Search Results

Wright Plaster of Paris Pellets are intended to be gently packed into non-loadbearing long bone voids. These bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The Wright Plaster of Paris Pellets provide a bone filler that resorbs and is replaced with bone during the healing process.

Wright Plaster of Paris Pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in 30 to 60 days when used according to labeling. Wright Plaster of Paris Pellets are 0.1g each and are supplied in pouches of 100 pellets.

This document, K960978, is a 510(k) Summary of Safety and Efficacy for Wright Plaster of Paris Pellets, submitted in 1996. It is a regulatory pre-market submission to demonstrate that the device is as safe and effective as a legally marketed device (predicate device).

Based on the provided information, the document describes a chemical composition, intended use, and a single dissolution study for the Wright Plaster of Paris Pellets. It does not present a study that includes acceptance criteria and reported device performance in the context of diagnostic or classification tasks typically seen in AI/ML medical devices.

Therefore, I cannot populate the requested table and answer questions 2-9 in the format usually associated with studies for machine learning or AI device performance.

Here's why and what information related to acceptance criteria and "studies" is present:

Context of the Document:

This 510(k) summary is for a medical device (Wright Plaster of Paris Pellets) that is a physical product (bone filler), not a diagnostic or AI/ML software device. The "performance" being evaluated is related to its physical and biological properties (dissolution and resorption), not its ability to classify, detect, or predict.

Information Related to "Acceptance Criteria" and "Studies" from the Document:

1. A table of acceptance criteria and the reported device performance:

   Acceptance Criteria (Implied)	Reported Device Performance
   Biocompatibility and safety for the intended use	"Provided sterile for single patient use."
   Resorption within a specific timeframe	"Resorbed in 30 to 60 days when used according to labeling."
   Equivalent dissolution rates to the predicate device	"Dissolution studies demonstrate Wright Plaster of Paris Pellets to possess equivalent dissolution rates to the predicate device."
   Material composition meeting specifications	"Made of 98% medical grade calcium dihydrate (CaSO4 . 2H20) and 2% stearic acid."
   Radiopacity for imaging purposes	"radiopaque pellets"
   Suitability for packing into non-loadbearing long bone voids	"Intended to be gently packed into non-loadbearing long bone voids."
   Ability to be replaced by bone during healing	"provide a bone filler that resorbs and is replaced with bone during the healing process."

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 provided. The document mentions "Dissolution studies" but does not detail their methodology, sample size, or data provenance.

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 is not applicable as the studies described (dissolution studies) do not involve expert interpretation or ground truth establishment in the context of diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable for the type of studies mentioned.

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 is not applicable. The device is a physical bone filler, not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No, this is not applicable. The device is a physical bone filler, not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For the dissolution studies, the "ground truth" would likely be laboratory measurements of dissolution rates and comparison against the predicate device's measured rates. For biocompatibility and bone replacement, it would stem from preclinical (animal) or potentially clinical studies (though none are detailed here) and established biological responses.

8. The sample size for the training set:

   • Not applicable. There is no training set in the context of AI/ML for this device.

9. How the ground truth for the training set was established:

   • Not applicable as there is no training set.

Conclusion:

This 510(k) summary provides basic information about a physical medical device and one type of laboratory study (dissolution studies) to demonstrate equivalence to a predicate device. It explicitly states that "dissolution studies demonstrate Wright Plaster of Paris Pellets to possess equivalent dissolution rates to the predicate device." This would be the core "study" proving a key performance aspect for this type of product. The document does not describe studies or criteria relevant to AI/ML or diagnostic performance, which is what the detailed questions 2-9 are tailored for.

Ask a specific question about this device