(29 days)
The OSS bodies are indicated for cemented use only in cases of:
- Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved
- Correction of varus, valgus, functional or post traumatic deformity
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
- Ligament deficiencies
- Tumor resections
- Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
- Trauma
- Revision of previously failed total joint arthroplasty
The Orthopedic Salvage System- OSS offers a variety of component options for the treatment of patients that require proximal femoral, total femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibial and distal femur. These devices are single use implants. These devices are for cemented use only.
The provided text describes a 510(k) premarket notification for the Orthopedic Salvage System - OSS. It explicitly states that clinical testing was not required for the predicate device, and therefore, this submission contains no clinical testing.
This means that the type of study described in your request (one that proves the device meets acceptance criteria) was not performed. Instead, the device's substantial equivalence to a legally marketed predicate device (Orthopedic Salvage System- OSS, K002757) was established through non-clinical testing.
Here's a breakdown of the requested information based on the provided text, highlighting where data is unavailable due to the lack of clinical testing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as this was not a clinical performance study. The implied acceptance criterion for this 510(k) submission was "substantial equivalence" to the predicate device based on design, intended use, contraindications, and design specifications.
- Reported Device Performance:
- Non-Clinical Testing: An engineering analysis was performed on the modified and predicate devices comparing their profiles.
- Results: "The results indicated that the device was functional within its intended use."
| Criteria Type | Acceptance Criteria | Reported Device Performance (from Non-Clinical Testing) |
|---|---|---|
| Functional Design | Implied: Similar or identical designs, intended use, contraindications, and design specifications to predicate device (K002757). Functionality within intended use. | Engineering analysis compared profiles of modified and predicate devices. Results indicated the device was functional within its intended use. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. No clinical test set was used. The non-clinical engineering analysis would involve comparing design specifications and potentially physical prototypes/CAD models.
- Data Provenance: Not applicable. No clinical data.
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)
- Not applicable. No clinical test set or ground truth established by experts as part of a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set.
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
- No. This device is an orthopedic implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is an orthopedic implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For the non-clinical engineering analysis, "ground truth" would be established by engineering principles and design specifications, rather than clinical outcomes or pathology.
8. The sample size for the training set
- Not applicable. No clinical training set.
9. How the ground truth for the training set was established
- Not applicable. No clinical training set.
Summary based on the provided text:
The submission for the Orthopedic Salvage System - OSS (K052685) did not include any clinical testing to prove it met specific acceptance criteria. Instead, it relied on a non-clinical "engineering analysis" that compared the modified device to a legally marketed predicate device (K002757). The results of this analysis indicated that the device was "functional within its intended use," which supported the claim of substantial equivalence. This approach is common for 510(k) submissions where a device is substantially equivalent to a predicate that also did not require clinical data for its initial clearance.
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.