(133 days)
The packaging change which is the subject of this submission does not affect the intended uses of any of the commercially available UHMWPE components subject to the packaging change.
The components which contain UHMWPE as a bearing will be packaged in an inert environment. The packaging method will reduce the oxygen content within the package, thereby retarding oxidation.
The devices which are subject to the proposed packaging change are Osteonics implants which contain UHMWPE as a bearing. These devices all have their own, previously established 510(k) clearances. This 510(k) does not address any changes to any component or its device description; it addresses only a change to the way that the devices will be packaged.
As before, Osteonics' UHMWPE devices will continue to be packaged according to the previously featured "double blister" style method. However, in order to create an inert environment, the component packages will be flushed with Nitrogen and then vacuum sealed. This "N,/Vac" feature requires the following changes to the package itself:
Changes to Actual Package:
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- The current blister material is replaced with a less gas-permeable material.
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- The current lid stock is replaced with a less gas-permeable lid stock.
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- The inner/outer blister assembly will be placed within a pouch, adding another gas transmission barrier to the final package.
The proposed change in Osteonics' packaging does not affect the device sterility. The sealed inner and outer packaging blisters meet the same package and seal requirements as the traditional Osteonics' packaging. The radiation dose required for sterility is not affected by the new packaging materials, and the sterility assurance level (SAL) of 106 remains unchanged.
This 510(k) submission (K955944) is for a change in packaging for existing Osteonics' UHMWPE components, moving from standard room air packaging to a Nitrogen flush/vacuum sealing process. The goal of this change is to reduce oxygen content within the package, thereby retarding oxidation of the UHMWPE components.
Based on the provided document, there is no acceptance criteria or study that proves device performance in the context of an AI/ML device. This submission is for a packaging change for a physical medical device (UHMWPE components), not an AI-powered diagnostic or therapeutic tool. Therefore, the questions related to AI/ML device performance, sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable to this 510(k) summary.
The document primarily focuses on demonstrating that the new packaging method does not negatively impact the sterility or intended use of the previously cleared UHMWPE components. It achieves this by comparing the new packaging materials and process to existing packaging standards and methods used by other manufacturers.
Here's a breakdown of the relevant information provided, adapted to the context of a packaging change:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is for a packaging change, "device performance" in this context would relate to the packaging's ability to maintain an inert environment and sterility, and the UHMWPE components maintaining their characteristics. The document doesn't explicitly state numerical acceptance criteria in a table, but it implies the following:
| Acceptance Criteria (Implied for Packaging) | Reported Performance (Implied from Submission) |
|---|---|
| Maintain original device sterility (SAL of 10-6) | New packaging materials and process (N2/Vac) are stated to meet the same package and seal requirements as traditional Osteonics' packaging. Radiation dose for sterility is unaffected, and SAL of 10-6 remains unchanged. |
| Reduce oxygen content within the package to retard oxidation of UHMWPE components | Packaging method will reduce oxygen content within the package, thereby retarding oxidation. |
| Not affect intended uses of the UHMWPE components | The packaging change does not affect the intended uses of any of the commercially available UHMWPE components. |
| Packaging materials less gas-permeable than previous materials | Current blister and lid stock replaced with less gas-permeable materials. An additional gas transmission barrier is added (pouch). |
| Equivalence to predicate devices/packaging | Devices packaged under N2/Vac process are substantially equivalent to devices packaged under standard room air conditions and other orthopedic implant packaging methods (reference K934060, K936292, K9940743). |
2. Sample size used for the test set and the data provenance: Not applicable. This is not a study involving a "test set" of data for an AI/ML device. The "test" in this context would likely involve physical testing of the packaging integrity, gas permeation, and sterility, which is not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" establishment in the context of expert review for an AI/ML device. Decisions are based on material science and engineering principles related to packaging and sterilization.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/ML device analysis. The "truth" here is established through material science testing, sterilization validation, and comparison to regulatory standards and predicate devices.
8. The sample size for the training set: Not applicable. There is no "training set."
9. How the ground truth for the training set was established: Not applicable. There is no "training set" or corresponding ground truth.
In summary, the provided document describes a regulatory submission for a packaging change, leveraging established principles of material science and sterilization, rather than presenting a performance study for an AI/ML diagnostic or therapeutic 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.”