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Reprocessed Arthroscopic Shavers are intended for resecting tissue and bone found in articular body cavities during orthopedic, maxillofacial, hand, foot and plastic surgery in patients requiring arthroscopic or orthopedic surgery.

Reprocessed Arthroscopic Burs are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.

Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses.

The arthroscopic shaver components reprocessed by Alliance Medical Corporation include a Bur or blade at the end of a long rod that rotates within a long hollow stain- less steel housing. The housing has a window cut out on one side of the distal end, allowing the Bur to cut one structure while the adjacent one is still protected by the housing on the opposite side of the bur on blade. This system attaches to a motorized handpiece that drives the internal bur or blade inside the outer housing and provides suction to pull the cut tissue away from the surgical site

The provided document K012652 is a 510(k) summary for "Reprocessed Arthroscopic Burs" and does not describe an AI/ML device. Therefore, it does not contain information related to acceptance criteria or studies proving device performance typical for AI/ML devices, such as those involving sensitivity, specificity, or human expert performance.

Specifically, the document focuses on demonstrating substantial equivalence of reprocessed medical devices to predicate devices. The performance data mentioned relates to:

• Biocompatibility
• Validation of reprocessing
• Function Test(s)

The conclusion states that performance testing demonstrates that Reprocessed Arthroscopic Burs perform as originally intended, implying that they meet the same performance standards as new, unreprocessed devices, which are the predicate devices.

Since this is not an AI/ML device submission, the requested information elements such as a table of acceptance criteria vs. reported AI performance, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable and are not present in the provided text.

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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.

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:

1. 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.
2. 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.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
8. 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.

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