(48 days)
The Medline ReNewal Reprocessed Stryker SERFAS Energy Probe is a disposable, radio frequency probe used in electrosurgical procedures for resection, ablation of soft tissue, as well as the hemostasis of blood vessels in patients undergoing arthroscopic surgery of the knee, shoulder, ankle, hip, elbow, and wrist.
The Medline ReNewal Reprocessed Stryker SERFAS Energy Probes are single-use devices that have been cleaned, disinfected, inspected, refurbished, tested, packaged, labeled, and sterilized. All models can be operated with integrated finger switches on the device handle to control ablation, coagulation and power level. Each model also has a suction line that removes tissue and fluids from the surgical site. In addition, the models can be operated with foot switches, which offer another mode with which to control ablation, coagulation, and the power setting. The devices are connected to the appropriate generator by a connector cable. The generators and the foot switches are not included in the scope of this project, and they will not be reprocessed.
The provided document describes the acceptance criteria and study proving the device meets those criteria for the Medline ReNewal Reprocessed Stryker SERFAS Energy Probes.
1. Table of acceptance criteria and the reported device performance:
The document focuses on demonstrating substantial equivalence to the predicate device, the Stryker SERFAS Energy Probes. The acceptance criteria are implicitly tied to various performance tests aiming to show that the reprocessed device functions identically and safely as the original. The performance reported indicates that the device met these criteria, suggesting equivalence.
| Acceptance Criteria Category | Specific Tests/Evaluations | Reported Device Performance (Implied) |
|---|---|---|
| Safety and Functionality | - Sterilization Validation | Equivalent to predicate |
| - Biocompatibility (cytotoxicity, sensitization, irritation) | Equivalent to predicate | |
| - Pyrogenicity | Equivalent to predicate | |
| - Acute Systemic Toxicity | Equivalent to predicate | |
| - Electrical Testing (electromagnetic compatibility (IEC 60601-1-2), electrical safety (IEC 60601-1 and IEC 60601-2-2), basic safety (IEC 60601-1 and IEC 60601-2-2)) | Equivalent to predicate | |
| Performance Qualification | - Simulated Use | Equivalent to predicate |
| - Critical Function Bending Equivalence Test | Equivalent to predicate | |
| - Critical Function Suction Equivalence Test | Equivalent to predicate | |
| - Critical Function Thermal Tissue Damage Equivalence Test | Equivalent to predicate | |
| - Critical Function Drop Equivalence Test | Equivalent to predicate | |
| - Critical Function Device Equivalence Integrity | Equivalent to predicate | |
| - Product Stability | Equivalent to predicate | |
| Cleaning Effectiveness | - Cleaning: Protein | Equivalent to predicate |
| - Cleaning: Hemoglobin | Equivalent to predicate | |
| Overall Equivalence | "The functional characteristics of the proposed Medline ReNewal Reprocessed Stryker SERFAS Energy Probe have been evaluated and found to be equivalent to the Stryker SERFAS Energy Probe predicate devices based on the following tests:" (conclusion statement) | Substantially Equivalent |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes for each specific test (e.g., number of reprocessed devices tested for "simulated use" or "electrical safety"). It mentions "reprocessed single-use device models" and lists specific model numbers, implying that tests were conducted on these reprocessed units.
- Sample Size: Not explicitly stated for individual tests. The testing covers specific reprocessed models (279-351-100, 279-351-230, 279-351-250, 279-351-300, 279-351-400, and 279-401-100).
- Data Provenance: The tests were conducted by Surgical Instrument Service and Savings (dba Medline ReNewal), indicating a prospective testing approach specific to their reprocessing methods. The country of origin for the data is not explicitly stated but is implied to be within the U.S. from the FDA submission context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable to this type of device submission. This document pertains to the reprocessing of a surgical instrument, not an AI/ML device requiring expert interpretation of medical images or data. The "ground truth" here is the established safety and performance profile of the original Stryker SERFAS Energy Probe, against which the reprocessed version is compared using objective engineering and performance tests.
4. Adjudication method for the test set:
Not applicable. As this is not an AI/ML device, there's no need for expert adjudication of outputs. The tests performed are objective, measurable performance validations against predetermined specifications or the predicate device's performance.
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:
The ground truth for this submission is the established safety and performance characteristics of the legally marketed predicate device (Stryker SERFAS Energy Probes). Medline ReNewal's reprocessed devices are evaluated against these known characteristics to demonstrate "substantial equivalence." This includes:
- Engineering specifications and operational parameters of the original device.
- Performance in specific functional tests (e.g., electrical, suction, bending).
- Cleaning effectiveness benchmarks.
- Biocompatibility and sterilization standards.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device; therefore, there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it in this context. The "ground truth" for demonstrating substantial equivalence is based on the performance and safety of the predicate device as initially cleared by the FDA.
§ 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.