(77 days)
The Tecomet Global Unite Short Stem Instrumentation (GUSS) are intended to be used to implant the DePuy GLOBAL UNITE Shoulder System Short Stem Shoulder, in accordance with its cleared indications for use and contraindications.
The Tecomet Global Unite Short Stem Instrumentation (GUSS) is intended only for use as surgical instrumentation for the DePuy GLOBAL UNITE Shoulder System Short Stem Shoulder. Tecomet manufactures this instrumentation exclusively for DePuy. The instrumentation is intended to be used with the GLOBAL UNITE Short Stem Shoulder System which was cleared separately under premarket notification K202098 (K202098 did not include instruments). The Tecomet GUSS instruments are a combination of Class I General Use Instruments, Class II Short Stem Shoulder-specific instruments and a Class II Sterilization Tray. The instruments include Humeral Stem Brosteotomes in 8mm-16mm sizes, a Stem Wrench, 155° Proximal Reaming Guides, 145° Proximal Reaming Guides, Bullet Tip Reamers and a sterilization tray. Although the tray is included in the system, it is not the subject of this premarket notification. The tray is already cleared by the Tecomet (Symmetry Medical) 510(k) K012105 (Polyvac Surgical Instrument Delivery System).
The Tecomet Global Unite Short Stem Instrumentation (GUSS) is all manufactured from 17-4 PH SST Stainless Steel. The instruments are exclusively for, and must be used in accordance with the DePuy GLOBAL UNITE Platform Anatomic and Reverse Shoulder Surgical Technique. The devices are reusable and must be sterilized by the user prior to use.
Here's a breakdown of the acceptance criteria and study information for the Tecomet Global Unite Short Stem Instrumentation, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Type of Testing | Acceptance Criteria | Reported Device Performance/Result |
|---|---|---|
| Pre-vacuum sterilization efficacy | 10⁻⁶ SAL (Sterility Assurance Level) | PASSED |
| Pre-vacuum dry time (3 minutes) | Establish Minimum Dry Time (specific time not explicitly stated as acceptance criteria, but as a goal) | 40 minutes |
| Pre-vacuum dry time (4 minutes) | Establish Minimum Dry Time (specific time not explicitly stated as acceptance criteria, but as a goal) | 40 minutes |
| Design Validation | Acceptable performance for reverse and anatomic shoulder preparation | PASSED |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the sterilization efficacy, dry time, or design validation testing. Specifically:
- Sterilization and Dry Time: No sample size is mentioned for these tests.
- Design Validation: "N/A design validation cadaver testing" is mentioned, implying cadavers were used, but the quantity is not specified.
- Data Provenance: The document does not provide information on the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
- The document does not provide information on the number of experts used or their qualifications for establishing ground truth for any of the tests.
4. Adjudication Method
- The document does not specify any adjudication method for the test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This device is surgical instrumentation, not an AI or imaging diagnostic tool that would typically involve human readers.
6. Standalone (Algorithm Only) Performance
- This question is not applicable. The device is surgical instrumentation, not an algorithm or software.
7. Type of Ground Truth Used
- Sterilization Efficacy: The ground truth is the demonstration of a 10⁻⁶ SAL, which is a microbiological standard.
- Pre-vacuum Dry Time: The ground truth is the established minimum dry time achieved necessary for effective sterilization.
- Design Validation: The ground truth is "acceptable performance" during cadaver testing, likely assessed by surgeons or qualified personnel evaluating the functionality and usability of the instruments in a simulated surgical environment.
8. Sample Size for the Training Set
- This question is not applicable as the device is surgical instrumentation and does not involve a training set as would be found in machine learning models.
9. How Ground Truth for the Training Set Was Established
- This question is not applicable as there is no training set for this type of device.
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”