(188 days)
The Alpha Omega Disposable Sterile LeadConfirm for MER is intended to be used in neurosurgery for connecting a compatible DBS Lead to a compatible recording and stimulation device.
The Alpha Omega Disposable Sterile LeadConfirm for MER is indicated for assisting Neurosurgeons, in the operating room during functional neurosurgery, to aid in the placement of a compatible DBS Lead.
The Alpha Omega Disposable Sterile LeadConfirm should only be used to connect a compatible DBS Lead to a compatible recording and stimulation device.
Alpha Omega's Sterile LeadConfirm cable and adaptor connects the DBS lead to Alpha Omega's approved physiological navigation systems for recording and stimulation system: Neuro Omega (K171581) and NeuroSmart (K172042).
The purpose of the submission is to introduce the Sterile LeadConfirm Cable and Adaptor, the subject devices are sterile Hardware only.
There are three types of the subject device, Alpha Omega's Sterile LeadConfirm Cables:
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- Sterile LeadConfirm M Cable that connects to Medtronic Lead P960009 (3389, 3387)
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- Sterile LeadConfirm B Cable that connects to Boston Scientific Lead P150031 (BSC-DB-2201, BSC-DB-2202)
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- Sterile LeadConfirm A Cable that connects to Abbott Lead P140009 (6170/ 6171/ 6172/ 6173/ 6178/ 6170/ 6180/ 6181)
In addition, there are two types of Sterile LeadConfirm Adaptors:
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- Sterile LeadConfirm M Adaptor
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- Sterile LeadConfirm A Adaptor
AOE (Alpha Omega Engineering) stimulation with LeadConfirm cable and adaptor is identical to IPG/ test stimulator, with the following parameters:
- a) Pulse shape: Square wave, Lili pulse
- b) Amplitude up to 12mA
- c) Duration up to 500uSec
Here's an analysis of the provided text to extract information about acceptance criteria and the study that proves the device meets them:
Disclaimer: This device is a sterile cable and adaptor, not an AI/ML powered device. Therefore, many of the requested criteria for AI/ML device studies (such as MRMC, human-in-the-loop, training set details, and expert qualifications for ground truth) are not applicable to this submission. The information provided focuses on the non-clinical performance validation.
Acceptance Criteria and Device Performance (Non-Clinical)
The "Sterile LeadConfirm" device is a hardware component (cable and adaptor) intended for connecting a Deep Brain Stimulation (DBS) lead to a recording and stimulation device during neurosurgery. The acceptance criteria and performance are focused on the safety and effectiveness of the hardware itself, primarily through verification and sterilization validation.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied from tests) | Reported Device Performance |
|---|---|
| Verification and Validation: | |
| Meets design input specifications for complete Sterile LeadConfirm devices. | "Sterile LeadConfirm devices have been verified under a complete verification plan traceable to Sterile LeadConfirm design input. All samples passed the acceptance criteria which determines the effectiveness of Sterile LeadConfirm devices." (Implied: Design inputs were met, and effectiveness was confirmed.) |
| Sterilization Validation (LeadConfirm Adaptors): | |
| Effectiveness of Gamma Radiation Sterilization for adaptors at specified dose and SAL. | "The purpose of the study was to validate the effectiveness of the Gamma Radiation Sterilization for Alpha Omega Engineering Ltd. LeadConfirm adaptors, according to VDmax Method. According to the test results (section 13), the gamma radiation sterilization process of LeadConfirm Adaptors Cat. No. STR-000071-00, STR-000072-00 and STR-000073-00, at a sterilization dose of 20kGy, was sustained. This dose gave a SAL of 6 magnitudes as requested by the standards." (Result: Sterilization effective, SAL of 10^-6 achieved at 20kGy.) |
| Sterilization Validation (LeadConfirm B Cable): | |
| Effectiveness of Gamma Radiation Sterilization for B Cable at specified dose and SAL. | "The purpose of the study was to validate the effectiveness of the Gamma Radiation Sterilization for LeadConfirm B Cable, according to Vdmax Method. According to the test results (Section 13), the gamma radiation sterilization process of Electrodes lead cable, at a sterilization dose of 20kGy, was sustained. This dose gave a SAL of 6 magnitudes as requested by the standards." (Result: Sterilization effective, SAL of 10^-6 achieved at 20kGy.) |
| Sterilization Validation (LeadConfirm M & A Cables): | |
| Effectiveness of Gamma Radiation Sterilization for M & A Cables at specified dose and SAL. | "The purpose of the study was to validate the effectiveness of the Gamma Radiation Sterilization for LeadConfirm M & A Cables, according to Vdmax Method. According to the test results (Section 13), the gamma radiation sterilization process of Electrodes lead cable, at a sterilization dose of 20kGy, was sustained. This dose gave a SAL of 6 magnitudes as requested by the standards." (Result: Sterilization effective, SAL of 10^-6 achieved at 20kGy.) |
| Integrity of materials and functionality after sterilization: (Implied from comparison) | "Functionality and materials stability, including packaging verified, after irradiation sterilization." (Comparison with predicate states "Identical", implying the subject device also maintained integrity.) |
| Sterility achievement method: (Implied from comparison) | "Sterilized by Alpha omega using irradiation sterilization and delivered sterile, validated process." (Comparison with predicate states "Identical", implying the subject device also uses this method and validated process.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of devices or units. The sterilization validation studies mention testing "complete Sterile LeadConfirm Adaptors" or "complete Sterile LeadConfirm B Cable," implying that a representative sample of each type of device was used. Standard sterilization validation protocols (like VDmax method mentioned) involve specific sample sizes based on lot size and desired Sterility Assurance Level (SAL), but the exact number is not provided in this summary.
- Data Provenance: The studies were non-clinical bench tests performed internally by Alpha Omega Engineering Ltd. (Israel). The data is generated from laboratory testing of the physical devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable. This submission is for a hardware medical device (cable and adaptor), not an AI/ML-powered diagnostic or decision support tool. Therefore, there is no "ground truth" in the clinical sense established by human experts for a test set. The validation is based on engineering and microbiology standards for functionality and sterilization.
4. Adjudication Method for the Test Set:
- Not applicable. As this is a non-clinical hardware validation, there is no need for adjudication involving human readers or experts to determine a "truth" for the test results. The results are objective measurements against defined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This is not an AI/ML device that interacts with human readers. The effectiveness is determined through physical verification and sterilization validation of the hardware.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This device is hardware and does not contain an algorithm. Performance is assessed through physical and sterility testing.
7. The Type of Ground Truth Used:
- The "ground truth" in this context refers to established engineering standards, design specifications, and internationally recognized sterilization validation methods (e.g., VDmax Method for Gamma Radiation Sterilization) and a Sterility Assurance Level (SAL) of 10^-6. These are objective, scientifically defined criteria, not medically determined "ground truth" from patient data.
8. The Sample Size for the Training Set:
- Not applicable. This is a hardware device; therefore, there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. There is no training set for this hardware device.
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).