance letter. |
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: As this is a 510(k) summary focused on substantial equivalence to existing devices, there is no mention of a clinical "test set" in the context of performance metrics like sensitivity or specificity. This document does not describe a clinical study that would involve such a test set. The "data provenance" would refer to the technical specifications and design comparisons made with predicate devices.
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 information pertains to a study involving human readers and ground truth, which is not described in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: This information pertains to a study involving human readers and adjudication, which is not described in this 510(k) summary.
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
- Not Applicable: The device is a surgical instrument (Endoscopic Tissue Recession and Release System), not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI assistance improvement effect size are not relevant or discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This device is a manual surgical instrument. It is not an algorithm that would have standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Provided: Ground truth in the context of device performance (like sensitivity/specificity) is not discussed because such a performance study is not described. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices to which it is compared.
8. The sample size for the training set
- Not Applicable / Not Provided: This implies machine learning or AI training, which is not relevant to this mechanical surgical instrument.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: As above, this is unrelated to the device described.
Summary of what the document does provide:
- Device Name: Mondeal Endoscopic Tissue Recession and Release System
- Intended Use: To endoscopically recess the gastrocnemius tendon or the plantar fascia ligament and to release the transverse carpal tunnel ligament.
- Indications for Use: Endoscopic Gastrocnemius Tenotomy (EGT), Endoscopic Plantar Fasciotomy (EPF), Carpal Tunnel Release (ECTR) for specific conditions after non-surgical treatment failure.
- Predicate Devices: Instratek EndoTrack System (K925083), Instratek Endoscopic Carpal Tunnel Instrument (K922391), A.M. Surgical Mountable Endoscopic Knife (K982142).
- Basis of Substantial Equivalence: Comparison to the listed predicate devices regarding intended use, design, materials, energy used, and performance characteristics (implied to be similar or identical, thus leading to similar safety and effectiveness). The document does not provide details of how this comparison was done (e.g., specific tests performed), other than the general statement of substantial equivalence.
§ 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.