(90 days)
The PMS750 Fingerswitch is intended to be used in general electrosurgical applications for cutting and coagulating during surgical procedures. It is provided non-sterile and is intended for limited reuse.
The PMS750 Reusable (Autoclavable) Fingerswitch Pencil is intended to be used in general electrosurgical applications for cutting and coagulating during electrosurgical procedures. It is provided non-sterile and is intended to be autoclavable for 100+ cycles.
The PMS750 Fingerswitch Pencil is a non-sterile, limited reusable electrosurgical handcontrol pencil. It utilizes an insert-molded body that houses a printed circuit board; depression of the yellow button will activate the CUT circuit and depression of the blue button will activate the COAG circuit. It is an accessory to an ESU (electrosurgical unit or generator).
The provided document (K991669) does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically seen for AI/ML-driven medical devices. Instead, it is a 510(k) premarket notification for a traditional medical device (an electrosurgical handcontrol pencil).
The core of this submission is demonstrating substantial equivalence to predicate devices already on the market, rather than a clinical study with specific performance metrics and acceptance criteria for a novel technology.
Therefore, many of the requested fields regarding AI/ML device evaluation are not applicable to this document. I will fill in the relevant available information and state "Not Applicable" where the information is not present or relevant to this type of device submission.
Here's a breakdown of the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary focuses on demonstrating substantial equivalence rather than meeting specific quantifiable performance criteria compared to an absolute standard. The "performance" assessment is comparative to predicate devices.
| Feature | Wallach Surgical PMS750 Fingerswitch (K991669) | Predicate Devices (Aaron, Medtrex, E&M, Conmed) | Acceptance Criteria (Implicit) |
|---|---|---|---|
| Materials | polypropylene | similar | Materials are similar to legally marketed predicate devices, implying comparable biocompatibility and durability. |
| Sterilization | autoclavable | equivalent | Device is autoclavable, demonstrating equivalent sterilization methods as predicate devices. |
| Design | Encapsulated circuit board | equivalent | Design features (e.g., encapsulated circuit board) are equivalent to predicate devices. |
| Intended Use | With an ESU for CUT & COAG | equivalent | Intended use for general electrosurgical applications (cutting and coagulating) is equivalent to predicate devices. |
| Where Used | By a Physician | equivalent | Usage by a physician is equivalent to predicate devices. |
| Hazard Analysis | No new hazards presented | N/A (compared to predicates) | Hazard analysis indicates no new hazards compared to predicate devices. |
| Limited Reuse | Intended for limited reuse (autoclavable for 100+ cycles) | N/A (implied by "reusable" predicates) | Durability for limited reuse (specifically 100+ cycles) is acceptable. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a "test set" in the context of an AI/ML algorithm. The document mentions "Testing that was performed on the PMS750 Fingerswitch," but no specific number of units tested is provided for performance validation.
- Data Provenance: Not applicable. This is a conventional medical device, not an AI/ML system.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable: This type of assessment (expert-established ground truth) is for AI/ML devices or diagnostic outputs. This submission for an electrosurgical pencil would typically involve engineering testing, material compatibility, and electrical safety assessments, not expert image review or diagnosis.
4. Adjudication Method for the Test Set
- Not Applicable: There is no "test set" for expert adjudication in this type of submission. Performance is assessed through engineering testing and comparison to predicates.
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: This is not an AI/ML device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an AI/ML device.
7. The Type of Ground Truth Used
- Not Applicable: For a device like an electrosurgical pencil, "ground truth" generally refers to established engineering standards, electrical safety standards (e.g., IEC standards), biocompatibility standards, and the functional performance of existing, legally marketed predicate devices. The "truth" is that the device performs its intended function safely and effectively, and is substantially equivalent to known safe and effective devices.
8. The Sample Size for the Training Set
- Not Applicable: This is not an AI/ML device, so there is no training set.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: This is not an AI/ML device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.