(59 days)
Total Performance System Shaver handpiece is intended to be used in conjunction with the Stryker Total Performance System by surgeons in the following orthopedic joints:
Knee
Shoulder
Ankle
Elbow
Wrist
Hip
Temporamandibular.
The Total Performance System Shaver Handpiece will be used to resect tissue and bur bone.
Examples of uses of the product would include resection of torn knee cartilage, subacromial decompression and resection of synovial tissue in other joints.
The Total Performance System Shaver handpiece, constructed of a motor housing with a coupling mechanism for securing cutters and burs to the handpiece, valve for suction control, tapered fitting for attaching suction tubing to the handpiece and cable for connecting the shaver to the TPS is equivalent in intended use, safety and effectiveness to existing shaver marketed by Smith & Nephew Dyonics per 510(k)953096.
The provided document is a 510(k) premarket notification for a medical device (Stryker Total Performance System Shaver). This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a study in the same way a new, novel device might.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, especially related to AI-driven performance metrics, ground truth, and expert evaluation, is not applicable to this document. The document describes a comparison study to a predicate device rather than a performance study against predefined objective criteria.
However, I can extract the information relevant to this specific type of submission:
Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence Claim)
For this 510(k) submission, the "acceptance criteria" are effectively the demonstration of substantial equivalence to a legally marketed predicate device. The "device performance" is established by showing that the new device has "equivalent intended use, safety and effectiveness" and does not raise "any new safety and efficacy concerns" compared to the predicate.
| Acceptance Criteria (Demonstrated) | Reported Device Performance (Claimed) |
|---|---|
| Intended Use Equivalence | The Total Performance System Shaver handpiece is intended to be used in conjunction with the Stryker Total Performance System by surgeons in orthopedic joints (Knee, Shoulder, Ankle, Elbow, Wrist, Hip, Temporomandibular) to resect tissue and bur bone, which is equivalent to the predicate. |
| Safety and Effectiveness Equivalence | The device is equivalent in safety and effectiveness to the Smith & Nephew Dyonics EP-1 Shaver (510(k) 953096). Power modality, intended use, mode of operation, cutting technique, methods of sterilization, and safety risks are substantially equivalent. |
| No New Safety/Efficacy Concerns | The Stryker Total Performance System Shaver does not raise any new safety and efficacy concerns when compared to the Dyonics device. |
| Packaging Validation | Validated per ASTM standards 4169, D999, D775, F88, D3078. |
| Electrical Safety Validation | Validated per IEC 601-1 and IEC 601-1-2. |
| Material/Construction Equivalence | Constructed of a motor housing with a coupling mechanism for securing cutters and burs, valve for suction control, tapered fitting for attaching suction tubing, and cable for connecting to the TPS, consistent with existing marketed shavers. |
| Technological Equivalence | The powered instrumentation technology utilized in this device is equivalent to existing marketed products; it does not introduce new technological characteristics that raise new questions of safety or effectiveness. |
Since this is a substantial equivalence claim for a mechanical surgical device from 1997, the following points are largely not applicable as they relate to modern AI/software device evaluation:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. There isn't a "test set" in the context of AI performance evaluation. The substantial equivalence relies on comparison of design, materials, technological characteristics, and intended use against a predicate.
- 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. There is no "ground truth" establishment in the AI sense.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 a mechanical surgical shaver, not an AI diagnostic/interpretive tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of the "Study" (Comparison for Substantial Equivalence):
The "study" in this context is the company's analysis and comparison of its Total Performance System Shaver Handpiece to the predicate device, the Smith & Nephew Dyonics EP-1 Shaver (510(k) 953096). This is a retrospective comparison based on existing market data, regulatory filings, and technical specifications of the predicate device, along with internal testing of the new device against relevant industry standards.
- Comparison Basis: The Stryker shaver was compared to the predicate device based on:
- Intended Use
- Power Modality
- Mode of Operation
- Cutting Technique
- Methods of Sterilization
- Safety Risks
- Construction and Components
- Technological Equivalence
- Safety Testing:
- Packaging: Validated per ASTM standards 4169, D999, D775, F88, D3078.
- Electrical Safety: Validated per IEC 601-1 and IEC 601-1-2.
The conclusion of this comparison was that the Stryker Total Performance System Shaver is substantially equivalent to the Smith & Nephew Dyonics EP-1 Shaver, meaning it is considered equally safe and effective for its intended use.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.