(133 days)
The device is indicated for use in fixation of prosthetic material to soft tissue in minimally invasive ventral and minimally invasive groin hernia repair procedures.
The MaxTack™ Motorized Fixation Device is a single-use, sterile device that contains 30 absorbable tacks, preloaded into a standard shaft. The device is designed for introduction and use through a 5 mm or larger cannula. The device's tacks are constructed of an absorbable synthetic polyester copolymer derived from lactic and glycolic acid. The first 25 tacks are dyed with D&C Violet No. 2. The last 5 tacks are dyed with D&C Green No. 6. to serve as an indicator of low tack count to the user. The distal end of the shaft has a mesh manipulation/grip feature that may be used to facilitate positioning of the mesh.
The device is intended for use in a sterile operating room environment in surgical procedures where fixation of prosthetic material, such as mesh, to soft tissues is indicated. This device is designed, tested, and manufactured for single patient use only. Intended users are healthcare professionals who have been trained in applicable surgical procedures and approaches involving fixation devices prior to employing this device.
The MaxTack™ Motorized Fixation Device is a medical device for fixing prosthetic material to soft tissue in minimally invasive hernia repair. The FDA's 510(k) summary provides details on non-clinical performance data to demonstrate substantial equivalence to a predicate device.
1. Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary for the MaxTack™ Motorized Fixation Device does not explicitly list quantitative acceptance criteria with specific thresholds alongside reported device performance. Instead, it indicates that "applicable design verification and validation activities... showed conformance to applicable technical design specifications and performance" and that the design differences from the predicate device "were found to have no impact on safety or effectiveness."
The "Summary of Studies" section outlines various performance tests conducted. While specific quantitative results are not provided in this summary document, the implication is that the device met the internal specifications and standards set for these tests to demonstrate substantial equivalence.
To illustrate, based on the document, here's a conceptual table of what acceptance criteria might have been inferred, along with the reported high-level outcome:
| Acceptance Criteria Category | Implicit Acceptance Criteria Description | Reported Device Performance (Summary) |
|---|---|---|
| Functional Reliability of Tack Deployment | Successful and consistent deployment of all 30 tacks without malfunction, jamming, or partial deployment, across various firing angles (including perpendicular and non-perpendicular). | "Reliability study performed to confirm the reliability of tack deployment..." (Outcome: Confirmed reliability, implying successful deployment). |
| Fixation Strength (Perpendicular & Non-Perpendicular) | Maintenance or increase of current fixation strength compared to the predicate device, for both perpendicular and non-perpendicular tack firings. | "...to maintain/increase current fixation strength at both perpendicular and non-perpendicular tack firings." (Outcome: Achieved, implying satisfactory strength). |
| Mesh Manipulation/Grip Feature Integrity | The mesh manipulation/grip feature at the distal end of the device functions as intended for facilitating mesh positioning without failure or compromise. | "...functional integrity of the mesh manipulation grip feature at the distal end of the device." (Outcome: Confirmed integrity, implying proper function). |
| Material Strength of Tacks (In-vivo & In-vitro) | Tacks maintain adequate strength (force at break) for a defined period (e.g., during healing) and exhibit expected strength loss over time. Correlation between in-vitro and in-vivo strength. | "MaxTack™ in-vivo material strength study: MEDSD-2106 GLP Strength Loss Study of a Hernia Fixation Tack in a Rat Model"; "MaxTack™ in-vitro material strength correlation study"; "MaxTack™ in-vitro Mass Loss Study" (Outcome: Studies imply satisfactory material strength and degradation profile). |
| Biocompatibility | All device components (including green tacks) meet ISO 10993 series and FDA guidance for patient contact, with no unacceptable biological response. Safety of D&C Green No. 6 demonstrated. | "Biocompatibility testing of the green tacks and delivery system conducted in accordance with the FDA's 2020 guidance and ISO 10993-1..." (Outcome: Conformed to standards). |
| Software Verification & Validation | Software functions correctly and safely, ensuring proper motor control, tack deployment, and warning indicators (e.g., low tack count). Compliance with IEC 62304. | "Software verification & validation activities completed following the FDA's guidance documents and IEC 62304." (Outcome: Completed, implying satisfactory performance). |
| Electrical Safety & EMC | Device meets electrical safety standards (IEC 60601-1) and electromagnetic compatibility requirements (IEC 60601-1-2). | "Electrical safety testing per IEC 60601-1 and electromagnetic compatibility (EMC) testing per IEC 60601-1-2." (Outcome: Met standards). |
| Usability | Device design changes (e.g., motorized mechanism) do not introduce new use errors or significantly increase risk, ensuring safe and effective operation by trained users. Compliance with IEC 62366-1. | "Usability study performed to fulfil the primary objectives supporting design change following the FDA's quidance as well as IEC 62366-1." (Outcome: Met usability objectives). |
| Sterility & Packaging Integrity | Device achieves and maintains a minimum Sterility Assurance Level (SAL) of 10-6 through its shelf life, and packaging protects product integrity during shipping and storage. | "Ethylene oxide (EO) sterilization for the single use devices with a minimum Sterility Assurance Level (SAL) of 10-6"; "protection of the product during shipping and storage was evaluated using packaging & product integrity testing." (Outcome: Achieved sterility and packaging integrity). |
2. Sample Size and Data Provenance for Test Set
The document does not specify the exact sample sizes for each of the non-clinical tests (benchtop, ex-vivo, reliability, in-vivo, in-vitro studies, usability testing). It also does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. However:
- Non-clinical (benchtop, ex-vivo, in-vitro) studies: These are typically conducted in a controlled laboratory setting (prospective by nature of setting up experiments). The document mentions a "Rat Model" for the in-vivo strength study, which is a controlled animal study.
- Usability study: These are prospective studies involving human users in a simulated or actual use environment.
- Reliability study: Typically prospective testing under defined conditions.
3. Number of Experts used to establish Ground Truth and Qualifications:
The document does not describe the use of human experts to establish ground truth for this device in the way it would for an AI/CADe device. The MaxTack™ Motorized Fixation Device is a mechanical fixation device, not an image analysis or diagnostic AI device. Therefore, the "ground truth" is established through physical, chemical, and mechanical performance testing, as well as biological response studies (e.g., biocompatibility) against established engineering specifications and regulatory standards, rather than expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set:
Not applicable, as this is primarily a hardware/mechanical device with software control, not an AI diagnostic system requiring adjudication of interpretations. Performance is measured against physical and engineering metrics, not expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for AI-powered diagnostic or assistive devices, where the performance of human readers with and without AI assistance is evaluated. The MaxTack™ Motorized Fixation Device is a surgical tool, not an AI diagnostic assistant.
6. Standalone (Algorithm Only) Performance:
Not applicable. This device is a motorized surgical tool, not a standalone algorithm. Its "performance" is inherently tied to its mechanical and software functions as a complete system.
7. Type of Ground Truth Used:
The "ground truth" for this device's performance is established through empirical data from various non-clinical tests, including:
- Pre-defined Engineering Specifications: Performance metrics (e.g., force required for tack deployment, fixation strength, battery life, dimensional tolerances) are compared against predetermined design and functional requirements.
- Biocompatibility Standards: Adherence to ISO 10993 series and FDA guidance for biological safety.
- Usability Metrics: Compliance with IEC 62366-1 regarding safety and effectiveness of use.
- Electrical Safety and EMC Standards: Adherence to IEC 60601-1 and IEC 60601-1-2.
- Sterilization and Packaging Standards: Compliance with SAL of 10-6 and packaging integrity standards (ASTM D4169, EN ISO 11607-1).
- Benchtop and In-Vitro Measurements: Direct measurements of physical properties and performance in controlled environments.
- In-Vivo (Animal Model) Outcomes: Biological responses and material degradation in a living system (rat model).
8. Sample Size for the Training Set:
Not applicable. This device is a mechanical/software system, not a machine learning model that requires a "training set" in the context of AI. The software within the device controls the motor and tack deployment, and its "training" or development would involve traditional software engineering and validation, not machine learning model training.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no "training set" in the machine learning sense for this device. The software's truth is established by its design specifications and validated through software verification and validation activities (e.g., unit testing, integration testing, system testing, compliance with IEC 62304) to ensure it correctly executes the intended functions (e.g., motor control for tack deployment, low tack count indication).
§ 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.