(111 days)
The Reprocessed Hand-Activated 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 Hand-Activated 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 a functional length of 36cm. The instrument jaws are opened and closed using proximal ring handles, styled in a pistol-type grip. The instrument tip and shaft can be rotated 360° in either direction using a knob on the handle. The Scalpel has a curved active blade. 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. The proximal handle of the Hand-Activated Ultrasonic Scalpel has two integrated push buttons that allow hand control of the ultrasonic power level (minimum or maximum power level). 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 text is a 510(k) summary for a reprocessed medical device, specifically a Hand-Activated Ultrasonic Scalpel. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and biocompatibility testing of the reprocessed device itself, rather than a clinical study evaluating its performance against specific acceptance criteria.
As such, none of the requested information regarding acceptance criteria, study design, sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies is present in the provided text. The document is about the reprocessing process validation and comparison of device characteristics to those of new predicate devices, not about a clinical performance study with AI.
However, I can extract the available information which primarily relates to the device itself and its regulatory clearance:
1. Table of Acceptance Criteria and Reported Device Performance
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Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for AI or clinical efficacy. The implicit acceptance criterion is that the reprocessed device performs "as intended" and is "safe and effective," demonstrating substantial equivalence to the original predicate devices without negative impact due to reprocessing. This is shown through the following:
- Technological Characteristics Equivalence: Device materials, specifications, and technological characteristics are equivalent to OEM devices.
- Performance and Test Data: Cleaning, sterilization, packaging validations, and performance and biocompatibility testing demonstrate the reprocessed devices perform as intended.
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Reported Device Performance:
- Device Description: Functions to cut and coagulate tissue when connected to a compatible ultrasonic handpiece and generator. 5mm diameter, 36cm functional length, pistol-type grip, 360° rotation, curved active blade, integrated push buttons for power control.
- Equivalence Claim: Vanguard Reprocessed Hand-Activated Ultrasonic Scalpels are "essentially identical" and "substantially equivalent" to currently marketed Original Equipment Manufacturer (OEM) devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document describes validation and testing of the reprocessed device itself (e.g., cleaning, sterilization, biocompatibility, performance), not a clinical study on patient data. Therefore, there is no "test set" in the context of patient data; instead, there are batches of reprocessed devices tested.
- The sample sizes for these internal device validation tests are not specified in the provided text.
- Data provenance: Not applicable in the context of clinical patient data. The testing is internal to Vanguard Medical Concepts, Inc. (later Ascent Healthcare Solutions).
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. This document pertains to the regulatory clearance of a reprocessed medical device, not an AI or diagnostic study requiring expert-established ground truth on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As above, this is not a study assessing diagnostic performance where adjudication of ground truth would be needed.
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 was not done. This document does not describe any AI component or human-in-the-loop performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This document is about a reprocessed surgical instrument, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of clinical AI performance. The "ground truth" for the device's performance is established through engineering and biological safety testing (e.g., sterility testing, material strength testing, biocompatibility assays) to ensure it meets specifications and performs equivalently to new devices.
8. The sample size for the training set
- Not applicable. There is no AI component or "training set" of data described.
9. How the ground truth for the training set was established
- Not applicable. There is no AI component or "training set" of data described.
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