(85 days)
The Reprocessed Linvatec shavers and burs are intended for use with the Linvatec Integrated Drive/Pump System to perform resection of soft tissue and bone. The fields of application include Otolaryngology, Neurological Surgical, Orthopedic, and Spinal surgical procedures.
The Reprocessed Smith & Nephew shavers and burs are intended for use with the Smith & Nephew DYONICS Power II Shaver System control unit, for resection of soft and osseous tissues including but not limited to, use in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS application is limited to those small blades which are appropriate for the procedure.
The Reprocessed Styker Shavers and Burs are intended for use with the Styker Total Performance System Shaver handpiece and the Stryker Total Performance System by surgeons in the following orthopedic joints:
Knee
Shoulder
Ankle
Elbow
Wrist
Hip
Temporamandibular
The Reprocessed Styker Shavers and Burs 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 Reprocessed Shavers and Burs are intended to be used for arthroscopic and laparoscopic surgical techniques. Shavers have sharp rotating inner blades housed in an outer shaft designed to cut tissue. Burs have an abrasive wearing surface that rotate in an outer sheath to grind down bone. The housing has a window cut out on one side of the distal end, allowing the bur to cut one part of the intended anatomy, while the adjacent one is still protected by the housing on the opposite side of the abrader, bur or blade. There are various configurations of diameter, length, and cutting or grinding surfaces. The materials of construction are generally: metal shafts, lubricants (between the inner and outer components to reduce friction and heat), and polymer hubs bonded to the shafts. The polymer hub connects to a user-supplied motorized hand piece, which drives the internal abrader, bur or blade inside the outer housing. The handpiece provides suction to remove tissue which has been cut during the surgical procedure.
There are 39 Stryker shavers and 33 Stryker burs included in this submission. The Stryker shavers and burs are used with the Total Performance System Shaver handpiece is made of a motor housing with a coupling mechanism to secure the shavers/burs to the handpiece.
There are 31 Smith & Nephew shavers and 32 Smith & Nephew burs included in this submission. The Smith & Nephew shavers and burs are intended to be used with the Smith & Nephew DYONICS Power II Shaver System control unit. This system is compatible with DYONICS POWER handpieces.
There are 94 ConMed/Linvatec shavers and 26 ConMed/Linvatec burs included in this submission. The Linvatec shavers and burs are intended to be used with the Linvatec Integrated Drive/Pump system. The system has three different handpieces that ca be used for otolaryngology, neurological surgical, orthopedic, and spinal procedures.
Here's a breakdown of the acceptance criteria and study information based on the provided text, extracting what is available and noting what is not mentioned.
Acceptance Criteria and Study Information for Reprocessed Shavers/Burs
Note: The provided document is a 510(k) summary for ReNovo, Inc.'s Reprocessed Shavers/Burs. It focuses on demonstrating substantial equivalence to predicate devices, which means proving the reprocessed devices perform as safely and effectively as new OEM devices. Therefore, the "acceptance criteria" here refer to the performance benchmarks set against the new OEM devices, and the "study" is the comparison testing performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Specific Test | Acceptance Criteria (against new OEM device) | Reported Device Performance (Reprocessed Device) |
|---|---|---|---|
| Functional Testing | Sharpness (Shavers/Burs) | Performed equivalently to new OEM device | Performed equivalently to new OEM device |
| Bending (Shavers/Burs) | Performed equivalently to new OEM device | Performed equivalently to new OEM device | |
| Drop Testing | Performed equivalently to new OEM device | Performed equivalently to new OEM device | |
| Cleaning Validation | Residual Protein and Carbohydrates | As clean as a new OEM device | Cleaned to the condition of a new OEM device |
| Visual Inspection | Clean (absence of visible residues) | Met visual inspection criteria | |
| Cleaning Performance Qualification | Met qualification standards | Met qualification standards | |
| Biocompatibility | Cytotoxicity | Met ISO 10993 standards | Met ISO 10993 standards |
| (General statement - | Irritation | Met ISO 10993 standards | Met ISO 10993 standards |
| specific results not | Acute Systemic Toxicity | Met ISO 10993 standards | Met ISO 10993 standards |
| detailed) | Material Mediated Pyrogenicity | Met ISO 10993 standards | Met ISO 10993 standards |
| Sensitization | Met ISO 10993 standards | Met ISO 10993 standards | |
| Product Stability | Shelf Life Testing (Accelerated Aging) | 1-Year shelf life maintained (equivalence to OEM) | Demonstrated 1-year shelf life |
| Sterilization & Packaging | EtO Sterilization Validation | Validated for sterility | Validated as sterile |
| EtO Residuals Testing | Met allowable residual limits | Met allowable residual limits | |
| Simulated Shipment Testing | Maintained device integrity and sterility | Maintained device integrity and sterility |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not explicitly state the numerical sample size for the test set used for performance testing (e.g., how many reprocessed shavers/burs of each type were tested). It only states that "side-by-side testing of the reprocessed devices to an identical new OEM device" was performed, and this testing was done "after three reprocessing cycles."
- Data Provenance: The data comes from benchtop performance testing conducted by ReNovo, Inc. (the submitter). The country of origin for the data is USA. The study is not retrospective or prospective in the clinical sense, as it is a benchtop comparison study, not a study involving patient data.
3. Number of Experts and Qualifications for Ground Truth
- Ground Truth for Test Set: This is not applicable in the context of this 510(k) summary. The "ground truth" for these reprocessed medical devices is their performance equivalence to new OEM devices. There are no "experts" establishing a "ground truth" for patient-specific data or diagnostic interpretations. The assessment is based on quantifiable engineering and biological performance metrics compared against the predicate device.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable. The tests performed are objective, quantitative measurements (e.g., sharpness, bending properties, chemical residue levels, sterility). There is no subjective interpretation requiring an adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive AI systems involving human readers and clinical cases, not for the performance validation of reprocessed surgical instruments.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study: No, a standalone performance study (algorithm only) was not done. This is not an AI/algorithm-driven device. The "device" here refers to the physical reprocessed surgical instruments.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" here is the performance of new, original equipment manufacturer (OEM) devices. The reprocessed devices are compared directly against these new OEM devices across various functional, cleaning, and material characteristics to establish substantial equivalence.
8. Sample Size for Training Set
- Training Set Sample Size: Not applicable. This document describes the validation of reprocessed physical medical devices, not an AI or machine learning model that would require a training set.
9. How Ground Truth for Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML model for these devices.
§ 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.