(85 days)
The S-ROM Femoral Hip Stem - Sizes 12 x 06 x 115 and 12 x 07 x 115 is intended for non-cemented fixation as the femoral component of a total hip replacement system. The stems are indicated for use in primary and revision replacement surgery. The prosthesis may be used for the following conditions, as appropriate:
- Osteoarthritis; .
- . Traumatic Fractures;
- . Rheumatoid Arthritis;
- Avascular Necrosis; and .
- Congenital Dislocation. .
The S-ROM Femoral Hip Stems (Sizes 12 x 06 x 115 and 12 x 07 x 115) are manufactured from Ti-6Al-4V, the same material used to manufacture the S-ROM femoral hip stems in the larger sizes and that has been used in orthopaedic implants for many years with established clinical success. The S-ROM Femoral Hip Stems are anatomically shaped with flutes and a coronal slot in the distal portion of the stem. The size 12 x 06 x 115 and 12 x 07 x 115 stems, as well as the larger size S-ROM femoral hip stems, can be used in either the right or left hip.
This 510(k) summary (K9619399) describes the S-ROM® Total Hip System, specifically the S-ROM® Femoral Hip Stems - Sizes 12 x 06 x 115 and 12 x 07 x 115. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and outcome metrics for a novel AI/software device.
Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or cannot be extracted from this document, as it pertains to a physical medical device (a hip stem) and its substantial equivalence to existing devices.
The document primarily addresses the substantial equivalence of the new hip stem sizes to previously cleared S-ROM Femoral Hip Stems and other hip prostheses based on materials, intended use, design, manufacturing, packaging, and sterilization. It also references mechanical testing.
Here's an attempt to answer the questions based on the provided text, while acknowledging the inherent limitations due to the nature of the submission:
1. A table of acceptance criteria and the reported device performance
For this type of device (femoral hip stem), acceptance criteria are typically related to mechanical properties, biocompatibility, and substantial equivalence to predicate devices. The document does not provide a specific table of acceptance criteria with numerical performance targets and reported results in the way one would expect for an AI/software device measuring diagnostic accuracy.
Instead, the "performance" is implicitly demonstrated through:
- Substantial Equivalence: The primary "performance" metric here is the assertion that the new sizes are substantially equivalent to already marketed and cleared hip prostheses. This means they are expected to perform similarly to those predicate devices.
- Material Compatibility: "composed of the same materials as similar stems marketed in the United States."
- Design & Manufacture: "intended use, design, and manufacture... are substantially equivalent to currently distributed hip stems."
- Sterilization: "packaging and method of sterilization are currently utilized for other S-ROM stems, as well as other stems currently distributed in the United States."
- Mechanical Testing: "Testing was conducted per the FDA's Draft Guidance Document for Femoral Stem Prostheses, in accordance with ISO 7206-4." This indicates mechanical integrity testing was performed, but specific acceptance criteria (e.g., fatigue strength minimums) and detailed results are not provided in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is a physical medical device submission demonstrating substantial equivalence, not a study involving a "test set" of patient data for an algorithm. The "test" mentioned refers to mechanical testing of the physical stems.
3. 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)
This information is not applicable. There is no "ground truth" derived from expert consensus on patient data described in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is 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
There was no MRMC comparative effectiveness study described as this is a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. There is no algorithm or software device described.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable. The "truth" for this submission is established through comparisons to predicate devices (substantial equivalence) and adherence to recognized mechanical testing standards (ISO 7206-4).
8. The sample size for the training set
This information is not applicable. There is no training set for an algorithm described.
9. How the ground truth for the training set was established
This information is not applicable. There is no training set for an algorithm described.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.