HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER by LIFECORE BIOMEDICAL, INC.

HAPSET is intended for use in facial reconstructive surgery as a paste implant that will set up into a solid block implant of hydroxylapatite and medical grade calcium sulfate. This hydroxylapatite block serves to correct contour defects of facial structures such as chin, mandible, malar region, and maxilla.

Device Description

HAPSET consists of hydroxylapatite particulate which is supplied dry, in a mixing cup with medical grade calcium sulfate. The dry material is packaged with a diluent in a syringe that is used to mix with the separate hydroxylapatite/calcium sulfate. The resulting product is a paste-like plaster that is delivered with the appropriate instruments to the prepared surgical site and molded to the desired contours.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text, focusing on the "HAPSET hydroxylapatite/calcium sulfate plaster" device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative "acceptance criteria" or specific "device performance" metrics in a typical sense for a diagnostic device. The document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than meeting pre-defined performance thresholds like accuracy or sensitivity.

Instead, the "performance" described relates to biocompatibility, stability, and clinical success compared to predicate devices and established medical knowledge.

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Non-toxic, non-irritating, non-hemolytic	HAPSET has been found to be non-toxic, non-irritating, and non-hemolytic. (Compared favorably or as an improvement over toxicological profiles of other available materials.) No side effects, adverse events, or toxic symptoms reported to date (since 1991).
Effectiveness: Successful augmentation, stable, addresses particle migration drawback	Clinicians report implanted hydroxylapatite (the main component) is biocompatible, stable, and provides successful augmentation. HAPSET's plaster form stabilizes the particles and lessens particle migration by setting into a solid block, addressing a known drawback of hydroxylapatite particles.
Substantial Equivalence: Similar intended use and technological characteristics	Substantially equivalent to hydroxylapatite blocks and other facial implants (silicone, PTFE, PTFE with carbon fibers, vitreous carbon). Shares chemical equivalence with commercially distributed hydroxylapatite particles.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of a traditional "test set" for a diagnostic algorithm. The "test" here refers to clinical use and non-clinical biocompatibility testing.
- Non-clinical tests: HAPSET underwent non-clinical tests for toxicity, irritation, and hemolysis. The sample size for these in vitro or in vivo tests is not specified.
- Clinical data: References are made to "reports in the literature" and "clinicians are reporting" regarding hydroxylapatite particles. HAPSET itself has been commercially distributed since 1991, and "no side effects, adverse events or toxic symptoms have been reported to date according to Lifecore and MDR databases." This implies a large, real-world retrospective dataset of patients who have received HAPSET since 1991, but a specific "sample size" or structured "test set" as one would define for an AI algorithm is not provided.
Data Provenance:
- Non-clinical test data: Generated in a lab setting (not specified if internal or external, or country).
- Clinical literature: From scientific literature (global, various authors).
- Clinician reports: From clinical practice (global).
- Lifecore and MDR databases: Real-world post-market surveillance data, likely originating from clinical use in the US and potentially other regions where the product was marketed. This is retrospective observational data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not an AI diagnostic device where expert ground truth is established for a test set. The "ground truth" for safety and effectiveness is derived from:

Biocompatibility testing results.
Published clinical literature by various "clinicians."
Post-market surveillance (MDR databases and company records) reporting on adverse events, which implicitly validates safety and effectiveness for its intended use.

4. Adjudication Method for the Test Set

Not applicable. No formal adjudication method is mentioned for a structured test set. Clinical judgment from individual clinicians and review of post-market surveillance data are the "adjudication" methods.

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

Not applicable. This is a medical implant device, not an AI diagnostic system designed to assist human readers.

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

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

Biocompatibility: Laboratory test results (non-toxic, non-irritating, non-hemolytic).
Clinical Effectiveness/Safety:
- Expert Consensus/Clinical Observation: "Reports in the literature indicate that the use of hydroxylapatite particles for aesthetic and medical augmentation have been successful since at least 1985. Clinicians are reporting that the implanted hydroxylapatite is biocompatible, stable and provides successful augmentation."
- Outcomes Data/Post-Market Surveillance: "No side effects, adverse events or toxic symptoms have been reported to date according to Lifecore and MDR databases." This represents real-world clinical outcomes over several years.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm requiring a training set. The "training" equivalency would be the cumulative clinical experience and research on hydroxylapatite and calcium sulfate, which is vast and spans many years and patients globally, but not quantifiable as a single "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set as per AI methodology. The "ground truth" for the underlying materials (hydroxylapatite and calcium sulfate) is established through extensive scientific research, biocompatibility testing, pre-clinical studies, and decades of clinical use and observation documented in medical literature and regulatory databases.

Summary

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K961511

510 (k) SUMMARY

JUN 2 8 1996

1.1 Manufacturer's Name:

Lifecore Biomedical Inc. 3515 Lyman Blvd. Chaska, MN 55318

I C A L

(612) 368-4300 (612)368-3411 - FAX Contact Person: Lynn Cuperus

Date Prepared: April 8, 1996 1.2

1-3 Device Name: HAPSET hydroxylapatite/calcium sulfate plaster

1.4 Common Name: Prosthesis, Pacial augmentation implant

1.5 Classification:

Implant for cheek and chin, facial/cranial contour filling and bone augmentation for use with oralmaxillofacial fracture reduction procedures.

1.6 Substantially Equivalent Devices:

Prosthesis, Chin, Internal Implantech Interpore Vitek

Mesh, Surgical, Polymeric Davol Ethicon Gambro W.L. Gore and Associates Prosthesis, PTFE/Carbon Fiber vitek Polytetrafluoroethylene Vitreous Carbon Materials for Maxillofacial Reconstruction Biomet Kimberly-Clark Deminieralized Bone Graft products Grafton Tissue Bank sources

3 5 1 5 - 5 6 1 2 - 3 6 - 6 1 2 - 3 6 - 6 1 2 - 3 6 - 3 0 5 1 - U S A 612 - 3 6 8 - 4 3 0 0 F A X : 6 1 2 - 3 6 8 - 3 4 1 1

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Kabisii 2.43

1.7 Device Description

HAPSET consists of hydroxylapatite particulate which 15 supplied dry, in a mixing cup with medical grade calcium The dry material is packaged with a diluent in a sulfate. syringe that -İs used to mix with the separate hydroxylapatite/calcium sulfate. The resulting product is a paste-like plaster that is delivered with the appropriate instruments to the prepared surgical site and molded to the desired contours.

1.8 Intonded Use:

1.9 Technological Characteristics:
HAPSET is manufactured, from hydroxylapatite particles and medical grade calcium sulfate. The hydroxylapatite particles chemically equivalent to the hydroxylapatite blocks are commercially distributed for the same intended use. other substantially equivalent devices with the same intended use are manufactured from materials such as silicone, PTFE, PTFE with carbon fibers, and vitreous carbon. Hydroxylapatite and medical grade calcium sulfate are known to be biocompatible and non-toxic which is an advantage over some of the other materials currently available.
1.10 Nonclinical Test:
HAPSET has been found to be non-toxic, non-irritating, and This is the same or an improvement over the non-hemolytic. toxicological profiles of the other material available for this intended use.

1.11 Clinical Test:

Reports ជួ the literature indicate that the use or hydroxylapatite particles for aesthetic and medical augmentation have been successful since at least 1985. Clinicians are reporting that the implanted hydroxylapatite is biocompatible, stable and provides successful augmentation. The only reported drawback of the hydroxylapatite particles has been migration of the particles. HAPSET, in its plaster form, stabilize the particles and lessen the opportunity for particle migration by the setting of the implant into a solid block implant.

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K961511 3 of3

Further, HAPSET has been commercially distributed by Lifecore since 1991, cleared for marketing by 510(k) K910432. No side effects, adverse events or toxic symptoms have been reported to date according to Lifecore and MDR databases. The HA-500 portion of HA is commercially marketed under 510(k) K842163 and K852766. Calcium Sulfate is marketed under the trade name CAPSET and was cleared to market via K943186 and K955096. All of these related devices have been shown in the medical industry to be non-toxic, safe and effective for the intended use on the product labeling.

1.12 Conclusions:
HAPSET, when used according to labeled directions, provides an implant that is substantially equivalent to hydroxylapatite blocks and other facial implants as noted. It İs biocompatible and has demonstrated clinical safety and effectiveness for the same intended use as the gurrent labeling applications listed. HAPSET use is being expanded for indications that include augmentation of the '

chin or cheek defects such as those created during autogenous bone grafting, and fracture reduction.

095

Regulation Number and Section

§ 878.3550 Chin prosthesis.

(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.