(77 days)
The Burch/Schneider Reinforcement Cage is intended to bridge the areas of acetabular bone loss in patients with acetabular bone deficiency. In addition, the Burch/Schneider Reinforcement Cage, like the predicate devices, is intended to provide support for an all polyethylene acetabular implant in a cemented application.
Diagnostic indications for use of this device include, but are not limited to, acetabular dysplasia, osteoporosis, protrusio acetabuli, cystic acetabular roof, reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery.
The general indications associated with the use of Burch/Schneider Reinforcement Cage in total hip arthroplasty include:
- Advanced joint destruction resulting from degenerative, posttraumatic or rheumatoid arthritis,
- Fracture or avascular necrosis of the femoral head,
- Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty and total hip replacement.
The Burch/Schneider Reinforcement Cage is a modified version of the preamendment H.B. Burch Anti-Protrusio Reinforcement Cage, manufactured by Protek AG (now consolidated into Sulzer Orthopedics Limited), that has been in commercial distribution in the United States prior to 1976.
The Burch/Schneider Reinforcement Cage will be manufactured from either stainless steel (AISI 316L) or commercially pure (CP) Titanium (International Organization for Standards (ISO) 5832-2). The design of the Burch/Schneider Reinforcement Cage include the following:
- a dome area with a dome hole and screwholes.
- a superior flange employing screwholes for the optional attachment to the ilium.
- an inferior flange employing screwholes for the optional attachment to the ischium,
- available in thickness of 2.0 (+0.0. -0.3)mm
This 510(k) Premarket Notification Summary for the Burch/Schneider Reinforcement Cage does not contain information typically found in medical device studies with acceptance criteria and performance data. This document is a product approval application based on substantial equivalence to predicate devices, not a study report. Therefore, I cannot provide most of the requested information.
Here's what can be inferred and what is not available from the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting specific acceptance criteria for a new study and its performance results.
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 available. No test set is described.
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 available. No test set or ground truth establishment process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available. No test set or adjudication process is described.
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
This information is not available. The device is a physical reinforcement cage, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study with AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not available. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available. No specific study with ground truth is described. The basis for approval is substantial equivalence to pre-existing devices.
8. The sample size for the training set
This information is not available. No training set is described.
9. How the ground truth for the training set was established
This information is not available. No training set or ground truth establishment process is described.
Summary based on available information:
The provided document describes a medical device (Burch/Schneider Reinforcement Cage) seeking 510(k) clearance based on its substantial equivalence to previously marketed predicate devices. It does not contain primary clinical study data, acceptance criteria, or performance metrics in the way one would expect for a diagnostic or AI-based device. The "study" mentioned is implicitly the comparison of characteristics to predicate devices.
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510(k) Premarket Notification Summary of Safety and Effectiveness for Burch/Schneider Reinforcement Cage
MAY - 3 1996
In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a 510(k) Summary for the Burch/Schneider Reinforcement Cage.
| Submitter: | Intermedics Orthopedics, Inc.9900 Spectrum DriveAustin, Texas, 78717Tel.: (512) 432-9900Fax: (512) 432-9291 | ||
|---|---|---|---|
| Contact Person: | Regarding this submission:Name: Sam MirzaTel.: 512-432-9751Fax: 512-432-9291 | ||
| Official CorrespondentName: Jacquelyn HughesTel.: 512-432-9687Fax.: 512-432-9291 | |||
| Date: | February 15, 1996 | ||
| Proprietary name | Burch/Schneider Reinforcement Cage | ||
| Common Name: | Acetabular reinforcement cage | ||
| Classification name: | Prosthesis, Hip, Semi-constrained, Metal/Polymer, Cemented(21CFR 888.3350). Class 2 | ||
| Predicate Devices: | The features employed by Burch/Schneider Reinforcement Cage are substantially equivalent to the features employed by the following predicate legally marketed devices: | ||
| ► Preamendment H.B. Burch Anti-Protrusio Reinforcement cage: Sulzer Orthopedics Limited (Preamendment Status) | |||
| ► Acetabular Roof Reinforcement Ring: Sulzer Orthopedics Limited (510(k) number K953578) | |||
| ► Anti-Protrusio Reinforcement cage: Depuy Inc. (510(k) number unknown to IOI). | |||
| Device Description: | The Burch/Schneider Reinforcement Cage is a modified version of the preamendment H.B. Burch Anti-Protrusio Reinforcement Cage, manufactured by Protek AG (now consolidated into Sulzer |
Burch/Schneider Reinforcement Cage Summary of Safety and Effectiveness Page SSE1
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Orthopedics Limited), that has been in commercial distribution in the United States prior to 1976.
The Burch/Schneider Reinforcement Cage will be manufactured from either stainless steel (AISI 316L) or commercially pure (CP) Titanium (International Organization for Standards (ISO) 5832-2). The design of the Burch/Schneider Reinforcement Cage include the following:
- a dome area with a dome hole and screwholes. ♪
-
a superior flange employing screwholes for the optional attachment to the ilium.
- ♪ an inferior flange employing screwholes for the optional attachment to the ischium,
- ♪ available in thickness of 2.0 (+0.0. -0.3)mm
The Burch/Schneider Reinforcement Cage is intended to bridge Intended Use: the areas of acetabular bone loss in patients with acetabular bone In addition, the Burch/Schneider Reinforcement deficiency. Cage, like the predicate devices, is intended to provide support for an all polyethylene acetabular implant in a cemented application.
Diagnostic indications for use of this device include, but are not limited to, acetabular dysplasia, osteoporosis, protrusio acetabuli, cystic acetabular roof, reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery.
The general indications associated with the use of Burch/Schneider Reinforcement Cage in total hip arthroplasty include:
-
- Advanced joint destruction resulting from degenerative, posttraumatic or rheumatoid arthritis,
-
- Fracture or avascular necrosis of the femoral head,
-
- Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty and total hip replacement.
Summary of Technological Characteristics:
Substantial equivalence determination for the Burch/Schneider Reinforcement Cage is based upon the comparison of the subject device to the following legally marketed predicate Sulzer Orthopedics Limited and competitive devices:
- ♪ Preamendment H.B. Burch Anti-Protrusio Reinforcement Cage: Sulzer Orthopedics Limited (Preamendment Status)
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- Acetabular Roof Reinforcement Ring: Sulzer Orthopedics ♪ Limited (510(k) number K953578)
- Anti-Protrusio Reinforcement cage: Depuy Inc. (510(k) ♪ number unknown to IOI)
The characteristics of the Burch/Schneider Reinforcement Cage, either alone or in combination, are substantially equivalent to the aforementioned predicate devices in terms of materials, intended use, and design characteristics. A side by side tabular comparison of the characteristics of the Burch/Schneider Reinforcement Cage to those of the predicate devices follows:
| Subject Device | Predicate Devices | |||
|---|---|---|---|---|
| Characteristics | Burch/SchneiderReinforcementCage | H.B. BurchAnti-ProtrusioReinforcementCage | Anti-ProtrusioReinforcementCage | AcetabularRoofReinforcementRing |
| Manufacturer | SulzerOrthopedicsLimited | SulzerOrthopedicsLimited | Depuy Inc. | SulzerOrthopedicsLimited |
| 510(k) No. | - | Preamendment | Unknown to IOI | K953578 |
| Application | Cemented | Cemented | Cemented | Cemented |
| Material | Stainless Steel orCP Titanium | Stainless Steel | Stainless Steel | CP Titanium |
| Superior Flange | Yes | Yes | Yes | No |
| Inferior Flange | Yes | Yes | Yes | No |
| Screwholes | Yes | Yes | Yes | Yes |
| Sterile | Yes | No | Unknown to IOI | Yes |
| Sizes | 44 and 50mmLeft/Right | 44 and 50mmLeft/Right | 44 and 50mmLeft/Right | Diameters 36 -58mm (2mmIncrements) |
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§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular 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.