(244 days)
Wright Plaster of Paris Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Wright Plaster of Paris Pellets are indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets provide a bone void filler that resorbs and is replaced with bone during the healing process. Because the pellets are biodegradable and biocompatible, they may be used at an infected site.
Wright Plaster of Paris Pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 days when used according to labeling. Wright Plaster of Paris Pellets are made of medical grade calcium sulfate and stearic acid (as a tableting aid).
I am sorry, but the provided text does not contain the information required to answer your request regarding the acceptance criteria and a study proving a device meets them. The text is a 510(k) summary for "Wright Plaster of Paris Pellets" and explicitly states:
"Since a determination of substantial equivalence was not based on an assessment of performance data, no performance data was submitted."
Therefore, there is no information about:
- Acceptance criteria
- Reported device performance
- Sample sizes for test sets or training sets
- Data provenance
- Ground truth establishment or type
- Number or qualifications of experts
- Adjudication methods
- MRMC studies
- Standalone algorithm performance
The document focuses on establishing substantial equivalence to a predicate device based on identical technological characteristics, rather than on performance data.
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Image /page/0/Picture/4 description: The image shows a partial view of a company logo or letterhead. The text "WRIGHT" is prominently displayed, with the words "MEDICAL TECHNOLOGY" underneath. Below that, the text "5677 AIRLINE" and "ARLINGTON, TN" are visible, suggesting an address. The phone number "901-867-99" is also present.
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
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Submitter's name: (1) Submitter's address: Submitter's telephone number: Contact person: Date summary prepared:
Wright Medical Technology, Inc. 5677 Airline Road, Arlington, Tennessee 38002 901/867-9971 Robert Churinetz May 6, 1997 -
Trade or proprietary device name: Common or usual name: Classification name:
Wright Plaster of Paris Pellets Calcium sulfate Unknown -
Legally marketed predicate device: Plaster of Paris Pellets (Ethicon)
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Subject device description: (4)
Wright Plaster of Paris Pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 days when used according to labeling. Wright Plaster of Paris Pellets are made of medical grade calcium sulfate and stearic acid (as a tableting aid).
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Subject device intended use:
Wright Plaster of Paris Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Wright Plaster of Paris Pellets are indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets provide a bone void filler that resorbs and is replaced with bone during the healing process. Because the pellets are biodegradable and biocompatible, they may be used at an infected site. -
Technological characteristics: (6)
The new device and the predicate device as described in (a) (3) are identical. In summary, the subject device has the same technological characteristics (i.e., design, material, and chemical composition) when compared to the predicate device.
(b) Performance data
Since a determination of substantial equivalence was not based on an assessment of performance data, no performance data was submitted.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.