(120 days)
The Reprocessed Ultrasonic Scalpel is intended for use during minimally invasive laparoscopic and open surgical procedures where coagulation and incision of soft tissue is required.
The Reprocessed Ultrasonic Scalpels are hand held instruments which may be used to cut and coagulate tissue when connected to a compatible ultrasonic handpiece and generator. Scalpels are 5mm in diameter with functional lengths of 14 to 36cm. The instrument jaws are opened and closed using proximal ring handles, available with a pistol or scissor grip style. The instrument tip and shaft can be rotated 360° in either direction using a knob on the handle. Scalpels are available with various blade configurations: curved, blunt, and knife down.
The proximal handle is designed for attachment to a compatible handpiece and microprocessor controller. Electrical outputs from the controller are converted by an ultrasonic transducer within the handpiece to mechanical vibrations that are transmitted through the instrument shaft to the distal scalpel blade.
Vanguard receives previously used Ultrasonic Scalpels from healthcare facilities; cleans, inspects, tests, packages, labels, and sterilizes the devices; and returns them to a healthcare facility for subsequent use.
The provided documentation is a 510(k) Summary for the Vanguard Reprocessed Ultrasonic Scalpel. This type of regulatory submission is for demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study. Therefore, the document does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement for a performance study.
Here's what can be inferred from the provided text, and what is explicitly missing:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself. The "acceptance" for this regulatory submission is demonstrating substantial equivalence to predicate devices.
- Reported Device Performance: The document states that "Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective." However, it does not provide specific performance metrics (e.g., cutting force, coagulation time, re-use cycle durability) or the numerical results of these tests against any pre-defined acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Missing: This information is not provided. The document mentions "performance and biocompatibility testing" but offers no details about the sample sizes of devices tested, the type of data collected, or its origin.
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):
- Missing: This is not applicable in the context of this 510(k) submission. The "ground truth" here is typically established through engineering and laboratory testing for reprocessing efficacy and device function, not through expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Missing: Not applicable for this type of submission.
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:
- No: An MRMC comparative effectiveness study is not relevant to this device. This device is an ultrasonic surgical scalpel, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No: This is not an AI algorithm. It is a reprocessed physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Inferred Ground Truth: For a reprocessed surgical instrument, the "ground truth" would typically involve:
- Cleaning efficacy: Absence of residual biological material (e.g., protein, hemoglobin) after reprocessing, confirmed by laboratory assays.
- Sterilization efficacy: Confirmation of sterility (e.g., sterility assurance level, bacterial endotoxin testing).
- Functional performance: Verification that the reprocessed device performs according to OEM specifications (e.g., cutting ability, coagulation, instrument articulation, electrical isolation) through mechanical and electrical testing.
- Biocompatibility: Confirmation that reprocessing does not introduce cytotoxic or allergenic residues.
- Explicitly Stated: The document refers to "Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing."
8. The sample size for the training set:
- Missing: This document is not about an AI device that would have a training set.
9. How the ground truth for the training set was established:
- Missing: Not applicable as it's not an AI device.
Summary of what the document focuses on:
The entire submission focuses on establishing substantial equivalence to existing, legally marketed ultrasonic scalpels. The core argument for substantial equivalence of the reprocessed device rests on:
- Identical Technological Characteristics: "The Vanguard Reprocessed Ultrasonic Scalpels are essentially identical to the currently marketed Original Equipment Manufacturer (OEM) devices. No changes are made to the device materials or specifications and the reprocessed Ultrasonic Scalpels possess identical technological characteristics."
- Demonstrated Safety and Performance: Through "Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing."
The 510(k) process for a reprocessed device primarily requires demonstrating that the reprocessing method reliably restores the device to its original performance specifications and that the device remains safe and effective for its intended use, without significantly altering its fundamental technology or indications for use. It does not typically involve the kind of elaborate clinical or AI performance studies requested in the prompt.
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